Orange Book Companion
Products that will have a patent expiration in September

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 No.: 001 DISC (0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
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 No.: 003 DISC (5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
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.


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
Last edited: 1 September 2018
2001-2018 Bruce A. Pokras, All rights reserved worldwide