Veklury is a drug owned by Gilead Sciences Inc. It is protected by 32 US drug patents filed from 2021 to 2024 out of which none have expired yet. Veklury's patents will be open to challenges from 13 January, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 28, 2041. Details of Veklury'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. | |||
| US9949994 | Methods for treating Filoviridae virus infections |
Oct, 2035
(10 years from now) | Active |
| US9724360 | Methods for treating Filoviridae virus infections |
Oct, 2035
(10 years from now) | Active |
| US11492353 | Methods and compounds for treating Paramyxoviridae virus infections |
Dec, 2031
(6 years from now) | Active |
| US10065958 | Methods and compounds for treating Paramyxoviridae virus infections |
Sep, 2031
(6 years from now) | Active |
| US8008264 | 1′-substituted carba-nucleoside analogs for antiviral treatment |
Sep, 2029
(4 years from now) | Active |
| US8318682 | 1′substituted carba-nucleoside analogs for antiviral treatment |
Apr, 2029
(3 years from now) | Active |
| USRE46762 | 1′-substituted carba-nucleoside analogs for antiviral treatment |
Apr, 2029
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US11903953 (Pediatric) | Remdesivir treatment methods |
Nov, 2041
(16 years from now) | Active |
|
US11975012 (Pediatric) | Remdesivir treatment methods |
Nov, 2041
(16 years from now) | Active |
|
US11491169 (Pediatric) | Remdesivir treatment methods |
Nov, 2041
(16 years from now) | Active |
| US11491169 | Remdesivir treatment methods |
May, 2041
(15 years from now) | Active |
| US11975012 | Remdesivir treatment methods |
May, 2041
(15 years from now) | Active |
| US11903953 | Remdesivir treatment methods |
May, 2041
(15 years from now) | Active |
|
US11975017 (Pediatric) | Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections |
Jan, 2039
(13 years from now) | Active |
|
US11266681 (Pediatric) | Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections |
Jan, 2039
(13 years from now) | Active |
|
US10675296 (Pediatric) | Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections |
Jan, 2039
(13 years from now) | Active |
| US11975017 | Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections |
Jul, 2038
(13 years from now) | Active |
| US10675296 | Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections |
Jul, 2038
(13 years from now) | Active |
| US11266681 | Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections |
Jul, 2038
(13 years from now) | Active |
|
US10695361 (Pediatric) | Methods for treating arenaviridae and coronaviridae virus infections |
Mar, 2037
(11 years from now) | Active |
|
US11382926 (Pediatric) | Methods for treating Arenaviridae and Coronaviridae virus infections |
Mar, 2037
(11 years from now) | Active |
|
US11007208 (Pediatric) | Methods for treating arenaviridae and coronaviridae virus infections |
Mar, 2037
(11 years from now) | Active |
| US11007208 | Methods for treating arenaviridae and coronaviridae virus infections |
Sep, 2036
(11 years from now) | Active |
| US11382926 | Methods for treating Arenaviridae and Coronaviridae virus infections |
Sep, 2036
(11 years from now) | Active |
| US10695361 | Methods for treating arenaviridae and coronaviridae virus infections |
Sep, 2036
(11 years from now) | Active |
|
US9949994 (Pediatric) | Methods for treating Filoviridae virus infections |
Apr, 2036
(10 years from now) | Active |
|
US9724360 (Pediatric) | Methods for treating Filoviridae virus infections |
Apr, 2036
(10 years from now) | Active |
|
US11492353 (Pediatric) | Methods and compounds for treating Paramyxoviridae virus infections |
Jun, 2032
(6 years from now) | Active |
|
US10065958 (Pediatric) | Methods and compounds for treating Paramyxoviridae virus infections |
Mar, 2032
(6 years from now) | Active |
|
US8008264 (Pediatric) | 1′-substituted carba-nucleoside analogs for antiviral treatment |
Mar, 2030
(4 years from now) | Active |
|
US8318682 (Pediatric) | 1′substituted carba-nucleoside analogs for antiviral treatment |
Oct, 2029
(4 years from now) | Active |
|
USRE46762 (Pediatric) | 1′-substituted carba-nucleoside analogs for antiviral treatment |
Oct, 2029
(4 years 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 Veklury's patents.
Latest Legal Activities on Veklury's Patents
Given below is the list of recent legal activities going on the following patents of Veklury.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 May, 2024 | US8318682 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9724360 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9949994 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8318682 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8008264 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US10065958 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US9724360 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US10065958 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US8008264 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US8318682 |
FDA has granted several exclusivities to Veklury. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Veklury, 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 Veklury.
Exclusivity Information
Veklury holds 5 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Veklury's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-183) | Jan 21, 2025 |
| New Patient Population(NPP) | Apr 25, 2025 |
| New Chemical Entity Exclusivity(NCE) | Oct 22, 2025 |
| M(M-301) | Jul 13, 2026 |
| Pediatric Exclusivity(PED) | Jan 13, 2027 |
US patents provide insights into the exclusivity only within the United States, but Veklury 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 Veklury's family patents as well as insights into ongoing legal events on those patents.
Veklury's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Veklury's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 28, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Veklury Generics:
There are no approved generic versions for Veklury as of now.
About Veklury
Veklury is a drug owned by Gilead Sciences Inc. It is used for treatment of COVID-19 in hospitalized and non-hospitalized adults and pediatric patients when concurrent use of other medications is not recommended. Veklury uses Remdesivir as an active ingredient. Veklury was launched by Gilead Sciences Inc in 2020.
Approval Date:
Veklury was approved by FDA for market use on 22 October, 2020.
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 Veklury is 22 October, 2020, its NCE-1 date is estimated to be 13 January, 2026.
Active Ingredient:
Veklury uses Remdesivir as the active ingredient. Check out other Drugs and Companies using Remdesivir ingredient
Treatment:
Veklury is used for treatment of COVID-19 in hospitalized and non-hospitalized adults and pediatric patients when concurrent use of other medications is not recommended.
Dosage:
Veklury is available in the following dosage forms - solution form for intravenous use, powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/20ML (5MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 100MG/VIAL | POWDER | Prescription | INTRAVENOUS |