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Sirolimus - Generic Drug Details
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What are the generic drug sources for sirolimus and what is the scope of freedom to operate?
Sirolimus
is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Amneal, Apotex, Novitium Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-one drug master file entries for sirolimus. Eleven suppliers are listed for this compound.
Summary for sirolimus
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 8 |
| Drug Master File Entries: | 21 |
| Suppliers / Packagers: | 11 |
| Bulk Api Vendors: | 62 |
| Clinical Trials: | 577 |
| Patent Applications: | 7,582 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for sirolimus |
| What excipients (inactive ingredients) are in sirolimus? | sirolimus excipients list |
| DailyMed Link: | sirolimus at DailyMed |
Recent Clinical Trials for sirolimus
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chong Kun Dang Pharmaceutical | Phase 4 |
| University of Pisa | Phase 2 |
| The Hospital for Sick Children | N/A |
Pharmacology for sirolimus
| Drug Class | mTOR Inhibitor Immunosuppressant Kinase Inhibitor |
| Mechanism of Action | mTOR Inhibitors Protein Kinase Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for sirolimus
US Patents and Regulatory Information for sirolimus
| 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 | Start Trial | Start Trial | Start Trial | |||
| Zydus Pharms | SIROLIMUS | sirolimus | TABLET;ORAL | 201676-003 | Jan 8, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Glenmark Pharms Ltd | SIROLIMUS | sirolimus | TABLET;ORAL | 208691-003 | Oct 16, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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 sirolimus
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | Start Trial | Start Trial |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | Start Trial | Start Trial |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | Start Trial | Start Trial |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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 verification 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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