VYNDAQEL Drug Patent Profile
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Which patents cover Vyndaqel, and when can generic versions of Vyndaqel launch?
Vyndaqel is a drug marketed by Foldrx Pharms and is included in one NDA. There are four patents protecting this drug.
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 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 May 3, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VYNDAQEL
International Patents: | 35 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 4 |
Drug Prices: | Drug price information for VYNDAQEL |
What excipients (inactive ingredients) are in VYNDAQEL? | VYNDAQEL excipients list |
DailyMed Link: | VYNDAQEL at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity 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 |
Anatomical Therapeutic Chemical (ATC) Classes for VYNDAQEL
US Patents and Regulatory Information for VYNDAQEL
VYNDAQEL is protected by four US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYNDAQEL is See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM)
Pharmaceutically acceptable salt of 6-carboxy-2-(3,5 dichlorophenyl)-benzoxazole, and a pharmaceutical composition comprising the salt thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods for treating transthyretin amyloid diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
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: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for VYNDAQEL
When does loss-of-exclusivity occur for VYNDAQEL?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 03303196
Estimated Expiration: See Plans and Pricing
Patent: 10201263
Estimated Expiration: See Plans and Pricing
Austria
Patent: 5840
Estimated Expiration: See Plans and Pricing
Patent: 4741
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 17463
Estimated Expiration: See Plans and Pricing
Patent: 0317463
Estimated Expiration: See Plans and Pricing
Canada
Patent: 10455
Estimated Expiration: See Plans and Pricing
Patent: 00237
Estimated Expiration: See Plans and Pricing
China
Patent: 47965
Estimated Expiration: See Plans and Pricing
Patent: 0448852
Estimated Expiration: See Plans and Pricing
Patent: 1413143
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 08467
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 87821
Estimated Expiration: See Plans and Pricing
Patent: 88397
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 87821
Estimated Expiration: See Plans and Pricing
Patent: 88397
Estimated Expiration: See Plans and Pricing
Patent: 25651
Estimated Expiration: See Plans and Pricing
Germany
Patent: 323155
Estimated Expiration: See Plans and Pricing
Patent: 2012000007
Estimated Expiration: See Plans and Pricing
Japan
Patent: 65076
Estimated Expiration: See Plans and Pricing
Patent: 56151
Estimated Expiration: See Plans and Pricing
Patent: 06511612
Estimated Expiration: See Plans and Pricing
Patent: 10270134
Estimated Expiration: See Plans and Pricing
Patent: 13256521
Estimated Expiration: See Plans and Pricing
Luxembourg
Patent: 935
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 87821
Estimated Expiration: See Plans and Pricing
Patent: 88397
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 87821
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0505034
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1089904
Estimated Expiration: See Plans and Pricing
Patent: 050090410
Estimated Expiration: See Plans and Pricing
Spain
Patent: 12857
Estimated Expiration: See Plans and Pricing
Patent: 73639
Estimated Expiration: See Plans and Pricing
Patent: 24803
Estimated Expiration: See Plans and Pricing
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 VYNDAQEL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 60323155 | See Plans and Pricing | |
Denmark | 1587821 | See Plans and Pricing | |
China | 1747965 | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2004056315 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYNDAQEL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1587821 | C20120001 00050 | Estonia | See Plans and Pricing | PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011 |
1587821 | 382 | Finland | See Plans and Pricing | |
1587821 | 126 5003-2012 | Slovakia | See Plans and Pricing | PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
1587821 | 6/2012 | Austria | See Plans and Pricing | PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |