.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Lamivudine - Generic Drug Details

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

This ingredient has ninety-two patent family members in forty-eight countries.

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

Summary for Generic Name: lamivudine

Tradenames:6
Patents:7
Applicants:15
NDAs:26
Drug Master File Entries: see list26
Suppliers / Packagers: see list22
Bulk Api Vendors: see list86
Clinical Trials: see list151
Patent Applications: see list2,022
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lamivudine at DailyMed

Tentative approvals for LAMIVUDINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL150MG; 300MG; 200MG
<disabled><disabled>TABLET; ORAL150MG; 300MG; 200MG
<disabled><disabled>TABLET; ORAL150MG; 300MG; 600MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd V
LAMIVUDINE
lamivudine
TABLET;ORAL203260-001Jan 2, 2014RXNoNo► subscribe► subscribe
Lupin Ltd
LAMIVUDINE
lamivudine
TABLET;ORAL205217-001Dec 18, 2014RXNoNo► subscribe► subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 1995RXYesNo► subscribe► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 19985,047,407*PED► subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 19957,119,202*PED► subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 19985,532,246*PED► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: lamivudine

Country Document Number Estimated Expiration
South Africa9204007► subscribe
Denmark0517145► subscribe
El Salvador1998000040► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: LAMIVUDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
80018Netherlands► subscribePRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
C0022France► subscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
C0020Belgium► subscribePRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.

`abc