Orange Book Companion
"What's New" Sample
(Vol. 41, Supp. 05)
Changes to patent and exclusivity information

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


ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
PatentsExpirationChange
Pat. No. 10980803
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Pat. Sub. Date(s): All strengths: May 19, 2021
Claim Types: Method of use
Use Code: U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
Use Code: U-543: Treatment of schizophrenia
Sep 24, 2033New patent for this product

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 001 DISC (0.055MG/INH); 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH)
PatentsExpirationChange
Pat. No. 10918816 DP*
Compliance monitoring module for a breath-actuated inhaler
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Claim Types: Device; Method of administration
Dec 14, 2035New patent for this product

AUBAGIO (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: SANOFI AVENTIS US      NDA No.: 202992  Prod. No.: 001 RX (7MG); 002 RX (14MG)
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-61: Revisions to labeling based on data submitted in response to pediatric written requestOct 30, 2024 PEDNew exclusivity for this product

AZSTARYS (CAPSULE) (ORAL) DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Drug Classes: central nervous system stimulant
NDA Applicant: COMMAVE THERAP      NDA No.: 212994  Prod. No.: 001 RX (EQ 5.2MG BASE;EQ 26.1MG BASE); 002 RX (EQ 7.8MG BASE;EQ 39.2MG BASE); 003 RX (EQ 10.4MG BASE;EQ 52.3MG BASE)
PatentsExpirationChange
Pat. No. 9079928 DP*
Methylphenidate-oxoacid conjugates, processes of making and using the same
Pat. Sub. Date(s): All strengths: May 17, 2021
Claim Types: Composition
Jul 27, 2032New product in Orange Book
Pat. No. 10584112 DS* DP*
Methylphenidate-prodrugs, processes of making and using the same
Pat. Sub. Date(s): All strengths: May 17, 2021
Claim Types: Compound; Composition
Dec 9, 2037New product in Orange Book
Pat. No. 10584113 DP*
Methylphenidate-prodrugs, processes of making and using the same
Pat. Sub. Date(s): All strengths: May 17, 2021
Claim Types: Composition
Dec 9, 2037New product in Orange Book
Pat. No. 10759778 DP*
Methylphenidate-prodrugs, processes of making and using the same
Pat. Sub. Date(s): All strengths: May 17, 2021
Claim Types: Kit
Dec 9, 2037New product in Orange Book
Pat. No. 10858341
Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Pat. Sub. Date(s): All strengths: May 17, 2021
Claim Types: Method of use
Use Code: U-3094: Treatment of attention-deficit hyperactivity disorder (ADHD) with serdexmethylphenidate and dexmethylphenidate
Dec 9, 2037New product in Orange Book
Pat. No. 10954213
Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Pat. Sub. Date(s): All strengths: May 17, 2021
Claim Types: Method of use
Use Code: U-3094: Treatment of attention-deficit hyperactivity disorder (ADHD) with serdexmethylphenidate and dexmethylphenidate
Dec 9, 2037New product in Orange Book
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity May 7, 2026New product in Orange Book

BINOSTO (TABLET, EFFERVESCENT) (ORAL) ALENDRONATE SODIUM
NDA Applicant: ASCEND THERAPS US      NDA No.: 202344  Prod. No.: 001 RX (EQ 70MG BASE)
PatentsExpirationChange
Pat. No. 9592195 DP*
Stable effervescent bisphosphonate formulations with rapid solubilization characteristics
Pat. Sub. Date(s): 001: May 12, 2021
Claim Types: Formulation
Dec 5, 2031New patent for this product

BRUKINSA (CAPSULE) (ORAL) ZANUBRUTINIB
NDA Applicant: BEIGENE      NDA No.: 213217  Prod. No.: 001 RX (80MG)
PatentsExpirationChange
Pat. No. 10570139 DS* DP*
Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Pat. Sub. Date(s): 001: Jun 4, 2021
Claim Types: Method of use
Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Apr 22, 2034New patent for this product

BYFAVO (POWDER) (INTRAVENOUS) REMIMAZOLAM BESYLATE
NDA Applicant: ACACIA      NDA No.: 212295  Prod. No.: 001 RX (EQ 20MG BASE/VIAL)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Oct 6, 2025New expiration date. Was previously Jul 2, 2025

CALCITONIN-SALMON (INJECTABLE) (INJECTION) CALCITONIN SALMON [GENERIC AP]
Drug Classes: calcitonin
NDA Applicant: CUSTOPHARM INC      NDA No.: 212416  Prod. No.: 001 RX (200 IU/ML)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Nov 10, 2021New product in Orange Book

CARBAGLU (TABLET, FOR SUSPENSION) (ORAL) CARGLUMIC ACID
Drug Classes: Carbamoyl Phosphate Synthetase 1 (CPS 1) activator
NDA Applicant: RECORDATI RARE      NDA No.: 022562  Prod. No.: 001 RX (200MG)
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-345: In pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA)Jan 22, 2028New exclusivity for this product

CYCLOSET (TABLET) (ORAL) BROMOCRIPTINE MESYLATE
Drug Classes: ergot derivative
NDA Applicant: VEROSCIENCE      NDA No.: 020866  Prod. No.: 001 RX (EQ 0.8MG BASE)
PatentsExpirationChange
Pat. No. 11000522
Bromocriptine formulations
Pat. Sub. Date(s): 001: Jun 3, 2021
Claim Types: Formulation claimed by its inherent performace characteristics
Use Code: U-3119: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 11
Use Code: U-3120: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1, 11, and 12
Use Code: U-3121: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 13 and 23
Use Code: U-3122: Adjunct to diet exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 13, 23, and 24
Apr 30, 2032New patent for this product

DIOVAN (TABLET) (ORAL) VALSARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 021283  Prod. No.: 001 RX (80MG); 002 RX (160MG); 004 RX (40MG)
ExclusivityExpirationChange
Exclusivity Code: NPP - New patient population Apr 19, 2024New exclusivity for this product

