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 and one Paragraph IV challenge.

This drug has sixty-six patent family members in twenty-seven 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 was eligible for patent challenges on May 3, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 19, 2026. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VYNDAMAX

International Patents:	66
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Patent Applications:	262
Drug Prices:	Drug price information for VYNDAMAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYNDAMAX
DailyMed Link:	VYNDAMAX at DailyMed

See drug prices for VYNDAMAX

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

Constraining patent/regulatory exclusivity:

7,214,695

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.

Paragraph IV (Patent) Challenges for VYNDAMAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VYNDAMAX	Capsules	tafamidis	61 mg	212161	3	2023-05-03

US Patents and Regulatory Information for VYNDAMAX

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

This potential generic entry date is based on patent 7,214,695.

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
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes	9,770,441		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	7,214,696
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes	7,214,695		Y	Y

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/002294Vyndaqel 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

See the table below for patents covering VYNDAMAX around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	405840
Austria	524741
Australia	2003303196	COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING
Australia	2010201263	Compositions and methods for stabilizing transthyretin inhibiting transthyretin misfolding
Brazil	0317463	Métodos de triar para um composto que evita ou reduz a dissolução de um tetrâmero de transtiretina e de tratar uma doença amilóide transtiretina

Supplementary Protection Certificates for VYNDAMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	C300516	Netherlands		PRODUCT NAME: TAFAMIDIS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TAFAMIDIS MEGLUMINE ZOUT; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	91935	Luxembourg		91935, EXPIRES: 20261116
1587821	C20120001 00050	Estonia		PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011
1587821	CA 2012 00006	Denmark
1587821	1290005-6	Sweden		PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117

DrugChatter Q&A for VYNDAMAX

Vyndamax mexico market authorisation?
When will vyndamax become generic?
When does vyndamax patent expire?
Vyndamax or tafamidis or amvuttra or vutrisiran or voxzogo or vosoritide?
When does vyndamax go generic?