Dovato is a drug owned by Viiv Healthcare Co. It is protected by 5 US drug patents filed from 2019 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 24, 2031. Details of Dovato'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. | |||
| US9242986 | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates |
Dec, 2029
(4 years from now) | Active |
| US8129385 | Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness |
Oct, 2027
(2 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). | |||
| US11234985 | Antiviral therapy |
Jan, 2031
(5 years from now) | Active |
|
US9242986 (Pediatric) | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates |
Jun, 2030
(5 years from now) | Active |
|
US8129385 (Pediatric) | Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness |
Apr, 2028
(2 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 Dovato's patents.
Latest Legal Activities on Dovato's Patents
Given below is the list of recent legal activities going on the following patents of Dovato.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Aug, 2023 | US8129385 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jun, 2023 | US9242986 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Feb, 2022 | US11234985 |
| Recordation of Patent Grant Mailed Critical | 01 Feb, 2022 | US11234985 |
| Email Notification Critical | 13 Jan, 2022 | US11234985 |
| Issue Notification Mailed Critical | 12 Jan, 2022 | US11234985 |
| Application Is Considered Ready for Issue Critical | 16 Dec, 2021 | US11234985 |
| Dispatch to FDC | 16 Dec, 2021 | US11234985 |
| Issue Fee Payment Verified Critical | 15 Dec, 2021 | US11234985 |
| Issue Fee Payment Received Critical | 15 Dec, 2021 | US11234985 |
FDA has granted several exclusivities to Dovato. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dovato, 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 Dovato.
Exclusivity Information
Dovato holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Dovato's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Apr 08, 2022 |
| New Indication(I-839) | Aug 06, 2023 |
| New Patient Population(NPP) | Apr 05, 2027 |
Several oppositions have been filed on Dovato'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 Dovato's generic, the next section provides detailed information on ongoing and past EP oppositions related to Dovato patents.
Dovato's Oppositions Filed in EPO
Dovato 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 |
| EP16187411A | May, 2019 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP16187411A | May, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP16187411A | May, 2019 | Sandoz AG | Granted and Under Opposition |
| EP16187411A | May, 2019 | Cooke, Richard | Granted and Under Opposition |
| EP15164931A | Dec, 2018 | Cooke, Richard | Granted and Under Opposition |
| EP15164931A | Dec, 2018 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP16154531A | Dec, 2018 | Gilead Sciences, Inc. | Patent maintained as amended |
| EP06822311A | Nov, 2016 | Zwicker Schnappauf & Partner PartG mbB | Opposition procedure closed |
| EP11737484A | Feb, 2016 | LEK Pharmaceuticals d.d. | Revoked |
| EP11737484A | Feb, 2016 | Page White & Farrer Limited | Revoked |
| EP11737484A | Feb, 2016 | Ter Meer Steinmeister & Partner Patentanwälte mbB | Revoked |
| EP11737484A | Feb, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP06758843A | May, 2014 | Ahrens, Gabriele | Opposition procedure closed |
US patents provide insights into the exclusivity only within the United States, but Dovato 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 Dovato's family patents as well as insights into ongoing legal events on those patents.
Dovato's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dovato's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 24, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dovato Generics:
There are no approved generic versions for Dovato as of now.
How can I launch a generic of Dovato before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Dovato's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Dovato'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 Dovato -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/300 mg | 30 Jul, 2019 | 1 | 08 Dec, 2029 |
Alternative Brands for Dovato
Dovato which is used for the treatment of HIV infection., has several other brand drugs in the same treatment category and using the same active ingredient (Dolutegravir Sodium; Lamivudine). 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
| |||||||||||||||
| Agouron Pharms |
| |||||||||||||||
| Bristol Myers Squibb |
| |||||||||||||||
| Gilead |
| |||||||||||||||
| Gilead Sciences |
| |||||||||||||||
| Gilead Sciences Inc |
| |||||||||||||||
| Glaxosmithkline |
| |||||||||||||||
| Msd Sub Merck |
| |||||||||||||||
| Viiv Hlthcare |
| |||||||||||||||
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. Dolutegravir Sodium; Lamivudine. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Viiv Hlthcare |
|
About Dovato
Dovato is a drug owned by Viiv Healthcare Co. It is used for the treatment of HIV infection. Dovato uses Dolutegravir Sodium; Lamivudine as an active ingredient. Dovato was launched by Viiv Hlthcare in 2019.
Approval Date:
Dovato was approved by FDA for market use on 08 April, 2019.
Active Ingredient:
Dovato uses Dolutegravir Sodium; Lamivudine as the active ingredient. Check out other Drugs and Companies using Dolutegravir Sodium; Lamivudine ingredient
Treatment:
Dovato is used for the treatment of HIV infection.
Dosage:
Dovato is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE;300MG | TABLET | Prescription | ORAL |