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RAPAMUNE Drug Profile
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» See Plans and PricingWhen 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. Ten suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
US ANDA 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 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 118 |
| Patent Applications: | 7,920 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RAPAMUNE |
| DailyMed Link: | RAPAMUNE at DailyMed |
Recent Clinical Trials for RAPAMUNE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| City of Hope Medical Center | Phase 2 |
| Dana-Farber Cancer Institute | Phase 1 |
| Walter K. Kraft | Phase 1 |
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 | Start Trial | Start Trial | Start Trial | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | AB | RX | Yes | 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 RAPAMUNE
| 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 | 021110-001 | Aug 25, 2000 | Start Trial | Start Trial |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | 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 | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | Start Trial | Start Trial |
| Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | 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 |
International Patents for RAPAMUNE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | H0373158 | Start Trial |
| Australia | 688782 | Start Trial |
| Japan | 2009197003 | Start Trial |
| Spain | 2124852 | Start Trial |
| Australia | 5686590 | Start Trial |
| Finland | 920321 | Start Trial |
| European Patent Office | 0401747 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RAPAMUNE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0763039 | PA2008009,C0763039 | Lithuania | Start Trial | PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0401747 | CA 2001 00025 | Denmark | Start Trial | |
| 0648494 | C300055 | Netherlands | Start Trial | 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 |
| 0648494 | 01C0037 | France | Start Trial | PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001-005 20010313; FIRST REGISTRATION: IKS55243 20000926 |
| 0763039 | 122008000023 | Germany | Start Trial | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0763039 | PA2008009 | Lithuania | Start Trial | PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119 |
| 0648494 | SPC/GB01/037 | United Kingdom | Start Trial | PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
