Patent and Exclusivity Expirations Report
Report generated for the week of 2025-06-09 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 6 drugs in the patent and exclusivity list. They are:
Tafinlar by Novartis Pharmaceuticals, containing active ingredient Dabrafenib Mesylate
Mekinist by Novartis Pharmaceuticals, containing active ingredient Trametinib Dimethyl Sulfoxide
Xtampza ER by Collegium Pharmaceutical, containing active ingredient Oxycodone
Olumiant by Eli Lilly, containing active ingredient Baricitinib
Moxidectin by Medicines Development for Global Health, containing active ingredient Moxidectin
Zepzelca by Jazz Pharmaceuticals, containing active ingredient Lurbinectedin
Patents Expiring This Week
DABRAFENIB MESYLATE - CAPSULE;ORAL - TAFINLAR
From NOVARTIS PHARMACEUTICALS CORP; a kinase inhibitor used to treat patients with specific types of melanoma, non-small cell lung cancer, and thyroid cancer.
EQ 75MG BASE
Approved in May 29, 2013, used as Reference Listed Drug and Reference Standard
EQ 50MG BASE
Approved in May 29, 2013, used as Reference Listed Drug
There are 13 future patent(s) for this application. The earliest expires on 2025-12-10, and the latest expires on 2034-02-28.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8835443 | U-2026 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST. | 2025-06-10 | Pyrimidine compound and medical use thereof |
| 8835443 | U-2296 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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 | 2025-06-10 | Pyrimidine compound and medical use thereof |
| 8835443 | U-2298 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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 | 2025-06-10 | Pyrimidine compound and medical use thereof |
| 8835443 | U-2027 | TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST. | 2025-06-10 | Pyrimidine compound and medical use thereof |
DABRAFENIB MESYLATE - TABLET, FOR SUSPENSION;ORAL - TAFINLAR
From NOVARTIS PHARMACEUTICALS CORP; a kinase inhibitor used to treat patients with specific types of melanoma, non-small cell lung cancer, and thyroid cancer.
EQ 10MG BASE
Approved in Mar 16, 2023, used as Reference Listed Drug and Reference Standard
There are 9 future patent(s) for this application. The earliest expires on 2025-12-10, and the latest expires on 2038-12-29.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8835443 | U-3565 | TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY | 2025-06-10 | Pyrimidine compound and medical use thereof |
OXYCODONE - CAPSULE, EXTENDED RELEASE;ORAL - XTAMPZA ER
From COLLEGIUM PHARMACEUTICAL INC; an opioid used in the management of moderate to severe pain.
36MG
Approved in Apr 26, 2016, used as Reference Listed Drug and Reference Standard
9MG; 13.5MG; 18MG; 27MG
Approved in Apr 26, 2016, used as Reference Listed Drug
There are 7 future patent(s) for this application. The earliest expires on 2030-12-10, and the latest expires on 2036-09-02.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8758813 | U-1556 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE | 2025-06-10 | Abuse-deterrent drug formulations |
TRAMETINIB DIMETHYL SULFOXIDE - SOLUTION;ORAL - MEKINIST
From NOVARTIS PHARMACEUTICALS CORP; a kinase inhibitor used alone or in combination with dabrafenib to treat patients with cancers with specific BRAF mutations, such as melanoma and non-small cell lung cancer.
EQ 0.05MG BASE/ML
Approved in Mar 16, 2023, used as Reference Listed Drug and Reference Standard
There are 5 future patent(s) for this application. The earliest expires on 2025-12-10, and the latest expires on 2031-04-15.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8835443 | U-3564 | MEKINIST IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY | 2025-06-10 | Pyrimidine compound and medical use thereof |
TRAMETINIB DIMETHYL SULFOXIDE - TABLET;ORAL - MEKINIST
From NOVARTIS PHARMACEUTICALS CORP; a kinase inhibitor used alone or in combination with dabrafenib to treat patients with cancers with specific BRAF mutations, such as melanoma and non-small cell lung cancer.
EQ 2MG
Approved in May 29, 2013, used as Reference Listed Drug and Reference Standard
EQ 0.5MG
Approved in May 29, 2013, used as Reference Listed Drug
There are 17 future patent(s) for this application. The earliest expires on 2025-12-10, and the latest expires on 2034-02-28.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8835443 | U-2302 | MEKINIST 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 | 2025-06-10 | Pyrimidine compound and medical use thereof |
| 8835443 | U-1582 | TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA | 2025-06-10 | Pyrimidine compound and medical use thereof |
| 8835443 | U-2020 | MEKINIST IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST | 2025-06-10 | Pyrimidine compound and medical use thereof |
| 8835443 | U-1581 | IN COMBINATION WITH DABRAFENIB FOR THE TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA. | 2025-06-10 | Pyrimidine compound and medical use thereof |
| 8835443 | U-2037 | MEKINIST IS INDICATED, AS A SINGLE AGENT OR IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST | 2025-06-10 | Pyrimidine compound and medical use thereof |
| 8835443 | U-2305 | MEKINIST IS INDICATED, IN COMBINATION WITH DABRAFENIB, 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 | 2025-06-10 | Pyrimidine compound and medical use thereof |
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
Approved in Oct 8, 2019, used as Reference Listed Drug
2MG
Approved in May 31, 2018, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-13 | TREATMENT OF ADULT PATIENTS WITH SEVERE ALOPECIA AREATA |
LURBINECTEDIN - POWDER;INTRAVENOUS - ZEPZELCA
From JAZZ PHARMACEUTICALS IRELAND LTD; a chemotherapeutic DNA alkylating agent used in the treatment of metastatic small-cell lung cancer.
4MG/VIAL
Approved in Jun 15, 2020, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-06-15, and the latest expires on 2027-06-15.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-15 | NEW CHEMICAL ENTITY |
MOXIDECTIN - TABLET;ORAL - MOXIDECTIN
From MEDICINES DEVELOPMENT FOR GLOBAL HEALTH; a potent, broad-spectrum endectocide (antiparasitic that is active against endo- and ecto-parasites) with activity against nematodes, insects, and acari.
2MG
Approved in Jun 13, 2018, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2028-02-07, and the latest expires on 2028-02-07.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-06-13 | INDICATED FOR THE TREATMENT OF ONCHOCERCIASIS DUE TO ONCHOCERCA VOLVULUS IN PATIENTS AGED 12 YEARS AND OLDER |
