Patent and Exclusivity Expirations Report

Report generated for the week of 2024-12-23 by Unibest Digital Center. Current analysis scope only include the US FDA.

Summary of Expirations

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

Patents Expiring This Week

ELACESTRANT DIHYDROCHLORIDE - TABLET;ORAL - ORSERDU

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.

EQ 345MG BASE

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

EQ 86MG BASE

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

Exclusivities Expiring This Week

BREXPIPRAZOLE - TABLET;ORAL - REXULTI

From OTSUKA PHARMACEUTICAL CO LTD

0.25MG

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

0.5MG

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

1MG

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

2MG

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

3MG

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

4MG

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

DEUTETRABENAZINE - TABLET;ORAL - AUSTEDO

From TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

12MG

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

6MG

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

9MG

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

UBROGEPANT - TABLET;ORAL - UBRELVY

From ABBVIE INC

100MG

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

50MG

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