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 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 December 19, 2026. This may change due to patent challenges or generic licensing.
There have been four 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
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for VYNDAQEL?
- What are the global sales for VYNDAQEL?
- What is Average Wholesale Price for VYNDAQEL?
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VYNDAQEL
Generic Entry Date for VYNDAQEL*:
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.
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 one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYNDAQEL is ⤷ Start Trial.
This potential generic entry date is based on patent 7,214,695.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| 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 | DISCN | Yes | No | 7,214,696 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | DISCN | Yes | No | 7,214,695 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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 | 8,168,663 | ⤷ Start Trial |
| Foldrx Pharms | VYNDAQEL | tafamidis meglumine | CAPSULE;ORAL | 211996-001 | May 3, 2019 | 8,653,119 | ⤷ Start Trial |
| >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 |
|---|---|---|---|
| Austria | 405840 | ⤷ Start Trial | |
| Austria | 524741 | ⤷ Start Trial | |
| Australia | 2003303196 | COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING | ⤷ Start Trial |
| Australia | 2010201263 | Compositions and methods for stabilizing transthyretin inhibiting transthyretin misfolding | ⤷ Start Trial |
| Brazil | 0317463 | Métodos de triar para um composto que evita ou reduz a dissolução de um tetrâmero de transtiretina e de tratar uma doença amilóide transtiretina | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYNDAQEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1587821 | C300516 | Netherlands | ⤷ Start Trial | 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 |
| 1587821 | 91935 | Luxembourg | ⤷ Start Trial | 91935, EXPIRES: 20261116 |
| 1587821 | C20120001 00050 | Estonia | ⤷ Start Trial | PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011 |
| 1587821 | CA 2012 00006 | Denmark | ⤷ Start Trial | |
| 1587821 | 1290005-6 | Sweden | ⤷ Start Trial | PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
DrugChatter Q&A for VYNDAQEL
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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