Tafamidis - Generic Drug Details

What are the generic drug sources for tafamidis and what is the scope of patent protection?

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:	29
Patent Applications:	65
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tafamidis
DailyMed Link:	tafamidis at DailyMed

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

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 tafamidis

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

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 4
Yale University	Phase 1
Columbia University	Phase 4

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	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes			Y	Y
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes

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/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 tafamidis

Country	Patent Number	Title	Estimated Expiration
Germany	60323155
Japan	2006511612
Luxembourg	91935

Supplementary Protection Certificates for tafamidis

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	2012/007	Ireland		PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	C01587821/01	Switzerland		PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67083 09.03.2020
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

Tafamidis Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tafamidis

Introduction to Tafamidis

Tafamidis, marketed under the brand name Vyndaqel, is a medication specifically designed to treat transthyretin amyloidosis (ATTR), a rare and often fatal condition characterized by the accumulation of abnormal proteins in various organs, particularly the heart and nerves.

Market Size and Projections

The Tafamidis Meglumine market is experiencing significant growth, driven by increasing awareness and diagnosis of ATTR. As of 2023, the market size was valued at USD 0.76 billion and is projected to reach USD 1.4 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.4% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Awareness and Diagnosis

The growing incidence of transthyretin amyloidosis and heightened awareness among medical professionals are major factors propelling the Tafamidis Meglumine market. Earlier and more accurate diagnoses, facilitated by advancements in diagnostic techniques, have increased the number of patients receiving treatment[1].

Clinical Efficacy

Tafamidis has demonstrated statistically significant reductions in all-cause mortality and cardiovascular-related hospitalizations in patients with transthyretin cardiomyopathy. The ATTR-ACT study showed that tafamidis was generally well-tolerated and improved health-related quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)[2][5].

Expanding Access and Healthcare Investments

Rising healthcare investments in developing nations and expanding access to medicines are contributing to the market's growth. Ongoing research and development are expected to expand the drug's application, leading to further market expansion[1].

Market Segmentation

By Type

The market is segmented into tafamidis meglumine capsules and oral solutions. The oral administration of tafamidis enhances patient compliance, which is a significant factor in its market share[1].

By Application

Tafamidis is primarily used for the treatment of transthyretin amyloidosis (ATTR), including both wild-type and hereditary forms. The drug's efficacy in reducing cardiovascular mortality and hospitalizations makes it a preferred treatment option[1][4].

By Distribution Channel

Hospital pharmacies play a crucial role in the distribution of tafamidis due to the specialized care required for patients with ATTR. Retail and online pharmacies also contribute to the market, but hospital pharmacies drive the majority of the distribution[4].

Financial Trajectory

Cost and Reimbursement

The treatment with tafamidis is costly, with an annual cost of approximately $195,012 per patient. Despite the high cost, the Canadian Drug Expert Committee (CDEC) recommends reimbursement for tafamidis due to its significant clinical benefits and the absence of effective alternative treatments[5].

Market Share

In the U.S. transthyretin amyloidosis treatment market, the tafamidis segment is estimated to contribute the highest market share of 39.3% in 2024. This dominance is attributed to its status as the first FDA-approved treatment for hereditary ATTR amyloidosis and its patent protection until 2030[4].

Revenue Projections

The U.S. transthyretin amyloidosis treatment market, where tafamidis is a key player, is valued at USD 59.7 million in 2024 and is expected to reach USD 111.9 million by 2031, growing at a CAGR of 9.4% from 2024 to 2031[4].

Challenges and Restraints

High Treatment Costs

The high cost of tafamidis treatment is a significant barrier to access. The annual cost of $195,012 per patient can be prohibitive for many, despite the clinical benefits[5].

Limited Approved Treatments

The scarcity of approved drugs for transthyretin amyloidosis can limit market growth. However, ongoing research and clinical trials are expected to introduce new treatment options, mitigating this challenge[4].

Industry Insights and Trends

Research and Development

Continuous research and development efforts are crucial in boosting demand for transthyretin amyloidosis treatments. Collaborations between pharmaceutical companies and research institutions are driving innovation in this field[4].

Awareness Initiatives

Awareness initiatives led by non-profit organizations and support groups are expected to propel market growth by increasing diagnosis rates and treatment initiation[4].

Quotes from Industry Experts

"The growing incidence of transthyretin amyloidosis and heightened awareness among medical professionals are major factors propelling the Tafamidis Meglumine market."

Market Research Intellect[1]

Illustrative Statistics

• Market Size: The Tafamidis Meglumine market was valued at USD 0.76 billion in 2023 and is expected to reach USD 1.4 billion by 2031[1].
• CAGR: The market is growing at a CAGR of 8.4% from 2024 to 2031[1].
• Treatment Cost: The annual cost of tafamidis treatment is approximately $195,012 per patient[5].
• Market Share: The tafamidis segment is estimated to contribute 39.3% of the U.S. transthyretin amyloidosis treatment market in 2024[4].

Key Takeaways

• The Tafamidis Meglumine market is driven by increasing awareness and diagnosis of transthyretin amyloidosis.
• Tafamidis has demonstrated significant clinical benefits, including reduced mortality and hospitalizations.
• The market is segmented by type, application, and distribution channel, with hospital pharmacies playing a key role.
• High treatment costs and limited approved treatments are significant challenges.
• Ongoing research and awareness initiatives are expected to drive market growth.

FAQs

Q: What is the current market size of the Tafamidis Meglumine market?

A: The Tafamidis Meglumine market was valued at USD 0.76 billion in 2023[1].

Q: What is the projected growth rate of the Tafamidis Meglumine market?

A: The market is expected to grow at a CAGR of 8.4% from 2024 to 2031[1].

Q: What are the primary applications of tafamidis?

A: Tafamidis is primarily used for the treatment of transthyretin amyloidosis (ATTR), including both wild-type and hereditary forms[1].

Q: How much does tafamidis treatment cost annually?

A: The annual cost of tafamidis treatment is approximately $195,012 per patient[5].

Q: What is the market share of tafamidis in the U.S. transthyretin amyloidosis treatment market?

A: The tafamidis segment is estimated to contribute 39.3% of the U.S. transthyretin amyloidosis treatment market in 2024[4].

Sources

1. Market Research Intellect: Global Tafamidis Meglumine Market Size and Projections[1].
2. Pfizer: Pfizer Announces Positive Topline Results From Phase 3 ATTR-ACT Study Of Tafamidis In Patients With Transthyretin Cardiomyopathy[2].
3. GlobeNewswire: Global Transthyretin Amyloidosis Treatment Market–Analysis and Demand with Forecast Overview to 2029[3].
4. Coherent Market Insights: US Transthyretin Amyloidosis Treatment Market Size and Trends[4].
5. CADTH: Tafamidis Meglumine (Vyndaqel) - Canada's Drug Agency[5].