Patents whose numbers
are in italics have been extended under 35 USC 156. All expiration
dates include applicable Sec. 156 and pediatric (PED) extensions.
The "[Img]" link takes you to the patent image at the EPO. However,
please note that the EPO does not include Certificates of Correction.
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9717852
DP* [Img] Cartridge holder and pen-type injector Claim Types: Device |
Apr 8, 2033 | New patent for this product |
AIRDUO RESPICLICK (POWDER) FLUTICASONE
PROPIONATE; SALMETEROL XINAFOATE
NDA Applicant:
TEVA
PHARM NDA No.: 208799 Prod. No.:
001 RX (0.055MG/INH;EQ 0.014MG BASE/INH); 002 RX (0.113MG/INH;EQ
0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9987229
DP* [Img] Process for preparing a medicament Claim Types: Product-by-process; Process |
Sep 1, 2024 | New patent for this product |
ALIQOPA
(POWDER) COPANLISIB
DIHYDROCHLORIDE
NDA Applicant:
BAYER
HEALTHCARE NDA No.: 209936 Prod. No.:
001 RX (60MG/VIAL)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE46856
DS* DP* [Img] Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis Claim Types: Compound; Composition; Kit; Method of use Use Code: U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies |
Oct 22, 2029 | New patent for this product |
| Pat. No. 8466283
DS* DP* [Img] Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative d Claim Types: Compound; Composition; Formulation; Drug in a container; Method of use Use Code: U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies |
Oct 22, 2029 | This patent is no longer listed for this product |
APIDRA SOLOSTAR (INJECTABLE) INSULIN
GLULISINE RECOMBINANT
NDA Applicant:
SANOFI AVENTIS
US NDA No.: 021629 Prod. No.:
003 RX (300 UNITS/3ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9717852
DP* [Img] Cartridge holder and pen-type injector Claim Types: Device |
Apr 8, 2033 | New patent for this product |
AURYXIA
(TABLET) FERRIC
CITRATE
NDA Applicant:
KERYX
BIOPHARMS NDA No.: 205874 Prod. No.:
001 RX (EQ 210MG IRON)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 5753706
DP* [Img] Methods for treating renal failure Claim Types: Method of use; Formulation Use Code: U-1577: Control of serum phosphorous levels |
Feb 3, 2019 | New patent for this product |
BAXDELA
(TABLET)
DELAFLOXACIN MEGLUMINE
NDA Applicant:
MELINTA NDA No.:
208610 Prod. No.:
001 RX (EQ 450MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8497378
DS* [Img] Process for making quinolone compounds Claim Types: Process; Composition |
Dec 28, 2029 | This patent is no longer listed for this product |
BAXDELA (POWDER) DELAFLOXACIN
MEGLUMINE
NDA Applicant:
MELINTA NDA No.:
208611 Prod. No.:
001 RX (EQ 300MG BASE/VIAL)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8497378
DS* [Img] Process for making quinolone compounds Claim Types: Process; Composition |
Dec 28, 2029 | This patent is no longer listed for this product |
BENDEKA
(SOLUTION)
BENDAMUSTINE HYDROCHLORIDE
NDA Applicant:
EAGLE
PHARMS NDA No.: 208194 Prod. No.:
001 RX (100MG/4ML (25MG/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-179: Treatment of patients with CLL and treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen | Dec 7, 2022 | New exclusivity for this product |
BETHKIS
(SOLUTION)
TOBRAMYCIN
NDA Applicant:
CHIESI USA
INC NDA No.: 201820 Prod. No.:
001 RX (300MG/4ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7696178
DP* [Img] Optimised formulation of tobramycin for aerosolization Claim Types: Formulation; Process |
Sep 22, 2022 | New expiration date. Was previously Mar 17, 2023; New Drug Substance/Drug Product flag |
BRAFTOVI
(CAPSULE)
ENCORAFENIB
NDA Applicant:
ARRAY BIOPHARMA
INC NDA No.: 210496 Prod. No.:
001 RX (50MG); 002 RX (75MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Jun 27, 2023 | New product in Orange Book |
