Patent and Exclusivity Expirations Report
Report generated for the week of 2025-06-23 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 18 drugs in the patent and exclusivity list. They are:
Latuda by Sunovion Pharmaceuticals, containing active ingredient Lurasidone Hydrochloride
Trikafta by Vertex Pharmaceuticals, containing active ingredient Elexacaftor, Ivacaftor, Tezacaftor
Kalydeco by Vertex Pharmaceuticals, containing active ingredient Ivacaftor
Symdeko by Vertex Pharmaceuticals, containing active ingredient Ivacaftor, Tezacaftor
Kazano by Takeda Pharmaceuticals, containing active ingredient Alogliptin Benzoate, Metformin Hydrochloride
Alyftrek by Vertex Pharmaceuticals, containing active ingredient Deutivacaftor, Tezacaftor, Vanzacaftor Calcium
Nucynta by Collegium Pharmaceutical, containing active ingredient Tapentadol Hydrochloride
Nucynta ER by Collegium Pharmaceutical, containing active ingredient Tapentadol Hydrochloride
Exondys 51 by Sarepta Therapeutics, containing active ingredient Eteplirsen
Amondys 45 by Sarepta Therapeutics, containing active ingredient Casimersen
Vyondys 53 by Sarepta Therapeutics, containing active ingredient Golodirse
Vyleesi by Cosette Pharmaceuticals, containing active ingredient Bremelanotide Acetate
Abilify Maintena Kit by Otsuka Pharmaceutical, containing active ingredient Aripiprazole
Abilify Asimtufii by Otsuka Pharmaceutical, containing active ingredient Aripiprazole
Qsymia by Vivus, containing active ingredient Phentermine Hydrochloride, Topiramate
Braftovi by Array Biopharma, containing active ingredient Encorafenib
Mektovi by Array Biopharma, containing active ingredient Binimetinib
Signifor LAR Kit by Recordati Rare Diseases, containing active ingredient Pasireotide Pamoate
Patents Expiring This Week
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - TABLET;ORAL - KAZANO
From TAKEDA PHARMACEUTICALS USA INC; oral diabetes medicines that help control blood sugar levels
EQ 12.5MG BASE;1GM
Approved in Jan 25, 2013, used as Reference Listed Drug and Reference Standard
EQ 12.5MG BASE;500MG
Approved in Jan 25, 2013, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2028-06-27, and the latest expires on 2029-05-24.
| Patent No | Patent Expiration Date | Patent Title |
| 8288539 | 2025-06-24 | Dipeptidyl peptidase inhibitors |
ARIPIPRAZOLE - FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - ABILIFY MAINTENA KIT
From OTSUKA PHARMACEUTICAL CO LTD; an atypical antipsychotic used in the treatment of a wide variety of mood and psychotic disorders, such as schizophrenia, bipolar I, major depressive disorder, irritability associated with autism, and Tourette's syndrome.
400MG/VIAL
Approved in Feb 28, 2013, used as Reference Listed Drug and Reference Standard
300MG/VIAL
Approved in Feb 28, 2013, used as Reference Listed Drug
300MG; 400MG
Approved in Sep 29, 2014, used as Reference Listed Drug
There are 6 future patent(s) for this application. The earliest expires on 2033-09-24, and the latest expires on 2034-04-06.
| Patent No | Patent Expiration Date | Patent Title |
| 8399469 | 2025-06-29 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
ARIPIPRAZOLE - SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - ABILIFY ASIMTUFII
From OTSUKA PHARMACEUTICAL CO LTD; an atypical antipsychotic used in the treatment of a wide variety of mood and psychotic disorders, such as schizophrenia, bipolar I, major depressive disorder, irritability associated with autism, and Tourette's syndrome.
960MG/3.2ML (300MG/ML)
Approved in Apr 27, 2023, used as Reference Listed Drug and Reference Standard
720MG/2.4ML (300MG/ML)
Approved in Apr 27, 2023, used as Reference Listed Drug
There are 4 future patent(s) for this application. The earliest expires on 2033-04-23, and the latest expires on 2033-04-23.
| Patent No | Patent Expiration Date | Patent Title |
| 8399469 | 2025-06-29 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
BREMELANOTIDE ACETATE - SOLUTION;SUBCUTANEOUS - VYLEESI (AUTOINJECTOR)
From COSETTE PHARMACEUTICALS INC; a 7 amino acid peptide used to treat hypoactive sexual desire disorder in premenopausal women.
EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)
Approved in Jun 21, 2019, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2033-11-05, and the latest expires on 2041-04-29.
| Patent No | Patent Expiration Date | Patent Title |
| 6794489 | 2025-06-28 | Compositions and methods for treatment of sexual dysfunction |
CASIMERSEN - SOLUTION;INTRAVENOUS - AMONDYS 45
From SAREPTA THERAPEUTICS INC; an antisense phosphorodiamidate morpholino oligonucleotide used to treat Duchenne muscular dystrophy patients with mutations amenable to exon 45 skipping.
100MG/2ML (50MG/ML)
Approved in Feb 25, 2021, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2030-11-12, and the latest expires on 2030-11-12.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9447415 |
|
| 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| RE48960 | U-3088 | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING | 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| RE48960 | U-3087 | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING BY INDUCING EXON-SKIPPING OF EXON 45 | 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM - TABLET;ORAL - ALYFTREK
From VERTEX PHARMACEUTICALS INC; used to treat cystic fibrosis (CF) in people aged 6 years and older with at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
125MG;50MG;EQ 10MG BASE
Approved in Dec 20, 2024, used as Reference Listed Drug and Reference Standard
50MG;20MG;EQ 4MG BASE
Approved in Dec 20, 2024, used as Reference Listed Drug
There are 32 future patent(s) for this application. The earliest expires on 2026-07-06, and the latest expires on 2043-01-10.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8629162 | U-4084 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AND D-IVA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - GRANULES;ORAL - TRIKAFTA (COPACKAGED)
From VERTEX PHARMACEUTICALS INC; used to treat adults and children aged 2 years and older with cystic fibrosis (CF) with at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation responsive to treatment with Trikafta based on clinical and/or laboratory data.
100MG, 75MG, 50MG;75MG
Approved in Apr 26, 2023, used as Reference Listed Drug and Reference Standard
80MG, 60MG, 40MG;59.5MG
Approved in Apr 26, 2023, used as Reference Listed Drug
There are 31 future patent(s) for this application. The earliest expires on 2026-07-06, and the latest expires on 2037-12-08.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8629162 | U-3592 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
| 8629162 | U-4072 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 2 TO <6 YEARS WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELX, TEZ, AND IVA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - TABLET;ORAL - TRIKAFTA (COPACKAGED)
From VERTEX PHARMACEUTICALS INC; used to treat adults and children aged 2 years and older with cystic fibrosis (CF) with at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation responsive to treatment with Trikafta based on clinical and/or laboratory data.
100MG,75MG,50MG; 150MG
Approved in Oct 21, 2019, used as Reference Listed Drug and Reference Standard
There are 27 future patent(s) for this application. The earliest expires on 2026-07-06, and the latest expires on 2037-12-08.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8629162 | U-3030 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
| 8629162 | U-3146 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
| 8629162 | U-4079 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELX, TEZ, AND IVA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
50MG,37.5MG,25MG; 75MG
Approved in Jun 8, 2021, used as Reference Listed Drug
There are 27 future patent(s) for this application. The earliest expires on 2026-07-06, and the latest expires on 2037-12-08.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8629162 | U-3146 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
| 8629162 | U-4079 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELX, TEZ, AND IVA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
ETEPLIRSEN - SOLUTION;INTRAVENOUS - EXONDYS 51
From SAREPTA THERAPEUTICS INC; an antisense oligonucleotide used to treat Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.
100MG/2ML (50MG/ML)
Approved in Sep 19, 2016, used as Reference Listed Drug and Reference Standard
500MG/10ML (50MG/ML)
Approved in Sep 19, 2016, used as Reference Listed Drug and Reference Standard
There are 6 future patent(s) for this application. The earliest expires on 2028-10-27, and the latest expires on 2034-03-14.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| RE47751 | U-1918 | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING | 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| RE47751 | U-2664 | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY INDUCING SKIPPING OF EXON 51 | 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| RE47751 | U-2673 | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY CORRECTING A DEFECTIVE GENE FOR DYSTROPHIN | 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| RE47751 | U-2674 | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY RESTORING OR INCREASING FUNCTIONAL DYSTROPHIN PROTEIN PRODUCTION | 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| 10781451 |
|
| 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| 9018368 |
|
| 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
GOLODIRSEN - SOLUTION;INTRAVENOUS - VYONDYS 53
From SAREPTA THERAPEUTICS INC; a drug used to treat certain mutations that cause Duchenne muscular dystrophy (DMD).
