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Dolutegravir sodiumis 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.
Summary for dolutegravir sodium
|Drug Master File Entries:||17|
|Suppliers / Packagers:||3|
|Bulk Api Vendors:||32|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for dolutegravir sodium|
|DailyMed Link:||dolutegravir sodium at DailyMed|
Recent Clinical Trials for dolutegravir sodium
Identify potential brand extensions & 505(b)(2) entrants
|St Stephens Aids Trust||Phase 4|
Generic filers with tentative approvals for DOLUTEGRAVIR SODIUM
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for dolutegravir sodium
|Drug Class||Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor |
|Mechanism of Action||HIV Integrase Inhibitors |
Multidrug and Toxin Extrusion Transporter 1 Inhibitors
Organic Cation Transporter 2 Inhibitors
|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|
|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||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|
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