Orange Book Companion
Patent Expiration View
Products whose next patent expiration occurs in Sept.-Dec. 2018

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

Products tagged as GENERIC have had a generic equivalent approved for at least one strength of the product.


LYBREL (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL
Drug Classes: estrogen; progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: WYETH PHARMS INC      NDA No.: 021864  Prod. No.: 001 DISC (0.02MG;0.09MG**)
PatentsExpirationPatented Use
Pat. No. 6500814 Hormonal contraceptive
Claim Types: Method of use
Sep 3, 2018U-1: Prevention of pregnancy

CICLOPIROX (GEL) (TOPICAL) CICLOPIROX [GENERIC AB]
NDA Applicant: CNTY LINE PHARMS      NDA No.: 020519  Prod. No.: 001 RX (0.77%)
PatentsExpirationPatented Use
Pat. No. 7018656 DP* Antimycotic gel with high active substance release
Claim Types: Formulation
Sep 5, 2018 

EXUBERA (POWDER) (INHALATION) INSULIN RECOMBINANT HUMAN
Drug Classes: insulin analog
NDA Applicant: PFIZER      NDA No.: 021868  Prod. No.: 001 DISC (1MG/INH); 002 DISC (3MG/INH)
PatentsExpirationPatented Use
Pat. No. 6685967 DP* Methods and compositions for pulmonary delivery of insulin
Claim Types: Formulation; Composition; Process
Sep 11, 2018 
Pat. No. 6257233 Dry powder dispersing apparatus and methods for their use
Claim Types: Device; Method of use
May 14, 2019U-704: Method of administering insulin via inhalation
Pat. No. 6546929 Dry powder dispersing apparatus and methods for their use
Claim Types: Device; Method of use
May 14, 2019U-704: Method of administering insulin via inhalation
Pat. No. 6582728 DP* Spray drying of macromolecules to produce inhaleable dry powders
Claim Types: Product-by-process; Process
Jun 24, 2020 

RAPAMUNE (TABLET) (ORAL) SIROLIMUS [GENERIC AB]
Drug Classes: kinase inhibitor; mTor inhibitor immunosuppressant
NDA Applicant: PF PRISM CV      NDA No.: 021110  Prod. No.: 001 RX (1MG); 002 RX (2MG); 004 RX (0.5MG) NDA No.: 021110  Prod. No.: 003 DISC (5MG**)
PatentsExpirationPatented Use
Pat. No. 5989591 DP* Rapamycin formulations for oral administration
Claim Types: Formulation; Process
Sep 11, 2018 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 28, 2022ODE-92: Treatment of lymphangioleiomyomatosis (LAM)

COMTAN (TABLET) (ORAL) ENTACAPONE [GENERIC AB]
Drug Classes: catechol o-methyl transferase (COMT) inhibitor
NDA Applicant: ORION PHARMA      NDA No.: 020796  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 6599530 DP* Oral compacted composition comprising catechol derivatives
Claim Types: Formulation; Process; Method of use
Sep 14, 2018U-219: Treatment of Parkinson's disease

NITROSTAT (TABLET) (SUBLINGUAL) NITROGLYCERIN [GENERIC AB]
Drug Classes: nitrate vasodilator
NDA Applicant: PFIZER PHARMS      NDA No.: 021134  Prod. No.: 001 RX (0.3MG); 002 RX (0.4MG); 003 RX (0.6MG)
PatentsExpirationPatented Use
Pat. No. 6500456 Compressed nitroglycerin tablet and its method of manufacture
Claim Types: Formulation
Sep 16, 2018 

ASMANEX TWISTHALER (POWDER) (INHALATION) MOMETASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021067  Prod. No.: 001 RX (0.22MG/INH); 002 RX (0.11MG/INH)
PatentsExpirationPatented Use
Pat. No. 6503537 DP* Preparation of powder agglomerates
Claim Types: Composition; Product-by-process; Device; Process
Sep 17, 2018 *PED 
Pat. No. 8173172 DP* Preparation of powder agglomerates
Claim Types: Formulation; Process
Sep 17, 2018 *PED 

EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.: 022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML))
PatentsExpirationPatented Use
Pat. No. 8182835 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Product-by-process; Method of administration; Method of use
Sep 18, 2018U-1246: Single dose administration into the surgical site to produce postsurgical analgesia
Pat. No. 8834921 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Formulation; Method of use; Process
Sep 18, 2018U-1587: Single-dose infiltration into the surgical site to produce postsurgical analgesia.
Pat. No. 9585838 DP* Production of multivesicular liposomes
Claim Types: Product-by-process; Process
Dec 24, 2021 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 6, 2021I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia

EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.: 022496  Prod. No.: 002 RX (266MG/20ML (13.3MG/ML))
PatentsExpirationPatented Use
Pat. No. 8182835 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Product-by-process; Method of administration; Method of use
Sep 18, 2018U-1246: Single dose administration into the surgical site to produce postsurgical analgesia
Pat. No. 8834921 DP* Sustained-release liposomal anesthetic compositions
Claim Types: Formulation; Method of use; Process
Sep 18, 2018U-1587: Single-dose infiltration into the surgical site to produce postsurgical analgesia.
Pat. No. 9205052 Sustained-release liposomal anesthetic compositions
Claim Types: Method of use; Method of administration
Sep 18, 2018U-1246: Single dose administration into the surgical site to produce postsurgical analgesia
Pat. No. 9585838 DP* Production of multivesicular liposomes
Claim Types: Product-by-process; Process
Dec 24, 2021 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 6, 2021I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia

SOOLANTRA (CREAM) (TOPICAL) IVERMECTIN
Drug Classes: antiparasitic; pediculicide
NDA Applicant: GALDERMA LABS LP      NDA No.: 206255  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 5952372 Method for treating rosacea using oral or topical ivermectin
Claim Types: Method of use
Sep 18, 2018U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 6133310 Method of treatment of rosacea
Claim Types: Method of administration
Apr 26, 2019U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 7550440 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8080530 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8093219 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Formulation; Method of use
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8415311 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8470788 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8815816 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9089587 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9233117 Treatment of inflammatory lesions of rosacea with ivermectin
Claim Types: Method of use
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9233118 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9782425 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.

EPIVIR (SOLUTION) (ORAL) LAMIVUDINE [GENERIC AA]
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 020596  Prod. No.: 001 RX (10MG/ML)
PatentsExpirationPatented Use
Pat. No. 6004968 DP* Pharmaceutical compositions containing lamivudine
Claim Types: Formulation; Composition; Method of use
Sep 20, 2018 *PEDU-248: Treatment of HIV

EPIVIR-HBV (SOLUTION) (ORAL) LAMIVUDINE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021004  Prod. No.: 001 RX (5MG/ML)
PatentsExpirationPatented Use
Pat. No. 6004968 Pharmaceutical compositions containing lamivudine
Claim Types: Formulation; Composition; Method of use
Sep 20, 2018 *PED 

DAYTRANA (FILM, EXTENDED RELEASE) (TRANSDERMAL) METHYLPHENIDATE
Drug Classes: central nervous system stimulant
NDA Applicant: NOVEN PHARMS INC      NDA No.: 021514  Prod. No.: 001 RX (10MG/9HR (1.1MG/HR)); 002 RX (15MG/9HR (1.6MG/HR)); 003 RX (20MG/9HR (2.2MG/HR)); 004 RX (30MG/9HR (3.3MG/HR))
PatentsExpirationPatented Use
Pat. No. 6210705 DP* Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate
Claim Types: Formulation; Method of use
Sep 30, 2018U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 6348211 DP* Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate
Claim Types: Formulation; Method of use
Sep 30, 2018U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Pat. No. 8632802 DP* Device for transdermal administration of drugs including acrylic polymers
Claim Types: Formulation
Oct 7, 2025 
Pat. No. 9034370 DP* Device for transdermal administration of drugs including acrylic polymers
Claim Types: Formulation; Method of administration
Oct 7, 2025 
Pat. No. 9668981 Device for transdermal administration of drugs including acrylic based polymers
Claim Types: Method of administration
Oct 7, 2025U-2024: Method for transdermally delivering a drug to a user in need thereof

ZYPREXA RELPREVV (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) OLANZAPINE PAMOATE
Drug Classes: atypical antipsychotic
NDA Applicant: ELI LILLY CO      NDA No.: 022173  Prod. No.: 001 RX (EQ 210MG BASE/VIAL); 002 RX (EQ 300MG BASE/VIAL); 003 RX (EQ 405MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6169084 DS* DP* 2-methyl-thieno-benzodiazepine formulation
Claim Types: New polymorph, salt or hydrate
Sep 30, 2018U-1026: A method of treating human suffering from or susceptible to psychosis.

