Dovato Patent Expiration

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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
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).
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
US11234985 Antiviral therapy
Jan, 2031

(6 years from now)

Active


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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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
Patent litigations
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 PatentanwƤlte 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

Dovato has patent protection in a total of 47 countries. It's US patent count contributes only to 16.8% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Dovato.

Family Patents

Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response šŸ„³



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




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.

Market Authorisation 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