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Generated: June 25, 2017
What are the generic sources for dolutegravir sodium and what is the scope of dolutegravir sodium patent protection?
Dolutegravir sodium is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 13 |
| Suppliers / Packagers: see list | 2 |
| Clinical Trials: see list | 2,442 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | dolutegravir sodium at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-001 | Aug 12, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-001 | Aug 12, 2013 | RX | Yes | Yes | 8,129,385 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | RX | Yes | No | 8,129,385 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-003 | Jun 9, 2016 | RX | Yes | No | 8,129,385 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-001 | Aug 12, 2013 | RX | Yes | Yes | 9,242,986 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,858,788 | Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity | ► Subscribe | |||||||||||||||||||||||||||
| 8,410,103 | (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent | ► Subscribe | |||||||||||||||||||||||||||
| 8,778,943 | Substituted 10-hydroxy-9,11-dioxo-2,3,4a,5,9,11,13,13a-octahydro-1h-pyrido[1,2-.alpha- .]pyrrolo[1',2':3,4]imidazo[1,2-d]pyrazine-8-carboxamides | ► Subscribe | |||||||||||||||||||||||||||
| 8,624,023 | Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates | ► Subscribe | |||||||||||||||||||||||||||
| 8,188,271 | Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2744019 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | 2007013351 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2008540343 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1874117 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20081892 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014021,C1874117 | Lithuania | ► Subscribe | PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116 | ||||||||||||||||||||||||||
| /2014 | Austria | ► Subscribe | PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DELUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121 | ||||||||||||||||||||||||||
| 2 50006-2014 | Slovakia | ► Subscribe | PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121 | ||||||||||||||||||||||||||
| 1874117/01 | Switzerland | ► Subscribe | PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014 | ||||||||||||||||||||||||||
| 2014000066 | Germany | ► Subscribe | PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116 | ||||||||||||||||||||||||||
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