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Serving 500+ biopharmaceutical companies globally:

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Generated: June 25, 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 four 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 seventy-six patent family members in fifty-seven 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

Tradenames:4
Patents:4
Applicants:5
NDAs:7
Drug Master File Entries: see list11
Suppliers / Packagers: see list9
Clinical Trials: see list1,175
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
► Subscribe► Subscribe60MG; 30MGTABLET; ORAL
► Subscribe► SubscribeEQ 600MG BASE; 300MGTABLET; ORAL
► Subscribe► 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
Viiv Hlthcare
TRIZIVIR
abacavir sulfate; lamivudine; zidovudine
TABLET;ORAL021205-001Nov 14, 2000ABRXYesYes6,294,540*PED► SubscribeY► Subscribe
Lupin Ltd
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL204990-001Mar 28, 2017ABRXNoNo► Subscribe► Subscribe
Teva Pharms Usa
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
TABLET;ORAL079246-001Sep 29, 2016ABRXNoNo► Subscribe► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 2004ABRXYesYes6,294,540*PED► SubscribeY► 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, 20045,905,082*PED► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 20047,119,202*PED► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 20045,034,394*PED► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 20046,417,191*PED► Subscribe
Viiv Hlthcare
EPZICOM
abacavir sulfate; lamivudine
TABLET;ORAL021652-001Aug 2, 20045,089,500*PED► Subscribe
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International Patent Family for Ingredient: abacavir sulfate; lamivudine

Country Document Number Estimated Expiration
Hungary0002754► Subscribe
European Patent Office0817637► Subscribe
Colombia4950569► Subscribe
South Africa9204007► Subscribe
European Patent Office1099700► 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
C016/2005Ireland► SubscribeSPC016/2005: 20060407, EXPIRES: 20191216
C/GB05/027United Kingdom► SubscribeSPC/GB05/027: 20050922, EXPIRES: 20191216
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
/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
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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
Merck
Medtronic
Julphar
McKinsey
Express Scripts
Moodys
Argus Health
Baxter
Covington

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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