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Generated: November 23, 2017

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, 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 forty patent family members in fifty countries and nine supplementary protection certificates in six 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.

Tentative approvals for ABACAVIR SULFATE

Applicant Application No. Strength Dosage Form
u► Subscribe60MGTABLET; ORAL
u► Subscribe60MG; 30MGTABLET; ORAL
u► Subscribe60MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
ABACAVIR SULFATE
abacavir sulfate
TABLET;ORAL091294-001Jun 18, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL202912-001Dec 5, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 2000ABRXYesYes► Subscribe► Subscribe ► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Cipla Ltd
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL091144-001Mar 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Hetero Labs Ltd Iii
ABACAVIR SULFATE
abacavir sulfate
TABLET;ORAL091560-001Sep 13, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► SubscribeY► 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► SubscribeY► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004ABRXYesYes► 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
SOLUTION;ORAL020978-001Dec 17, 1998► Subscribe► Subscribe
Viiv Hlthcare
ZIAGEN
abacavir sulfate
TABLET;ORAL020977-001Dec 17, 1998► Subscribe► Subscribe
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International Patent Family for Ingredient: abacavir sulfate

Country Document Number Estimated Expiration
Australia8017298► Subscribe
Austria259811► Subscribe
Canada2289655► Subscribe
Serbia49953► Subscribe
Turkey200002293► Subscribe
Panama8451301► Subscribe
Iceland5569► Subscribe
United Kingdom9719883► Subscribe
Hungary0002754► Subscribe
Peru02712000► 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
99C0033Belgium► SubscribePRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 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
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
/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
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
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
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
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Chubb
McKinsey
Deloitte
QuintilesIMS
Merck
Mallinckrodt
Moodys
Accenture

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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