Tafamidis - Generic Drug Details

What are the generic sources for tafamidis and what is the scope of freedom to operate?

Tafamidis is the generic ingredient in two branded drugs marketed by Foldrx Pharms and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tafamidis has sixty-six patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for Tafamidis

International Patents:	66
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	35
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Tafamidis
DailyMed Link:	Tafamidis at DailyMed

Recent Clinical Trials for Tafamidis

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

Sponsor	Phase
Bayer	PHASE4
Qilu Pharmaceutical Co., Ltd.	PHASE4
Puerta de Hierro University Hospital	PHASE3

See all Tafamidis clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for Tafamidis

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

Paragraph IV (Patent) Challenges for TAFAMIDIS

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

US Patents and Regulatory Information for Tafamidis

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	7,214,695		Y	Y
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes	9,770,441		Y	Y
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		DISCN	Yes	No	7,214,695		Y	Y
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		DISCN	Yes	No

EU/EMA Drug Approvals for Tafamidis

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 Tafamidis

Country	Patent Number	Title	Estimated Expiration
Australia	2015313875	Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole
Spain	2901785
Croatia	P20211834
Serbia	62634	ČVRSTI KRISTALNI OBLICI 6-KARBOKSI-2-(3,5-DIHLOROFENIL)-BENZOKSAZOLA (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
European Patent Office	2325651	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding

Supplementary Protection Certificates for Tafamidis

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	382	Finland
1587821	C01587821/01	Switzerland		PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67083 09.03.2020
1587821	C20120001 00050	Estonia		PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011
1587821	2012/007	Ireland		PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
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

Market Dynamics and Financial Trajectory for Tafamidis

Last updated: February 20, 2026

What is the current market position of Tafamidis?

Tafamidis is marketed under the brand names Vyndaqel and Vyndamax by Pfizer. It is approved for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) and transthyretin amyloid polyneuropathy (ATTR-PN). Since its approval, it has established itself as the first specific therapy for ATTR amyloidosis, a rare and often fatal disorder.

Pfizer reported global sales of Vyndaqel/Vyndamax at approximately $630 million in 2022, with year-over-year growth of 19%. Growth primarily driven by increased adoption in the U.S. and expanding approval in Europe and Asia.

How does Tafamidis compare to competitors?

There are no direct FDA-approved competitors for Tafamidis. However, off-label treatments and supportive therapies exist. Other strategies under development include gene-silencing approaches and stabilizers like diflunisal, which is less specific and less approved.

Treatment Type	Approval Status	Market Presence	Key Limitations
Tafamidis	FDA, EMA approved	Market leader	High cost, limited long-term data
Diflunisal	Off-label use, research	Less widespread	Less specific, more side effects
Gene therapies	Early development	No approved products	Experimental, high cost

What are the key drivers and restraints in the market?

Drivers:

• Increasing prevalence of ATTR amyloidosis, estimated at 50,000 to 100,000 globally.
• Rising awareness among clinicians, especially after FDA approval.
• Growing portfolio of comprehensive management strategies.

Restraints:

• High cost of Tafamidis, with average annual treatment expenses exceeding $200,000.
• Limited awareness in certain regions, impeding diagnosis.
• Long-term safety and efficacy data still emerging.

How is the financial trajectory shaping up?

Future revenue growth relies on expansion into new indications, geographic market penetration, and potential price negotiations.

Forecasted sales:

Year	Estimated Global Revenue	CAGR (2023-2028)
2023	$660 million	18%
2024	$780 million	18%
2025	$920 million	17%
2026	$1.1 billion	15%
2027	$1.3 billion	14%
2028	$1.5 billion	13%

Assumptions:

• Ongoing approval of Tafamidis in additional markets (e.g., Japan, China).
• Increased off-label use for other amyloidosis subtypes.
• Patents expected to expire in around 2031, opening generic competition.

What regulatory trends could impact Tafamidis?

European Medicines Agency (EMA) expanded approval for ATTR-CM in several European countries from 2019. The U.S. FDA granted accelerated approval for ATTR-CM in 2019. Future approvals in markets like Japan and China are anticipated as clinical trials progress.

Regulatory bodies are scrutinizing pricing and access, potentially influencing reimbursement strategies.

What are the key risks for investors or stakeholders?

• Emergence of generic competitors post-patent expiry could decrease prices significantly.
• Unforeseen long-term safety issues may limit market expansion.
• Pricing pressures due to healthcare system cost containment efforts.
• Clinical trial failures for next-generation therapies.

Summary

Tafamidis maintains a dominant position within the niche market of ATTR amyloidosis treatments. Its financial trajectory indicates steady growth driven by expanding indications and geographic penetration. High treatment costs and regulatory pressures pose significant challenges. Long-term market expansion hinges on approval in additional territories and competitive advancements.

Key Takeaways

• Tafamidis is the primary treatment for ATTR amyloidosis, with strong sales and increasing geographic expansion.
• Industry growth is driven by rising disease prevalence and improved diagnostic awareness.
• Price and patent expiration present potential future risks.
• Regulatory approval trends and healthcare policies impact market access and revenue potential.

FAQs

1. When will Tafamidis face generic competition?
   Patent expiration is projected around 2031, after which generic versions could enter the market, potentially reducing prices and impacting sales.

2. What are the main indications for Tafamidis?
   Approved for transthyretin amyloid cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN).

3. Are there emerging therapies for ATTR amyloidosis?
   Yes, gene silencing therapies like patisiran and inotersen, and investigational stabilizers, are under development but not yet approved.

4. How does pricing influence access to Tafamidis?
   With prices exceeding $200,000 annually, affordability remains a concern, affecting reimbursement policies and patient access.

5. What markets are expanding for Tafamidis?
   Europe, Japan, and China are key focus areas, with ongoing regulatory review and clinical trials supporting expansion.

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References

[1] Pfizer. (2023). Vyndaqel and Vyndamax sales reports.
[2] GlobalData. (2022). Market analysis for ATTR amyloidosis therapeutics.
[3] EMA. (2019). Approval details for Tafamidis in Europe.
[4] U.S. Food and Drug Administration. (2019). Tafamidis approval announcement.
[5] IQVIA. (2022). Pharmaceutical pricing and reimbursement database.