Vyndaqel is a drug owned by Foldrx Pharmaceuticals Llc A Wholly Owned Sub Of Pfizer Inc. It is protected by 4 US drug patents filed in 2019. Out of these, 2 drug patents are active and 2 have expired. Vyndaqel's patents have been open to challenges since 04 May, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 19, 2026. Details of Vyndaqel's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7214695 | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding |
Dec, 2026
(1 year, 1 month from now) | Active |
| US8168663 | Pharmaceutically acceptable salt of 6-carboxy-2-(3,5 dichlorophenyl)-benzoxazole, and a pharmaceutical composition comprising the salt thereof |
Dec, 2023
(1 year, 10 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7214696 | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding |
Dec, 2026
(1 year, 1 month from now) | Active |
| US8653119 | Methods for treating transthyretin amyloid diseases |
Dec, 2023
(1 year, 10 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Vyndaqel's patents.
Latest Legal Activities on Vyndaqel's Patents
Given below is the list of recent legal activities going on the following patents of Vyndaqel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 29 Apr, 2024 | US7214696 |
| Second letter to regulating agency to determine regulatory review period | 29 Apr, 2024 | US7214695 |
| Letter from FDA or Dept of Agriculture re PTE application | 08 Feb, 2024 | US7214695 |
| Letter from FDA or Dept of Agriculture re PTE application | 08 Feb, 2024 | US7214696 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Oct, 2023 | US8168663 |
| Interim Patent Term Extension Granted
Critical | 13 Oct, 2023 | US7214695 |
| Interim Patent Term Extension Granted
Critical | 13 Oct, 2023 | US7214696 |
| Email Notification
Critical | 23 Aug, 2023 | US8168663 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 23 Aug, 2023 | US8168663 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 22 Aug, 2023 | US8653119 |
FDA has granted several exclusivities to Vyndaqel. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Vyndaqel, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Vyndaqel.
Exclusivity Information
Vyndaqel holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Vyndaqel's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 03, 2024 |
| Orphan Drug Exclusivity(ODE-237) | May 03, 2026 |
US patents provide insights into the exclusivity only within the United States, but
Vyndaqel is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Vyndaqel's family patents as well as insights into
ongoing legal events
on those patents.
Vyndaqel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vyndaqel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 19, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vyndaqel Generics:
There are no approved generic versions for Vyndaqel as of now.
Alternative Brands for Vyndaqel
Vyndaqel which is used for treating the cardiomyopathy associated with transthyretin-mediated amyloidosis., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Foldrx Pharms |
| |||
About Vyndaqel
Vyndaqel is a drug owned by Foldrx Pharmaceuticals Llc A Wholly Owned Sub Of Pfizer Inc. It is used for treating the cardiomyopathy associated with transthyretin-mediated amyloidosis. Vyndaqel uses Tafamidis Meglumine as an active ingredient. Vyndaqel was launched by Foldrx Pharms in 2019.
Approval Date:
Vyndaqel was approved by FDA for market use on 03 May, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Vyndaqel is 03 May, 2019, its NCE-1 date is estimated to be 04 May, 2023.
Active Ingredient:
Vyndaqel uses Tafamidis Meglumine as the active ingredient. Check out other Drugs and Companies using Tafamidis Meglumine ingredient
Treatment:
Vyndaqel is used for treating the cardiomyopathy associated with transthyretin-mediated amyloidosis.
Dosage:
Vyndaqel is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | CAPSULE | Prescription | ORAL |