Injectable Patent Expiration View
Injectable products whose first patent expiration is in 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.


BYETTA (INJECTABLE) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.:
021773  Prod. No.: 001 RX (300MCG/1.2ML (250MCG/ML)); 002 RX (600MCG/2.4ML (250MCG/ML))
PatentsExpirationPatented Use
Pat. No. 6956026 Use of exendins for the reduction of food intake
Claim Types: Method of use
Jan 7, 2018U-1074: Use of exenatide may result in reduction in body weight
U-1623: Use of exenatide may result in reduction in appetite.
U-687: Reducing food intake in a subject with Type 2 diabetes by administering an exendin, such as exendin-4
Pat. No. 7741269 Exendins and exendin agonists for weight reduction and obesity
Claim Types: Method of use
Jan 7, 2018U-1074: Use of exenatide may result in reduction in body weight
U-1108: Treating Type 2 diabetes mellitus with exenatide by stimulating insulin release
U-653: Stimulating insulin release by administering exenatide
Pat. No. 6872700 Methods for glucagon suppression
Claim Types: Method of use
Jan 14, 2020U-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4
Pat. No. 6902744 DP* Exendin agonist formulations and methods of administration thereof
Claim Types: Formulation
Jan 14, 2020 

FOLLISTIM AQ (INJECTABLE) FOLLITROPIN ALFA/BETA
Drug Classes: gonadotropin
NDA Applicant: ORGANON USA INC      NDA No.:
021211  Prod. No.: 001 RX (300 IU/0.36ML); 002 RX (600 IU/0.72ML); 004 RX (900 IU/1.08ML) NDA No.: 021211  Prod. No.: 003 DISC (150 IU/0.18ML)
PatentsExpirationPatented Use
Pat. No. 5929028 DP* Liquid gonadotropin containing formulations
Claim Types: Drug in a container; Process; Method of use
Jan 14, 2018U-1366: Treatment of infertility through induction of ovulation and pregnancy to anovulatory infertile women
U-567: Method of treating infertility
Pat. No. 7446090 DP* FSH formulation
Claim Types: Process; Drug in a container; Formulation
Aug 23, 2019 
Pat. No. 7563763 FSH and FSH variant formulations, products and methods
Claim Types: Method of administration; Method of use; Kit
Aug 23, 2019U-1183: A method for administering follicle stimulating hormone (FSH) for ovarian follicle or testicular stimulation in the human
U-1367: Method of administering FSH for the treatment of infertility through induction of ovulation and pregnancy in anovulatory infertile women
U-993: Method of treating infertility

FOLLISTIM AQ (INJECTABLE) FOLLITROPIN ALFA/BETA
Drug Classes: gonadotropin
NDA Applicant: ORGANON USA INC      NDA No.:
021273  Prod. No.: 001 DISC (75 IU/0.5ML); 002 DISC (150 IU/0.5ML)
PatentsExpirationPatented Use
Pat. No. 5929028 DP* Liquid gonadotropin containing formulations
Claim Types: Drug in a container; Process; Method of use
Jan 14, 2018U-1366: Treatment of infertility through induction of ovulation and pregnancy to anovulatory infertile women

ULTIVA (INJECTABLE) REMIFENTANIL HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist
NDA Applicant: MYLAN INSTITUTIONAL      NDA No.:
020630  Prod. No.: 001 RX (EQ 1MG BASE/VIAL); 002 RX (EQ 2MG BASE/VIAL); 003 RX (EQ 5MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 5866591 DP* Stable formulations of remifentanil
Claim Types: Formulation
Mar 10, 2018 *PED 

NEUTREXIN (INJECTABLE) TRIMETREXATE GLUCURONATE
NDA Applicant: MEDIMMUNE ONCOLOGY      NDA No.:
020326  Prod. No.: 001 DISC (EQ 25MG BASE/VIAL); 002 DISC (EQ 200MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6017922 Thermally stable trimetrexates and processes for producing the same
Claim Types: New polymorph, salt or hydrate; Composition
May 18, 2018 

