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Stavudine - Generic Drug Details

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Stavudine is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Cipla Ltd, Hetero Labs Ltd Iii, Mylan, Aurobindo Pharma, and Matrix Labs Ltd, and is included in nine NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for stavudine. Nine suppliers are listed for this compound. There are ten tentative approvals for this compound.

Summary for Generic Name: stavudine

Tradenames:3
Patents:1
Applicants:6
NDAs:9
Drug Master File Entries: see list14
Suppliers / Packaging: see list9
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Tentative approvals for STAVUDINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL40MG; 150MG; 200MG
<disabled><disabled>TABLET; ORAL40MG; 150MG
<disabled><disabled>TABLET; ORAL40MG; 150MG; 200MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd Iii
STAVUDINE
stavudine
CAPSULE;ORAL078957-004Dec 29, 2008RXNo► subscribe► subscribe
Aurobindo Pharma
STAVUDINE
stavudine
CAPSULE;ORAL077672-004Dec 29, 2008RXNo► subscribe► subscribe
Bristol Myers Squibb
ZERIT XR
stavudine
CAPSULE, EXTENDED RELEASE;ORAL021453-001Dec 31, 2002DISCNNo7,135,465*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: stavudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
ZERIT
stavudine
CAPSULE;ORAL020412-001Jun 24, 19944,978,655*PED► subscribe
Bristol Myers Squibb
ZERIT
stavudine
CAPSULE;ORAL020412-005Jun 24, 19944,978,655*PED► subscribe
Bristol Myers Squibb
ZERIT
stavudine
FOR SOLUTION;ORAL020413-001Sep 6, 19964,978,655*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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