Patent and Exclusivity Expirations Report
Report generated for the week of 2025-05-05 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 9 drugs in the patent and exclusivity list. They are:
Vizimpro by Pfizer, containing active ingredient Dacomitinib
Aptiom by Sumitomo Pharma America, containing active ingredient Eslicarbazepine Acetate
Symbicort by AstraZeneca, containing active ingredient Budesonide; Formoterol Fumarate Dihydrate
Valtoco by Neurelis, containing active ingredient Diazepam
Tabrecta by Novartis, containing active ingredient Capmatinib Hydrochloride
Retevmo by Eli Lilly, containing active ingredient Selpercatinib
Sprycel by Bristol Myers Squibb, containing active ingredient Dasatinib
Brilinta by AstraZeneca, containing active ingredient Ticagrelor
Olumiant by Eli Lilly, containing active ingredient Baricitinib
Patents Expiring This Week
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - AEROSOL, METERED;INHALATION - SYMBICORT
From ASTRAZENECA LP; for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
0.08MG/INH;0.0045MG/INH
0.16MG/INH;0.0045MG/INH
Approved in Jul 21, 2006, used as Reference Listed Drug and Reference Standard
There are 8 future patent(s) for this application. The earliest expires on 2026-04-10, and the latest expires on 2029-10-07.
| Patent No | Patent Expiration Date | Patent Title |
| 8875699*PED | 2025-05-10 | Inhaler cap strap |
DACOMITINIB - TABLET;ORAL - VIZIMPRO
From PFIZER INC; to treat non small cell lung cancer with EGFR exon 19 deletion of exon 21 L858R substitution.
45MG
Approved in Sep 27, 2018, used as Reference Listed Drug and Reference Standard
15MG; 30MG
Approved in Sep 27, 2018, used as Reference Listed Drug
There are 3 future patent(s) for this application. The earliest expires on 2026-02-02, and the latest expires on 2028-08-26.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8623883 | U-1403 | FIRST-LINE TREATMENT OF METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST | 2025-05-05 | 4-phenylamino-quinazolin-6-yl-amides |
DIAZEPAM - SPRAY;NASAL - VALTOCO
From NEURELIS INC; for the short-term treatment of seizure clusters as a nasal spray.
10MG/SPRAY
Approved in Jan 10, 2020, used as Reference Listed Drug and Reference Standard
5MG/SPRAY; 7.5MG/SPRAY
Approved in Jan 10, 2020, used as Reference Listed Drug
There are 4 future patent(s) for this application. The earliest expires on 2025-07-21, and the latest expires on 2029-03-27.
| Patent No | Patent Expiration Date | Patent Title |
| 9642913 | 2025-05-11 | Pharmaceutical composition including alkyl glycoside and an anti-seizure agent |
| 10265402 | 2025-05-11 | Absorption enhancers for drug administration |
ESLICARBAZEPINE ACETATE - TABLET;ORAL - APTIOM
From SUMITOMO PHARMA AMERICA INC; an anticonvulsant agent used as an adjunct to treat partial-onset seizures in patients with inadequate clinical response to conventional antiepileptic therapy.
800MG
Approved in Nov 8, 2013, used as Reference Listed Drug and Reference Standard
200MG; 400MG; 600MG
Approved in Nov 8, 2013, used as Reference Listed Drug
There are 7 future patent(s) for this application. The earliest expires on 2026-04-21, and the latest expires on 2032-08-24.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 11364247 | U-2501 | TREATMENT OF PARTIAL-ONSET SEIZURES | 2025-05-06 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
| 10695354 | U-2501 | TREATMENT OF PARTIAL-ONSET SEIZURES | 2025-05-06 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
| 11364247 | U-2831 | TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES | 2025-05-06 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
| 10695354 | U-2831 | TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES | 2025-05-06 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
| 10702536 | U-2501 | TREATMENT OF PARTIAL-ONSET SEIZURES | 2025-05-06 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
| 10675287 | U-2041 | TREATMENT OF PARTIAL-ONSET SEIZURES | 2025-05-06 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
| 10675287 | U-2831 | TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES | 2025-05-06 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
Exclusivities Expiring This Week
BARICITINIB - TABLET;ORAL - OLUMIANT
From ELI LILLY AND CO; a Janus kinase inhibitor used to treat moderate to severe rheumatoid arthritis that has responded poorly to at least one TNF antagonist.
4MG
Approved in May 10, 2022, used as Reference Listed Drug and Reference Standard
1MG; 2MG
Approved in Oct 8, 2019, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-13, and the latest expires on 2025-06-13.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-10 | TREATMENT OF COVID-19 IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NONINVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) |
CAPMATINIB HYDROCHLORIDE - TABLET;ORAL - TABRECTA
From NOVARTIS PHARMACEUTICAL CORP; a kinase inhibitor targeting c-Met receptor tyrosine kinase in the treatment of non-small cell lung cancer with MET exon 14 skipping.
EQ 200MG BASE
Approved in May 6, 2020, used as Reference Listed Drug and Reference Standard
EQ 150MG BASE
Approved in May 6, 2020, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-05-06, and the latest expires on 2027-05-06.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-06 | NEW CHEMICAL ENTITY |
DASATINIB - TABLET;ORAL - SPRYCEL
From BRISTOL MYERS SQUIBB CO; a tyrosine kinase inhibitor used for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myeloid leukemia.
100MG
Approved in May 30, 2008, used as Reference Listed Drug and Reference Standard
20MG; 50MG; 70MG; 80MG; 140MG
Approved in Jun 28, 2006, used as Reference Listed Drug
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-12-21, and the latest expires on 2026-06-21.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-09 | PEDIATRIC EXCLUSIVITY |
SELPERCATINIB - CAPSULE;ORAL - RETEVMO
From ELI LILLY AND CO; a RET receptor tyrosine kinase inhibitor for the treatment of RET-driven non-small cell lung cancer, medullary thyroid cancer, and thyroid cancer in appropriate patient populations.
40MG
Approved in May 8, 2020, used as Reference Listed Drug
80MG
Approved in May 8, 2020, used as Reference Listed Drug and Reference Standard
There are 11 future exclusivity(ies) for this drug product. The earliest expires on 2027-05-08, and the latest expires on 2031-05-29.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-08 | NEW CHEMICAL ENTITY |
SELPERCATINIB - TABLET;ORAL - RETEVMO
From ELI LILLY AND CO; a RET receptor tyrosine kinase inhibitor for the treatment of RET-driven non-small cell lung cancer, medullary thyroid cancer, and thyroid cancer in appropriate patient populations.
160MG
Approved in Apr 10, 2024, used as Reference Listed Drug and Reference Standard
40MG; 80MG; 120MG
Approved in Apr 10, 2024, used as Reference Listed Drug
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2027-09-27, and the latest expires on 2027-09-27.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-08 | NEW CHEMICAL ENTITY |
TICAGRELOR - TABLET;ORAL - BRILINTA
From ASTRAZENECA PHARMACEUTICALS LP; a P2Y12 platelet inhibitor used in patients with a history of myocardial infarction or with acute coronary syndrome (ACS) to prevent future myocardial infarction, stroke and cardiovascular death.
60MG
Approved in Sep 3, 2015, used as Reference Listed Drug
90MG
Approved in Jul 20, 2011, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2025-11-09, and the latest expires on 2025-11-09.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-09 | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HESTIA3 |
