VYNDAMAX Drug Patent Profile

When do Vyndamax patents expire, and when can generic versions of Vyndamax launch?

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

This drug has sixty-three patent family members in twenty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Vyndamax

Vyndamax 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 August 31, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VYNDAMAX

International Patents:	63
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Patent Applications:	30
Drug Prices:	Drug price information for VYNDAMAX
DailyMed Link:	VYNDAMAX at DailyMed

See drug prices for VYNDAMAX

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VYNDAMAX

NDA:

212161

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.

Anatomical Therapeutic Chemical (ATC) Classes for VYNDAMAX

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

US Patents and Regulatory Information for VYNDAMAX

VYNDAMAX is protected by three US patents and two FDA Regulatory Exclusivities.

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 VYNDAMAX

FDA Regulatory Exclusivity protecting VYNDAMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes			Y	Y
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes			Y	Y
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes

EU/EMA Drug Approvals for VYNDAMAX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Vyndaqel	tafamidis	EMEA/H/C/002294 Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.	Authorised	no	no	yes	2011-11-16

International Patents for VYNDAMAX

When does loss-of-exclusivity occur for VYNDAMAX?

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

Argentina

Australia

Brazil

Canada

China

Croatia

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

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 VYNDAMAX around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	101778	FORMAS SÓLIDAS CRISTALINAS DE 6-CARBOXI-2-(3,5-DICLOROFENIL)-BENZOXAZOL
Israel	251037
Japan	2022024014	６－カルボキシ－２－（３，５－ジクロロフェニル）－ベンゾオキサゾールの結晶性固体形態 (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
China	1747965	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
European Patent Office	3191461	FORMES CRISTALLINES SOLIDES DU 6-CARBOXY-2-(3,5-DICHLOROPHÉNYL)-BENZOXAZOLE (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
China	106715405	6‑羧基‑2‑(3,5‑二氯苯基)苯并噁唑的结晶固体形式 (Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole)
Cyprus	1108467

Supplementary Protection Certificates for VYNDAMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	C 2012 004	Romania		PRODUCT NAME: TAFAMIDISMEGLUMINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/717/001; DATE OF NATIONAL AUTHORISATION: 20111116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/717/001; DATE OF FIRST AUTHORISATION IN EEA: 20111116
1587821	SPC/GB12/009	United Kingdom		PRODUCT NAME: TAFAMIDIS, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE MEGLUMINE SALT; REGISTERED: UK EU/1/11/717/001 20111118
1587821	91935	Luxembourg		91935, EXPIRES: 20261116
1587821	126 5003-2012	Slovakia		PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	C20120001 00050	Estonia		PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011
1587821	6/2012	Austria		PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	1290005-6	Sweden		PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117