CINVANTI
(EMULSION)
APREPITANT
NDA Applicant:
HERON THERAPS
INC NDA No.: 209296 Prod. No.:
001 RX (130MG/18ML (7.2MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9974742
DP* [Img] Emulsion formulations of an NK-1 receptor antagonist and uses thereof Claim Types: Formulation; Process |
Sep 18, 2035 | New patent for this product |
| Pat. No. 9974793
DP* [Img] Emulsion formulations of aprepitant Claim Types: Formulation |
Sep 18, 2035 | New patent for this product |
| Pat. No. 9974794
DP* [Img] Emulsion formulations of aprepitant Claim Types: Formulation; Method of use Use Code: U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy |
Sep 18, 2035 | New patent for this product |
DEXMEDETOMIDINE HYDROCHLORIDE
(SOLUTION)
DEXMEDETOMIDINE HYDROCHLORIDE
NDA Applicant:
HQ SPCLT
PHARMA NDA No.: 206628 Prod. No.:
003 RX (EQ 200MG BASE/50ML (EQ 4MCG BASE/ML)); 004 RX (EQ 400MG
BASE/100ML (EQ 4MCG BASE/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9649296
DP* [Img] Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container Claim Types: Drug in a container; Formulation; Packaging or device material |
Apr 20, 2036 | New strength or variation of this product |
| Pat. No. 9717796
DP* [Img] Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container Claim Types: Drug in a container; Formulation; Packaging or device material |
Apr 20, 2036 | New strength or variation of this product |
DOPTELET
(TABLET)
AVATROMBOPAG MALEATE
NDA Applicant:
AKARX
INC NDA No.: 210238 Prod. No.:
001 RX (EQ 20MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7638536
DS* DP* [Img] 2-Acylaminothiazole derivative or salt thereof Claim Types: Compound; Composition |
May 5, 2025 | New patent for this product |
| Pat. No. 8765764
[Img] 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Use Code: U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET |
Jan 15, 2023 | New patent for this product |
ESKATA
(SOLUTION) HYDROGEN
PEROXIDE
NDA Applicant:
ACLARIS THERAPS
INC NDA No.: 209305 Prod. No.:
001 RX (40%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9980983
[Img] Peroxide formulations and methods and applicators for using the same Claim Types: Method of use Use Code: U-2205: Treatment of seborrheic keratoses that are raised |
Apr 21, 2035 | New patent for this product |
GATTEX
KIT (POWDER)
TEDUGLUTIDE RECOMBINANT
NDA Applicant:
NPS PHARMS
INC NDA No.: 203441 Prod. No.:
001 RX (5MG/VIAL)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9987335
[Img] Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Use Code: U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
Nov 1, 2025 | New patent for this product |
| Pat. No. 9993528
[Img] Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Use Code: U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
Nov 1, 2025 | New patent for this product |
GILENYA
(CAPSULE)
FINGOLIMOD HYDROCHLORIDE
NDA Applicant:
NOVARTIS NDA No.:
022527 Prod. No.:
001 RX (EQ 0.5MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 5604229
DS* [Img] 2-amino-1,3-propanediol compound and immunosuppressant Claim Types: Compound; Method of use Use Code: U-1086: Treatment of autoimmune disease |
Feb 18, 2020 *PED | New expiration date. Was previously Aug 18, 2019 *PED |
GLUMETZA
(TABLET, EXTENDED
RELEASE) METFORMIN HYDROCHLORIDE [GENERIC
AB3]
NDA Applicant:
SANTARUS
INC NDA No.: 021748 Prod. No.:
002 RX (1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6488962
DS* DP* [Img] Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Claim Types: Composition |
Jun 20, 2020 | This patent is no longer listed for this product |
IMVEXXY
(INSERT) ESTRADIOL
NDA Applicant:
THERAPEUTICSMD
INC NDA No.: 208564 Prod. No.:
