Lamivudine - Generic Drug Details
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What are the generic drug sources for lamivudine and what is the scope of patent protection?
Lamivudine
is the generic ingredient in ten branded drugs marketed by Viiv Hlthcare, Glaxosmithkline, Aurobindo Pharma Ltd, Lannett Co Inc, Annora, Apotex, Appco, Breckenridge, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Strides Pharma, Micro Labs, Merck Sharp Dohme, Celltrion, Anda Repository, Chartwell Rx, Hetero Labs Ltd Iii, and Pharmacare, and is included in forty-one NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are twenty-nine drug master file entries for lamivudine. Seventeen suppliers are listed for this compound. There are forty-five tentative approvals for this compound.
Summary for lamivudine
US Patents: | 5 |
Tradenames: | 10 |
Applicants: | 22 |
NDAs: | 41 |
Drug Master File Entries: | 29 |
Finished Product Suppliers / Packagers: | 17 |
Raw Ingredient (Bulk) Api Vendors: | 132 |
Clinical Trials: | 635 |
Patent Applications: | 5,378 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for lamivudine |
What excipients (inactive ingredients) are in lamivudine? | lamivudine excipients list |
DailyMed Link: | lamivudine at DailyMed |
Recent Clinical Trials for lamivudine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Phase 1/Phase 2 |
The Aurum Institute NPC | Phase 1/Phase 2 |
Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands. | Phase 3 |
Generic filers with tentative approvals for LAMIVUDINE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 150MG; 300MG; 200MG | TABLET; ORAL |
See Plans and Pricing | See Plans and Pricing | 150MG; 300MG; 600MG | TABLET; ORAL |
See Plans and Pricing | See Plans and Pricing | 150MG; 300MG; 300MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for lamivudine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Strides Pharma | LAMIVUDINE | lamivudine | TABLET;ORAL | 090457-001 | Apr 19, 2018 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for lamivudine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | See Plans and Pricing | See Plans and Pricing |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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