CRESTOR (TABLET) (ORAL) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.: 021366  Prod. No.: 002 RX (5MG); 003 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7030152 Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 7964614 Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 6316460 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Feb 4, 2021 *PED 
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Jun 17, 2022 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
U-1807: Treatment of pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HEFH)
U-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, ApoB,nonHDL-c or TG levels;to increase HDL-c; in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationNov 20, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

CRESTOR (TABLET) (ORAL) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.: 021366  Prod. No.: 004 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 7030152 Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 7964614 Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 6316460 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Feb 4, 2021 *PED 
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Jun 17, 2022 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
U-1807: Treatment of pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HEFH)
U-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, ApoB,nonHDL-c or TG levels;to increase HDL-c; in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 27, 2019I-732: Treatment of pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia to reduce LDL-C, total C, NonHDL-C and APOB as an adjunct to diet, either alone or with other lipid-lowering treatments
Exclusivity Code: NPP - New patient populationNov 20, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

CRESTOR (TABLET) (ORAL) ROSUVASTATIN CALCIUM [GENERIC AB]
Drug Classes: HMG CoA-reductase inhibitor
NDA Applicant: IPR      NDA No.: 021366  Prod. No.: 005 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 7030152 Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 7964614 Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Claim Types: Method of use
Oct 2, 2018 *PEDU-1032: Use of rosuvastatin calcium for the primary prevention of cardiovascular disease in individuals without clinically evident coronary heart disease but with increased risk factors
Pat. No. 6316460 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Feb 4, 2021 *PED 
Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Claim Types: Method of use
Jun 17, 2022 *PEDU-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, ApoB,nonHDL-c or TG levels;to increase HDL-c; in adult patients with primary hyperlipidemia or mixed dyslipidemia; and to slow the progression of atherosclerosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMay 27, 2023ODE-118: An adjunct to diet to reduce LDL-C, total-C, nonHDL-C and apob in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)

NOXAFIL (SUSPENSION) (ORAL) POSACONAZOLE
Drug Classes: azole antifungal
NDA Applicant: SCHERING      NDA No.: 022003  Prod. No.: 001 RX (40MG/ML)
PatentsExpirationPatented Use
Pat. No. 6958337 DS* DP* Crystalline antifungal polymorph
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Oct 5, 2018U-760: Prophylaxis of invasive aspergillus and candida infections and treatment of oropharyngeal candidiasis
Pat. No. 5661151 DS* DP* [Extended 1788 days (4.9 years)]
Tetrahydrofuran antifungals
Claim Types: Compound; Composition
Jul 19, 2019U-760: Prophylaxis of invasive aspergillus and candida infections and treatment of oropharyngeal candidiasis
Pat. No. 8263600 DP* Antifungal composition with enhanced bioavailability
Claim Types: Formulation
Apr 1, 2022 

SPINRAZA (SOLUTION) (INTRATHECAL) NUSINERSEN SODIUM
Drug Classes: antisense oligonucleotide; survival motor neuron-2 (SMN2)-directed
NDA Applicant: BIOGEN IDEC      NDA No.: 209531  Prod. No.: 001 RX (12MG/5ML (2.4MG/ML))
PatentsExpirationPatented Use
Pat. No. 6210892 Alteration of cellular behavior by antisense modulation of mRNA processing
Claim Types: Method of use
Oct 7, 2018U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA
Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines
Claim Types: Compound
Sep 5, 2023 
Pat. No. 8110560 Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Claim Types: Method of use
Dec 5, 2025U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA
U-1943: Treatment of spinal muscular atrophy
U-1944: Treatment of spinal muscular atrophy by inhibiting an SMN2 pre-mRNA intronic splicing silencer site
Pat. No. 7838657 DS* Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
Claim Types: Compound
Jul 11, 2027 
Pat. No. 8361977 DS* DP* Compositions and methods for modulation of SMN2 splicing
Claim Types: Compound; Composition
May 27, 2030 
Pat. No. 9717750 Compositions and methods for modulation of SMN2 splicing in a subject
Claim Types: Method of use; Method of administration
Jun 17, 2030U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA
U-1943: Treatment of spinal muscular atrophy
U-2093: Treatment of type ii spinal muscular atrophy
U-2094: Treatment of type iii spinal muscular atrophy
Pat. No. 8980853 Compositions and methods for modulation of SMN2 splicing in a subject
Claim Types: Method of use
Nov 24, 2030U-1941: Treatment of infantile-onset spinal muscular atrophy
Pat. No. 9926559 Compositions and methods for modulation of SMN2 splicing in a subject
Claim Types: Method of use
Jan 9, 2034U-1943: Treatment of spinal muscular atrophy
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 14, 2021M-226: Changes to the labeling based on results from a controlled clinical trial in patients with later-onset spinal muscular atrophy
Exclusivity Code: NCE - New chemical entityDec 23, 2021 
Exclusivity Code: ODE - Orphan drug exclusivityDec 23, 2023ODE-127: Treatment of spinal muscular atrophy in pediatric and adult patients

ZEMPLAR (SOLUTION) (INTRAVENOUS) PARICALCITOL [GENERIC AP]
Drug Classes: vitamin D3 analog
NDA Applicant: ABBVIE      NDA No.: 020819  Prod. No.: 001 RX (0.005MG/ML (0.005MG/ML)); 002 RX (0.002MG/ML (0.002MG/ML)); 003 RX (0.01MG/2ML (0.005MG/ML))
PatentsExpirationPatented Use
Pat. No. 6136799 Cosolvent formulations
Claim Types: Formulation; Process
Oct 8, 2018 *PED 
Pat. No. 6361758 DP* Cosolvent formulations
Claim Types: Formulation
Oct 8, 2018 *PED 

TIKOSYN (CAPSULE) (ORAL) DOFETILIDE [GENERIC AB]
Drug Classes: antiarrhythmic
NDA Applicant: PFIZER      NDA No.: 020931  Prod. No.: 001 RX (0.125MG); 002 RX (0.25MG); 003 RX (0.5MG)
PatentsExpirationPatented Use
Pat. No. 6124363 Dofetilide polymorphs
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Oct 9, 2018 

VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: proton pump inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: HORIZON PHARMA USA      NDA No.: 022511  Prod. No.: 001 RX (EQ 20MG BASE;500MG)
PatentsExpirationPatented Use
Pat. No. 7745466 DP* Form of S-omeprazole
Claim Types: Formulation; Method of use
Oct 13, 2018U-1053: Risk-reduction of nsaid-associated gastric ulcer
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-1053: Risk-reduction of nsaid-associated gastric ulcer
Pat. No. 7411070 DS* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate
Nov 25, 2018 *PEDU-1053: Risk-reduction of nsaid-associated gastric ulcer
Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
May 31, 2022 
Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS
Claim Types: Formulation; Method of use
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Method of use
May 31, 2022U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment
Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
May 31, 2022U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
May 31, 2022 
Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
May 31, 2022 
Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Feb 28, 2023U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof
Claim Types: Method of administration
Sep 3, 2029U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9220698 Method for delivering a pharmaceutical composition to patient in need thereof
Claim Types: Method of use; Method of administration
Mar 10, 2031U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer
Claim Types: Method of use; Method of administration
Oct 17, 2031U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJul 6, 2020 

VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: proton pump inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: HORIZON PHARMA USA      NDA No.: 022511  Prod. No.: 002 RX (EQ 20MG BASE;375MG)
PatentsExpirationPatented Use
Pat. No. 7745466 DP* Form of S-omeprazole
Claim Types: Formulation; Method of use
Oct 13, 2018U-1053: Risk-reduction of nsaid-associated gastric ulcer
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-1053: Risk-reduction of nsaid-associated gastric ulcer
Pat. No. 7411070 DS* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate
Nov 25, 2018 *PEDU-1053: Risk-reduction of nsaid-associated gastric ulcer
Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
May 31, 2022 
Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS
Claim Types: Formulation; Method of use
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Method of use
May 31, 2022U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment
Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
May 31, 2022U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
May 31, 2022 
Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
May 31, 2022 
Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Feb 28, 2023U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof
Claim Types: Method of administration
Sep 3, 2029U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer
Claim Types: Method of use; Method of administration
Oct 17, 2031U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJul 6, 2020 

EXTINA (AEROSOL, FOAM) (TOPICAL) KETOCONAZOLE [GENERIC AT]
Drug Classes: azole antifungal
NDA Applicant: MYLAN PHARMS INC      NDA No.: 021738  Prod. No.: 001 RX (2%)
PatentsExpirationPatented Use
Pat. No. 7553835 DP* Topical antifungal composition
Claim Types: Method of use; Formulation
Oct 19, 2018U-245: Treatment of seborrhea dermatitis in humans
Pat. No. 8026238 DP* Topical antifungal composition
Claim Types: Method of use; Formulation
Oct 19, 2018U-1213: Topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older

MYDAYIS (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [Has competitive generic]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE DEV LLC      NDA No.: 022063  Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
PatentsExpirationPatented Use
Pat. No. RE41148 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Oct 21, 2018 
Pat. No. RE42096 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Oct 21, 2018 
Pat. No. 6913768 DP* Sustained release delivery of amphetamine salts
Claim Types: Formulation; Method of use
May 24, 2023U-2025: Treatment of attention deficit hyperactivity disorder
Pat. No. 9173857 Controlled dose drug delivery system
Claim Types: Method of use
May 12, 2026U-2025: Treatment of attention deficit hyperactivity disorder
Pat. No. 8846100 DP* Controlled dose drug delivery system
Claim Types: Formulation
Aug 24, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJun 20, 2020 

PROSCAR (TABLET) (ORAL) FINASTERIDE [GENERIC AB]
Drug Classes: 5-alpha reductase inhibitor
NDA Applicant: MERCK      NDA No.: 020180  Prod. No.: 001 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 5942519 Prevention of precipitated acute urinary retention
Claim Types: Method of use
Oct 23, 2018U-280: Treating precipitated acute urinary retention with finasteride