001 RX (0.004MG); 002 RX (0.01MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9180091
DP* [Img] Soluble estradiol capsule for vaginal insertion Claim Types: Formulation; Method of use Use Code: U-2316: Treatment of dyspareunia Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy |
Dec 20, 2033 | New patent for this product |
| Pat. No. 9289382
DP* [Img] Vaginal inserted estradiol pharmaceutical compositions and methods Claim Types: Formulation |
Nov 21, 2032 | New patent for this product |
INTELENCE
(TABLET) ETRAVIRINE
NDA Applicant:
JANSSEN R AND
D NDA No.: 022187 Prod. No.:
001 RX (100MG); 002 RX (200MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6878717
[Img] HIV replication inhibiting pyrimidines Claim Types: Method of use Use Code: U-1016: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents Use Code: U-1237: Combo w/ other antiretrovirals for tx of HIV-1 in antiretroviral tx-experienced pt 6 years up, who have evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other antiretrovirals Use Code: U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents |
May 5, 2020 *PED | New expiration date. Was previously Nov 5, 2019 |
| Pat. No. 7037917
DS* DP* [Img]
[Extended 404 days (1.1 years)] HIV replication inhibiting pyrimidines Claim Types: Compound; Composition; Formulation; Process; Method of use Use Code: U-1016: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents Use Code: U-1237: Combo w/ other antiretrovirals for tx of HIV-1 in antiretroviral tx-experienced pt 6 years up, who have evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other antiretrovirals Use Code: U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents |
Jun 13, 2021 *PED | New expiration date. Was previously Dec 13, 2020; New Drug Substance/Drug Product flag |
| Pat. No. 7887845
DP* [Img] Antiviral compositions Claim Types: Formulation; Process; Drug in a container |
Sep 25, 2019 *PED | New expiration date. Was previously Mar 25, 2019; New Drug Substance/Drug Product flag |
| Pat. No. 8003789
DS* DP* [Img] HIV replication inhibiting pyrimidines Claim Types: Compound; Composition; Process; Method of use |
May 1, 2020 *PED | New expiration date. Was previously Nov 1, 2019; New Drug Substance/Drug Product flag |
INTELENCE
(TABLET) ETRAVIRINE
NDA Applicant:
JANSSEN R AND
D NDA No.: 022187 Prod. No.:
003 RX (25MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6878717
[Img] HIV replication inhibiting pyrimidines Claim Types: Method of use Use Code: U-1016: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents Use Code: U-1237: Combo w/ other antiretrovirals for tx of HIV-1 in antiretroviral tx-experienced pt 6 years up, who have evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other antiretrovirals Use Code: U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents |
May 5, 2020 *PED | New expiration date. Was previously Nov 5, 2019 |
| Pat. No. 7037917
DS* DP* [Img]
[Extended 404 days (1.1 years)] HIV replication inhibiting pyrimidines Claim Types: Compound; Composition; Formulation; Process; Method of use Use Code: U-1237: Combo w/ other antiretrovirals for tx of HIV-1 in antiretroviral tx-experienced pt 6 years up, who have evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other antiretrovirals |
Jun 13, 2021 *PED | New expiration date. Was previously Dec 13, 2020; New Drug Substance/Drug Product flag |
| Pat. No. 7887845
DP* [Img] Antiviral compositions Claim Types: Formulation; Process; Drug in a container |
Sep 25, 2019 *PED | New expiration date. Was previously Mar 25, 2019; New Drug Substance/Drug Product flag |
| Pat. No. 8003789
DS* DP* [Img] HIV replication inhibiting pyrimidines Claim Types: Compound; Composition; Process; Method of use |
May 1, 2020 *PED | New expiration date. Was previously Nov 1, 2019; New Drug Substance/Drug Product flag |
