Apretude is a drug owned by Viiv Healthcare Co. It is protected by 4 US drug patents filed from 2022 to 2024 out of which none have expired yet. Apretude's patents have been open to challenges since 21 January, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 15, 2031. Details of Apretude'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. | |||
| US10927129 | N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity |
Apr, 2026
(9 months from now) | Active |
| US8410103 | (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent |
Apr, 2026
(9 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12138264 | Pharmaceutical compositions |
Sep, 2031
(6 years from now) | Active |
| US11224597 | Pharmaceutical compositions |
Sep, 2031
(6 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 Apretude's patents.
Latest Legal Activities on Apretude's Patents
Given below is the list of recent legal activities going on the following patents of Apretude.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 25 Jan, 2024 | US8410103 |
| Second letter to regulating agency to determine regulatory review period | 26 Jan, 2023 | US8410103 |
| Letter from FDA or Dept of Agriculture re PTE application | 28 Sep, 2022 | US8410103 |
| Email Notification Critical | 03 Feb, 2022 | US11224597 |
| Mail Certificate of Correction Memo | 02 Feb, 2022 | US11224597 |
| Certificate of Correction Memo | 27 Jan, 2022 | US11224597 |
| Post Issue Communication - Certificate of Correction | 27 Jan, 2022 | US11224597 |
| Patent Issue Date Used in PTA Calculation Critical | 18 Jan, 2022 | US11224597 |
| Recordation of Patent Grant Mailed Critical | 18 Jan, 2022 | US11224597 |
| Email Notification Critical | 29 Dec, 2021 | US11224597 |
FDA has granted several exclusivities to Apretude. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Apretude, 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 Apretude.
Exclusivity Information
Apretude holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Apretude's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 21, 2026 |
Several oppositions have been filed on Apretude'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 Apretude's generic, the next section provides detailed information on ongoing and past EP oppositions related to Apretude patents.
Apretude's Oppositions Filed in EPO
Apretude has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 28, 2014, by Ahrens, Gabriele. This opposition was filed on patent number EP06758843A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17195280A | Feb, 2020 | Gilead Sciences, Inc. | Opposition rejected |
| EP16154531A | Dec, 2018 | Gilead Sciences, Inc. | Patent maintained as amended |
| EP06822311A | Nov, 2016 | Zwicker Schnappauf & Partner PartG mbB | Opposition procedure closed |
| EP06758843A | May, 2014 | Ahrens, Gabriele | Opposition procedure closed |
US patents provide insights into the exclusivity only within the United States, but Apretude 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 Apretude's family patents as well as insights into ongoing legal events on those patents.
Apretude's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Apretude's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 15, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Apretude Generics:
There are no approved generic versions for Apretude as of now.
Alternative Brands for Apretude
There are several other brand drugs using the same active ingredient (Cabotegravir) as Apretude. 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 | ||
|---|---|---|---|
| Viiv Hlthcare |
|
About Apretude
Apretude is a drug owned by Viiv Healthcare Co. Apretude uses Cabotegravir as an active ingredient. Apretude was launched by Viiv Hlthcare in 2021.
Approval Date:
Apretude was approved by FDA for market use on 20 December, 2021.
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 Apretude is 20 December, 2021, its NCE-1 date is estimated to be 21 January, 2025.
Active Ingredient:
Apretude uses Cabotegravir as the active ingredient. Check out other Drugs and Companies using Cabotegravir ingredient
Dosage:
Apretude is available in suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600MG/3ML (200MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |