LAMIVUDINE - Generic Drug Details
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What are the generic drug sources for lamivudine and what is the scope of freedom to operate?
Lamivudine
is the generic ingredient in ten branded drugs marketed by Viiv Hlthcare, Glaxosmithkline, Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Annora, Apotex, Aurobindo Pharma Ltd, Aurobindo Pharma Usa, Breckenridge, Cipla, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Strides Pharma, Upsher Smith Labs, Micro Labs, Merck Sharp Dohme, Chartwell Rx, Anda Repository, and Pharmacare, and is included in forty-two NDAs. There are two 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. Sixteen suppliers are listed for this compound. There are forty-four tentative approvals for this compound.
Summary for LAMIVUDINE
US Patents: | 2 |
Tradenames: | 10 |
Applicants: | 23 |
NDAs: | 42 |
Drug Master File Entries: | 29 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 146 |
Clinical Trials: | 641 |
Patent Applications: | 7,135 |
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 |
---|---|
University of Wisconsin, Madison | Early Phase 1 |
The Aurum Institute NPC | Phase 1/Phase 2 |
Johns Hopkins University | Phase 1/Phase 2 |
Generic filers with tentative approvals for LAMIVUDINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 150MG; 300MG; 200MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 150MG; 300MG; 600MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Strides Pharma | LAMIVUDINE | lamivudine | TABLET;ORAL | 090457-002 | Apr 19, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hetero Labs Ltd V | LAMIVUDINE | lamivudine | TABLET;ORAL | 203277-001 | Jan 6, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Macleods Pharms Ltd | LAMIVUDINE | lamivudine | TABLET;ORAL | 090198-002 | May 1, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hetero Labs Ltd Iii | LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 079124-001 | Sep 17, 2015 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LAMIVUDINE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Teva B.V. | Lamivudine Teva Pharma B.V. | lamivudine | EMEA/H/C/001111 Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children. |
Authorised | yes | no | no | 2009-12-10 | |
Teva B.V. | Lamivudine Teva | lamivudine | EMEA/H/C/001113 Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1). |
Authorised | yes | no | no | 2009-10-23 | |
GlaxoSmithKline (Ireland) Limited | Zeffix | lamivudine | EMEA/H/C/000242 Zeffix is indicated for the treatment of chronic hepatitis B in adults with:, , , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;, decompensated liver disease in combination with a second agent without cross-resistance to lamivudine., , |
Authorised | no | no | no | 1999-07-29 | |
ViiV Healthcare BV | Epivir | lamivudine | EMEA/H/C/000107 Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children., |
Authorised | no | no | no | 1996-08-08 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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