KYPROLIS
(POWDER) CARFILZOMIB
NDA Applicant:
ONYX
THERAP NDA No.: 202714 Prod. No.:
003 RX (10MG/VIAL)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7232818
DS* DP* [Img] Compounds for enzyme inhibition Claim Types: Compound; Composition |
Apr 14, 2025 | New strength or variation of this product |
| Pat. No. 7417042
DS* DP* [Img] Compounds for enzyme inhibition Claim Types: Compound; Composition |
Jul 20, 2026 | New strength or variation of this product |
| Pat. No. 7491704
[Img] Compounds for enzyme inhibition Claim Types: Method of use Use Code: U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy Use Code: U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy |
Apr 14, 2025 | New strength or variation of this product |
| Pat. No. 7737112
DP* [Img] Composition for enzyme inhibition Claim Types: Formulation |
Dec 7, 2027 | New strength or variation of this product |
| Pat. No. 8129346
[Img] Compounds for enzyme inhibition Claim Types: Method of use Use Code: U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy Use Code: U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy |
Apr 14, 2025 | New strength or variation of this product |
| Pat. No. 8207125
DS* DP* [Img] Compounds for enzyme inhibition Claim Types: Compound; Composition; Formulation |
Apr 14, 2025 | New strength or variation of this product |
| Pat. No. 8207126
DP* [Img] Compounds for enzyme inhibition Claim Types: Process; Product-by-process |
Apr 14, 2025 | New strength or variation of this product |
| Pat. No. 8207127
[Img] Compounds for enzyme inhibition Claim Types: Method of use Use Code: U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy Use Code: U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy |
Apr 14, 2025 | New strength or variation of this product |
| Pat. No. 8207297
DS* DP* [Img] Compounds for enzyme inhibition Claim Types: Process; Product-by-process |
Apr 14, 2025 | New strength or variation of this product |
| Pat. No. 9493582
DP* [Img] Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Formulation; Product-by-process; Process |
Feb 27, 2033 | New strength or variation of this product |
| Pat. No. 9511109
[Img] Combination therapy with peptide epoxyketones Claim Types: Method of use Use Code: U-1924: KYPROLIS is indicated in combination with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy |
Oct 21, 2029 | New strength or variation of this product |
LEVOTHYROXINE SODIUM (POWDER) LEVOTHYROXINE
SODIUM [GENERIC AP]
NDA Applicant:
PIRAMAL
CRITICAL NDA No.: 206163 Prod. No.:
001 RX (100MCG/VIAL); 002 RX (500MCG/VIAL)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Sep 29, 2018 | New exclusivity for this product |
LYNPARZA
(TABLET) OLAPARIB
NDA Applicant:
ASTRAZENECA
PHARMS NDA No.: 208558 Prod. No.:
001 RX (100MG); 002 RX (150MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-180: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy | Aug 17, 2024 | New exclusivity for this product |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-181: Treatment of adult patients with deleterious or suspected deleterious germline brca-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy | Aug 17, 2024 | New exclusivity for this product |
MEKINIST
(TABLET) TRAMETINIB
DIMETHYL SULFOXIDE
NDA Applicant:
NOVARTIS PHARMS
CORP NDA No.: 204114 Prod. No.:
001 RX (EQ 0.5MG); 003 RX (EQ 2MG) NDA No.: 204114 Prod. No.:
002 DISC (EQ 1MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-182: Trametinib is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection | Apr 30, 2025 | New exclusivity for this product |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-183: Trametinib and dabrafenib in combination, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options | May 4, 2025 | New exclusivity for this product |
