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RAPAMUNE Drug Profile
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When do Rapamune patents expire, and what generic alternatives are available?
Rapamune is a drug marketed by Pf Prism Cv and is included in two NDAs.
The generic ingredient in RAPAMUNE is sirolimus. There are twenty-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rapamune
A generic version of RAPAMUNE was approved as sirolimus by ZYDUS PHARMS on January 8th, 2014.
Summary for RAPAMUNE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| Clinical Trials: | 125 |
| Patent Applications: | 4,378 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RAPAMUNE |
| What excipients (inactive ingredients) are in RAPAMUNE? | RAPAMUNE excipients list |
| DailyMed Link: | RAPAMUNE at DailyMed |
Recent Clinical Trials for RAPAMUNE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Perron Institute | Phase 3 |
| University of Kansas Medical Center | Phase 3 |
| West China Hospital | Phase 3 |
Pharmacology for RAPAMUNE
| Drug Class | mTOR Inhibitor Immunosuppressant Kinase Inhibitor |
| Mechanism of Action | mTOR Inhibitors Protein Kinase Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
US Patents and Regulatory Information for RAPAMUNE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | AA | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | AB | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | AB | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| >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 RAPAMUNE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | Try Before You Buy | Try Before You Buy |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | Try Before You Buy | Try Before You Buy |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RAPAMUNE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 281631 | Try Before You Buy |
| Israel | 100754 | Try Before You Buy |
| Japan | 2969150 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RAPAMUNE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0648494 | C300055 | Netherlands | Try Before You Buy | PRODUCT NAME: SIROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; NATL. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: CH CH/55243 20000926 |
| 0763039 | 18/2008 | Austria | Try Before You Buy | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0648494 | SPC020/2001 | Ireland | Try Before You Buy | SPC020/2001: 20050808, EXPIRES: 20150925 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
