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Generated: June 23, 2017
What are the generic drug sources for stavudine and what is the scope of stavudine freedom to operate?
Stavudine is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Cipla Ltd, Hetero Labs Ltd Iii, Mylan, Aurobindo Pharma, and Mylan Labs Ltd, and is included in nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 2 |
| Applicants: | 6 |
| NDAs: | 9 |
| Drug Master File Entries: see list | 14 |
| Suppliers / Packagers: see list | 8 |
| Bulk Api Vendors: see list | 76 |
| Clinical Trials: see list | 153 |
| Patent Applications: see list | 5,818 |
| Therapeutic Class: | Antivirals |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | stavudine at DailyMed |
| Ingredient-type | Nucleoside Analog |
| Drug Class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 40MG; 150MG; 200MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 40MG; 150MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 40MG; 150MG; 200MG | TABLET; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | STAVUDINE | stavudine | CAPSULE;ORAL | 079069-001 | Dec 29, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Aurobindo Pharma | STAVUDINE | stavudine | CAPSULE;ORAL | 077672-003 | Dec 29, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hetero Labs Ltd Iii | STAVUDINE | stavudine | CAPSULE;ORAL | 078957-002 | Dec 29, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Aurobindo Pharma | STAVUDINE | stavudine | CAPSULE;ORAL | 077672-004 | Dec 29, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Aurobindo Pharma | STAVUDINE | stavudine | CAPSULE;ORAL | 077672-002 | Dec 29, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol Myers Squibb | ZERIT | stavudine | CAPSULE;ORAL | 020412-004 | Jun 24, 1994 | 4,978,655*PED | ► Subscribe | ||||||||||||||||||||||
Bristol Myers Squibb | ZERIT | stavudine | FOR SOLUTION;ORAL | 020413-001 | Sep 6, 1996 | 4,978,655*PED | ► Subscribe | ||||||||||||||||||||||
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-001 | Dec 31, 2002 | 4,978,655*PED | ► Subscribe | ||||||||||||||||||||||
Bristol Myers Squibb | ZERIT | stavudine | CAPSULE;ORAL | 020412-001 | Jun 24, 1994 | 4,978,655*PED | ► Subscribe | ||||||||||||||||||||||
Bristol Myers Squibb | ZERIT | stavudine | CAPSULE;ORAL | 020412-005 | Jun 24, 1994 | 4,978,655*PED | ► Subscribe | ||||||||||||||||||||||
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Export unavailable in trial.
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Serving 500+ biopharmaceutical companies globally:
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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