100MG/2ML (50MG/ML)
Approved in Dec 12, 2019, used as Reference Listed Drug and Reference Standard
There are 1 future patent(s) for this application. The earliest expires on 2028-06-28, and the latest expires on 2028-06-28.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 10266827 | 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 | 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| 10995337 | 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 | 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| 10227590 |
|
| 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| 10968450 |
|
| 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| 9024007 |
|
| 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| 10421966 |
|
| 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| 9994851 |
|
| 2025-06-28 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
IVACAFTOR - GRANULE;ORAL - KALYDECO
From VERTEX PHARMACEUTICALS INC; a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator used alone or in combination products to treat cystic fibrosis in patients who have specific genetic mutations that are responsive to the medication.
75MG/PACKET
Approved in Mar 17, 2015, used as Reference Listed Drug and Reference Standard
50MG/PACKET
Approved in Mar 17, 2015, used as Reference Listed Drug
25MG/PACKET
Approved in Apr 29, 2019, used as Reference Listed Drug
There are 20 future patent(s) for this application. The earliest expires on 2026-07-06, and the latest expires on 2033-02-27.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8629162 | U-2529 | TREATMENT OF A MODERATE MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR IN A PATIENT AGE 6 MONTHS TO <6 YEARS WHO HAS ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
| 8629162 | U-2234 | USE OF IVACAFTOR FOR TREATING CYSTIC FIBROSIS IN A PATIENT WITH A MILD TO MODERATE CF PHENOTYPE WITH AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
13.4MG/PACKET; 5.8MG/PACKET
Approved in May 3, 2023, used as Reference Listed Drug
There are 20 future patent(s) for this application. The earliest expires on 2026-07-06, and the latest expires on 2033-02-27.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8629162 | U-3607 | TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF USING IVACAFTOR IN A PATIENT AGE 1 MONTH TO <4 MONTHS WHO HAS AT LEAST ONE CFTR MUTATION RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
IVACAFTOR - TABLET;ORAL - KALYDECO
From VERTEX PHARMACEUTICALS INC; a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator used alone or in combination products to treat cystic fibrosis in patients who have specific genetic mutations that are responsive to the medication.
150MG
Approved in Jan 31, 2012, used as Reference Listed Drug and Reference Standard
There are 15 future patent(s) for this application. The earliest expires on 2026-07-06, and the latest expires on 2030-02-13.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8629162 | U-2234 | USE OF IVACAFTOR FOR TREATING CYSTIC FIBROSIS IN A PATIENT WITH A MILD TO MODERATE CF PHENOTYPE WITH AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA | 2025-06-24 | Modulators of ATP-binding cassette transporters |
IVACAFTOR; IVACAFTOR, TEZACAFTOR - TABLET;ORAL - SYMDEKO (COPACKAGED)
From VERTEX PHARMACEUTICALS INC; used to treat cystic fibrosis in adults and children who are at least 6 years old.
150MG;150MG, 100MG
Approved in Feb 12, 2018, used as Reference Listed Drug and Reference Standard
75MG;75MG, 50MG
Approved in Jun 21, 2019, used as Reference Listed Drug
There are 24 future patent(s) for this application. The earliest expires on 2026-07-06, and the latest expires on 2035-04-14.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8629162 | U-2247 | TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF PATIENTS WITH A MILD TO MODERATE CLINICAL PHENOTYPE OF CYSTIC FIBROSIS HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE | 2025-06-24 | Modulators of ATP-binding cassette transporters |
LURASIDONE HYDROCHLORIDE - TABLET;ORAL - LATUDA
From SUNOVION PHARMACEUTICALS INC; an atypical antipsychotic used to treat schizophrenia and depressive episodes associated with bipolar I disorder.