FOSRENOL (TABLET, CHEWABLE) (ORAL) LANTHANUM CARBONATE [GENERIC AB]
Drug Classes: phosphate binder
NDA Applicant: SHIRE LLC      NDA No.: 021468  Prod. No.: 002 RX (EQ 500MG BASE); 003 RX (EQ 750MG BASE); 004 RX (EQ 1GM BASE) NDA No.: 021468  Prod. No.: 001 DISC (EQ 250MG BASE)
PatentsExpirationPatented Use
Pat. No. 5968976 DP* [Extended 951 days* (2.6 years)]
Pharmaceutical composition containing selected lanthanum carbonate hydrates
Claim Types: Composition; Process; Method of use
Oct 26, 2018U-613: Reduction of serum phosphate
Pat. No. 7381428 Stabilized lanthanum carbonate compositions
Claim Types: Method of improving a treatment
Aug 26, 2024U-890: Reduction of serum phosphate in patients with end stage renal disease
Pat. No. 7465465 DP* Pharmaceutical formulation comprising lanthanum compounds
Claim Types: Formulation
Aug 26, 2024 

FOSRENOL (POWDER) (ORAL) LANTHANUM CARBONATE
Drug Classes: phosphate binder
NDA Applicant: SHIRE DEV LLC      NDA No.: 204734  Prod. No.: 001 RX (EQ 750MG BASE); 002 RX (EQ 1GM BASE)
PatentsExpirationPatented Use
Pat. No. 5968976 DP* [Extended 951 days* (2.6 years)]
Pharmaceutical composition containing selected lanthanum carbonate hydrates
Claim Types: Composition; Process; Method of use
Oct 26, 2018U-1592: To reduce serum phosphate in patients with end stage renal disease
Pat. No. 7465465 DP* Pharmaceutical formulation comprising lanthanum compounds
Claim Types: Formulation
Aug 26, 2024 
Pat. No. 8980327 DP* Capsule and powder formulations containing lanthanum compounds
Claim Types: Formulation
Dec 1, 2030 
Pat. No. 9023397 DP* Capsule and powder formulations containing lanthanum compounds
Claim Types: Drug in a container
Dec 1, 2030 

ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.: 021343  Prod. No.: 001 RX (7.5MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Process; Method of use; Kit
Oct 28, 2018U-801: Method of treating cancer
Pat. No. 6773714 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Product-by-process; Method of use; Process; Kit
Oct 28, 2018U-801: Method of treating cancer
Pat. No. 9254307 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Method of use
Oct 28, 2018 
Pat. No. 6626870 DP* Stoppering method to maintain sterility
Claim Types: Device; Process
Mar 27, 2020 

ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.: 021379  Prod. No.: 001 RX (22.5MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Process; Method of use; Kit
Oct 28, 2018U-801: Method of treating cancer
Pat. No. 6773714 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Product-by-process; Method of use; Process; Kit
Oct 28, 2018U-801: Method of treating cancer
Pat. No. 8486455 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Method of use
Oct 28, 2018 
Pat. No. 9283282 DS* DP* Sustained release polymer
Claim Types: Formulation
Oct 28, 2018 
Pat. No. 6626870 DP* Stoppering method to maintain sterility
Claim Types: Device; Process
Mar 27, 2020 
Pat. No. 8840916 DP* Sustained release polymer
Claim Types: Compound
Nov 13, 2020 
Pat. No. 9539333 DS* DP* Sustained release polymer
Claim Types: Intermediate; Formulation; Method of use
Nov 13, 2020U-621: Method of treating cancer
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Oct 15, 2023U-621: Method of treating cancer

ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.: 021488  Prod. No.: 001 RX (30MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Process; Method of use; Kit
Oct 28, 2018U-801: Method of treating cancer
Pat. No. 6773714 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Product-by-process; Method of use; Process; Kit
Oct 28, 2018U-801: Method of treating cancer
Pat. No. 8486455 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Method of use
Oct 28, 2018 
Pat. No. 9283282 DS* DP* Sustained release polymer
Claim Types: Formulation
Oct 28, 2018 
Pat. No. 6626870 DP* Stoppering method to maintain sterility
Claim Types: Device; Process
Mar 27, 2020 
Pat. No. 8840916 DP* Sustained release polymer
Claim Types: Compound
Nov 13, 2020 
Pat. No. 9539333 DS* DP* Sustained release polymer
Claim Types: Intermediate; Formulation; Method of use
Nov 13, 2020U-621: Method of treating cancer
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Oct 15, 2023U-621: Method of treating cancer

ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP      NDA No.: 021731  Prod. No.: 001 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6565874 DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Process; Method of use; Kit
Oct 28, 2018U-621: Method of treating cancer
Pat. No. 6773714 Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Product-by-process; Method of use; Process; Kit
Oct 28, 2018U-621: Method of treating cancer
Pat. No. 8486455 DS* DP* Polymeric delivery formulations of leuprolide with improved efficacy
Claim Types: Formulation; Method of use
Oct 28, 2018 
Pat. No. 9283282 DS* DP* Sustained release polymer
Claim Types: Formulation
Oct 28, 2018 
Pat. No. 6626870 DP* Stoppering method to maintain sterility
Claim Types: Device; Process
Mar 27, 2020 
Pat. No. 8840916 DP* Sustained release polymer
Claim Types: Compound
Nov 13, 2020 
Pat. No. 9539333 DS* DP* Sustained release polymer
Claim Types: Intermediate; Formulation; Method of use
Nov 13, 2020U-621: Method of treating cancer
Pat. No. 9914802 DS* DP* Sustained release polymer
Claim Types: Method of use; Process; Formulation
Nov 13, 2020U-1666: Palliative treatment of prostate cancer
Pat. No. 8470359 DS* DP* Sustained release polymer
Claim Types: Formulation; Method of use
Oct 15, 2023U-621: Method of treating cancer

OTEZLA (TABLET) (ORAL) APREMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: CELGENE CORP      NDA No.: 205437  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 6020358 DS* DP* Substituted phenethylsulfones and method of reducing TNF.alpha. levels
Claim Types: Compound; Method of use; Composition
Oct 30, 2018U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4
Pat. No. 6962940 (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof
Claim Types: Method of use
Mar 19, 2023U-1504: Use of OTEZLA (apremilast) for inhibiting PDE4
Pat. No. 7208516 Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
Pat. No. 7659302 Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
Pat. No. 8455536 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi-soindoline 1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
Pat. No. 8802717 Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
Pat. No. 9018243 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof
Claim Types: Method of use
Mar 19, 2023U-1505: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
Pat. No. 9724330 Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Claim Types: Method of use
Mar 19, 2023U-1561: Use of OTEZLA (apremilast) for the treatment of psoriatic arthritis
U-1595: Use of OTEZLA (apremilast) for the treatment of psoriasis
Pat. No. 7893101 DS* DP* Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition
Dec 9, 2023 
Pat. No. 7427638 DS* DP* (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof
Claim Types: Composition; Formulation
Feb 16, 2028 
Pat. No. 9872854 Methods for the treatment of psoriatic arthritis using apremilast
Claim Types: Method of use
May 29, 2034U-2232: Treatment of psoriatic arthritis using a dosage titration schedule
U-2233: Treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMar 21, 2019 

WELLBUTRIN XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE [GENERIC AB3]
Drug Classes: aminoketone
NDA Applicant: VALEANT INTL      NDA No.: 021515  Prod. No.: 001 RX (150MG); 002 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 6096341 Delayed release tablet of bupropion hydrochloride
Claim Types: Formulation
Oct 30, 2018 

LEVITRA (TABLET) (ORAL) VARDENAFIL HYDROCHLORIDE
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: BAYER HLTHCARE      NDA No.: 021400  Prod. No.: 001 RX (5MG); 002 RX (10MG); 004 RX (20MG) NDA No.: 021400  Prod. No.: 003 DISC (2.5MG)
PatentsExpirationPatented Use
Pat. No. 6362178 DS* DP* 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use
Oct 31, 2018U-533: Erectile dysfunction
Pat. No. 7696206 DS* DP* 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use
Oct 31, 2018U-533: Erectile dysfunction
Pat. No. 8841446 DP* Medicaments containing vardenafil hydrochloride trihydrate
Claim Types: Formulation
Jul 3, 2023 
Pat. No. 8273876 Medicaments containing vardenafil hydrochloride trihydrate
Claim Types: Method of use; Process
Jul 23, 2027U-1288: Treatment of erectile dysfunction by administering a film-coated tablet

STAXYN (TABLET, ORALLY DISINTEGRATING) (ORAL) VARDENAFIL HYDROCHLORIDE
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: BAYER HLTHCARE      NDA No.: 200179  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6362178 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use
Oct 31, 2018U-155: Treatment of erectile dysfunction
Pat. No. 7696206 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Claim Types: Compound; Composition; Method of use
Oct 31, 2018U-155: Treatment of erectile dysfunction
Pat. No. 8613950 DP* Pharmaceutical forms with improved pharmacokinetic properties
Claim Types: Formulation
Dec 23, 2028 

