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Serving hundreds of leading biopharmaceutical companies globally:

UBS
AstraZeneca
McKinsey
Harvard Business School
QuintilesIMS
Covington
Julphar
Teva
Fuji

Generated: August 20, 2018

DrugPatentWatch Database Preview

Abacavir sulfate; dolutegravir sodium; lamivudine - Generic Drug Details

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What are the generic sources for abacavir sulfate; dolutegravir sodium; lamivudine and what is the scope of abacavir sulfate; dolutegravir sodium; lamivudine patent protection?

Abacavir sulfate; dolutegravir sodium; lamivudine 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 and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Abacavir sulfate; dolutegravir sodium; lamivudine has one hundred and ninety-eight patent family members in fifty-eight countries.

There are eleven drug master file entries for abacavir sulfate; dolutegravir sodium; lamivudine. One supplier is listed for this compound.

Summary for abacavir sulfate; dolutegravir sodium; lamivudine

US Patents and Regulatory Information for abacavir sulfate; dolutegravir sodium; lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for abacavir sulfate; dolutegravir sodium; lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for abacavir sulfate; dolutegravir sodium; lamivudine

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 ➤ Sign Up
8,188,271 Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity ➤ Sign Up
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 ➤ Sign Up
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 ➤ Sign Up
9,051,337 Substituted 10-hydroxy-9,11-dioxo-2,3,4a,5,9,11,13,13a-octahydro-1h-pyrido[1,2-a]pyrr- olo[1',2':3,4]imidazo[1,2-d]pyrazine-8-carboxamides ➤ Sign Up
9,273,065 Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors ➤ Sign Up
8,624,023 Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for abacavir sulfate; dolutegravir sodium; lamivudine

Country Document Number Estimated Expiration
Jordan 2032 ➤ Sign Up
Taiwan 480259 ➤ Sign Up
Russian Federation 2011121785 ➤ Sign Up
Taiwan 200800988 ➤ Sign Up
World Intellectual Property Organization (WIPO) 9852570 ➤ Sign Up
Australia 2009325128 ➤ Sign Up
United Kingdom 9719883 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for abacavir sulfate; dolutegravir sodium; lamivudine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00195 Netherlands ➤ Sign Up PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDB AAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HEMISULFAAT, EN LAMIV UDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT; REGISTRTION NO/DATE: EU/04/298/001-002 20041217
/2014 Austria ➤ Sign Up 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
0140020 00130 Estonia ➤ Sign Up PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
99C0033 Belgium ➤ Sign Up PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
/2005 Austria ➤ Sign Up PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217
C0022 France ➤ Sign Up PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
7 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Farmers Insurance
Moodys
Chubb
Fish and Richardson
Baxter
Johnson and Johnson
Colorcon
US Army

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 verifification 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.