MEKTOVI
(TABLET) BINIMETINIB
NDA Applicant:
ARRAY BIOPHARMA
INC NDA No.: 210498 Prod. No.:
001 RX (15MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Jun 27, 2023 | New product in Orange Book |
MOXIDECTIN
(TABLET) MOXIDECTIN
NDA Applicant:
MDGH NDA No.:
210867 Prod. No.:
001 RX (2MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Jun 13, 2023 | New product in Orange Book |
NETSPOT
(POWDER) GALLIUM
DOTATATE GA-68
NDA Applicant:
AAA USA
INC NDA No.: 208547 Prod. No.:
001 RX (2.1-5.5mCi/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9375498
DP* [Img] Process for the preparation of complexes of .sup.68Ga Claim Types: Kit; Product-by-process; Drug in a container; Process |
Aug 10, 2032 | New patent for this product |
NOCDURNA
(TABLET)
DESMOPRESSIN ACETATE
NDA Applicant:
FERRING PHARMS
INC NDA No.: 022517 Prod. No.:
001 RX (0.0277MG); 002 RX (0.0553MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NP - New product | Jun 21, 2021 | New product in Orange Book |
NORVIR
(POWDER) RITONAVIR
NDA Applicant:
ABBVIE
INC NDA No.: 209512 Prod. No.:
001 RX (100MG/PACKET)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-184: Indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection | Jun 7, 2024 | New exclusivity for this product |
NUPLAZID
(CAPSULE)
PIMAVANSERIN TARTRATE
NDA Applicant:
ACADIA PHARMS
INC NDA No.: 210793 Prod. No.:
001 RX (EQ 34MG BASE)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Apr 29, 2021 | New product in Orange Book |
OFIRMEV
(SOLUTION)
ACETAMINOPHEN [GENERIC AP]
NDA Applicant:
MALLINCKRODT
IP NDA No.: 022450 Prod. No.:
001 RX (1GM/100ML (10MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9987238
[Img] Reduced dose intravenous acetaminophen Claim Types: Method of use Use Code: U-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics |
Nov 13, 2028 | New patent for this product |
OLUMIANT
(TABLET) BARICITINIB
NDA Applicant:
ELI LILLY AND
CO NDA No.: 207924 Prod. No.:
001 RX (2MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8158616
DS* DP* [Img] Azetidine and cyclobutane derivatives as JAK inhibito Claim Types: Compound; Composition |
Jun 8, 2030 | New patent for this product |
| Pat. No. 8420629
[Img] Azetidine and cyclobutane derivatives as JAK inhibitors Claim Types: Method of use Use Code: U-247: Treatment of rheumatoid arthritis |
Mar 10, 2029 | New patent for this product |
OXYCONTIN
(TABLET, EXTENDED
RELEASE) OXYCODONE HYDROCHLORIDE
NDA Applicant:
PURDUE PHARMA
LP NDA No.: 022272 Prod. No.:
005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7674799
DP* [Img] Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone Claim Types: Formulation |
Mar 30, 2025 | This patent is no longer listed for this product |
| Pat. No. 7674800
DS* [Img] Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Process; Product-by-process |
Mar 30, 2025 | This patent is no longer listed for this product |
| Pat. No. 7683072
DS* [Img] Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone Claim Types: Compound |
Mar 30, 2025 | This patent is no longer listed for this product |
| Pat. No. 7776314
DP* [Img] Abuse-proofed dosage system Claim Types: Formulation |
Apr 19, 2025 | This patent is no longer listed for this product |
PREVACID
(TABLET, ORALLY
DISINTEGRATING, DELAYED RELEASE) LANSOPRAZOLE
[GENERIC AB]
Drug Classes:
DISORDERS, ACID/PEPTIC;
GASTROINTESTINAL, MISCELLANEOUS
NDA Applicant:
TAKEDA PHARMS
USA NDA No.: 021428 Prod. No.:
001 RX (15MG); 002 RX (30MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9901546
DP* [Img] Orally disintegrable tablets Claim Types: Formulation |
Nov 17, 2019 *PED | New expiration date. Was previously May 17, 2019; New Drug Substance/Drug Product flag |
