STAVUDINE - Generic Drug Details
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What are the generic sources for stavudine and what is the scope of patent protection?
Stavudine
is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Aurobindo Pharma, Hetero Labs Ltd Iii, Norvium Bioscience, Bristol, and Cipla Ltd, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are fourteen drug master file entries for stavudine. There are ten tentative approvals for this compound.
Summary for STAVUDINE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 6 |
NDAs: | 9 |
Drug Master File Entries: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 119 |
Clinical Trials: | 173 |
Patent Applications: | 6,712 |
What excipients (inactive ingredients) are in STAVUDINE? | STAVUDINE excipients list |
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 |
Willem Daniel Francois Venter | Phase 3 |
Generic filers with tentative approvals for STAVUDINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 40MG; 150MG; 200MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 40MG; 150MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 40MG; 150MG; 200MG | 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.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Norvium Bioscience | STAVUDINE | stavudine | CAPSULE;ORAL | 079069-001 | Dec 29, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bristol | ZERIT | stavudine | CAPSULE;ORAL | 020412-005 | Jun 24, 1994 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hetero Labs Ltd Iii | STAVUDINE | stavudine | CAPSULE;ORAL | 078957-004 | Dec 29, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Norvium Bioscience | STAVUDINE | stavudine | CAPSULE;ORAL | 078775-001 | Jan 5, 2009 | 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 | ||||
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-001 | Dec 31, 2002 | 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 STAVUDINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol | ZERIT | stavudine | CAPSULE;ORAL | 020412-005 | Jun 24, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Bristol | ZERIT | stavudine | CAPSULE;ORAL | 020412-004 | Jun 24, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-001 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-002 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-003 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-004 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |