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Generated: June 25, 2017
What are the generic drug sources for sirolimus and what is the scope of sirolimus freedom to operate?
Sirolimus is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Zydus Pharms Usa Inc, and Dr Reddys Labs Ltd, and is included in four NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 2 |
| Applicants: | 3 |
| NDAs: | 4 |
| Drug Master File Entries: see list | 18 |
| Suppliers / Packagers: see list | 7 |
| Bulk Api Vendors: see list | 43 |
| Clinical Trials: see list | 471 |
| Patent Applications: see list | 9,931 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | sirolimus at DailyMed |
| Drug Class | mTOR Inhibitor Immunosuppressant Kinase Inhibitor |
| Mechanism of Action | mTOR Inhibitors Protein Kinase Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys Labs Ltd | SIROLIMUS | sirolimus | TABLET;ORAL | 201578-002 | Oct 27, 2014 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Zydus Pharms Usa Inc | SIROLIMUS | sirolimus | TABLET;ORAL | 201676-003 | Jan 8, 2014 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | DISCN | Yes | No | 5,989,591*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | 5,403,833*PED | ► Subscribe | ||||||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | 5,308,847*PED | ► Subscribe | ||||||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | 5,212,155*PED | ► Subscribe | ||||||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | 5,403,833*PED | ► Subscribe | ||||||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | 5,100,899*PED | ► Subscribe | ||||||||||||||||||||||
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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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