PREZCOBIX
(TABLET)
COBICISTAT; DARUNAVIR ETHANOLATE
NDA Applicant:
JANSSEN
PRODS NDA No.: 205395 Prod. No.:
001 RX (150MG;EQ 800MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8148374
DS* DP* [Img] Modulators of pharmacokinetic properties of therapeutics Claim Types: Composition; Compound; Method of use Use Code: U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase |
Sep 3, 2029 | New Use Code; New Drug Substance/Drug Product flag |
RAVICTI
(LIQUID) GLYCEROL
PHENYLBUTYRATE
NDA Applicant:
HORIZON THERAPS
INC NDA No.: 203284 Prod. No.:
001 RX (1.1GM/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9962359
[Img] Methods of therapeutic monitoring of nitrogen scavenging drugs Claim Types: Method of use Use Code: U-1816: Treatment of a urea cycle disorder |
Sep 22, 2030 | New patent for this product |
RUBRACA
(TABLET) RUCAPARIB
CAMSYLATE
NDA Applicant:
CLOVIS ONCOLOGY
INC NDA No.: 209115 Prod. No.:
001 RX (EQ 200MG BASE); 002 RX (EQ 300MG BASE); 003 RX (EQ 250MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9987285
DP* [Img] High dosage strength tablets of rucaparib Claim Types: Formulation |
Aug 17, 2035 | New patent for this product |
SOLIQUA
100/33 (SOLUTION)
INSULIN GLARGINE; LIXISENATIDE
NDA Applicant:
SANOFI-AVENTIS
US NDA No.: 208673 Prod. No.:
001 RX (300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9717852
DP* [Img] Cartridge holder and pen-type injector Claim Types: Device |
Apr 8, 2033 | New patent for this product |
SYMDEKO (COPACKAGED) (TABLET, TABLET)
IVACAFTOR; IVACAFTOR, TEZACAFTOR
NDA Applicant:
VERTEX PHARMS
INC NDA No.: 210491 Prod. No.:
001 RX (150MG,N/A;150MG, 100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9974781
DP* [Img] Modulators of ATP-binding cassette transporters Claim Types: Method of use; Composition Use Code: U-2318: Treatment of cystic fibrosis in patients aged 12 and older, who are homozygous for the F508del mutation or have at least one CFTR gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor |
Apr 9, 2027 | New patent for this product |
TAFINLAR
(CAPSULE)
DABRAFENIB MESYLATE
NDA Applicant:
NOVARTIS PHARMS
CORP NDA No.: 202806 Prod. No.:
001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-182: Trametinib is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection | Apr 30, 2025 | New exclusivity for this product |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-183: Trametinib and dabrafenib in combination, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options | May 4, 2025 | New exclusivity for this product |
TASIGNA
(CAPSULE) NILOTINIB
HYDROCHLORIDE
NDA Applicant:
NOVARTIS NDA No.:
022068 Prod. No.:
003 RX (EQ 50MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7169791
DS* DP* [Img] Inhibitors of tyrosine kinases Claim Types: Compound; Process; Composition Use Code: U-836: A method for the treatment of leukemias |
Jan 4, 2024 *PED | New expiration date. Was previously Jul 4, 2023; New Drug Substance/Drug Product flag |
| Pat. No. 8163904
DS* DP* [Img] Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide Claim Types: New polymorph, salt or hydrate; Process; Composition |
Feb 23, 2029 *PED | New expiration date. Was previously Aug 23, 2028; New Drug Substance/Drug Product flag |
| Pat. No. 8293756
DP* [Img] Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate Claim Types: Process; Product-by-process |
Mar 25, 2028 *PED | New expiration date. Was previously Sep 25, 2027; New Drug Substance/Drug Product flag |
| Pat. No. 8389537
DS* DP* [Img] Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide Claim Types: Method of use Use Code: U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) |
Jan 18, 2027 *PED | New expiration date. Was previously Jul 18, 2026; New Drug Substance/Drug Product flag |