DOCETAXEL (INJECTABLE) (INJECTION) DOCETAXEL [GENERIC AP]
Drug Classes: microtubule inhibitor
NDA Applicant: SHILPA      NDA No.: 205934  Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (80MG/4ML (20MG/ML)); 003 RX (160MG/8ML (20MG/ML))
PatentsExpirationChange
Pat. No. 10842770 DP*
Non-aqueous taxane pro-emulsion formulations and methods of making and using the same
Pat. Sub. Date(s): All strengths: Dec 15, 2020
Claim Types: Formulation; Method of administration; Kit
Use Code: U-2998: Method of administering docetaxel to a subject combining the docetaxel pro-emulsion formulation with an aqueous medium to produce docetaxel emulsion
Aug 7, 2031New expiration date. Was previously Aug 4, 2031

EMPAVELI (SOLUTION) (SUBCUTANEOUS) PEGCETACOPLAN
NDA Applicant: APELLIS PHARMS      NDA No.: 215014  Prod. No.: 001 RX (1080MG/20ML (54MG/ML))
PatentsExpirationChange
Pat. No. 7888323 DS*
Potent compstatin analogs
Pat. Sub. Date(s): 001: Jun 9, 2021
Claim Types: Compound
Dec 4, 2027New product in Orange Book
Pat. No. 7989589 DS*
Compstatin analogs with improved activity
Pat. Sub. Date(s): 001: Jun 9, 2021
Claim Types: Compound
Dec 4, 2027New product in Orange Book
Pat. No. 9169307 DS*
Potent compstatin analogs
Pat. Sub. Date(s): 001: Jun 9, 2021
Claim Types: Compound; Process; Method of use
Use Code: U-3123: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of complement inhibitor pegcetacoplan
Nov 18, 2027New product in Orange Book
Pat. No. 10035822 DS*
Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Pat. Sub. Date(s): 001: Jun 9, 2021
Claim Types: Compound
Nov 15, 2033New product in Orange Book
Pat. No. 10125171 DS*
Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Pat. Sub. Date(s): 001: Jun 9, 2021
Claim Types: Compound
Aug 2, 2033New product in Orange Book
Pat. No. 10875893 DS*
Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Pat. Sub. Date(s): 001: Jun 9, 2021
Claim Types: Compound; Method of use
Use Code: U-3124: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan
Nov 15, 2033New product in Orange Book
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-351: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)May 14, 2028New product in Orange Book

EPCLUSA (TABLET) (ORAL) SOFOSBUVIR; VELPATASVIR
Drug Classes: hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208341  Prod. No.: 001 RX (400MG;100MG)
PatentsExpirationChange
Pat. No. 8575135 DS* DP*
Antiviral compounds
Pat. Sub. Date(s): 001: Jul 15, 2016
Claim Types: Compound; Composition; Method of use
Use Code: U-1470: For the treatment of hepatitis C
May 16, 2033 *PEDNew expiration date. Was previously Nov 16, 2032
Pat. No. 8735372
Nucleoside phosphoramidate prodrugs
Pat. Sub. Date(s): 001: Jul 15, 2016
Claim Types: Method of use
Use Code: U-1470: For the treatment of hepatitis C
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8921341 DS* DP*
Antiviral compounds
Pat. Sub. Date(s): 001: Jul 15, 2016
Claim Types: Compound; Composition; Method of use
Use Code: U-1470: For the treatment of hepatitis C
May 16, 2033 *PEDNew expiration date. Was previously Nov 16, 2032
Pat. No. 8940718 DS* DP*
Antiviral compounds
Pat. Sub. Date(s): 001: Jul 15, 2016
Claim Types: Compound; Composition; Method of use
Use Code: U-1470: For the treatment of hepatitis C
May 16, 2033 *PEDNew expiration date. Was previously Nov 16, 2032
Pat. No. 9757406 DP*
Combination formulation of two antiviral compounds
Pat. Sub. Date(s): 001: Sep 26, 2017
Claim Types: Formulation
Jul 30, 2034 *PEDNew expiration date. Was previously Jan 30, 2034
Pat. No. 10086011
Combination formulation of two antiviral compounds
Pat. Sub. Date(s): 001: Oct 23, 2018
Claim Types: Method of use
Use Code: U-1470: For the treatment of hepatitis C
Jul 30, 2034 *PEDNew expiration date. Was previously Jan 30, 2034
ExclusivityExpirationChange
Exclusivity Code: D - New Dosing Schedule: D-177: Information added to the dosing section in regard to the treatment of chronic hepatitis C virus infection in patients with severe renal impairment including patients with end stage renal disease on dialysisMay 15, 2023 PEDNew expiration date. Was previously Nov 15, 2022
Exclusivity Code: M - Miscellaneous: M-264: Information added to the labeling describing a phase 2, multicenter, open-label study to evaluate the safety/efficacy of sofosbuvir/velpatasvir in subjects with chronic HCV infection who have received a liver transplantJan 14, 2024 PEDNew expiration date. Was previously Jul 14, 2023
Exclusivity Code: NPP - New patient population Sep 19, 2023 PEDNew expiration date. Was previously Mar 19, 2023
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-293: Tx of ped pts 6 yrs of age & older or weighing at least 17 kg with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirinSep 19, 2027 PEDNew expiration date. Was previously Mar 19, 2027

