vyndaqel Drug Patent Profile
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Which patents cover Vyndaqel, and what generic alternatives are available?
Vyndaqel is a drug marketed by Foldrx Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
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 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 May 3, 2026. This may change due to patent challenges or generic licensing.
There have been two 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
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Questions you can ask:
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Summary for vyndaqel
International Patents: | 35 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 4 |
Drug Prices: | Drug price information for vyndaqel |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for vyndaqel |
What excipients (inactive ingredients) are in vyndaqel? | vyndaqel excipients list |
DailyMed Link: | vyndaqel at DailyMed |
![vyndaqel drug patent expirations Drug patent expirations by year for vyndaqel](/p/graph/s/t/vyndaqel-patent-expirations.png)
![Drug Prices for vyndaqel](/p/graph/drug-price/vyndaqel.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vyndaqel
Generic Entry 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:
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 |
Paragraph IV (Patent) Challenges for VYNDAQEL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VYNDAQEL | Capsules | tafamidis meglumine | 20 mg | 211996 | 1 | 2023-05-03 |
US Patents and Regulatory Information for vyndaqel
vyndaqel is protected by two US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of vyndaqel is ⤷ Sign Up.
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
Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM)
FDA Regulatory Exclusivity protecting vyndaqel
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for vyndaqel
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for vyndaqel
See the table below for patents covering vyndaqel around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 1587821 | ⤷ Sign Up | |
Portugal | 1988397 | ⤷ Sign Up | |
Canada | 2510455 | COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING | ⤷ Sign Up |
Japan | 2010270134 | COMPOSITION AND METHOD FOR STABILIZING TRANSTHYRETIN AND INHIBITING MISFOLDING OF TRANSTHYRETIN | ⤷ Sign Up |
Brazil | PI0317463 | ⤷ Sign Up | |
Canada | 2800237 | COMPOSITIONS ET METHODES PERMETTANT DE STABILISER LA TRANSTHYRETINE ET D'INHIBER UN MAUVAIS REPLIEMENT DE LA TRANSTHYRETINE (COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for vyndaqel
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1587821 | C 2012 004 | Romania | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: TAFAMIDIS, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE MEGLUMINE SALT; REGISTERED: UK EU/1/11/717/001 20111118 |
1587821 | 126 5003-2012 | Slovakia | ⤷ Sign Up | PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
1587821 | 91935 | Luxembourg | ⤷ Sign Up | 91935, EXPIRES: 20261116 |
1587821 | C01587821/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67083 09.03.2020 |
1587821 | 2012/007 | Ireland | ⤷ Sign Up | PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |