DrugPatentWatch Database Preview➤ Get the DrugPatentWatch Daily Briefing
« Back to Dashboard
Dolutegravir sodiumis the generic ingredient in four branded drugs marketed by Viiv Hlthcare and is included in four 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-five patent family members in thirty-three countries.
There are seventeen drug master file entries for dolutegravir sodium. Four suppliers are listed for this compound. There are eight tentative approvals for this compound.
Summary for DOLUTEGRAVIR SODIUM
|Drug Master File Entries:||17|
|Finished Product Suppliers / Packagers:||4|
|Raw Ingredient (Bulk) Api Vendors:||32|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for DOLUTEGRAVIR SODIUM|
|What excipients (inactive ingredients) are in DOLUTEGRAVIR SODIUM?||DOLUTEGRAVIR SODIUM excipients list|
|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
|Country||Patent Number||Estimated Expiration|
|South Korea||20160003889||⤷ Free Forever Trial|
|Ukraine||96568||⤷ Free Forever Trial|
|Morocco||29879||⤷ Free Forever Trial|
|Denmark||3045206||⤷ Free Forever Trial|
|Japan||WO2007049675||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|2465580||122021000021||Germany||⤷ Free Forever Trial||PRODUCT NAME: CABOTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1481 20201217|
|2932970||300957||Netherlands||⤷ Free Forever Trial||PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS DOLUTEGRAVIR NATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS RILPIVIRINE HYDROCHLORIDE); REGISTRATION NO/DATE: NOT AVAILABLE|
|2932970||1890039-9||Sweden||⤷ Free Forever Trial||PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518|
|1874117||SPC/GB14/041||United Kingdom||⤷ Free Forever Trial||PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121|
|2932970||CR 2018 00036||Denmark||⤷ Free Forever Trial||PRODUCT NAME: KOMBINATION AF DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. DOLUTEGRAVIRNATRIUM, OG RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. RILPIVIRINHYDROCHLORID; REG. NO/DATE: EU/1/18/1282/001-002 20180518|
|>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:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.