VYNDAQEL Drug Patent Profile

Which patents cover Vyndaqel, and when can generic versions of Vyndaqel launch?

Vyndaqel is a drug marketed by Foldrx Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-five patent family members in seventeen countries.

The generic ingredient in VYNDAQEL is tafamidis meglumine. One supplier is listed for this compound. Additional details are available on the tafamidis meglumine profile page.

DrugPatentWatch^® Generic Entry Outlook for Vyndaqel

Vyndaqel will be eligible for patent challenges on May 3, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 3, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VYNDAQEL

International Patents:	35
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Drug Prices:	Drug price information for VYNDAQEL
What excipients (inactive ingredients) are in VYNDAQEL?	VYNDAQEL excipients list
DailyMed Link:	VYNDAQEL at DailyMed

See drug prices for VYNDAQEL

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VYNDAQEL

Constraining patent/regulatory exclusivity:

TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION

NDA:

211996

Dosage:

CAPSULE;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.

Recent Clinical Trials for VYNDAQEL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 4
Pfizer	Phase 1
Pfizer

See all VYNDAQEL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VYNDAQEL

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for VYNDAQEL

VYNDAQEL is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION.

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

Patents protecting VYNDAQEL

FDA Regulatory Exclusivity protecting VYNDAQEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes			Y	Y
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes			Y	Y

International Patents for VYNDAQEL

When does loss-of-exclusivity occur for VYNDAQEL?

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

Australia

Austria

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Germany

Japan

Luxembourg

Portugal

Slovenia

South Africa

South Korea

Spain

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 VYNDAQEL around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	60323155
Denmark	1587821
China	1747965	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
World Intellectual Property Organization (WIPO)	2004056315

Supplementary Protection Certificates for VYNDAQEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	C20120001 00050	Estonia		PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011
1587821	382	Finland
1587821	126 5003-2012	Slovakia		PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	6/2012	Austria		PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116