40MG
Approved in Oct 28, 2010, used as Reference Listed Drug and Reference Standard
80MG
Approved in Oct 28, 2010, used as Reference Listed Drug
20MG
Approved in Dec 7, 2011, used as Reference Listed Drug
120MG
Approved in Apr 26, 2012, used as Reference Listed Drug
60MG
Approved in Jul 12, 2013, used as Reference Listed Drug
There are 11 future patent(s) for this application. The earliest expires on 2025-12-23, and the latest expires on 2031-11-23.
| Patent No | Patent Expiration Date | Patent Title |
| RE45573 | 2025-06-23 | Process for producing imide compound |
TAPENTADOL HYDROCHLORIDE - TABLET, EXTENDED RELEASE;ORAL - NUCYNTA ER
From COLLEGIUM PHARMACEUTICAL INC; an opioid used to manage severe pain that has not responded to non-opioid medications, and for which opioid analgesic therapy is appropriate.
EQ 250MG BASE
Approved in Aug 25, 2011, used as Reference Listed Drug and Reference Standard
EQ 50MG BASE; EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE
Approved in Aug 25, 2011, used as Reference Listed Drug
There are 5 future patent(s) for this application. The earliest expires on 2025-12-27, and the latest expires on 2029-03-22.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7994364 | U-1276 | MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY | 2025-06-27 | Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride |
| 7994364 | U-1178 | RELIEF OF MODERATE TO SEVERE CHRONIC PAIN | 2025-06-27 | Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride |
TAPENTADOL HYDROCHLORIDE - TABLET;ORAL - NUCYNTA
From COLLEGIUM PHARMACEUTICAL INC; an opioid used to manage severe pain that has not responded to non-opioid medications, and for which opioid analgesic therapy is appropriate.
EQ 100MG BASE
Approved in Nov 20, 2008, used as Reference Listed Drug and Reference Standard
EQ 50MG BASE; EQ 75MG BASE
Approved in Nov 20, 2008, used as Reference Listed Drug
There are 1 future patent(s) for this application. The earliest expires on 2025-12-27, and the latest expires on 2025-12-27.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7994364 | U-931 | RELIEF OF MODERATE TO SEVERE ACUTE PAIN | 2025-06-27 | Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride |
Exclusivities Expiring This Week
BINIMETINIB - TABLET;ORAL - MEKTOVI
From ARRAY BIOPHARMA INC; used to treat metastatic melanoma with specific mutations.
15MG
Approved in Jun 27, 2018, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-10-11, and the latest expires on 2026-10-11.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-27 | ENCORAFENIB IS INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA-APPROVED TEST |
ENCORAFENIB - CAPSULE;ORAL - BRAFTOVI
From ARRAY BIOPHARMA INC; a kinase inhibitor used to treat unresectable or metastatic melanoma with specific mutations.
75MG
Approved in Jun 27, 2018, used as Reference Listed Drug and Reference Standard
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2026-10-11, and the latest expires on 2030-10-11.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-27 | ENCORAFENIB IS INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA-APPROVED TEST |
PASIREOTIDE PAMOATE - FOR SUSPENSION;INTRAMUSCULAR - SIGNIFOR LAR KIT
From RECORDATI RARE DISEASES INC; used to treat Cushing's disease or acromegaly (endocrine disorders).
EQ 60MG BASE/VIAL
Approved in Dec 15, 2014, used as Reference Listed Drug and Reference Standard
EQ 20MG BASE/VIAL; EQ 40MG BASE/VIAL
Approved in Dec 15, 2014, used as Reference Listed Drug
EQ 10MG BASE/VIAL; EQ 30MG BASE/VIAL
Approved in Jun 29, 2018, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-29 | INDICATED FOR TREATMENT OF PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - CAPSULE, EXTENDED RELEASE;ORAL - QSYMIA
From VIVUS LLC; used together with diet and exercise to help some adults and children 12 years and older with obesity, or some overweight adults who also have weight-related medical problems such as diabetes, high cholesterol, or high blood pressure, to lose weight and keep the weight off.
EQ 15MG BASE;92MG
Approved in Jul 17, 2012, used as Reference Listed Drug and Reference Standard
EQ 11.25MG BASE;69MG
EQ 3.75MG BASE;23MG
EQ 7.5MG BASE;46MG
Approved in Jul 17, 2012, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-09-13, and the latest expires on 2027-09-13.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-24 | NEW PATIENT POPULATION |