ISTALOL (SOLUTION/DROPS) (OPHTHALMIC) TIMOLOL MALEATE [GENERIC AT2]
Drug Classes: beta adrenergic blocker
NDA Applicant: BAUSCH AND LOMB      NDA No.: 021516  Prod. No.: 001 RX (EQ 0.5% BASE)
PatentsExpirationPatented Use
Pat. No. 6335335 DP* Prolonged-action eye drop
Claim Types: Method of use
Nov 2, 2018 
Pat. No. 6645963 DP* Prolonged-action eye drop
Claim Types: Formulation
Nov 16, 2018 

AXUMIN (SOLUTION) (INTRAVENOUS) FLUCICLOVINE F-18
Drug Classes: radioactive diagnostic agent
NDA Applicant: BLUE EARTH      NDA No.: 208054  Prod. No.: 001 RX (9-221mCi/ML)
PatentsExpirationPatented Use
Pat. No. 5808146 DS* Amino acid analogs for tumor imaging
Claim Types: Compound
Nov 9, 2018 
Pat. No. 9387266 Precursor compound of radioactive halogen-labeled organic compound
Claim Types: Diagnostic or surgical method
Nov 28, 2026U-1879: Method of diagnosing tumors using positron emission tomography
Pat. No. 10010632 DP* Precursor compound of radioactive halogen-labeled organic compound
Claim Types: Formulation
Nov 28, 2026 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 27, 2021 

FORTESTA (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: ENDO PHARMS      NDA No.: 021463  Prod. No.: 001 RX (10MG/0.5GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 6319913 Penetration enhancing and irritation reducing systems
Claim Types: Method of administration; Method of use
Nov 9, 2018U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 6579865 DP* Penetration enhancing and irritation reducing systems
Claim Types: Formulation
Nov 9, 2018 

TRISENOX (INJECTABLE) (INJECTION) ARSENIC TRIOXIDE
NDA Applicant: CEPHALON      NDA No.: 021248  Prod. No.: 001 DISC (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 6723351 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-573: Treatment of acute promyelogenous leukemia (APL)
Pat. No. 6855339 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-617: Treatment of acute promyelogenous leukemia (APL)
Pat. No. 6861076 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-617: Treatment of acute promyelogenous leukemia (APL)
Pat. No. 6884439 Process for producing arsenic trioxide formulations and methods for treatingcancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-651: Treatment of acute promyelocytic leukemia (APL)
Pat. No. 6982096 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
U-651: Treatment of acute promyelocytic leukemia (APL)
Pat. No. 8273379 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-1291: Treatment of acute promyelocytic leukemia (APL) in patients whose APL is characterized by the presence of the (15;17) translocation or pml/rar-alpha gene expression
U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 12, 2025ODE-167: Arsenic trioxide for use in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

TRISENOX (INJECTABLE) (INJECTION) ARSENIC TRIOXIDE
NDA Applicant: CEPHALON      NDA No.: 021248  Prod. No.: 002 RX (2MG/ML)
PatentsExpirationPatented Use
Pat. No. 6723351 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 6855339 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 6861076 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 6884439 Process for producing arsenic trioxide formulations and methods for treatingcancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 6982096 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
Pat. No. 8273379 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Claim Types: Method of use
Nov 10, 2018U-2204: Treating patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
U-2229: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-A gene expression
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 12, 2025ODE-167: Arsenic trioxide for use in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

TYVASO (SOLUTION) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 022387  Prod. No.: 001 RX (0.6MG/ML)
PatentsExpirationPatented Use
Pat. No. 6521212 Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation
Claim Types: Method of use
Nov 13, 2018U-1018: Treatment of pulmonary hypertension by inhalation
Pat. No. 6756033 Method for delivering benzindene prostaglandins by inhalation
Claim Types: Method of use
Nov 13, 2018U-1018: Treatment of pulmonary hypertension by inhalation
Pat. No. 9339507 DP* Treprostinil administration by inhalation
Claim Types: Kit
Mar 10, 2028 
Pat. No. 9358240 Treprostinil administration by inhalation
Claim Types: Method of use; Method of administration
May 5, 2028U-1849: Method of treating pulmonary hypertension by administering treprostinil or a salt thereof by inhalation using a device
Pat. No. 8497393 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM
Claim Types: Product-by-process
Dec 15, 2028 
Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Claim Types: Composition; New polymorph, salt or hydrate
Dec 15, 2028 
Pat. No. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Claim Types: Product-by-process
Dec 15, 2028 

EPZICOM (TABLET) (ORAL) ABACAVIR SULFATE; LAMIVUDINE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV; HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 021652  Prod. No.: 001 RX (EQ 600MG BASE;300MG)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-257: Treatment of HIV infection

TRIUMEQ (TABLET) (ORAL) ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV; human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 205551  Prod. No.: 001 RX (EQ 600MG BASE;EQ 50MG BASE;300MG)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-1572: Treatment of human immunodeficiency virus (HIV) infection.
Pat. No. 8129385 DS* DP* Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Claim Types: Compound; Composition
Oct 5, 2027 
Pat. No. 9242986 DS* DP* Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Claim Types: New polymorph, salt or hydrate
Dec 8, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 12, 2018 

TRIZIVIR (TABLET) (ORAL) ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV; HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 021205  Prod. No.: 001 RX (EQ 300MG BASE;150MG;300MG)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-65: Method of treatment of a patient infected with HIV

ZIAGEN (TABLET) (ORAL) ABACAVIR SULFATE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV
NDA Applicant: VIIV HLTHCARE      NDA No.: 020977  Prod. No.: 001 RX (EQ 300MG BASE)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-65: Method of treatment of a patient infected with HIV

ZIAGEN (SOLUTION) (ORAL) ABACAVIR SULFATE [GENERIC AA]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitors (HIV
NDA Applicant: VIIV HLTHCARE      NDA No.: 020978  Prod. No.: 001 RX (EQ 20MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections
Claim Types: Composition; Method of use
Nov 14, 2018 *PEDU-65: Method of treatment of a patient infected with HIV
Pat. No. 6641843 DP* Pharmaceutical compositions
Claim Types: Formulation; Process
Aug 4, 2019 *PED 

FINACEA (GEL) (TOPICAL) AZELAIC ACID
NDA Applicant: BAYER HLTHCARE      NDA No.: 021470  Prod. No.: 001 RX (15%)
PatentsExpirationPatented Use
Pat. No. 6534070 Composition with azelaic acid
Claim Types: Formulation; Method of use
Nov 18, 2018 

GENOTROPIN PRESERVATIVE FREE (INJECTABLE) (INJECTION) SOMATROPIN RECOMBINANT
Drug Classes: recombinant human growth hormone
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 020280  Prod. No.: 001 RX (0.2MG/VIAL); 002 RX (0.4MG/VIAL); 003 RX (0.6MG/VIAL); 005 RX (0.8MG/VIAL); 008 RX (1MG/VIAL); 009 RX (1.2MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6152897 DP* Syringe
Claim Types: Device
Nov 20, 2018 

RESCULA (SOLUTION/DROPS) (OPHTHALMIC) UNOPROSTONE ISOPROPYL
Drug Classes: prostaglandin analog
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021214  Prod. No.: 001 DISC (0.15%**)
PatentsExpirationPatented Use
Pat. No. 6770675 DP* Compositions and methods for reducing ocular hypertension
Claim Types: Formulation; Method of use; Process
Nov 24, 2018U-1322: Method of reducing ocular hypertension
Pat. No. 6458836 Treatment of ocular hypertension and glaucoma
Claim Types: Method of administration
Jul 9, 2021U-1315: The long term treatment of prophylactic management of ocular hypertension and glaucoma
U-333: Method of treating ocular hypertension

AZASITE (SOLUTION/DROPS) (OPHTHALMIC) AZITHROMYCIN
Drug Classes: macrolide antimicrobial
NDA Applicant: OAK PHARMS INC      NDA No.: 050810  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 6861411 Method of treating eye infections with azithromycin
Claim Types: Method of use
Nov 25, 2018U-709: Method of combating bacteria in a patient
Pat. No. 6239113 Topical treatment or prevention of ocular infections
Claim Types: Method of use
Mar 31, 2019U-709: Method of combating bacteria in a patient
Pat. No. 6569443 DP* Topical treatment or prevention of ocular infections
Claim Types: Formulation; Method of use
Mar 31, 2019U-709: Method of combating bacteria in a patient
Pat. No. 7056893 DP* Topical treatment for prevention of ocular infections
Claim Types: Formulation; Process; Method of use
Mar 31, 2019U-709: Method of combating bacteria in a patient

NEXIUM (CAPSULE, DELAYED REL PELLETS) (ORAL) ESOMEPRAZOLE MAGNESIUM [GENERIC AB]
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 021153  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-729: Treatment of gastroesophageal reflux disease (GERD), risk-reduction of NSAID-associated gastric ulcer, H.pylori eradication to reduce the risk of duodenal ulcer recurrence
U-770: Long-term treatment of pathological hypersecretory conditions
Pat. No. 7411070 DS* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate
Nov 25, 2018 *PED 
Pat. No. 8466175 Form of S-omeprazole
Claim Types: Method of use
Nov 25, 2018 *PEDU-1417: Use for treatment of Helicobacter infections
Pat. No. 6147103 Omeprazole process and compositions thereof
Claim Types: Formulation
Apr 9, 2019 *PED 
Pat. No. 6166213 Omeprazole process and compositions thereof
Claim Types: Product-by-process; Process
Comments: Omeprazole produced by the claimed process that has less than a specified level of residual solvent
Apr 9, 2019 *PED 
Pat. No. 6191148 Omerazole process and compositions thereof
Claim Types: Formulation
Comments: Omeprazole having specified purity and residual solvent levels
Apr 9, 2019 *PED 
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole
Claim Types: Formulation; Method of use; Process
May 3, 2020 *PEDU-469: Treatment of gastroesophageal reflex disease (GERD) and eradication of H. pylori to reduce risk of duodenal ulcer recurrence
U-729: Treatment of gastroesophageal reflux disease (GERD), risk-reduction of NSAID-associated gastric ulcer, H.pylori eradication to reduce the risk of duodenal ulcer recurrence
U-770: Long-term treatment of pathological hypersecretory conditions