EPCLUSA (TABLET) (ORAL) SOFOSBUVIR; VELPATASVIR
Drug Classes: hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208341  Prod. No.: 002 RX (200MG;50MG)
PatentsExpirationChange
Pat. No. 7964580 DS* DP*
Nucleoside phosphoramidate prodrugs
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Compound; Composition; Method of use; Process; Product-by-process
Use Code: U-1470: For the treatment of hepatitis C
Sep 26, 2029 *PEDNew expiration date. Was previously Mar 26, 2029
Pat. No. 8334270 DS* DP*
Nucleoside phosphoramidate prodrugs
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Compound; Composition; Method of use
Use Code: U-1470: For the treatment of hepatitis C
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8575135 DS* DP*
Antiviral compounds
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Compound; Composition; Method of use
Use Code: U-1470: For the treatment of hepatitis C
May 16, 2033 *PEDNew expiration date. Was previously Nov 16, 2032
Pat. No. 8580765 DS* DP*
Nucleoside phosphoramidate prodrugs
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Compound; Composition; Method of use; Process
Use Code: U-1470: For the treatment of hepatitis C
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8618076 DS* DP*
Nucleoside phosphoramidates
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Use Code: U-1470: For the treatment of hepatitis C
Jun 11, 2031 *PEDNew expiration date. Was previously Dec 11, 2030
Pat. No. 8633309 DS* DP*
Nucleoside phosphoramidates
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Compound; Composition; Method of use
Use Code: U-1470: For the treatment of hepatitis C
Sep 26, 2029 *PEDNew expiration date. Was previously Mar 26, 2029
Pat. No. 8735372
Nucleoside phosphoramidate prodrugs
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Method of use
Use Code: U-1470: For the treatment of hepatitis C
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8889159 DP*
Compositions and methods for treating hepatitis C virus
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Composition; Formulation; Process; Method of use
Use Code: U-1470: For the treatment of hepatitis C
Sep 26, 2029 *PEDNew expiration date. Was previously Mar 26, 2029
Pat. No. 8921341 DS* DP*
Antiviral compounds
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Compound; Composition; Method of use
Use Code: U-1470: For the treatment of hepatitis C
May 16, 2033 *PEDNew expiration date. Was previously Nov 16, 2032
Pat. No. 8940718 DS* DP*
Antiviral compounds
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Compound; Composition; Method of use
Use Code: U-1470: For the treatment of hepatitis C
May 16, 2033 *PEDNew expiration date. Was previously Nov 16, 2032
Pat. No. 9085573 DS* DP*
Nucleoside phosphoramidate prodrugs
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Compound; Composition; Method of use
Use Code: U-1470: For the treatment of hepatitis C
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 9284342 DS* DP*
Nucleoside phosphoramidates
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Use Code: U-1470: For the treatment of hepatitis C
Mar 13, 2031 *PEDNew expiration date. Was previously Sep 13, 2030
Pat. No. 9757406 DP*
Combination formulation of two antiviral compounds
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Formulation
Jul 30, 2034 *PEDNew expiration date. Was previously Jan 30, 2034
Pat. No. 10086011
Combination formulation of two antiviral compounds
Pat. Sub. Date(s): 002: Apr 16, 2020
Claim Types: Method of use
Use Code: U-1470: For the treatment of hepatitis C
Jul 30, 2034 *PEDNew expiration date. Was previously Jan 30, 2034
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-264: Information added to the labeling describing a phase 2, multicenter, open-label study to evaluate the safety/efficacy of sofosbuvir/velpatasvir in subjects with chronic HCV infection who have received a liver transplantJan 14, 2024 PEDNew expiration date. Was previously Jul 14, 2023
Exclusivity Code: NS - New strength Sep 19, 2023 PEDNew expiration date. Was previously Mar 19, 2023
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-293: Tx of ped pts 6 yrs of age & older or weighing at least 17 kg with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirinSep 19, 2027 PEDNew expiration date. Was previously Mar 19, 2027

ERIVEDGE (CAPSULE) (ORAL) VISMODEGIB
Drug Classes: hedgehog pathway inhibitor
NDA Applicant: GENENTECH      NDA No.: 203388  Prod. No.: 001 RX (150MG)
PatentsExpirationChange
Pat. No. 9790183
Pyridyl inhibitors of hedgehog signalling
Pat. Sub. Date(s): 001: May 19, 2021
Claim Types: Method of use
Use Code: U-3109: Method of using vismodegib to treat basal cell carcinoma
Sep 2, 2025New patent for this product

EYSUVIS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: corticosteroid
NDA Applicant: KALA PHARMS INC      NDA No.: 210933  Prod. No.: 001 RX (0.25%)
PatentsExpirationChange
Pat. No. 10993908
Compositions and methods for ophthalmic and/or other applications
Pat. Sub. Date(s): 001: May 26, 2021
Claim Types: Method of administration
Use Code: U-3117: Administration to the eye of a patient for treatment of dry eye condition
May 3, 2033New patent for this product

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 202293  Prod. No.: 001 RX (5MG); 002 RX (10MG)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progressionApr 30, 2024New exclusivity for this product

FERRIPROX (TABLET) (ORAL) DEFERIPRONE [GENERIC AB]
Drug Classes: iron chelator
NDA Applicant: CHIESI      NDA No.: 021825  Prod. No.: 001 RX (500MG); 002 RX (1GM)
PatentsExpirationChange
Pat. No. 7049328
Use for deferiprone
Pat. Sub. Date(s): 001: Oct 8, 2015; 002: Jan 31, 2020
Claim Types: Method of use; Method of administration
Use Code: U-3083: Method of treating transfusional iron overload
Jun 28, 2021New Use Code
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-859: Treatment of patients with transfusional iron overload due to sickle cell disease or other anemiasApr 30, 2024New exclusivity for this product

FERRIPROX (SOLUTION) (ORAL) DEFERIPRONE
Drug Classes: iron chelator
NDA Applicant: CHIESI      NDA No.: 208030  Prod. No.: 001 RX (100MG/ML); 002 RX (80MG/ML)
PatentsExpirationChange
Pat. No. 7049328
Use for deferiprone
Pat. Sub. Date(s): 001: Oct 6, 2015; 002: Jan 31, 2019
Claim Types: Method of use; Method of administration
Use Code: U-3083: Method of treating transfusional iron overload
Jun 28, 2021New Use Code
Pat. No. 8703156 DP*
Liquid formulation for deferiprone with palatable taste
Pat. Sub. Date(s): 001: Oct 6, 2015; 002: Jan 31, 2019
Claim Types: Formulation; Method of use
Use Code: U-3083: Method of treating transfusional iron overload
Oct 26, 2029New expiration date. Was previously Oct 29, 2029; New Use Code
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-859: Treatment of patients with transfusional iron overload due to sickle cell disease or other anemiasApr 30, 2024New exclusivity for this product

