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Last Updated: August 8, 2020

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Dolutegravir sodium - Generic Drug Details

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What are the generic drug sources for dolutegravir sodium and what is the scope of freedom to operate?

Dolutegravir sodium is the generic ingredient in three branded drugs marketed by Viiv Hlthcare and is included in three NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium has one hundred and thirty patent family members in thirty-three countries.

There are seventeen drug master file entries for dolutegravir sodium. Three suppliers are listed for this compound. There are five tentative approvals for this compound.

Recent Clinical Trials for dolutegravir sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St Stephens Aids TrustPhase 4

See all dolutegravir sodium clinical trials

Generic filers with tentative approvals for DOLUTEGRAVIR SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial50MGTABLET;ORAL
  Start Trial  Start Trial50MGTABLET;ORAL
  Start Trial  Start Trial50MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM
Tradename Dosage Ingredient NDA Submissiondate
TIVICAY TABLET;ORAL dolutegravir sodium 204790 2017-08-14

US Patents and Regulatory Information for dolutegravir sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for dolutegravir sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 C01874117/01 Switzerland   Start Trial PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
1874117 517 Finland   Start Trial
1874117 2014/032 Ireland   Start Trial PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Mallinckrodt
Colorcon
Moodys
Dow

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