NEXIUM (FOR SUSPENSION, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 021957  Prod. No.: 001 RX (EQ 20MG BASE/PACKET); 002 RX (EQ 40MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis
U-729: Treatment of gastroesophageal reflux disease (GERD), risk-reduction of NSAID-associated gastric ulcer, H.pylori eradication to reduce the risk of duodenal ulcer recurrence
U-773: Pathological hypersecretory conditions
Pat. No. 7411070 DS* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate
Nov 25, 2018 *PED 
Pat. No. 8466175 Form of S-omeprazole
Claim Types: Method of use
Nov 25, 2018 *PEDU-1417: Use for treatment of Helicobacter infections
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole
Claim Types: Formulation; Method of use; Process
May 3, 2020 *PEDU-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis
U-729: Treatment of gastroesophageal reflux disease (GERD), risk-reduction of NSAID-associated gastric ulcer, H.pylori eradication to reduce the risk of duodenal ulcer recurrence
U-773: Pathological hypersecretory conditions

NEXIUM (FOR SUSPENSION, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 021957  Prod. No.: 003 RX (EQ 2.5MG BASE/PACKET); 004 RX (EQ 5MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis
Pat. No. 7411070 DS* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate
Nov 25, 2018 *PED 
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole
Claim Types: Formulation; Method of use; Process
May 3, 2020 *PEDU-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis

NEXIUM (FOR SUSPENSION, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 022101  Prod. No.: 001 RX (EQ 10MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-858: Pediatric use aged 1-11 years, GERD and erosive esophagitis
Pat. No. 7411070 DS* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate
Nov 25, 2018 *PED 
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole
Claim Types: Formulation; Method of use; Process
May 3, 2020 *PEDU-858: Pediatric use aged 1-11 years, GERD and erosive esophagitis

NEXIUM 24HR (CAPSULE, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM [GENERIC OTC]
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA LP      NDA No.: 204655  Prod. No.: 001 OTC (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-1509: Treatment of frequent heartburn by administering a gastric acid reducer
U-1875: Treatment of frequent heartburn by administering s-omeprazole trihydrate according to claims 1-3
Pat. No. 7411070 DS* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate
Nov 25, 2018 *PED 
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole
Claim Types: Formulation; Method of use; Process
May 3, 2020 *PEDU-1509: Treatment of frequent heartburn by administering a gastric acid reducer
U-1874: Treatment of frequent heartburn by administering omeprazole according to claims 1-8

NEXIUM 24HR (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA LP      NDA No.: 207920  Prod. No.: 001 OTC (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 6369085 DS* DP* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Nov 25, 2018 *PEDU-1784: Method of treating frequent heartburn by administering an esomeprazole magnesium trihydrate as claimed
Pat. No. 7411070 DS* Form of S-omeprazole
Claim Types: New polymorph, salt or hydrate
Nov 25, 2018 *PED 
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole
Claim Types: Formulation; Method of use; Process
May 3, 2020 *PEDU-1785: Method of treating frequent heartburn by administering an esomeprazole magnesium formulation as claimed

DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE
Drug Classes: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 208056  Prod. No.: 001 DISC (30MG)
PatentsExpirationPatented Use
Pat. No. 7399485 DP* Rapidly Disintegrable solid preparation
Claim Types: Formulation; Process
Nov 26, 2018 *PED 
Pat. No. 6328994 DP* Orally disintegrable tablets
Claim Types: Formulation
Nov 17, 2019 *PED 
Pat. No. 7431942 DP* Orally disintegrable tablets
Claim Types: Formulation
Nov 17, 2019 *PED 
Pat. No. 7875292 DP* Orally disintegrable tablets
Claim Types: Formulation
Nov 17, 2019 *PED 
Pat. No. 9145389 DS* DP* Benzimidazole compound crystal
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition
Jun 15, 2020 
Pat. No. 6462058 DS* DP* Benzimidazole compound crystal
Claim Types: New polymorph, salt or hydrate; Composition; Process; Method of use
Dec 15, 2020 *PEDU-950: Maintain healing of erosive esophagitis (EE) for up to 6 months
U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
Pat. No. 6939971 Benzimidazole compound crystal
Claim Types: Method of use
Dec 15, 2020 *PEDU-950: Maintain healing of erosive esophagitis (EE) for up to 6 months
U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
Pat. No. 7285668 DS* Process for the crystallization of (R)- or (S)-lansoprazole
Claim Types: New polymorph, salt or hydrate; Process
Dec 15, 2020 *PED 
Pat. No. 6664276 DS* DP* Benzimidazole compound crystal
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Jul 30, 2023 *PEDU-950: Maintain healing of erosive esophagitis (EE) for up to 6 months
U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks
Pat. No. 8784885 DP* Controlled release preparation
Claim Types: Formulation; Method of use
Apr 15, 2024 *PED 
Pat. No. 9238029 DP* Multiple PPI dosage form
Claim Types: Formulation
Jan 17, 2026 
Pat. No. 9011926 DP* Method for producing granules
Claim Types: Product-by-process; Process
Feb 24, 2026 
Pat. No. 8461187 DP* Multiple PPI dosage form
Claim Types: Formulation; Method of use
Jul 17, 2026 *PED 
Pat. No. 8871273 DP* Method for producing granules
Claim Types: Formulation
Jul 11, 2028 *PED 
Pat. No. 9241910 DP* Orally-disintegrating solid preparation
Claim Types: Formulation
Mar 10, 2029 

IXEMPRA KIT (INJECTABLE) (IV (INFUSION)) IXABEPILONE
Drug Classes: microtubule inhibitor
NDA Applicant: R-PHARM US LLC      NDA No.: 022065  Prod. No.: 001 RX (15MG/VIAL); 002 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7125899 DS* DP* Epothilone derivatives
Claim Types: Compound; Method of use; Composition; New polymorph, salt or hydrate
Nov 26, 2018 *PEDU-957: A method of treating cancer in a patient comprising administering ixabepilone or pharmaceutical compositions comprising ixabepilone
Pat. No. RE41911 DS* DP* Epothilone derivatives
Claim Types: Compound; Method of use; Composition
Mar 28, 2021 *PEDU-961: Method of treating breast cancer by administering ixabepilone; a method of treating a cancer responsible to microtubule stabilization by administering ixabepilone
Pat. No. 6670384 DP* Methods of administering epothilone analogs for the treatment of cancer
Claim Types: Formulation; Method of use; Process
Jul 23, 2022 *PEDU-959: Method of treating cancer, IV admin, lyophylized ixabepilone diluted, every week or 3 weeks; lyophilized ixabepilone with solvent(dehydrated ethanol) diluted to concentration of 0.1mg/ml to 0.9mg/ml
U-960: Method of treating cancer in a patient comprising intravenously administering to the patient ixabepilone diluted in a parenteral diluent
Pat. No. 7022330 DP* Parenteral formulation for epothilone analogs
Claim Types: Product-by-process; Formulation; Method of use; Process
Jul 23, 2022 *PEDU-958: Method of treating patient comprising mixing first and second vials of product comprising lyophilized ixabepilone to provide an epothilone analog solution, diluting solution with a suitable diluent to prepare intravenous formulation for PT
Pat. No. RE41393 Treatment of refractory tumors using epothilone derivatives
Claim Types: Method of use
Aug 8, 2022 *PEDU-961: Method of treating breast cancer by administering ixabepilone; a method of treating a cancer responsible to microtubule stabilization by administering ixabepilone
Pat. No. 7312237 Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases
Claim Types: Method of use
Feb 21, 2025 *PEDU-965: Use of ixabepilone in combination with capecitabine in treatment of metastasis breast cancer

PREVACID (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) LANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021428  Prod. No.: 001 RX (15MG); 002 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 7399485 DP* Rapidly Disintegrable solid preparation
Claim Types: Formulation; Process
Nov 26, 2018 *PED 
Pat. No. 6328994 Orally disintegrable tablets
Claim Types: Formulation
Nov 17, 2019 *PED 
Pat. No. 7431942 DP* Orally disintegrable tablets
Claim Types: Formulation
Nov 17, 2019 *PED 
Pat. No. 7875292 DP* Orally disintegrable tablets
Claim Types: Formulation
Nov 17, 2019 *PED 
Pat. No. 9901546 DP* Orally disintegrable tablets
Claim Types: Formulation
Nov 17, 2019 *PED 