FERRIPROX (TABLET) (ORAL) DEFERIPRONE
Drug Classes: iron chelator
NDA Applicant: CHIESI      NDA No.: 212269  Prod. No.: 001 RX (1GM)
PatentsExpirationChange
Pat. No. 7049328
Use for deferiprone
Pat. Sub. Date(s): 001: Jun 16, 2020
Claim Types: Method of use; Method of administration
Use Code: U-3083: Method of treating transfusional iron overload
Use Code: U-735: Method of treating chronic iron overload
Jun 28, 2021New Use Code
Pat. No. 10780055 DP*
Delayed release deferiprone tablets and methods of using the same
Pat. Sub. Date(s): 001: Oct 7, 2020
Claim Types: Formulation; Method of use
Use Code: U-3083: Method of treating transfusional iron overload
Use Code: U-735: Method of treating chronic iron overload
Oct 25, 2038New Use Code
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-859: Treatment of patients with transfusional iron overload due to sickle cell disease or other anemiasApr 30, 2024New exclusivity for this product

FYCOMPA (TABLET) (ORAL) PERAMPANEL [GENERIC AB]
Drug Classes: non-competitive AMPA glutamate receptor antagonist
NDA Applicant: EISAI INC      NDA No.: 202834  Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (6MG); 004 RX (8MG); 005 RX (10MG); 006 RX (12MG)
PatentsExpirationChange
Pat. No. 6949571 DS* DP*
1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Pat. Sub. Date(s): All strengths: Nov 19, 2012
Claim Types: Compound; Composition; Method of use
Use Code: U-106: Treatment of epilepsy
Use Code: U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy
Use Code: U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy
Use Code: U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older
Use Code: U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older
Jun 8, 2022New expiration date. Was previously Jun 8, 2021

FYCOMPA (SUSPENSION) (ORAL) PERAMPANEL
Drug Classes: non-competitive AMPA glutamate receptor antagonist
NDA Applicant: EISAI INC      NDA No.: 208277  Prod. No.: 001 RX (0.5MG/ML)
PatentsExpirationChange
Pat. No. 6949571 DS* DP*
1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Pat. Sub. Date(s): 001: May 27, 2016
Claim Types: Compound; Composition; Method of use
Use Code: U-106: Treatment of epilepsy
Use Code: U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy
Use Code: U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy
Use Code: U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older
Use Code: U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older
Jun 8, 2022New expiration date. Was previously Jun 8, 2021

GIMOTI (SPRAY, METERED) (NASAL) METOCLOPRAMIDE HYDROCHLORIDE
Drug Classes: dopamine-2 (D2) antagonist
NDA Applicant: EVOKE PHARMA INC      NDA No.: 209388  Prod. No.: 001 RX (EQ 15MG BASE/SPRAY)
PatentsExpirationChange
Pat. No. 11020361
Nasal formulations of metoclopramide
Pat. Sub. Date(s): 001: Jun 3, 2021
Claim Types: Method of use
Use Code: U-2843: Nasal administration of metoclopramide for treatment of diabetic gastroparesis
Dec 22, 2029New patent for this product

GOPRELTO (SOLUTION) (NASAL) COCAINE HYDROCHLORIDE
NDA Applicant: GENUS LIFESCIENCES      NDA No.: 209963  Prod. No.: 001 RX (4%)
PatentsExpirationChange
Pat. No. 10973811
Pharmaceutical compositions and methods of using the same
Pat. Sub. Date(s): 001: May 13, 2021
Claim Types: Method of use
Use Code: U-2226: Method of administering a local anesthetic to the mucous membranes in patients with renal impairment
Feb 7, 2037New patent for this product
Pat. No. 10987347
Pharmaceutical compositions and methods of using the same
Pat. Sub. Date(s): 001: May 27, 2021
Claim Types: Method of use
Use Code: U-2225: Method of administering a local anesthetic to the mucous membranes in patients with hepatic impairment
Feb 7, 2037New patent for this product

INGREZZA (CAPSULE) (ORAL) VALBENAZINE TOSYLATE
Drug Classes: vesicular monoamine transporter 2 (VMAT2) inhibitor
NDA Applicant: NEUROCRINE      NDA No.: 209241  Prod. No.: 001 RX (EQ 40MG BASE); 002 RX (EQ 80MG BASE); 003 RX (EQ 60MG BASE)
PatentsExpirationChange
Pat. No. 10993941
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 19, 2021
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Oct 10, 2037New patent for this product

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))
PatentsExpirationChange
Pat. No. 8895612
Methods and compositions for administration of iron
Pat. Sub. Date(s): 001: Dec 17, 2014
Claim Types: Method of use; Method of administration
Use Code: U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
Use Code: U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
Use Code: U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
Use Code: U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
Use Code: U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
Jan 8, 2027New Use Code
Pat. No. 10519252 DS* DP*
Aqueous iron carbohydrate complexes, their production and medicaments containing them
Pat. Sub. Date(s): None
Claim Types: Formulation; Method of use
Use Code: U-2709: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose
Use Code: U-2710: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose
Use Code: U-2711: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide 750 mg of elemental iron
Use Code: U-2712: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide 750 mg of elemental iron
Use Code: U-3048: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron
Use Code: U-3049: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron
Oct 20, 2023This patent is no longer listed for this product

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 002 RX (500MG IRON/10ML (50MG IRON/ML)); 003 RX (1GM IRON/20ML (50MG IRON/ML))
PatentsExpirationChange
Pat. No. 8895612
Methods and compositions for administration of iron
Pat. Sub. Date(s): 002: Feb 2, 2021; 003: May 21, 2021
Claim Types: Method of use; Method of administration
Use Code: U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
Use Code: U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
Use Code: U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
Use Code: U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
Use Code: U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
Jan 8, 2027New Use Code
Pat. No. 10519252 DS* DP*
Aqueous iron carbohydrate complexes, their production and medicaments containing them
Pat. Sub. Date(s): None
Claim Types: Formulation; Method of use
Use Code: U-2709: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose
Use Code: U-2710: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose
Use Code: U-3048: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron
Use Code: U-3049: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron
Oct 20, 2023This patent is no longer listed for this product

