Dolutegravir sodium - Generic Drug Details
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
What are the generic drug sources for dolutegravir sodium and what is the scope of patent protection?
Dolutegravir sodium
is 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 fifty-two patent family members in thirty-four countries.
There are seventeen drug master file entries for dolutegravir sodium. Two suppliers are listed for this compound. There are eight tentative approvals for this compound.
Summary for dolutegravir sodium
International Patents: | 152 |
US Patents: | 7 |
Tradenames: | 4 |
Applicants: | 1 |
NDAs: | 4 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 1 |
Patent Applications: | 119 |
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
Sponsor | Phase |
---|---|
St Stephens Aids Trust | Phase 4 |
Generic filers with tentative approvals for DOLUTEGRAVIR SODIUM
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 50MG | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 50MG | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 50MG | TABLET;ORAL |
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
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TIVICAY PD | Tablets for Suspension | dolutegravir sodium | 5 mg | 213983 | 1 | 2021-07-21 |
TIVICAY | Tablets | dolutegravir sodium | 10 mg, 25 mg and 50 mg | 204790 | 4 | 2017-08-14 |
US Patents and Regulatory Information for dolutegravir sodium
International Patents for dolutegravir sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Singapore | 171308 | SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES | See Plans and Pricing |
Eurasian Patent Organization | 200801144 | ПОЛИЦИКЛИЧЕСКОЕ КАРБАМОИЛПИРИДОНОВОЕ ПРОИЗВОДНОЕ, ОБЛАДАЮЩЕЕ ИНГИБИТОРНОЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ ИНТЕГРАЗЫ ВИЧ | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2006116764 | See Plans and Pricing | |
Spain | 2743531 | See Plans and Pricing | |
Luxembourg | C00210 | See Plans and Pricing | |
Norway | 340111 | See Plans and Pricing | |
Netherlands | 300676 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dolutegravir sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2932970 | 18C1043 | France | See Plans and Pricing | PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518 |
2465580 | LUC00210 | Luxembourg | See Plans and Pricing | PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221 |
1874117 | C01874117/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014 |
2932970 | PA2018013,C2932970 | Lithuania | See Plans and Pricing | PRODUCT NAME: DERINYS, APIMANTIS DOLUTEGRAVIRA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., DOLUTEGRAVIRO NATRIO DRUSKA) IR RILPIVIRINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., RILPIVIRINO HIDROCHLORIDA); REGISTRATION NO/DATE: EU/1/18/1282/001-002 20180516 |
2932970 | CR 2018 00036 | Denmark | See Plans and Pricing | 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 |
1874117 | 14C0041 | France | See Plans and Pricing | PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
1874117 | CA 2014 00032 | Denmark | See Plans and Pricing | PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116 |
>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.