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RAPAMUNE Drug Profile
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The generic ingredient in RAPAMUNE is sirolimus. There are sixteen drug master file entries for this compound. Six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the sirolimus profile page.
Summary for Tradename: RAPAMUNE
| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 2 |
| Drug Prices: : | see details |
Pharmacology for Tradename: RAPAMUNE
| Drug Class | mTOR Inhibitor Immunosuppressant |
| Mechanism of Action | mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Clinical Trials for: RAPAMUNE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | RX | No | 5,989,591*PED | Sep 11, 2018 | Y | |||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | DISCN | No | 5,989,591*PED | Sep 11, 2018 | Y | |||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | RX | No | May 28, 2022 | |||||||||||||||||||||
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Expired Patents for Tradename: RAPAMUNE
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | 5,403,833*PED | <disabled> | ||||||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | 5,403,833*PED | <disabled> | ||||||||||||||||||||||
Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | 5,100,899*PED | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: RAPAMUNE
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| sirolimus | Tablets | 0.5 mg | Rapamune | 8/25/2010 |
| sirolimus | Tablets | 1 mg and 2 mg | Rapamune | 12/17/2009 |
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