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Serving leading biopharmaceutical companies globally:

Citi
Fish and Richardson
Deloitte
McKesson
QuintilesIMS
Johnson and Johnson
UBS
Chinese Patent Office
Merck
Julphar

Generated: October 22, 2017

DrugPatentWatch Database Preview

Abacavir sulfate; lamivudine - Generic Drug Details

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

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

Abacavir sulfate; lamivudine has one hundred and eighty-one patent family members in fifty-seven countries and fifteen supplementary protection certificates in ten countries.

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

Summary for Generic Name: abacavir sulfate; lamivudine

US Patents:3
Tradenames:4
Applicants:5
NDAs:7
Drug Master File Entries: see list11
Suppliers / Packagers: see list9
Clinical Trials: see list1,203
Therapeutic Class:Antivirals
Drug Prices:see low prices
DailyMed Link:abacavir sulfate; lamivudine at DailyMed

Tentative approvals for ABACAVIR SULFATE; LAMIVUDINE

Applicant Application No. Strength Dosage Form
u► Subscribe60MG; 30MGTABLET; ORAL
u► SubscribeEQ 600MG BASE; 300MGTABLET; ORAL
u► SubscribeEQ 300MG BASE; 150MG; 300MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL202912-001Dec 5, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 2000ABRXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms Usa
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL079246-001Sep 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 2000ABRXYesYes► Subscribe► Subscribe ► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004ABRXYesYes► Subscribe► Subscribe ► Subscribe
Aurobindo Pharma Ltd
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL206151-001Mar 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Cipla Ltd
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL091144-001Mar 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL204990-001Mar 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: abacavir sulfate; lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004► Subscribe► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004► Subscribe► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004► Subscribe► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004► Subscribe► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004► Subscribe► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004► Subscribe► Subscribe
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International Patent Family for Ingredient: abacavir sulfate; lamivudine

Country Document Number Estimated Expiration
Japan2851480► Subscribe
Canada2289655► Subscribe
Iceland1867► Subscribe
European Patent Office1019056► Subscribe
Portugal817637► Subscribe
Slovakia283825► Subscribe
Japan2954357► Subscribe
New Zealand510622► Subscribe
Czech Republic9703090► Subscribe
Germany69232387► 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; LAMIVUDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8Finland► Subscribe
99C0033Belgium► SubscribePRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
2005 00028Denmark► Subscribe
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
0195Netherlands► Subscribe300195, 20160328, EXPIRES: 20191216
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
/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
0817637/01Switzerland► SubscribePRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
C016/2005Ireland► SubscribeSPC016/2005: 20060407, EXPIRES: 20191216
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Novartis
Cantor Fitzgerald
Fuji
QuintilesIMS
Chubb
Healthtrust
Dow
Fish and Richardson
Covington
Colorcon

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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