VYNDAMAX Drug Patent Profile
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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.
This drug has sixty-three patent family members in twenty-eight 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 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 August 31, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VYNDAMAX
International Patents: | 63 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 58 |
Patent Applications: | 30 |
Drug Prices: | Drug price information for VYNDAMAX |
DailyMed Link: | VYNDAMAX at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for VYNDAMAX
Generic Entry Date for VYNDAMAX*:
Constraining patent/regulatory exclusivity:
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.
Anatomical Therapeutic Chemical (ATC) Classes for VYNDAMAX
US Patents and Regulatory Information for VYNDAMAX
VYNDAMAX is protected by three US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYNDAMAX is See Plans and Pricing.
This potential generic entry date is based on patent 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.
Patents protecting VYNDAMAX
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)
Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole
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 VYNDAMAX
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 | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Foldrx Pharms | VYNDAMAX | tafamidis | CAPSULE;ORAL | 212161-001 | May 3, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | 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 |
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/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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VYNDAMAX
When does loss-of-exclusivity occur for VYNDAMAX?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1778
Estimated Expiration: See Plans and Pricing
Australia
Patent: 15313875
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2017003421
Estimated Expiration: See Plans and Pricing
Canada
Patent: 03194
Estimated Expiration: See Plans and Pricing
China
Patent: 6715405
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0211834
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 91461
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 56583
Estimated Expiration: See Plans and Pricing
Israel
Patent: 1037
Estimated Expiration: See Plans and Pricing
Japan
Patent: 16065042
Estimated Expiration: See Plans and Pricing
Patent: 20055832
Estimated Expiration: See Plans and Pricing
Patent: 22024014
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 91461
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 17002954
Estimated Expiration: See Plans and Pricing
Poland
Patent: 91461
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 91461
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 92252
Estimated Expiration: See Plans and Pricing
Patent: 17107235
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 634
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 201700958Y
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 91461
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 2004059
Estimated Expiration: See Plans and Pricing
Patent: 170040314
Estimated Expiration: See Plans and Pricing
Spain
Patent: 01785
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 44902
Estimated Expiration: See Plans and Pricing
Patent: 1613880
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 VYNDAMAX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 101778 | FORMAS SÓLIDAS CRISTALINAS DE 6-CARBOXI-2-(3,5-DICLOROFENIL)-BENZOXAZOL | See Plans and Pricing |
Israel | 251037 | See Plans and Pricing | |
Japan | 2022024014 | 6-カルボキシ-2-(3,5-ジクロロフェニル)-ベンゾオキサゾールの結晶性固体形態 (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE) | See Plans and Pricing |
China | 1747965 | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding | See Plans and Pricing |
European Patent Office | 3191461 | FORMES CRISTALLINES SOLIDES DU 6-CARBOXY-2-(3,5-DICHLOROPHÉNYL)-BENZOXAZOLE (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE) | See Plans and Pricing |
China | 106715405 | 6‑羧基‑2‑(3,5‑二氯苯基)苯并噁唑的结晶固体形式 (Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole) | See Plans and Pricing |
Cyprus | 1108467 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYNDAMAX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1587821 | C 2012 004 | Romania | See Plans and Pricing | 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 | See Plans and Pricing | PRODUCT NAME: TAFAMIDIS, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE MEGLUMINE SALT; REGISTERED: UK EU/1/11/717/001 20111118 |
1587821 | 91935 | Luxembourg | See Plans and Pricing | 91935, EXPIRES: 20261116 |
1587821 | 126 5003-2012 | Slovakia | See Plans and Pricing | PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
1587821 | C20120001 00050 | Estonia | See Plans and Pricing | PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011 |
1587821 | 6/2012 | Austria | See Plans and Pricing | PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116 |
1587821 | 1290005-6 | Sweden | See Plans and Pricing | PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |