Views: 62 Author: Unibest Industrial Publish Time: 2024-12-23 Origin: Site
Report generated for the week of 2024-12-23 by Unibest Digital Center. Current analysis scope only include the US FDA.
This week, there are 4 drugs in the patent and exclusivity list. They are:
- STEMLINE THERAPEUTICS INC's ORSERDU, containing active ingredient ELACESTRANT DIHYDROCHLORIDE
- ABBVIE INC's UBRELVY, containing active ingredient UBROGEPANT
- TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC's AUSTEDO, containing active ingredient DEUTETRABENAZINE
- OTSUKA PHARMACEUTICAL CO LTD's REXULTI, containing active ingredient BREXPIPRAZOLE
From STEMLINE THERAPEUTICS INC; an estrogen receptor antagonist used to treat ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Approved in Jan 27, 2023, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2026-08-18, and the latest expires on 2038-01-05.
Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
---|---|---|---|---|
8399520 | U-3523 | TREATMENT OF AN ER-POSITIVE BREAST CANCER | 2024-12-25 | Selective estrogen receptor modulator |
Approved in Jan 27, 2023, used as Reference Listed Drug
There are 7 future patent(s) for this application. The earliest expires on 2026-08-18, and the latest expires on 2038-01-05.
Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
---|---|---|---|---|
8399520 | U-3523 | TREATMENT OF AN ER-POSITIVE BREAST CANCER | 2024-12-25 | Selective estrogen receptor modulator |
From OTSUKA PHARMACEUTICAL CO LTD
Approved in Jul 10, 2015, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-10, and the latest expires on 2027-11-08.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-27 | NEW PATIENT POPULATION |
Approved in Jul 10, 2015, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-10, and the latest expires on 2027-11-08.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-27 | NEW PATIENT POPULATION |
Approved in Jul 10, 2015, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-10, and the latest expires on 2027-11-08.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-27 | NEW PATIENT POPULATION |
Approved in Jul 10, 2015, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-10, and the latest expires on 2027-11-08.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-27 | NEW PATIENT POPULATION |
Approved in Jul 10, 2015, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-10, and the latest expires on 2027-11-08.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-27 | NEW PATIENT POPULATION |
Approved in Jul 10, 2015, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-10, and the latest expires on 2027-11-08.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-27 | NEW PATIENT POPULATION |
From TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Approved in Apr 3, 2017, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-24 | PEDIATRIC EXCLUSIVITY |
Approved in Apr 3, 2017, used as Reference Listed Drug
There are no future exclusivities for this application.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-24 | PEDIATRIC EXCLUSIVITY |
Approved in Apr 3, 2017, used as Reference Listed Drug
There are no future exclusivities for this application.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-24 | PEDIATRIC EXCLUSIVITY |
From ABBVIE INC
Approved in Dec 23, 2019, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-23 | NEW CHEMICAL ENTITY |
Approved in Dec 23, 2019, used as Reference Listed Drug
There are no future exclusivities for this application.
Exclusivity Date | Exclusivity Use Definition |
---|---|
2024-12-23 | NEW CHEMICAL ENTITY |