| Pat. No. 8415363
DS* DP* [Img] Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-1407: Treatment of newly diagnosed philadelphia chromosome positive chronic myeloid leukemia (PH + CML) |
Jan 18, 2027 *PED | New expiration date. Was previously Jul 18, 2026; New Drug Substance/Drug Product flag |
| Pat. No. 8501760
DS* DP* [Img] Pharmaceutical compositions comprising nilotinib or its salt Claim Types: Formulation |
Jan 18, 2027 *PED | New expiration date. Was previously Jul 18, 2026; New Drug Substance/Drug Product flag |
| Pat. No. 9061029
DS* DP* [Img] Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity Claim Types: Method of use; Formulation Use Code: U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) |
Oct 7, 2032 *PED | New expiration date. Was previously Apr 7, 2032; New Drug Substance/Drug Product flag |
TRI-LUMA
(CREAM)
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
Drug Classes:
DERMATOLOGICS
NDA Applicant:
GALDERMA LABS
LP NDA No.: 021112 Prod. No.:
001 RX (0.01%;4%;0.05%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7915243
DP* [Img] Topical skin care composition Claim Types: Formulation |
Sep 8, 2023 | New expiration date. Was previously Mar 22, 2026; New Drug Substance/Drug Product flag |
| Pat. No. 7939516
DP* [Img] Topical skin care composition Claim Types: Formulation |
Sep 8, 2023 | New expiration date. Was previously May 4, 2025; New Drug Substance/Drug Product flag |
| Pat. No. 8247395
DP* [Img] Topical skin care composition Claim Types: Formulation; Product-by-process |
Oct 25, 2022 | New expiration date. Was previously Oct 22, 2022; New Drug Substance/Drug Product flag |
VENCLEXTA
(TABLET) VENETOCLAX
NDA Applicant:
ABBVIE
INC NDA No.: 208573 Prod. No.:
001 RX (10MG); 002 RX (50MG); 003 RX (100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9174982
[Img] Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases Claim Types: Method of use Use Code: U-1835: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy Use Code: U-2323: Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy |
May 26, 2030 | New Use Code |
| Exclusivity | Expiration | Change |
| Exclusivity Code: I - New Indication: I-782: Revisions to indication for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy | Jun 8, 2021 | New exclusivity for this product |
| Exclusivity Code: M - Miscellaneous: M-228: Information added to the package insert regarding the revision of the monotherapy indication of venetoclax | Jun 8, 2021 | New exclusivity for this product |
VISIONBLUE
(SOLUTION) TRYPAN
BLUE
NDA Applicant:
DORC NDA No.:
021670 Prod. No.:
001 RX (0.06%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6367480
[Img] Methods for visualizing the anterior lens capsule of the human eye Claim Types: Method of use Use Code: U-2321: A method of applying trypan blue onto an outer surface of the anterior lens capsule to facilitate removal of the lens substance |
Oct 26, 2019 | New patent for this product |
| Pat. No. 6720314
[Img] Use of a vital dye for facilitating surgical procedures for cataract extraction Claim Types: Diagnostic or surgical method Use Code: U-2321: A method of applying trypan blue onto an outer surface of the anterior lens capsule to facilitate removal of the lens substance |
May 7, 2019 | New patent for this product |
VISTOGARD
(GRANULE) URIDINE
TRIACETATE
NDA Applicant:
WELLSTAT
THERAP NDA No.: 208159 Prod. No.:
001 RX (10GM/PACKET)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6258795
DP* [Img] Acylated uridine and cytidine and uses thereof Claim Types: Compound; Composition; Formulation |
Jul 10, 2019 | New expiration date. Was previously Jul 10, 2018; New Drug Substance/Drug Product flag |
XELJANZ
(TABLET)
TOFACITINIB CITRATE
NDA Applicant:
PF PRISM
