Vemlidy is a drug owned by Gilead Sciences Inc. It is protected by 7 US drug patents filed from 2016 to 2021. Out of these, 5 drug patents are active and 2 have expired. Vemlidy's patents have been open to challenges since 06 November, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 15, 2033. Details of Vemlidy'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. | |||
| US8754065 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(7 years from now) | Active |
| US9296769 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(7 years from now) | Active |
| US7390791 | Prodrugs of phosphonate nucleotide analogues |
Jan, 2025
(4 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8754065 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(7 years from now) | Active |
|
US9296769 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(7 years from now) | Active |
|
US7390791 (Pediatric) | Prodrugs of phosphonate nucleotide analogues |
Jul, 2025
(a month from now) | Active |
| US7803788 | Prodrugs of phosphonate nucoleotide analogues |
Feb, 2022
(3 years ago) |
Expired
|
FDA has granted several exclusivities to Vemlidy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vemlidy, 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 Vemlidy.
Exclusivity Information
Vemlidy holds 5 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Vemlidy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 11, 2019 |
| New Chemical Entity Exclusivity(NCE) | Nov 05, 2020 |
| M(M-255) | Feb 04, 2023 |
| M(M-266) | Aug 22, 2023 |
| New Patient Population(NPP) | Oct 17, 2025 |
Several oppositions have been filed on Vemlidy's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Vemlidy's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vemlidy patents.
Vemlidy's Oppositions Filed in EPO
Vemlidy has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 23, 2015, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP01961695A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP13164300A | Jan, 2018 | Georg Kalhammer/Stephan Teipel | Granted and Under Opposition |
| EP13164300A | Jan, 2018 | Aechter, Bernd | Granted and Under Opposition |
| EP13164300A | Jan, 2018 | Cooke, Richard | Granted and Under Opposition |
| EP12753867A | Jul, 2017 | FRKelly | Granted and Under Opposition |
| EP12753867A | Jul, 2017 | Sandoz GmbH | Granted and Under Opposition |
| EP12753867A | Jul, 2017 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP01961695A | Nov, 2015 | HEXAL PHARMA AG | Patent maintained as amended |
| EP01961695A | Nov, 2015 | Strawman Limited | Patent maintained as amended |
| EP01961695A | Nov, 2015 | Swindell & Pearson Limited | Patent maintained as amended |
| EP01961695A | Nov, 2015 | Teva Pharmaceutical Industries Ltd | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Vemlidy 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 Vemlidy's family patents as well as insights into ongoing legal events on those patents.
Vemlidy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vemlidy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 15, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vemlidy Generic API suppliers:
Tenofovir Alafenamide Fumarate is the generic name for the brand Vemlidy. 2 different companies have already filed for the generic of Vemlidy, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vemlidy's generic
How can I launch a generic of Vemlidy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vemlidy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vemlidy'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 Vemlidy -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg | 05 Nov, 2019 | 6 | 30 Mar, 2023 | 15 Aug, 2032 | Eligible |
Alternative Brands for Vemlidy
Vemlidy which is used for treating chronic hepatitis B in adult and pediatric patients., has several other brand drugs in the same treatment category and using the same active ingredient (Tenofovir Alafenamide Fumarate). 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 | ||
|---|---|---|---|---|
| Gilead Sciences Inc |
| |||
| Novartis |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Tenofovir Alafenamide Fumarate. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tenofovir Alafenamide Fumarate, Vemlidy's active ingredient. Check the complete list of approved generic manufacturers for Vemlidy
About Vemlidy
Vemlidy is a drug owned by Gilead Sciences Inc. It is used for treating chronic hepatitis B in adult and pediatric patients. Vemlidy uses Tenofovir Alafenamide Fumarate as an active ingredient. Vemlidy was launched by Gilead Sciences Inc in 2016.
Approval Date:
Vemlidy was approved by FDA for market use on 10 November, 2016.
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 Vemlidy is 10 November, 2016, its NCE-1 date is estimated to be 06 November, 2019.
Active Ingredient:
Vemlidy uses Tenofovir Alafenamide Fumarate as the active ingredient. Check out other Drugs and Companies using Tenofovir Alafenamide Fumarate ingredient
Treatment:
Vemlidy is used for treating chronic hepatitis B in adult and pediatric patients.
Dosage:
Vemlidy is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE | TABLET | Prescription | ORAL |