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Generated: September 26, 2017

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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, Aurobindo Pharma Ltd, Strides Pharma, Apotex Inc, Viiv Hlthcare, Mylan Pharms Inc, Cipla Ltd, Teva Pharms Usa, and Lupin Ltd, and is included in sixteen NDAs. There are six 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 thirty-seven patent family members in fifty countries.

There are eleven drug master file entries for abacavir sulfate. Twelve suppliers are listed for this compound. There are fourteen tentative approvals for this compound.

Summary for Generic Name: abacavir sulfate

Tradenames:7
Patents:6
Applicants:9
NDAs:16
Drug Master File Entries: see list11
Suppliers / Packagers: see list12
Bulk Api Vendors: see list72
Clinical Trials: see list824
Patent Applications: see list5,439
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:abacavir sulfate at DailyMed

Tentative approvals for ABACAVIR SULFATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe60MGTABLET; ORAL
► Subscribe► Subscribe60MG; 30MGTABLET; ORAL
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 1998ABRXYesYes► Subscribe► SubscribeY► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 1998AARXYesYes► Subscribe► Subscribe► Subscribe
Apotex Inc
ABACAVIR SULFATE
abacavir sulfate
TABLET;ORAL201570-001Dec 17, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL206151-001Mar 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Hetero Labs Ltd Iii
ABACAVIR SULFATE
abacavir sulfate
SOLUTION;ORAL201107-001Sep 26, 2016AARXNoNo► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004ABRXYesYes► Subscribe► Subscribe ► Subscribe
Lupin Ltd
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL202912-001Dec 5, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL079246-001Sep 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: abacavir sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 1998► Subscribe► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 1998► Subscribe► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 1998► Subscribe► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 1998► Subscribe► Subscribe
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International Patent Family for Ingredient: abacavir sulfate

Country Document Number Estimated Expiration
Norway324731► Subscribe
African Regional IP Organization (ARIPO)200001878► Subscribe
Argentina015668► Subscribe
Spain2214712► Subscribe
Brazil9809126► Subscribe
Canada2289655► Subscribe
Argentina012702► Subscribe
European Patent Office0979082► Subscribe
Slovakia156199► Subscribe
Colombia4950569► 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 Certificates for Tradename: ABACAVIR SULFATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00195Netherlands► SubscribePRODUCT 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
0028Netherlands► SubscribePRODUCT 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/GB99/032United Kingdom► SubscribePRODUCT 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
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
/1999Austria► SubscribePRODUCT 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
0817637/01Switzerland► SubscribePRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
/2005Austria► SubscribePRODUCT 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
90028Netherlands► SubscribePRODUCT 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
99C0033Belgium► SubscribePRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Chinese Patent Office
McKesson
Colorcon
Federal Trade Commission
Boehringer Ingelheim
QuintilesIMS
Harvard Business School
Citi
UBS

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.

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