LAMIVUDINE AND ZIDOVUDINE Drug Patent Profile
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When do Lamivudine And Zidovudine patents expire, and what generic alternatives are available?
Lamivudine And Zidovudine is a drug marketed by Anda Repository, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Pharmacare, and Strides Pharma. and is included in thirteen NDAs.
The generic ingredient in LAMIVUDINE AND ZIDOVUDINE is lamivudine; zidovudine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lamivudine And Zidovudine
A generic version of LAMIVUDINE AND ZIDOVUDINE was approved as lamivudine; zidovudine by LUPIN LTD on May 15th, 2012.
Summary for LAMIVUDINE AND ZIDOVUDINE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 188 |
| Patent Applications: | 185 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | LAMIVUDINE AND ZIDOVUDINE at DailyMed |
Recent Clinical Trials for LAMIVUDINE AND ZIDOVUDINE
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 |
| Médecins Sans Frontières, Belgium | Phase 2 |
Pharmacology for LAMIVUDINE AND ZIDOVUDINE
Anatomical Therapeutic Chemical (ATC) Classes for LAMIVUDINE AND ZIDOVUDINE
US Patents and Regulatory Information for LAMIVUDINE AND ZIDOVUDINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anda Repository | LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 206375-001 | Apr 10, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hetero Labs Ltd V | LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 203259-001 | Feb 3, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell Rx | LAMIVUDINE AND ZIDOVUDINE | lamivudine; zidovudine | TABLET;ORAL | 079081-001 | May 25, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for LAMIVUDINE AND 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 |
