Triumeq is a drug owned by Viiv Healthcare Co. It is protected by 10 US drug patents filed from 2014 to 2023. Out of these, 4 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 08, 2030. Details of Triumeq's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US5905082 | Crystalline oxathiolane derivatives |
May, 2016
(8 years ago) |
Expired
|
| US6294540 | Carbocyclic nucleoside hemisulfate and its use in treating viral infections |
May, 2018
(6 years ago) |
Expired
|
| US8129385 | Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness |
Oct, 2027
(3 years from now) | Active |
| US9242986 | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates |
Dec, 2029
(5 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6417191 | Synergistic combinations of zidovudine, 1592U89 and 3TC |
Mar, 2016
(8 years ago) |
Expired
|
|
US6417191 (Pediatric) | Synergistic combinations of zidovudine, 1592U89 and 3TC |
Sep, 2016
(7 years ago) |
Expired
|
|
US5905082 (Pediatric) | Crystalline oxathiolane derivatives |
Nov, 2016
(7 years ago) |
Expired
|
|
US6294540 (Pediatric) | Carbocyclic nucleoside hemisulfate and its use in treating viral infections |
Nov, 2018
(5 years ago) |
Expired
|
|
US8129385 (Pediatric) | Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness |
Apr, 2028
(3 years from now) | Active |
|
US9242986 (Pediatric) | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates |
Jun, 2030
(5 years from now) | Active |
FDA has granted several exclusivities to Triumeq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Triumeq, 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 Triumeq.
Exclusivity Information
Triumeq holds 4 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Triumeq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-147) | Mar 23, 2018 |
| New Chemical Entity Exclusivity(NCE) | Aug 12, 2018 |
| M(M-294) | Jun 15, 2026 |
| Pediatric Exclusivity(PED) | Dec 15, 2026 |
Several oppositions have been filed on Triumeq'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 Triumeq's generic, the next section provides detailed information on ongoing and past EP oppositions related to Triumeq patents.
Triumeq's oppositions filed in EPO
Triumeq 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 Triumeq 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 Triumeq's family patents as well as insights into ongoing legal events on those patents.
Triumeq's family patents
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Generic Launch
Generic Release Date:
Triumeq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 08, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Triumeq Generics:
There are no approved generic versions for Triumeq as of now.
How can I launch a generic of Triumeq before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Triumeq's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Triumeq'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 Triumeq -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 600 mg/50 mg/ 300 mg | 14 Aug, 2017 | 5 | 08 Dec, 2029 |
About Triumeq
Triumeq is a drug owned by Viiv Healthcare Co. It is used for treating Human Immunodeficiency Virus (HIV) infection. Triumeq uses Abacavir Sulfate; Dolutegravir Sodium; Lamivudine as an active ingredient. Triumeq was launched by Viiv Hlthcare in 2014.
Market Authorisation Date:
Triumeq was approved by FDA for market use on 22 August, 2014.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Triumeq is 22 August, 2014, its NCE-1 date is estimated to be 15 December, 2025
Active Ingredient:
Triumeq uses Abacavir Sulfate; Dolutegravir Sodium; Lamivudine as the active ingredient. Check out other Drugs and Companies using Abacavir Sulfate; Dolutegravir Sodium; Lamivudine ingredient
Treatment:
Triumeq is used for treating Human Immunodeficiency Virus (HIV) infection.
Dosage:
Triumeq is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 600MG BASE;EQ 50MG BASE;300MG | TABLET | Prescription | ORAL |