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Drug Patent & Exclusivity Expiration Report - Week of Jan 13 2024

Views: 46     Author: Unibest Industrial     Publish Time: 2025-01-13      Origin: Site

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Patent and Exclusivity Expirations Report

Report generated for the week of 2025-01-13 by Unibest Digital Center. Current analysis scope only include the US FDA.


Patent Watch Jan 13 2025 - 1Patent Watch Jan 13 2025 - 2Patent Watch Jan 13 2025 - 3


Summary of Expirations

This week, there are 6 drugs in the patent and exclusivity list. They are:
- BAUSCH AND LOMB INC's BEPREVE, containing active ingredient BEPOTASTINE BESILATE
- ITALFARMACO SPA's DUVYZAT, containing active ingredient GIVINOSTAT HYDROCHLORIDE
- NOVARTIS PHARMACEUTICALS CORP's ENTRESTO & ENTRESTO SPRINKLE, containing active ingredient SACUBITRIL; VALSARTAN
- GLENMARK SPECIALTY SA's RYALTRIS, containing active ingredient MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE
- ABBVIE INC's RINVOQ, containing active ingredient UPADACITINIB

Patents Expiring This Week

BEPOTASTINE BESILATE - SOLUTION/DROPS;OPHTHALMIC - BEPREVE

From BAUSCH AND LOMB INC; for treating itchiness associated with allergic conjunctivitis.


Bepotastine besilate


1.5%

Approved in Sep 8, 2009, used as Reference Listed Drug and Reference Standard

There are no future patents for this application.

Patent No Patent Use Code Patent Use Definition Patent Expiration Date Patent Title
8784789

2025-01-13 Aqueous liquid preparations and light-stabilized aqueous liquid preparations


GIVINOSTAT HYDROCHLORIDE - SUSPENSION;ORAL - DUVYZAT

From ITALFARMACO SPA; for treating Duchenne Muscular Dystrophy.


Givinostat hydrochloride monohydrate


EQ 8.86MG BASE/ML

Approved in Mar 21, 2024, used as Reference Listed Drug and Reference Standard

There are 3 future patent(s) for this application. The earliest expires on 2032-02-03, and the latest expires on 2036-10-28.

Patent No Patent Use Code Patent Use Definition Patent Expiration Date Patent Title
7329689

2025-01-15 Monohydrate hydrochloride of the 4-hydroxycarbamoyl-phenyl)-carbamic acid (6-diethylaminomethyl-naphtalen-2-yl) ester


SACUBITRIL; VALSARTAN - CAPSULE, PELLETS;ORAL - ENTRESTO SPRINKLE

From NOVARTIS PHARMACEUTICALS CORP; for treating adults with chronic heart failure to help reduce the risk of death and hospitalization, and for treating certain children aged 1 year and older who have symptomatic heart failure.


SacubitrilValsartan


15MG;16MG

Approved in Apr 12, 2024, used as Reference Listed Drug and Reference Standard

6MG;6MG

Approved in Apr 12, 2024, used as Reference Listed Drug

There are 3 future patent(s) for this application. The earliest expires on 2026-11-08, and the latest expires on 2037-02-02.

Patent No Patent Use Code Patent Use Definition Patent Expiration Date Patent Title
8101659

2025-01-15 Methods of treatment and pharmaceutical composition


SACUBITRIL; VALSARTAN - TABLET;ORAL - ENTRESTO

From NOVARTIS PHARMACEUTICALS CORP; for treating adults with chronic heart failure to help reduce the risk of death and hospitalization and to treat certain children aged 1 year and older who have symptomatic heart failure.


SacubitrilValsartan


24MG;26MG

Approved in Jul 7, 2015, used as Reference Listed Drug

49MG;51MG

Approved in Jul 7, 2015, used as Reference Listed Drug

97MG;103MG

Approved in Jul 7, 2015, used as Reference Listed Drug and Reference Standard

There are 9 future patent(s) for this application. The earliest expires on 2025-07-15, and the latest expires on 2036-05-09.

Patent No Patent Use Code Patent Use Definition Patent Expiration Date Patent Title
8101659

2025-01-15 Methods of treatment and pharmaceutical composition


Exclusivities Expiring This Week

MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE - SPRAY, METERED;NASAL - RYALTRIS

From GLENMARK SPECIALTY SA; for treating symptoms of seasonal allergies in people 12 years of age and older.


Mometasone FuroateOlopatadine Hydrochloride


0.025MG/SPRAY;0.665MG/SPRAY

Approved in Jan 13, 2022, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date Exclusivity Use Definition
2025-01-13 NEW PRODUCT


UPADACITINIB - TABLET, EXTENDED RELEASE;ORAL - RINVOQ

From ABBVIE INC; for treating several conditions that have inflammation as a characteristic symptom.


Upadacitinib


15MG

Approved in Aug 16, 2019, used as Reference Listed Drug

There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2025-03-16, and the latest expires on 2031-04-26.

Exclusivity Date Exclusivity Use Definition
2025-01-14 TREATMENT OF ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH REFRACTORY, MODERATE-TO-SEVERE ATOPIC DERMATITIS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH OTHER SYSTEMIC DRUG PRODUCTS, INCLUDING BIOLOGICS, OR WHEN USE OF THOSE THERAPIES ARE INADVISABLE

30MG

Approved in Jan 14, 2022, used as Reference Listed Drug

There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2025-03-16, and the latest expires on 2031-04-26.

Exclusivity Date Exclusivity Use Definition
2025-01-14 TREATMENT OF ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH REFRACTORY, MODERATE-TO-SEVERE ATOPIC DERMATITIS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH OTHER SYSTEMIC DRUG PRODUCTS, INCLUDING BIOLOGICS, OR WHEN USE OF THOSE THERAPIES ARE INADVISABLE