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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Healthtrust
Colorcon
Harvard Business School
Medtronic
Cerilliant
Citi
McKinsey
Teva

Generated: September 23, 2018

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Abacavir sulfate; lamivudine - Generic Drug Details

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

Abacavir sulfate; lamivudine is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Cipla Ltd, Lupin Ltd, Teva Pharms Usa, and Viiv Hlthcare, and is included in seven NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for abacavir sulfate; lamivudine. Ten suppliers are listed for this compound. There are six tentative approvals for this compound.

Tentative approvals for ABACAVIR SULFATE; LAMIVUDINE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up60MG; 30MGTABLET; ORAL
➤ Sign Up➤ Sign UpEQ 600MG BASE; 300MGTABLET; ORAL
➤ Sign Up➤ Sign UpEQ 300MG BASE; 150MG; 300MGTABLET; ORAL

US Patents and Regulatory Information for abacavir sulfate; lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 091144-001 Mar 28, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lupin Ltd ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912-001 Dec 5, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 206151-001 Mar 28, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare TRIZIVIR abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 021205-001 Nov 14, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up 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; lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for abacavir sulfate; lamivudine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90028 Netherlands ➤ Sign Up PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
0028 Netherlands ➤ Sign Up PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
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
/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
C/GB99/032 United Kingdom ➤ Sign Up PRODUCT NAME: ABACAVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE INCLUDING ABACAVIR SULPHATE; REGISTERED: CH CH 55048 001 19990628; CH CH 55049 002 19990628; UK EU/1/99/112/001 19990708; UK EU/1/99/112/002 19990708
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Healthtrust
Colorcon
Harvard Business School
Medtronic
Cerilliant
Citi
McKinsey
Teva

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