CV NDA No.: 203214 Prod. No.:
001 RX (EQ 5MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7842699
[Img] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Method of use Use Code: U-2322: Treatment of adult patients with moderately to severely active ulcerative colitis (UC) |
Dec 8, 2020 | New patent for this product |
XELJANZ (TABLET) TOFACITINIB
CITRATE
NDA Applicant:
PF PRISM
CV NDA No.: 203214 Prod. No.:
002 RX (EQ 10MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6956041
DP* [Img] Pyrrolo[2,3-d]pyrimidine compounds Claim Types: Composition; Method of use |
Dec 8, 2020 | New patent for this product |
| Pat. No. 6965027
DS* [Img] Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate Claim Types: New polymorph, salt or hydrate; Process |
Mar 25, 2023 | New patent for this product |
| Pat. No. 7265221
DS* [Img] Pyrrolo[2,3-d]pyrimidine compounds Claim Types: Compound |
Dec 8, 2020 | New patent for this product |
| Pat. No. 7301023
DS* [Img] Chiral salt resolution Claim Types: Compound |
May 23, 2022 | New patent for this product |
| Pat. No. 7842699
[Img] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Method of use Use Code: U-2322: Treatment of adult patients with moderately to severely active ulcerative colitis (UC) |
Dec 8, 2020 | New patent for this product |
| Pat. No. RE41783
DS* [Img] Pyrrolo[2,3-D]pyrimidine compounds Claim Types: Compound |
Dec 8, 2025 | New patent for this product |
XURIDEN
(GRANULE) URIDINE
TRIACETATE
NDA Applicant:
WELLSTAT
THERAP NDA No.: 208169 Prod. No.:
001 RX (2GM/PACKET)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6258795
DP* [Img] Acylated uridine and cytidine and uses thereof Claim Types: Compound; Composition; Formulation |
Jul 10, 2019 | New expiration date. Was previously Jul 10, 2018; New Drug Substance/Drug Product flag |
YONDELIS
(POWDER) TRABECTEDIN
NDA Applicant:
JANSSEN
PRODS NDA No.: 207953 Prod. No.:
001 RX (1MG/VIAL)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8895557
DP* [Img] Pharmaceutical formulations of ecteinascidin compounds Claim Types: Formulation; Process |
Jul 7, 2028 *PED | New expiration date. Was previously Jan 7, 2028; New Drug Substance/Drug Product flag |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NCE - New chemical entity | Apr 23, 2021 PED | New expiration date. Was previously Oct 23, 2020 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-100: For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen | Apr 23, 2023 PED | New expiration date. Was previously Oct 23, 2022 |
YOSPRALA
(TABLET, DELAYED
RELEASE) ASPIRIN; OMEPRAZOLE
NDA Applicant:
ARALEZ
PHARMS NDA No.: 205103 Prod. No.:
001 DISC (81MG;40MG); 002 DISC (325MG;40MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9987231
[Img] Compositions and methods for delivery of omeprazole plus acetylsalicylic acid Claim Types: Method of administration Use Code: U-2324: For secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers |
Jan 2, 2033 | New patent for this product |
ZEMDRI
(SOLUTION)
PLAZOMICIN SULFATE
NDA Applicant:
ACHAOGEN
INC NDA No.: 210303 Prod. No.:
001 RX (EQ 500MG BASE/10ML (EQ 50MG BASE/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: GAIN - Generating Antibiotic Incentives Now | Jun 25, 2028 | New product in Orange Book |
| Exclusivity Code: NCE - New chemical entity | Jun 25, 2023 | New product in Orange Book |
ZERVIATE
(SOLUTION/DROPS)
CETIRIZINE HYDROCHLORIDE
NDA Applicant:
EYEVANCE
PHARMS NDA No.: 208694 Prod. No.:
001 RX (EQ 0.24% BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9993471
[Img] Ophthalmic formulations of cetirizine and methods of use Claim Types: Method of use Use Code: U-1680: Treatment of ocular itching associated with allergic conjunctivitis |
Mar 15, 2030 | New patent for this product |