STAVUDINE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Stavudine, and when can generic versions of Stavudine launch?
Stavudine is a drug marketed by Aurobindo Pharma, Hetero Labs Ltd Iii, Norvium Bioscience, 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for STAVUDINE?
- What are the global sales for STAVUDINE?
- What is Average Wholesale Price for STAVUDINE?
Summary for STAVUDINE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 173 |
| Patent Applications: | 5,035 |
| 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 |
| amfAR, The Foundation for AIDS Research | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs Ltd Iii | STAVUDINE | stavudine | CAPSULE;ORAL | 078957-003 | Dec 29, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | STAVUDINE | stavudine | CAPSULE;ORAL | 077672-002 | Dec 29, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | STAVUDINE | stavudine | CAPSULE;ORAL | 079069-003 | Dec 29, 2008 | 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 |
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 |
