Lamivudine; zidovudine - Generic Drug Details
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What are the generic sources for lamivudine; zidovudine and what is the scope of freedom to operate?
Lamivudine; zidovudine
is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Anda Repository, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Natco, Norvium Bioscience, Pharmacare, and Strides Pharma, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.Nine suppliers are listed for this compound. There are fourteen tentative approvals for this compound.
Summary for lamivudine; zidovudine
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 14 |
NDAs: | 14 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 188 |
Patent Applications: | 370 |
DailyMed Link: | lamivudine; zidovudine at DailyMed |
Recent Clinical Trials for lamivudine; zidovudine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Aurum Institute NPC | Phase 1/Phase 2 |
Johns Hopkins University | Phase 1/Phase 2 |
University of Cape Town | Phase 2 |
Generic filers with tentative approvals for LAMIVUDINE; ZIDOVUDINE
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; zidovudine
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 AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 079128-001 | May 13, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 090246-001 | May 15, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Natco | LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 204005-001 | Aug 28, 2014 | DISCN | No | No | ⤷ 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; zidovudine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for lamivudine; zidovudine
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Teva Pharma B.V. | Lamivudine/Zidovudine Teva | lamivudine, zidovudine | EMEA/H/C/001236 Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection. |
Withdrawn | yes | no | no | 2011-02-28 | |
ViiV Healthcare BV | Combivir | lamivudine, zidovudine | EMEA/H/C/000190 Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection., |
Authorised | no | no | no | 1998-03-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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