KIMYRSA (POWDER) (INTRAVENOUS) ORITAVANCIN DIPHOSPHATE
Drug Classes: lipoglycopeptide antibacterial
NDA Applicant: MELINTA THERAP      NDA No.: 214155  Prod. No.: 001 RX (EQ 1.2GM BASE/VIAL)
ExclusivityExpirationChange
Exclusivity Code: NP - New product Mar 12, 2024New exclusivity for this product

KLOXXADO (SPRAY) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: HIKMA      NDA No.: 212045  Prod. No.: 001 RX (8MG/SPRAY)
PatentsExpirationChange
Pat. No. 10722510 DP*
Liquid naloxone spray
Pat. Sub. Date(s): 001: May 19, 2021
Claim Types: Formulation; Method of use
Use Code: U-3110: Use of naloxone for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients
Aug 26, 2034New patent for this product
Pat. No. 10973814 DP*
Liquid naloxone spray
Pat. Sub. Date(s): 001: May 19, 2021
Claim Types: Formulation; Method of use
Use Code: U-3110: Use of naloxone for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients
Aug 26, 2034New patent for this product

KYLEENA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: BAYER HLTHCARE      NDA No.: 208224  Prod. No.: 001 RX (19.5MG)
PatentsExpirationChange
Pat. No. 10987244 DP*
Inserter
Pat. Sub. Date(s): 001: May 25, 2021
Claim Types: Device
Apr 1, 2031New patent for this product

LEXETTE (AEROSOL, FOAM) (TOPICAL) HALOBETASOL PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: MAYNE PHARMA      NDA No.: 210566  Prod. No.: 001 RX (0.05%)
PatentsExpirationChange
Pat. No. 10857159 DP*
Halobetasol foam composition and method of use thereof
Pat. Sub. Date(s): 001: Dec 11, 2020
Claim Types: Formulation
May 30, 2037 *PEDNew expiration date. Was previously Nov 30, 2036

LORBRENA (TABLET) (ORAL) LORLATINIB
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER      NDA No.: 210868  Prod. No.: 001 RX (25MG); 002 RX (100MG)
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-349: Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test, excluding patients whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or alectinib or ceritinib as the first ALK inhibitor therapy for metastatic diseaseMar 3, 2028New exclusivity for this product

MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor; hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 209394  Prod. No.: 001 RX (100MG;40MG)
PatentsExpirationChange
Pat. No. 8648037 DS* DP*
Macrocyclic proline derived HCV serine protease inhibitors
Pat. Sub. Date(s): 001: Aug 29, 2017
Claim Types: Compound; Composition; Method of use
Use Code: U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Jul 19, 2032 *PEDNew expiration date. Was previously Jan 19, 2032
Pat. No. 8937150 DS* DP*
Anti-viral compounds
Pat. Sub. Date(s): 001: Aug 29, 2017
Claim Types: Compound; Composition
Nov 18, 2032 *PEDNew expiration date. Was previously May 18, 2032
Pat. No. 9321807 DS*
Crystal forms
Pat. Sub. Date(s): 001: Aug 29, 2017
Claim Types: New polymorph, salt or hydrate; Process
Dec 5, 2035 *PEDNew expiration date. Was previously Jun 5, 2035
Pat. No. 9586978
Anti-viral compounds
Pat. Sub. Date(s): 001: Aug 29, 2017
Claim Types: Method of use
Use Code: U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Dec 10, 2030 *PEDNew expiration date. Was previously Jun 10, 2030
Pat. No. 10028937
Anti-viral compounds
Pat. Sub. Date(s): 001: Aug 24, 2018
Claim Types: Method of use
Use Code: U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Dec 10, 2030 *PEDNew expiration date. Was previously Jun 10, 2030
Pat. No. 10039754
Anti-viral compounds
Pat. Sub. Date(s): 001: Sep 6, 2018
Claim Types: Method of use
Use Code: U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Dec 10, 2030 *PEDNew expiration date. Was previously Jun 10, 2030
Pat. No. 10286029
Method for treating HCV
Pat. Sub. Date(s): 001: May 31, 2019
Claim Types: Method of use
Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Sep 14, 2034 *PEDNew expiration date. Was previously Mar 14, 2034
ExclusivityExpirationChange
Exclusivity Code: D - New Dosing Schedule: D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 studyMar 26, 2023 PEDNew expiration date. Was previously Sep 26, 2022
Exclusivity Code: M - Miscellaneous: M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infectionOct 10, 2023 PEDNew expiration date. Was previously Apr 10, 2023
Exclusivity Code: NCE - New chemical entity Feb 3, 2023 PEDNew expiration date. Was previously Aug 3, 2022
Exclusivity Code: NPP - New patient population Oct 30, 2022 PEDNew expiration date. Was previously Apr 30, 2022
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-232: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)Oct 30, 2026 PEDNew expiration date. Was previously Apr 30, 2026
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-233: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not bothOct 30, 2026 PEDNew expiration date. Was previously Apr 30, 2026

MIRENA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: BAYER HLTHCARE      NDA No.: 021225  Prod. No.: 001 RX (52MG)
PatentsExpirationChange
Pat. No. 10987244 DP*
Inserter
Pat. Sub. Date(s): 001: May 25, 2021
Claim Types: Device
Apr 1, 2031New patent for this product

