STAVUDINE Drug Patent Profile
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Which patents cover Stavudine, and when can generic versions of Stavudine launch?
Stavudine is a drug marketed by Aurobindo Pharma, Hetero Labs Ltd Iii, Mylan, Mylan Labs Ltd, and Cipla Ltd. and is included in six NDAs.
The generic ingredient in STAVUDINE is stavudine. There are fourteen drug master file entries for this compound. Additional details are available on the stavudine profile page.
Summary for STAVUDINE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 173 |
| Patent Applications: | 5,327 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | STAVUDINE at DailyMed |
Recent Clinical Trials for STAVUDINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tufts University | Phase 4 |
| Christian Medical College, Vellore, India | Phase 4 |
| PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University | Phase 2/Phase 3 |
Medical Subject Heading (MeSH) Categories for STAVUDINE
Anatomical Therapeutic Chemical (ATC) Classes for STAVUDINE
US Patents and Regulatory Information for STAVUDINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | STAVUDINE | stavudine | CAPSULE;ORAL | 077672-003 | Dec 29, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hetero Labs Ltd Iii | STAVUDINE | stavudine | CAPSULE;ORAL | 078957-003 | Dec 29, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma | STAVUDINE | stavudine | CAPSULE;ORAL | 077672-002 | Dec 29, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | STAVUDINE | stavudine | CAPSULE;ORAL | 079069-004 | Dec 29, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hetero Labs Ltd Iii | STAVUDINE | stavudine | CAPSULE;ORAL | 078957-004 | Dec 29, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cipla Ltd | STAVUDINE | stavudine | FOR SOLUTION;ORAL | 078030-001 | Mar 20, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Labs Ltd | STAVUDINE | stavudine | CAPSULE;ORAL | 078775-002 | Jan 5, 2009 | 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 STAVUDINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Bristol-Myers Squibb Pharma EEIG | Zerit | stavudine | EMEA/H/C/000110 Hard capsulesZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.Powder for oral solutionZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible. |
Withdrawn | no | no | no | 1996-05-08 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
