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Serving leading biopharmaceutical companies globally:

Covington
Merck
Deloitte
Fish and Richardson
Healthtrust
Colorcon
Express Scripts
Boehringer Ingelheim
Queensland Health
QuintilesIMS

Generated: February 25, 2018

DrugPatentWatch Database Preview

Abacavir sulfate - Generic Drug Details

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What are the generic drug sources for abacavir sulfate and what is the scope of abacavir sulfate freedom to operate?

Abacavir sulfate
is the generic ingredient in seven branded drugs marketed by Hetero Labs Ltd Iii, Viiv Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Cipla Ltd, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, and Teva Pharms Usa, and is included in seventeen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Abacavir sulfate has one hundred and forty patent family members in fifty countries.

There are eleven drug master file entries for abacavir sulfate. Thirteen suppliers are listed for this compound. There are fourteen tentative approvals for this compound.
Tentative approvals for ABACAVIR SULFATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up60MGTABLET; ORAL
➤ Sign Up➤ Sign Up60MG; 30MGTABLET; ORAL
➤ Sign Up➤ Sign Up60MGTABLET; ORAL

US Patents and Regulatory Information for abacavir sulfate

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
Mylan Pharms Inc ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091294-001 Jun 18, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 079246-001 Sep 29, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 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 Y ➤ Sign Up
Cipla Ltd ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 078119-001 Nov 21, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apotex Inc ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 201570-001 Dec 17, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Strides Pharma ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091050-001 Oct 28, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ➤ Sign Up ➤ Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ➤ 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
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
/1999 Austria ➤ Sign Up PRODUCT NAME: ''ABACAVIR'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS, EINSCHLIESSLICH ABACAVIR-SULFAT.; NAT. REGISTRATION NO/DATE: EU/1/99/112/001 EU/1/99/112/002 19990708; FIRST REGISTRATION: LI 55048 001, 55049 002 19990628
99C0033 Belgium ➤ Sign Up PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
C0022 France ➤ Sign Up PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
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
0817637/01 Switzerland ➤ Sign Up PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
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
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:

Daiichi Sankyo
Citi
Merck
Deloitte
Fish and Richardson
US Army
Harvard Business School
Farmers Insurance
Dow

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