RAPAFLO (CAPSULE) (ORAL) SILODOSIN [GENERIC AB]
Drug Classes: alpha adrenergic blocker
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 022206  Prod. No.: 001 RX (4MG); 002 RX (8MG)
PatentsExpirationPatented Use
Pat. No. 5387603 DS* DP* [Extended 5 years]
1,5,7-trisubstituted indoline compounds and salts thereof
Claim Types: Compound; Composition; Method of use
Dec 1, 2018 

CLARINEX (SOLUTION) (ORAL) DESLORATADINE [GENERIC AA]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021300  Prod. No.: 001 RX (0.5MG/ML)
PatentsExpirationPatented Use
Pat. No. 6514520 DP* Stabilized antihistamine syrup
Claim Types: Formulation
Dec 1, 2018 *PED 

XOLEGEL (GEL) (TOPICAL) KETOCONAZOLE
Drug Classes: azole antifungal
NDA Applicant: AQUA PHARMS      NDA No.: 021946  Prod. No.: 001 RX (2%)
PatentsExpirationPatented Use
Pat. No. 7179475 DP* Anhydrous topical skin preparations
Claim Types: Formulation; Method of use
Dec 4, 2018U-792: Treatment of seborrhea dermatitis in humans
Pat. No. 8735393 DP* Anhydrous topical skin preparations
Claim Types: Formulation
Dec 4, 2018 
Pat. No. 8232276 DP* Anhydrous topical skin preparations
Claim Types: Formulation; Method of use
Nov 24, 2020 

FORTEO (INJECTABLE) (SUBCUTANEOUS) TERIPARATIDE RECOMBINANT HUMAN
Drug Classes: parathyroid hormone analog
NDA Applicant: LILLY      NDA No.: 021318  Prod. No.: 001 DISC (0.75MG/3ML (0.25MG/ML))
PatentsExpirationPatented Use
Pat. No. 6770623 DP* Stabilized teriparatide solutions
Claim Types: Drug in a container; Method of use; Process
Dec 8, 2018U-597: FORTEO is indicated for the treatment of post menopausal women with osteoporosis who are at high risk for fracture
Pat. No. 7144861 DP* Stabilized teriparatide solutions
Claim Types: Formulation; Process; Drug in a container
Dec 8, 2018 
Pat. No. 7550434 DP* Stabilized teriparatide solutions
Claim Types: Drug in a container; Method of use; Process
Dec 8, 2018U-982: A method of treating osteoporosis
Pat. No. 6977077 Method of increasing bone toughness and stiffness and reducing fractures
Claim Types: Method of use
Aug 19, 2019U-597: FORTEO is indicated for the treatment of post menopausal women with osteoporosis who are at high risk for fracture
Pat. No. 7163684 Method of increasing bone toughness and stiffness and reducing fractures
Claim Types: Method of use
Aug 19, 2019U-790: FORTEO is indicated for the treatment of post menopausal women with osteoporosis who are at risk for fracture. FORTEO can be used by people who have had a fracture related to osteoporosis
Pat. No. 7351414 Method of reducing the risk of bone fracture
Claim Types: Method of use
Aug 19, 2019U-865: Treatment of a woman with osteoporosis and a high risk for bone fracture by reducing the risk of vertebral and nonvertebral bone fracture
Pat. No. 7517334 DP* Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose
Claim Types: Device
Mar 25, 2025 

FORTEO (INJECTABLE) (SUBCUTANEOUS) TERIPARATIDE RECOMBINANT HUMAN
Drug Classes: parathyroid hormone analog
NDA Applicant: LILLY      NDA No.: 021318  Prod. No.: 002 RX (0.6MG/2.4ML (0.25MG/ML))
PatentsExpirationPatented Use
Pat. No. 6770623 DP* Stabilized teriparatide solutions
Claim Types: Drug in a container; Method of use; Process
Dec 8, 2018U-982: A method of treating osteoporosis
Pat. No. 7144861 DP* Stabilized teriparatide solutions
Claim Types: Formulation; Process; Drug in a container
Dec 8, 2018 
Pat. No. 7550434 DP* Stabilized teriparatide solutions
Claim Types: Drug in a container; Method of use; Process
Dec 8, 2018U-982: A method of treating osteoporosis
Pat. No. 6977077 Method of increasing bone toughness and stiffness and reducing fractures
Claim Types: Method of use
Aug 19, 2019U-982: A method of treating osteoporosis
U-994: Method of treatment of osteoporosis wherein the osteoporosis is steroid-induced
Pat. No. 7163684 Method of increasing bone toughness and stiffness and reducing fractures
Claim Types: Method of use
Aug 19, 2019U-983: Method of treating osteoporosis in a post-menopausal woman at risk for fracture
U-994: Method of treatment of osteoporosis wherein the osteoporosis is steroid-induced
Pat. No. 7351414 Method of reducing the risk of bone fracture
Claim Types: Method of use
Aug 19, 2019U-984: Method for the treatment of a woman with osteoporosis and at risk for bone fracture
U-994: Method of treatment of osteoporosis wherein the osteoporosis is steroid-induced
Pat. No. 7517334 DP* Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose
Claim Types: Device
Mar 25, 2025 

BANZEL (TABLET) (ORAL) RUFINAMIDE [GENERIC AB]
NDA Applicant: EISAI INC      NDA No.: 021911  Prod. No.: 002 RX (200MG); 003 RX (400MG) NDA No.: 021911  Prod. No.: 001 DISC (100MG**)
PatentsExpirationPatented Use
Pat. No. 8076362 DP* Crystal modification A of 1-(2,6-difluorobenzyI)-1 H-1,2,3-triazole-4-carboxamide and dosage forms and formulations thereof
Claim Types: Formulation
Dec 8, 2018 *PED 
Pat. No. 7750028 Crystal modifications of 1-(2,6-difluorobenzyl)-1H-1, 2,3-triazole-4-carboxamide
Claim Types: Method of use
Apr 19, 2019 *PEDU-106: Treatment of epilepsy
Pat. No. 6740669 DS* DP* [Extended 819 days (2.2 years)]
Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic
Claim Types: New polymorph, salt or hydrate; Composition
May 14, 2023 *PED 

HETLIOZ (CAPSULE) (ORAL) TASIMELTEON
Drug Classes: melatonin receptor agonist
NDA Applicant: VANDA PHARMS INC      NDA No.: 205677  Prod. No.: 001 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 5856529 DS* DP* Benzofuran and dihydrobenzofuran melatonergic agents
Claim Types: Compound; Composition; Method of use
Dec 9, 2018U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon
Pat. No. RE46604 Treatment of circadian rhythm disorders
Claim Types: Method of use
Jan 25, 2033U-2147: Treatment of non-24 hour sleep-wake disorder by orally administering 20mg of tasimelteon once daily before bedtime
Pat. No. 9060995 Treatment of circadian rhythm disorders
Claim Types: Method of improving a treatment
Jan 25, 2033U-1710: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with fluvoxamine
Pat. No. 9539234 Treatment of circadian rhythm disorders
Claim Types: Method of use
Jan 25, 2033U-1934: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with a strong cyp1a2 inhibitor
Pat. No. 9549913 Treatment of circadian rhythm disorders
Claim Types: Method of use
Jan 25, 2033U-1486: Treatment of non-24-hour sleep-wake disorder
Pat. No. 9855241 Treatment of circadian rhythm disorders
Claim Types: Method of use
Jan 25, 2033U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon
Pat. No. 9730910 Treatment of circadian rhythm disorders
Claim Types: Method of administration
May 17, 2034U-2085: Treatment of non-24-hour sleep-wake disorder by avoiding the use of tasimelteon in combination with rifampin
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 31, 2019 
Exclusivity Code: ODE - Orphan drug exclusivityJan 31, 2021ODE-59: Treatment of non-24-hour sleep-wake disorder

MOZOBIL (SOLUTION) (SUBCUTANEOUS) PLERIXAFOR
Drug Classes: hematopoietic stem cell mobilizer
NDA Applicant: GENZYME      NDA No.: 022311  Prod. No.: 001 RX (24MG/1.2ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. RE42152 DP* Aromatic-linked polyamine macrocyclic compounds with anti-HIV activity
Claim Types: Composition
Dec 10, 2018 
Pat. No. 6987102 Methods to mobilize progenitor/stem cells
Claim Types: Method of use
Jul 22, 2023U-936: Use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to peripheral blood for collection & subsequent autologous transplantation in patients with non-Hodgkin's lymphoma & multiple myeloma
Pat. No. 7897590 Methods to mobilize progenitor/stem cells
Claim Types: Method of use
Jul 22, 2023U-936: Use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to peripheral blood for collection & subsequent autologous transplantation in patients with non-Hodgkin's lymphoma & multiple myeloma

OFORTA (TABLET) (ORAL) FLUDARABINE PHOSPHATE
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: SANOFI AVENTIS US      NDA No.: 022273  Prod. No.: 001 DISC (10MG)
PatentsExpirationPatented Use
Pat. No. 7547776 DS* Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5%
Claim Types: New polymorph, salt or hydrate
Dec 10, 2018 
Pat. No. 7148207 DP* Oral fludara of high-purity formulation with quick release of active ingredient
Claim Types: Formulation
Dec 20, 2022U-944: Treatment of patients with B-cell chronic lymphocytic leukemia (CLL)

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 001 RX (30MG); 002 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 6165513 Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Dec 10, 2018 *PED 

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 003 RX (35MG)
PatentsExpirationPatented Use
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Dec 10, 2018 *PED 
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6432932 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PEDU-595: 35 mg orally once a week for prevention of osteoporosis in postmenopausal women; 35 mg orally once a week for treatment of osteoporosis in postmenopausal women
Pat. No. 6465443 DP* Method for inhibiting bone resorption
Claim Types: Composition; Kit
Feb 14, 2019 *PED 

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 004 DISC (75MG**)
PatentsExpirationPatented Use
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Dec 10, 2018 *PED 

ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 005 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Dec 10, 2018 *PED 
Pat. No. 7192938 Method of treatment using bisphosphonic acid
Claim Types: Method of use
Nov 6, 2023 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 7718634 Method of treatment using bisphosphonic acid
Claim Types: Method of use
Nov 6, 2023 *PEDU-662: Treatment of osteoporosis in postmenopausal women

ACTONEL WITH CALCIUM (COPACKAGED) (TABLET, TABLET) (ORAL) CALCIUM CARBONATE; RISEDRONATE SODIUM
NDA Applicant: WARNER CHILCOTT      NDA No.: 021823  Prod. No.: 001 DISC (EQ 500MG BASE,N/A;N/A,35MG**)
PatentsExpirationPatented Use
Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety
Claim Types: Formulation
Dec 10, 2018 *PED 
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6432932 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PEDU-595: 35 mg orally once a week for prevention of osteoporosis in postmenopausal women; 35 mg orally once a week for treatment of osteoporosis in postmenopausal women
Pat. No. 6465443 DP* Method for inhibiting bone resorption
Claim Types: Composition; Kit
Feb 14, 2019 *PED 

KENGREAL (POWDER) (INTRAVENOUS) CANGRELOR
Drug Classes: P2Y12 platelet inhibitor
NDA Applicant: CHIESI USA INC      NDA No.: 204958  Prod. No.: 001 RX (50MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6114313 DP* Pharmaceutical compositions for freeze drying
Claim Types: Formulation; Process; Method of use
Dec 11, 2018U-1715: P2y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a p2y12 platelet inhibitor and not given a glycoprotein iib/iiia inhibitor
Pat. No. 6130208 DP* Formulation containing a nucleotide analogue
Claim Types: Formulation; Method of use; Process
Jun 29, 2019U-1715: P2y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a p2y12 platelet inhibitor and not given a glycoprotein iib/iiia inhibitor
Pat. No. 8759316 Maintenance of platelet inhibition during antiplatelet therapy
Claim Types: Method of administration
May 13, 2029U-1715: P2y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a p2y12 platelet inhibitor and not given a glycoprotein iib/iiia inhibitor
Pat. No. 9925265 Methods of treating or preventing stent thrombosis
Claim Types: Method of use
May 13, 2029U-2260: Method of reducing the risk of periprocedural myocardial infarction, and stent thrombosis in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and then a continuous infusion
Pat. No. 9427448 Methods of treating, reducing the incidence of, and/or preventing ischemic events
Claim Types: Method of use
Nov 10, 2030U-1926: Method of treating, reducing the incidence of, or preventing an ischemic event in a patient undergoing PCI by administering intravenously 30 ug/kg bolus before PCI and continuous infusion of 4 ug/kg/min for at least 2 hours or the duration of the PCI
Pat. No. 8680052 Methods of treating, reducing the incidence of, and/or preventing ischemic events
Claim Types: Method of administration
Mar 9, 2033U-1715: P2y12 platelet inhibitor for use as adjunct to percutaneous coronary intervention to reduce risk of various diseases/conditions in patients not treated with a p2y12 platelet inhibitor and not given a glycoprotein iib/iiia inhibitor
Pat. No. 9295687 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Claim Types: Product-by-process; Drug in a container
Jul 10, 2035 
Pat. No. 9439921 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Claim Types: Formulation; Drug in a container
Jul 10, 2035 
Pat. No. 9700575 DP* Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same
Claim Types: Composition; Formulation; Drug in a container
Jul 10, 2035 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 22, 2020 

JYNARQUE (TABLET) (ORAL) TOLVAPTAN
Drug Classes: vasopressin V2-receptor antagonist
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 204441  Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG); 004 RX (60MG); 005 RX (90MG)
PatentsExpirationPatented Use
Pat. No. 5972882 Treatment of polycystic kidney disease using vasopressin V.sub.2 receptor antagonists
Claim Types: Method of use
Dec 14, 2018U-2307: Treatment of autosomal dominant polycystic kidney disease
Pat. No. 5753677 Benzoheterocyclic compounds
Claim Types: Method of use
May 19, 2020U-2307: Treatment of autosomal dominant polycystic kidney disease
Pat. No. 8501730 DS* Process for preparing benzazepine compounds or salts thereof
Claim Types: Product-by-process
Sep 1, 2026 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 23, 2021I-779: Use of tolvaptan to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)
Exclusivity Code: ODE - Orphan drug exclusivityApr 23, 2025ODE-178: Indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)

PYLERA (CAPSULE) (ORAL) BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE
Drug Classes: nitroimidazole antimicrobial; tetracycline class antimicrobial; tetracycline class drug; tetracycline class antibacterial
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 050786  Prod. No.: 001 RX (140MG;125MG;125MG)
PatentsExpirationPatented Use
Pat. No. 6350468 Double capsule for the administration of active principles in multiple therapies
Claim Types: Method of use; Formulation
Dec 14, 2018U-932: PYLERA capsules, in combination with omeprazole are indicated for the treatment of patients with helicobacter pylori infection and duodenal ulcer disease to eradicate H. pylori
U-956: Treatment of patients with H. pylori infection and duodenal ulcer disease

RAPIVAB (SOLUTION) (INTRAVENOUS) PERAMIVIR
Drug Classes: influenza neuraminidase inhibitor (NAI)
NDA Applicant: BIOCRYST      NDA No.: 206426  Prod. No.: 001 RX (200MG/20ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 6562861 DS* Substituted cyclopentane and cyclopentene compounds useful as neuraminidase inhibitors
Claim Types: Compound; Composition; Method of use
Dec 17, 2018 
Pat. No. 6503745 DS* Cyclopentane and cyclopentene compounds for influenza virus
Claim Types: Compound; Diagnostic or surgical method
Nov 5, 2019 
Pat. No. 8778997 Antiviral treatments
Claim Types: Method of use
May 7, 2027U-1627: Treatment of acute uncomplicated influenza in adults
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 19, 2019 
Exclusivity Code: NPP - New patient populationSep 20, 2020 

GEODON (CAPSULE) (ORAL) ZIPRASIDONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: PFIZER      NDA No.: 020825  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 60MG BASE); 004 RX (EQ 80MG BASE)
PatentsExpirationPatented Use
Pat. No. 6245766 Method of treating psychiatric conditions
Claim Types: Method of use
Dec 18, 2018U-601: Treatment of bipolar disorders
Pat. No. 6150366 DP* Ziprasidone formulations
Claim Types: Formulation; Method of use; Process
May 27, 2019 

GEODON (SUSPENSION) (ORAL) ZIPRASIDONE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: PFIZER INC      NDA No.: 021483  Prod. No.: 001 DISC (EQ 10MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 6245766 Method of treating psychiatric conditions
Claim Types: Method of use
Dec 18, 2018U-601: Treatment of bipolar disorders
Pat. No. 6150366 DP* Ziprasidone formulations
Claim Types: Formulation; Method of use; Process
May 27, 2019U-719: Treatent of psychosis
Pat. No. 7175855 DP* Ziprasidone suspension
Claim Types: Formulation
May 18, 2020 

VELPHORO (TABLET, CHEWABLE) (ORAL) SUCROFERRIC OXYHYDROXIDE
NDA Applicant: VIFOR FRESENIUS      NDA No.: 205109  Prod. No.: 001 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 6174442 DS* Adsorbent for phosphate from an aqueous medium, production and use of said adsorbent
Claim Types: Formulation; Process
Dec 19, 2018U-1468: Control of phosphorous levels in patients
Pat. No. 9561251 DP* Pharmaceutical compositions
Claim Types: Formulation; Process; Product-by-process; Method of use
Jan 23, 2030U-1468: Control of phosphorous levels in patients

TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: opioid antagonist; opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 205777  Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
PatentsExpirationPatented Use
Pat. No. 6277384 DP* Opioid agonist/antagonist combinations
Claim Types: Formulation; Method of use
Dec 22, 2018 
Pat. No. 6696066 DP* Opioid agonist/antagonist combinations
Claim Types: Formulation; Method of use
Dec 22, 2018 
Pat. No. 8673355 DP* Opioid agonist/antagonist combinations
Claim Types: Formulation; Method of use
Dec 22, 2018 
Pat. No. 8822487 DP* Opioid agonist/opioid antagonist/acetaminophen combinations
Claim Types: Formulation
Dec 22, 2018 
Pat. No. 9205082 DP* Opioid agonist/antagonist combinations
Claim Types: Method of use; Formulation
Dec 22, 2018U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9474750 DP* Opioid agonist/opioid antagonist/acetaminophen combinations
Claim Types: Formulation; Method of use
Dec 22, 2018U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9056051 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9084729 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9161937 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9168252 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9283216 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate
Pat. No. 9283221 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation
May 10, 2022U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate
Pat. No. 9345701 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate
Pat. No. 9511066 Abuse-resistant controlled-release opioid dosage form
Claim Types: Method of use
May 10, 2022U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product
Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Apr 4, 2023 
Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Apr 4, 2023 
Pat. No. 9555000 DP* Pharmaceutical preparation containing oxycodone and naloxone
Claim Types: Formulation; Method of use
Apr 4, 2023U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9907793 DP* Pharmaceutical preparation containing oxycodone and naloxone
Claim Types: Formulation; Method of use
Apr 4, 2023U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Mar 30, 2025 
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Mar 30, 2025 

TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: opioid antagonist; opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 205777  Prod. No.: 003 DISC (20MG;40MG)
PatentsExpirationPatented Use
Pat. No. 6277384 DP* Opioid agonist/antagonist combinations
Claim Types: Formulation; Method of use
Dec 22, 2018 
Pat. No. 6696066 DP* Opioid agonist/antagonist combinations
Claim Types: Formulation; Method of use
Dec 22, 2018 
Pat. No. 8673355 DP* Opioid agonist/antagonist combinations
Claim Types: Formulation; Method of use
Dec 22, 2018 
Pat. No. 8822487 DP* Opioid agonist/opioid antagonist/acetaminophen combinations
Claim Types: Formulation
Dec 22, 2018 
Pat. No. 9205082 DP* Opioid agonist/antagonist combinations
Claim Types: Method of use; Formulation
Dec 22, 2018U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9474750 DP* Opioid agonist/opioid antagonist/acetaminophen combinations
Claim Types: Formulation; Method of use
Dec 22, 2018U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9056051 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9084729 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9161937 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9168252 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation
May 10, 2022U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Pat. No. 9283216 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate
Pat. No. 9283221 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation
May 10, 2022U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate
Pat. No. 9345701 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
May 10, 2022U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate
Pat. No. 9511066 Abuse-resistant controlled-release opioid dosage form
Claim Types: Method of use
May 10, 2022U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product
Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Apr 4, 2023 
Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Apr 4, 2023 
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Mar 30, 2025 
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Mar 30, 2025 

SPRIX (SPRAY, METERED) (NASAL) KETOROLAC TROMETHAMINE
Drug Classes: cyclooxygenase inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: EGALET US INC      NDA No.: 022382  Prod. No.: 001 RX (15.75MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 6333044 DP* Therapeutic compositions for intranasal administration which include KETOROLAC.RTM.
Claim Types: Formulation; Method of use
Dec 25, 2018U-1057: Treatment of inflammation and pain using a nasal spray of ketorolac tromethamine

ELIDEL (CREAM) (TOPICAL) PIMECROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: VALEANT BERMUDA      NDA No.: 021302  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 6423722 Crystalline macrolides and process for their preparation
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Dec 26, 2018 *PED 

LYRICA (CAPSULE) (ORAL) PREGABALIN
NDA Applicant: PF PRISM CV      NDA No.: 021446  Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (75MG); 004 RX (100MG); 005 RX (150MG); 006 RX (200MG); 007 RX (225MG); 008 RX (300MG)
PatentsExpirationPatented Use
Pat. No. RE41920 Isobutylgaba and its derivatives for the treatment of pain
Claim Types: Method of use
Dec 30, 2018U-1250: Treatment of pain, including neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia
Pat. No. 6001876 [Extended 533 days* (1.5 years)]
Isobutylgaba and its derivatives for the treatment of pain
Claim Types: Method of use
Dec 30, 2018U-55: Treatment of pain
U-819: Management of fibromyalgia
Pat. No. 6197819 DS* DP* [Extended 300 days* (0.8 years)]
Gamma amino butyric acid analogs and optical isomers
Claim Types: Compound; Composition
Dec 30, 2018 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 22, 2019M-193: Information added to the labeling regarding a 15-week, randomized, double-blind, parallel-group, placebo-controlled flexible-dose safety and efficacy study of pregabalin in adolescents (12 through 17 years old) with fibromyalgia
Exclusivity Code: NPP - New patient populationMay 3, 2021 

LYRICA (SOLUTION) (ORAL) PREGABALIN
NDA Applicant: PF PRISM CV      NDA No.: 022488  Prod. No.: 001 RX (20MG/ML)
PatentsExpirationPatented Use
Pat. No. RE41920 Isobutylgaba and its derivatives for the treatment of pain
Claim Types: Method of use
Dec 30, 2018U-1250: Treatment of pain, including neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia
Pat. No. 6001876 [Extended 533 days* (1.5 years)]
Isobutylgaba and its derivatives for the treatment of pain
Claim Types: Method of use
Dec 30, 2018U-55: Treatment of pain
U-819: Management of fibromyalgia
Pat. No. 6197819 DS* DP* [Extended 300 days* (0.8 years)]
Gamma amino butyric acid analogs and optical isomers
Claim Types: Compound; Composition
Dec 30, 2018 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 22, 2019M-193: Information added to the labeling regarding a 15-week, randomized, double-blind, parallel-group, placebo-controlled flexible-dose safety and efficacy study of pregabalin in adolescents (12 through 17 years old) with fibromyalgia
Exclusivity Code: NPP - New patient populationMay 3, 2021 

LYRICA CR (TABLET, EXTENDED RELEASE) (ORAL) PREGABALIN
NDA Applicant: PFIZER INC      NDA No.: 209501  Prod. No.: 001 RX (82.5MG); 002 RX (165MG); 003 RX (330MG)
PatentsExpirationPatented Use
Pat. No. RE41920 Isobutylgaba and its derivatives for the treatment of pain
Claim Types: Method of use
Dec 30, 2018U-2136: Treatment of neuropathic pain associated with diabetic peripheral neuropathy
U-2137: Treatment of postherpetic neuralgia
Pat. No. 6197819 DS* DP* [Extended 300 days* (0.8 years)]
Gamma amino butyric acid analogs and optical isomers
Claim Types: Compound; Composition
Dec 30, 2018 
Pat. No. 8945620 DP* Solid pharmaceutical compositions containing pregabalin
Claim Types: Formulation; Method of use
Nov 2, 2026U-2136: Treatment of neuropathic pain associated with diabetic peripheral neuropathy
U-2137: Treatment of postherpetic neuralgia
Pat. No. 9144559 DP* Solid pharmaceutical compositions containing pregabalin
Claim Types: Formulation
Nov 2, 2026 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productOct 11, 2020 

VIVITROL (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) NALTREXONE
Drug Classes: opioid antagonist
NDA Applicant: ALKERMES      NDA No.: 021897  Prod. No.: 001 RX (380MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6194006 DP* Preparation of microparticles having a selected release profile
Claim Types: Product-by-process; Process
Dec 30, 2018 
Pat. No. 6379703 DP* Preparation of microparticles having a selected release profile
Claim Types: Product-by-process; Process
Dec 30, 2018 
Pat. No. 6596316 DP* Preparation of microparticles having a selected release profile
Claim Types: Product-by-process; Process
Dec 30, 2018 
Pat. No. 6331317 DP* Apparatus and method for preparing microparticles
Claim Types: Device; Product-by-process; Process
Nov 12, 2019 
Pat. No. 6395304 DP* Apparatus and method for preparing microparticles
Claim Types: Formulation; Product-by-process
Nov 12, 2019 
Pat. No. 6495166 DP* Apparatus and method for preparing microparticles using in-line solvent extraction
Claim Types: Formulation; Product-by-process
Nov 12, 2019 
Pat. No. 6537586 DP* Apparatus and method for preparing microparticles
Claim Types: Product-by-process; Process
Nov 12, 2019 
Pat. No. 6713090 DP* Apparatus and method for preparing microparticles
Claim Types: Product-by-process; Process
Nov 12, 2019 
Pat. No. 6939033 DP* Method and apparatus for preparing microparticles using in-line solvent extraction
Claim Types: Product-by-process; Process
Nov 12, 2019 
Pat. No. 6264987 DP* Method for preparing microparticles having a selected polymer molecular weight
Claim Types: Product-by-process; Process
May 19, 2020 
Pat. No. 6379704 DP* Method for preparing microparticles having a selected polymer molecular weight
Claim Types: Product-by-process; Process
May 19, 2020 
Pat. No. 6534092 DP* Method for preparing microparticles having a selected polymer molecular weight
Claim Types: Product-by-process; Process
May 19, 2020 
Pat. No. 6495164 DP* Preparation of injectable suspensions having improved injectability
Claim Types: Formulation; Process; Method of use; Product-by-process
May 25, 2020 
Pat. No. 6667061 DP* Preparation of injectable suspensions having improved injectability
Claim Types: Formulation
May 25, 2020 
Pat. No. 7799345 DP* Preparation of injectable suspensions having improved injectability
Claim Types: Composition
May 25, 2020 
Pat. No. 7919499 Naltrexone long acting formulations and methods of use
Claim Types: Method of use
Oct 15, 2029U-1123: Treatment of alcohol dependence
U-1124: Prevention of relapse to opioid dependence, following opioid detoxification


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
* Extension limited by the 14-year cap of 35 USC 156(c)(3)
**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Last edited: 3 September 2018
2001-2018 Bruce A. Pokras, All rights reserved worldwide