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Abacavir sulfate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for abacavir sulfate?

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, Teva Pharms Usa, and Lupin Ltd, and is included in thirteen NDAs. There are seven 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-four patent family members in forty-nine countries.

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

Summary for Generic Name: abacavir sulfate

Tradenames:7
Patents:7
Applicants:8
NDAs:13
Drug Master File Entries: see list11
Suppliers / Packagers: see list12
Bulk Api Vendors: see list72
Clinical Trials: see list311
Patent Applications: see list5,224
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. Form Dosage
► Subscribe► SubscribeTABLET; ORAL60MG
► Subscribe► SubscribeTABLET; ORAL60MG; 30MG
► Subscribe► SubscribeTABLET; ORAL60MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes6,417,191*PED► Subscribe ► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004RXYesYes5,905,082*PED► Subscribe ► Subscribe
Mylan Pharms Inc
ABACAVIR SULFATE
abacavir sulfate
TABLET;ORAL091294-001Jun 18, 2012RXNoNo► Subscribe► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 1998RXYesYes6,641,843*PED► SubscribeY► Subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 2000RXYesYes6,417,191*PED► 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, 19985,034,394*PED► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 19985,089,500*PED► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 19985,089,500*PED► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
SOLUTION;ORAL020978-001Dec 17, 19985,034,394*PED► Subscribe
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International Patent Family for Ingredient: abacavir sulfate

Country Document Number Estimated Expiration
Indonesia24910► Subscribe
Yugoslavia48200► Subscribe
Argentina015668► Subscribe
Canada2319010► Subscribe
Japan2000514096► 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
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
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
/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
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
99C0033Belgium► SubscribePRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
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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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