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Generated: May 30, 2017

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Lamivudine - Generic Drug Details

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What are the generic drug sources for lamivudine and what is the scope of lamivudine patent protection?

is the generic ingredient in six branded drugs marketed by Mylan Pharms Inc, Glaxosmithkline, Apotex, Lupin Ltd, Cipla Ltd, Aurobindo Pharma Ltd, Apotex Inc, Hetero Labs Ltd V, Silarx Pharms Inc, Viiv Hlthcare, Appco Pharma Llc, Centaur Pharms Pvt, Merck Sharp Dohme, Pharmacare, Hetero Labs Ltd Iii, Strides Pharma, and Teva Pharms, and is included in twenty-nine NDAs. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lamivudine has ninety-three patent family members in forty-eight countries.

There are twenty-six drug master file entries for lamivudine. Twenty-five suppliers are listed for this compound. There are fifty tentative approvals for this compound.

Summary for Generic Name: lamivudine

Drug Master File Entries: see list26
Suppliers / Packagers: see list25
Bulk Api Vendors: see list86
Clinical Trials: see list151
Patent Applications: see list3,299
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lamivudine at DailyMed

Tentative approvals for LAMIVUDINE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe150MG; 300MG; 200MGTABLET; ORAL
► Subscribe► Subscribe150MG; 300MG; 600MGTABLET; ORAL
► Subscribe► Subscribe150MG; 300MG; 300MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
TABLET;ORAL020564-003Jun 24, 2002ABRXYesYes5,905,082*PED► Subscribe ► Subscribe
Cipla Ltd
TABLET;ORAL077221-001Mar 3, 2017ABRXNoNo► Subscribe► Subscribe
Teva Pharms
lamivudine; zidovudine
TABLET;ORAL079081-001May 25, 2011ABRXNoNo► Subscribe► Subscribe
TABLET;ORAL091606-001Dec 2, 2011ABRXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
lamivudine; zidovudine
TABLET;ORAL077558-001May 5, 2017ABRXNoNo► Subscribe► Subscribe
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