WIDAPLIK Drug Patent Profile

When do Widaplik patents expire, and what generic alternatives are available?

Widaplik is a drug marketed by Azurity and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-nine patent family members in twenty-two countries.

The generic ingredient in WIDAPLIK is amlodipine besylate; indapamide; telmisartan. There are fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; indapamide; telmisartan profile page.

DrugPatentWatch^® Generic Entry Outlook for Widaplik

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 23, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for WIDAPLIK

International Patents:	69
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in WIDAPLIK?	WIDAPLIK excipients list
DailyMed Link:	WIDAPLIK at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for WIDAPLIK

Constraining patent/regulatory exclusivity:

10,322,117

NDA:

219423

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for WIDAPLIK

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker Thiazide-like Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

US Patents and Regulatory Information for WIDAPLIK

WIDAPLIK is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,322,117.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-001	Jun 5, 2025		RX	Yes	No	10,322,117		Y
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-003	Jun 5, 2025		RX	Yes	Yes
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-002	Jun 5, 2025		RX	Yes	No	10,799,487		Y

International Patents for WIDAPLIK

When does loss-of-exclusivity occur for WIDAPLIK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Finland

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering WIDAPLIK around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018213147	Compositions for the treatment of hypertension
Australia	2019309329	Compositions for the treatment of hypertension
Australia	2023274064	Compositions for the treatment of hypertension

Supplementary Protection Certificates for WIDAPLIK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222