VFEND (INJECTABLE) VORICONAZOLE [GENERIC AP]
Drug Classes: azole antifungal
NDA Applicant: PF PRISM CV      NDA No.:
021267  Prod. No.: 001 RX (200MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6632803 DP* Pharmaceutical formulations containing voriconazole
Claim Types: Formulation; Product-by-process
Jun 2, 2018 

GANIRELIX ACETATE (INJECTABLE) GANIRELIX ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) antagonist
NDA Applicant: ORGANON USA INC      NDA No.:
021057  Prod. No.: 001 RX (EQ 250MCG BASE/0.5ML)
PatentsExpirationPatented Use
Pat. No. 6653286 Gonadotropin releasing hormone antagonist
Claim Types: Method of use
Jun 16, 2018U-1354: Inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation with FSH

APIDRA (INJECTABLE) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US      NDA No.:
021629  Prod. No.: 001 RX (1000 UNITS/10ML (100 UNITS/ML)); 002 RX (300 UNITS/3ML (100 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action
Claim Types: Compound; Process; Composition; Intermediate
Jun 18, 2018U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation
Mar 22, 2022 
Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Method of use
Mar 22, 2022U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Process
Jan 25, 2023U-471: Method of treating a patient suffering from diabetes mellitus

APIDRA SOLOSTAR (INJECTABLE) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US      NDA No.:
021629  Prod. No.: 003 RX (300 UNITS/3ML)
PatentsExpirationPatented Use
Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action
Claim Types: Compound; Process; Composition; Intermediate
Jun 18, 2018U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation
Mar 22, 2022 
Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Method of use
Mar 22, 2022U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Process
Jan 25, 2023U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 8603044 DP* Pen-type injector
Claim Types: Device
Mar 2, 2024 
Pat. No. 9233211 DP* Relating to a pen-type injector
Claim Types: Device
Mar 2, 2024 
Pat. No. 9408979 DP* Pen-type injector
Claim Types: Device
Mar 2, 2024 
Pat. No. 9526844 DP* Pen-type injector
Claim Types: Device
Mar 2, 2024 
Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Mar 2, 2024 
Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Mar 2, 2024 
Pat. No. 9775954 DP* Pen-type injector
Claim Types: Device
Mar 2, 2024 
Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device; Method of administration
Mar 2, 2024U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve
Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Mar 3, 2024 
Pat. No. 9011391 Pen-type injector
Claim Types: Method of use
Mar 26, 2024U-1832: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve
Pat. No. 8992486 DP* Pen-type injector
Claim Types: Device
Jun 5, 2024 
Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Aug 16, 2024 
Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Aug 17, 2024 
Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Aug 19, 2024 
Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Aug 28, 2024 
Pat. No. 8512297 DP* Pen-type injector
Claim Types: Device
Sep 15, 2024 
Pat. No. 8679069 DP* Pen-type injector
Claim Types: Device
Apr 12, 2025 
Pat. No. 7918833 DP* Pen-type injector
Claim Types: Device
Sep 23, 2027 
Pat. No. 9717852 DP* Cartridge holder and pen-type injector
Claim Types: Device
Apr 8, 2033 

ZITHROMAX (INJECTABLE) AZITHROMYCIN [GENERIC AP]
Drug Classes: macrolide antimicrobial
NDA Applicant: PFIZER      NDA No.:
050733  Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6268489 DS* Azithromycin dihydrate
Claim Types: New polymorph, salt or hydrate; Process
Jul 31, 2018 

EXPAREL (INJECTABLE, LIPOSOMAL) 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: Process; Formulation; Method of use
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: Process; Product-by-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) 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: Process; Formulation; Method of use
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: Process; Product-by-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

ELIGARD (INJECTABLE) 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) 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) 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) 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

TRISENOX (INJECTABLE) ARSENIC TRIOXIDE
NDA Applicant: CEPHALON      NDA No.:
021248  Prod. No.: 001 RX (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) 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

GENOTROPIN PRESERVATIVE FREE (INJECTABLE) 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 

IXEMPRA KIT (INJECTABLE) 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: Process; Formulation; Method of use
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: Process; Product-by-process; Formulation; Method of use
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

FORTEO (INJECTABLE) 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: Process; Drug in a container; Method of use
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) 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: Process; Drug in a container; Method of use
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 


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
Last edited: 25 July 2018
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