NAMENDA XR (CAPSULE, EXTENDED RELEASE) (ORAL) MEMANTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: FOREST LABS LLC      NDA No.: 022525  Prod. No.: 001 RX (7MG); 002 RX (14MG); 003 RX (21MG); 004 RX (28MG)
PatentsExpirationChange
Pat. No. 8168209 DP*
Method and composition for administering an NMDA receptor antagonist to a subject
Pat. Sub. Date(s): None
Claim Types: Formulation
May 22, 2026 *PEDThis patent is no longer listed for this product
Pat. No. 8173708
Method and composition for administering an NMDA receptor antagonist to a subject
Pat. Sub. Date(s): None
Claim Types: Method of administration
Use Code: U-539: Treatment of moderate to severe dementia of the Alzheimer's type
May 22, 2026 *PEDThis patent is no longer listed for this product
Pat. No. 8283379
Methods and compositions for the treatment of CNS-related conditions
Pat. Sub. Date(s): None
Claim Types: Method of use
Use Code: U-539: Treatment of moderate to severe dementia of the Alzheimer's type
May 22, 2026 *PEDThis patent is no longer listed for this product
Pat. No. 8329752 DP*
Composition for administering an NMDA receptor antagonist to a subject
Pat. Sub. Date(s): None
Claim Types: Formulation
May 22, 2026 *PEDThis patent is no longer listed for this product
Pat. No. 8362085
Method for administering an NMDA receptor antagonist to a subject
Pat. Sub. Date(s): None
Claim Types: Method of use
Use Code: U-539: Treatment of moderate to severe dementia of the Alzheimer's type
May 22, 2026 *PEDThis patent is no longer listed for this product

NATROBA (SUSPENSION) (TOPICAL) SPINOSAD
Drug Classes: pediculicide
NDA Applicant: PARAPRO LLC      NDA No.: 022408  Prod. No.: 001 RX (0.9%)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-858: For the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and olderApr 28, 2024New exclusivity for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
NDA Applicant: ABBVIE INC      NDA No.: 211675  Prod. No.: 001 RX (15MG)
PatentsExpirationChange
Pat. No. 10981923 DS*
Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Pat. Sub. Date(s): 001: May 18, 2021
Claim Types: New polymorph, salt or hydrate; Process; Composition
Oct 17, 2036New patent for this product
Pat. No. 10981924 DP*
Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Pat. Sub. Date(s): 001: May 18, 2021
Claim Types: Formulation
Oct 17, 2036New patent for this product

SKYLA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: BAYER HLTHCARE      NDA No.: 203159  Prod. No.: 001 RX (13.5MG)
PatentsExpirationChange
Pat. No. 10987244 DP*
Inserter
Pat. Sub. Date(s): 001: May 25, 2021
Claim Types: Device
Apr 1, 2031New patent for this product

SOLOSEC (GRANULE) (ORAL) SECNIDAZOLE
Drug Classes: nitroimidazole antimicrobial
NDA Applicant: LUPIN      NDA No.: 209363  Prod. No.: 001 RX (2GM/PACKET)
PatentsExpirationChange
Pat. No. 11000507 DP*
Secnidazole for use in the treatment of bacterial vaginosis
Pat. Sub. Date(s): 001: Jun 7, 2021
Claim Types: Method of use
Use Code: U-2583: Treatment of bacterial vaginosis in adult women
Sep 4, 2035New patent for this product
Pat. No. 11000508 DP*
Secnidazole for use in the treatment of trichomoniasis
Pat. Sub. Date(s): 001: Jun 7, 2021
Claim Types: Method of use
Use Code: U-2583: Treatment of bacterial vaginosis in adult women
Sep 4, 2035New patent for this product

SOTYLIZE (SOLUTION) (ORAL) SOTALOL HYDROCHLORIDE
Drug Classes: antiarrhythmic
NDA Applicant: ARBOR PHARMS LLC      NDA No.: 205108  Prod. No.: 001 RX (5MG/ML (5MG/ML))
PatentsExpirationChange
Pat. No. 11013703 DP*
Sotalol compositions and uses of the same
Pat. Sub. Date(s): 001: May 26, 2021
Claim Types: Formulation
Apr 1, 2034New patent for this product

SUBLOCADE (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: partial opioid agonist
NDA Applicant: INDIVIOR INC      NDA No.: 209819  Prod. No.: 001 RX (100MG/0.5ML (100MG/0.5ML)); 002 RX (300MG/1.5ML (200MG/ML))
PatentsExpirationChange
Pat. No. 11000520
Buprenorphine dosing regimens
Pat. Sub. Date(s): All strengths: May 20, 2021
Claim Types: Method of use
Use Code: U-3111: Treating opioid use disorder
Nov 6, 2035New patent for this product

TECFIDERA (CAPSULE, DELAYED RELEASE) (ORAL) DIMETHYL FUMARATE [GENERIC AB]
NDA Applicant: BIOGEN INC      NDA No.: 204063  Prod. No.: 001 RX (120MG); 002 RX (240MG)
PatentsExpirationChange
Pat. No. 10994003
Dimethyl fumarate and vaccination regimens
Pat. Sub. Date(s): All strengths: May 28, 2021
Claim Types: Method of use
Use Code: U-3148: Method of treating relapsing forms of multiple sclerosis before and after administering an inactive vaccine
Mar 13, 2035New patent for this product
Pat. No. 11007166
Methods of treating multiple sclerosis
Pat. Sub. Date(s): All strengths: May 28, 2021
Claim Types: Method of use
Use Code: U-1384: Method of treating multiple sclerosis
Nov 16, 2035New patent for this product
Pat. No. 11007167
Methods of treating multiple sclerosis
Pat. Sub. Date(s): All strengths: May 28, 2021
Claim Types: Method of use
Use Code: U-1384: Method of treating multiple sclerosis
Nov 16, 2035New patent for this product

TIBSOVO (TABLET) (ORAL) IVOSIDENIB
NDA Applicant: SERVIER      NDA No.: 211192  Prod. No.: 001 RX (250MG)
PatentsExpirationChange
Pat. No. 10980788
Therapy for treating malignancies
Pat. Sub. Date(s): 001: May 20, 2021
Claim Types: Method of use
Use Code: U-3112: Treating newly diagnosed acute myelogenous leukemia (AML) characterized by the presence of a mutant allele of IDH1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal
Use Code: U-3113: Treating relapsed/refractory acute myelogenous leukemia (AML) characterized by the presence of a mutant allele of IDH1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal
Jun 7, 2039New patent for this product

