Vyndamax is a drug owned by Foldrx Pharmaceuticals Llc A Wholly Owned Sub Of Pfizer Inc. It is protected by 3 US drug patents filed in 2019 out of which none have expired yet. Vyndamax'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 Aug 31, 2035. Details of Vyndamax'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. | |||
| US9770441 | Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole |
Aug, 2035
(10 years from now) | Active |
| US7214695 | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding |
Dec, 2025
(1 year, 1 month from now) | Active |
| 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, 2025
(1 year, 1 month from now) | Active |
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 Vyndamax's patents.
Latest Legal Activities on Vyndamax's Patents
Given below is the list of recent legal activities going on the following patents of Vyndamax.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 29 Apr, 2024 | US7214695 |
| Second letter to regulating agency to determine regulatory review period | 29 Apr, 2024 | US7214696 |
| 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 |
| Interim Patent Term Extension Granted Critical | 13 Oct, 2023 | US7214695 |
| Interim Patent Term Extension Granted Critical | 13 Oct, 2023 | US7214696 |
| Initial letter Re: PTE Application to regulating agency | 31 Mar, 2022 | US7214695 |
| Initial letter Re: PTE Application to regulating agency | 31 Mar, 2022 | US7214696 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Sep, 2020 | US9770441 |
| Post Issue Communication - Certificate of Correction | 14 May, 2020 | US7214696 |
FDA has granted several exclusivities to Vyndamax. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vyndamax, 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 Vyndamax.
Exclusivity Information
Vyndamax holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Vyndamax'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 Vyndamax 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 Vyndamax's family patents as well as insights into ongoing legal events on those patents.
Vyndamax's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vyndamax's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 31, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vyndamax Generics:
There are no approved generic versions for Vyndamax as of now.
How can I launch a generic of Vyndamax before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vyndamax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vyndamax's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Vyndamax -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 61 mg | 03 May, 2023 | 4 | 31 Aug, 2035 |
Alternative Brands for Vyndamax
Vyndamax which is used for treating cardiomyopathy associated with wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)., has several other brand drugs in the same treatment category and using the same active ingredient (Tafamidis). 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 Vyndamax
Vyndamax is a drug owned by Foldrx Pharmaceuticals Llc A Wholly Owned Sub Of Pfizer Inc. It is used for treating cardiomyopathy associated with wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). Vyndamax uses Tafamidis as an active ingredient. Vyndamax was launched by Foldrx Pharms in 2019.
Approval Date:
Vyndamax 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 Vyndamax is 03 May, 2019, its NCE-1 date is estimated to be 04 May, 2023.
Active Ingredient:
Vyndamax uses Tafamidis as the active ingredient. Check out other Drugs and Companies using Tafamidis ingredient
Treatment:
Vyndamax is used for treating cardiomyopathy associated with wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).
Dosage:
Vyndamax is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 61MG | CAPSULE | Prescription | ORAL |