TOVIAZ (TABLET, EXTENDED RELEASE) (ORAL) FESOTERODINE FUMARATE [GENERIC AB]
NDA Applicant: PFIZER      NDA No.: 022030  Prod. No.: 001 RX (4MG); 002 RX (8MG)
PatentsExpirationChange
Pat. No. 6858650 DS* [Extended 1149 days (3.1 years)]
Stable salts of novel derivatives of 3,3-diphenylpropylamines
Pat. Sub. Date(s): All strengths: None
Claim Types: Compound; Process; Method of use
Use Code: U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Jan 3, 2023 *PEDNew expiration date. Was previously Jul 3, 2022
Pat. No. 7807715 DP*
Pharmaceutical compositions comprising fesoterodine
Pat. Sub. Date(s): All strengths: None
Claim Types: Formulation; Method of use
Use Code: U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Dec 7, 2027 *PEDNew expiration date. Was previously Jun 7, 2027
Pat. No. 8088398 DP*
Pharmaceutical compositions comprising fesoterodine
Pat. Sub. Date(s): All strengths: None
Claim Types: Formulation; Method of use
Use Code: U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Dec 7, 2027 *PEDNew expiration date. Was previously Jun 7, 2027
Pat. No. 8501723 DP*
Pharmaceutical compositions comprising fesoterodine
Pat. Sub. Date(s): All strengths: Aug 20, 2013
Claim Types: Formulation
Dec 7, 2027 *PEDNew expiration date. Was previously Jun 7, 2027

TRUSELTIQ (CAPSULE) (ORAL) INFIGRATINIB PHOSPHATE
NDA Applicant: QED THERAP      NDA No.: 214622  Prod. No.: 001 RX (25MG); 002 RX (100MG)
PatentsExpirationChange
Pat. No. 8552002 DS* DP*
Compounds and compositions as protein kinase inhibitors
Pat. Sub. Date(s): All strengths: Jun 8, 2021
Claim Types: Compound; Composition
Aug 25, 2029New product in Orange Book
Pat. No. 9067896 DS*
Crystalline forms of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl) -phenylamino]-pyrimidin-4-yl}-1-methyl-urea and salts thereof
Pat. Sub. Date(s): All strengths: Jun 8, 2021
Claim Types: New polymorph, salt or hydrate
Dec 20, 2026New product in Orange Book
Pat. No. 10278969 DP*
Pharmaceutical dosage forms
Pat. Sub. Date(s): All strengths: Jun 8, 2021
Claim Types: Formulation
Dec 11, 2034New product in Orange Book

TYMLOS (SOLUTION) (SUBCUTANEOUS) ABALOPARATIDE
Drug Classes: parathyroid hormone related peptide [PTHrP(1-34)] analog
NDA Applicant: RADIUS HEALTH INC      NDA No.: 208743  Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))
PatentsExpirationChange
Pat. No. 10996208 DP*
Abaloparatide formulations and methods of testing, storing, modifying, and using same
Pat. Sub. Date(s): 001: Jun 1, 2021
Claim Types: Formulation; Analytical method
Apr 30, 2038New patent for this product

VELPHORO (TABLET, CHEWABLE) (ORAL) FERRIC OXYHYDROXIDE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: VIFOR FRESENIUS      NDA No.: 205109  Prod. No.: 001 RX (EQ 500MG IRON)
PatentsExpirationChange
Pat. No. 9561251 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): 001: Mar 2, 2017
Claim Types: Formulation; Process; Product-by-process; Method of use
Use Code: U-1468: Control of phosphorous levels in patients
Jul 23, 2030 *PEDNew expiration date. Was previously Jan 23, 2030
Pat. No. 10624855 DP*
Pharmaceutical composition, comprising phosphate binder particles
Pat. Sub. Date(s): 001: Apr 27, 2020
Claim Types: Formulation
May 26, 2035 *PEDNew expiration date. Was previously Nov 26, 2034
Pat. No. 10682376 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): 001: Jun 17, 2020
Claim Types: Formulation
May 13, 2029 *PEDNew expiration date. Was previously Nov 13, 2028
Pat. No. 10695367 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): 001: Jul 1, 2020
Claim Types: Formulation
May 13, 2029 *PEDNew expiration date. Was previously Nov 13, 2028
Pat. No. 10925896 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): 001: Mar 10, 2021
Claim Types: Formulation
May 13, 2029 *PEDNew expiration date. Was previously Nov 13, 2028
Pat. No. 10925897 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): 001: Mar 10, 2021
Claim Types: Formulation
May 13, 2029 *PEDNew expiration date. Was previously Nov 13, 2028
Pat. No. 10933090 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): 001: Mar 10, 2021
Claim Types: Formulation
May 13, 2029 *PEDNew expiration date. Was previously Nov 13, 2028
Pat. No. 11013761 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): 001: Jun 2, 2021
Claim Types: Formulation
May 13, 2029 *PEDNew patent for this product
Pat. No. 11013762 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): 001: Jun 2, 2021
Claim Types: Formulation
May 13, 2029 *PEDNew patent for this product

VENCLEXTA (TABLET) (ORAL) VENETOCLAX
Drug Classes: BCL-2 inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 208573  Prod. No.: 001 RX (10MG); 002 RX (50MG); 003 RX (100MG)
PatentsExpirationChange
Pat. No. 10993942
Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Pat. Sub. Date(s): All strengths: May 24, 2021
Claim Types: Method of use; Dosaage regimen
Use Code: U-3114: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up that includes a dose of 50 mg per day for 1 week followed by 100 mg per day for 1 week
Sep 6, 2033New patent for this product

VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: mu-opioid receptor agonist
NDA Applicant: ALLERGAN HOLDINGS      NDA No.: 206940  Prod. No.: 001 RX (75MG); 002 RX (100MG)
PatentsExpirationChange
Pat. No. 11007179 DP*
Opioid receptor modulator dosage formulations
Pat. Sub. Date(s): All strengths: Jun 3, 2021
Claim Types: Formulation
Mar 14, 2033New patent for this product

VOSEVI (TABLET) (ORAL) SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
Drug Classes: hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor; hepatitis C virus (HCV) NS3/4A protease inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 209195  Prod. No.: 001 RX (400MG;100MG;100MG)
PatentsExpirationChange
Pat. No. 8575135 DS* DP*
Antiviral compounds
Pat. Sub. Date(s): 001: Jul 28, 2017
Claim Types: Compound; Composition; Method of use
Use Code: U-2039: Treatment of adult patients with chronic hcv infection who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an NS5A inhibitor
Use Code: U-2040: Treatment of adult patients with chronic hcv infection who have genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an NS5A inhibitor
May 5, 2034 *PEDNew expiration date. Was previously Nov 5, 2033
Pat. No. 8735372 DS* DP*
Nucleoside phosphoramidate prodrugs
Pat. Sub. Date(s): 001: Jul 28, 2017
Claim Types: Method of use
Use Code: U-2039: Treatment of adult patients with chronic hcv infection who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an NS5A inhibitor
Use Code: U-2040: Treatment of adult patients with chronic hcv infection who have genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an NS5A inhibitor
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8921341 DS* DP*
Antiviral compounds
Pat. Sub. Date(s): 001: Jul 28, 2017
Claim Types: Compound; Composition; Method of use
Use Code: U-2039: Treatment of adult patients with chronic hcv infection who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an NS5A inhibitor
Use Code: U-2040: Treatment of adult patients with chronic hcv infection who have genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an NS5A inhibitor
May 16, 2033 *PEDNew expiration date. Was previously Nov 16, 2032
Pat. No. 8940718 DS* DP*
Antiviral compounds
Pat. Sub. Date(s): 001: Jul 28, 2017
Claim Types: Compound; Composition; Method of use
Use Code: U-2039: Treatment of adult patients with chronic hcv infection who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an NS5A inhibitor
Use Code: U-2040: Treatment of adult patients with chronic hcv infection who have genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an NS5A inhibitor
May 16, 2033 *PEDNew expiration date. Was previously Nov 16, 2032

VYLEESI (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) BREMELANOTIDE ACETATE
NDA Applicant: PALATIN TECHNOLOGIES      NDA No.: 210557  Prod. No.: 001 RX (EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML))
PatentsExpirationChange
Pat. No. 6794489 DS* DP*
Compositions and methods for treatment of sexual dysfunction
Pat. Sub. Date(s): 001: Jul 10, 2019
Claim Types: Composition; Method of use; Compound; Kit
Jun 28, 2025New expiration date. Was previously Jun 28, 2021

VYONDYS 53 (SOLUTION) (INTRAVENOUS) GOLODIRSEN
NDA Applicant: SAREPTA THERAPS INC      NDA No.: 211970  Prod. No.: 001 RX (100MG/2ML (50MG/ML))
PatentsExpirationChange
Pat. No. 10968450 DS* DP*
Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Pat. Sub. Date(s): 001: Jun 1, 2021
Claim Types: Compound; Composition
Jun 28, 2025New patent for this product
Pat. No. 10995337 DP*
Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Pat. Sub. Date(s): 001: Jun 1, 2021
Claim Types: Method of use; Composition
Use Code: U-2675: Treatment of Duchenne muscular dystrophy (DMD) in patients having a confirmed mutation of the dmd gene that is amenable to exon 53 skipping
Jun 28, 2025New patent for this product

VYXEOS (POWDER) (INTRAVENOUS) CYTARABINE; DAUNORUBICIN
Drug Classes: nucleoside metabolic inhibitor; anthracycline topoisomerase inhibitor
NDA Applicant: CELATOR PHARMS      NDA No.: 209401  Prod. No.: 001 RX (100MG;44MG)
ExclusivityExpirationChange
Exclusivity Code: NPP - New patient population Mar 30, 2024New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-350: Treatment of newly-diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients ages 1 year and olderMar 30, 2028New exclusivity for this product

XADAGO (TABLET) (ORAL) SAFINAMIDE MESYLATE
Drug Classes: monoamine oxidase type B (MAO-B) inhibitor
NDA Applicant: MDD US      NDA No.: 207145  Prod. No.: 001 RX (50MG); 002 RX (100MG)
PatentsExpirationChange
Pat. No. 8283380
Methods for treatment of parkinson's disease
Pat. Sub. Date(s): All strengths: Apr 20, 2017
Claim Types: Method of use
Use Code: U-1993: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing 'off' episodes
Mar 21, 2031New expiration date. Was previously Sep 1, 2027

XPOVIO (TABLET) (ORAL) SELINEXOR
NDA Applicant: KARYOPHARM THERAPS      NDA No.: 212306  Prod. No.: 001 RX (20MG); 002 RX (40MG); 003 RX (50MG); 004 RX (60MG)
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-346: For the treatment of adult patients with multiple myeloma who have received at least one prior therapy, excluding adult patients covered by XPOVIO's previous indication for multiple myeloma approved on July 3, 2019Dec 18, 2027New exclusivity for this product

YUPELRI (SOLUTION) (INHALATION) REVEFENACIN
Drug Classes: anticholinergic
NDA Applicant: MYLAN IRELAND LTD      NDA No.: 210598  Prod. No.: 001 RX (175MCG/3ML)
PatentsExpirationChange
Pat. No. 11008289
Crystalline freebase forms of a biphenyl compound
Pat. Sub. Date(s): 001: May 20, 2021
Claim Types: Method of use
Use Code: U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Jul 14, 2030New patent for this product

ZEJULA (CAPSULE) (ORAL) NIRAPARIB TOSYLATE
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 208447  Prod. No.: 001 RX (EQ 100MG BASE)
PatentsExpirationChange
Pat. No. 8071623 DS* DP*
Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors
Pat. Sub. Date(s): 001: Apr 24, 2017
Claim Types: Compound; Composition
Mar 27, 2031New expiration date. Was previously Mar 22, 2030

ZYKADIA (TABLET) (ORAL) CERITINIB
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 211225  Prod. No.: 001 RX (150MG)
ExclusivityExpirationChange
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) Apr 29, 2021New exclusivity for this product
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) May 26, 2024New exclusivity for this product


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
Last edited: 16 June 2021
2001-2021 Bruce A. Pokras, All rights reserved worldwide