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RAPAMUNE Drug Profile
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When do Rapamune patents expire, and what generic alternatives are available?
The generic ingredient in RAPAMUNE is sirolimus. There are twenty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for RAPAMUNE
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 102 |
| Patent Applications: | 9,770 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RAPAMUNE |
| DailyMed Link: | RAPAMUNE at DailyMed |
Pharmacology for RAPAMUNE
| 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 RAPAMUNE
Synonyms for RAPAMUNE
| (-)-Rapamycin |
| (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(2S)-1-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]propan-2-yl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.0(4,9) |
| (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-{(2S)-1-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]propan-2-yl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]h |
| (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34 aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hex adecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydro xy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy- 6 |
| (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-4,9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-heptadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8 |
| (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-((1R)-2-((1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl)-1-methylethyl)-10,21-dimethoxy-6,8,1 |
| (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,1 |
| (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-3-{(1R)-2-[(1S,3R,4R)-4-hydroxy-3-(methyloxy)cyclohexyl]-1-methylethyl}-6,8,12,14,20,26-hexamethyl-10,21-bis(methyloxy)-9,10,12,13,14,21,22,23,24,25,26 |
| (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-3-{(2R)-1-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]propan-2-yl}-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34 |
| 1,18-Dihydroxy-12-[2-(4-hydroxy-3-methoxy-cyclohexyl)-1-methyl-ethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0*4,9*]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone (Rapamycin) |
| 1179372-35-0 |
| 1189166-54-8 |
| 1233221-34-5 |
| 123R889 |
| 1353039-01-6 |
| 1fkb |
| 1pbk |
| 23,27-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine |
| 53123-88-9 |
| A-275 |
| AC-722 |
| AKOS015850976 |
| AKOS015961618 |
| Ambotz53123-88-9 |
| Antibiotic AY 22989 |
| AS-11687 |
| AY 22989 |
| AY-22989 |
| AY22989 |
| BC207597 |
| BDBM36609 |
| BDBM50064359 |
| BIDD:PXR0165 |
| BiomolKI2_000084 |
| BRD-K84937637-001-04-0 |
| BRD-K89626439-001-01-0 |
| C51H79NO13 |
| CAS-53123-88-9 |
| CCG-100684 |
| CCRIS 9024 |
| CHEBI:9168 |
| CS-0063 |
| Cypher |
| DB00877 |
| DE-109 |
| DSSTox_CID_3582 |
| DSSTox_GSID_23582 |
| DSSTox_RID_77091 |
| DTXSID5023582 |
| EC 610-965-5 |
| EX-A1044 |
| FT-0082351 |
| HMS2089A21 |
| HMS3403F11 |
| HSDB 7284 |
| HY-10219 |
| LCP-Siro |
| LS-143290 |
| MFCD00867594 |
| MolPort-003-959-433 |
| MS-R001 |
| NCGC00021305-05 |
| NCGC00021305-06 |
| NCGC00021305-07 |
| NCGC00181146-01 |
| NSC 226080 |
| NSC226080 |
| Perceiva |
| PubChem16645 |
| Q-201659 |
| R0097 |
| RAP |
| RAPA |
| rapalimus |
| Rapammune |
| Rapamycin |
| Rapamycin (Sirolimus) |
| Rapamycin C-7, analog 4 |
| Rapamycin from Streptomyces hygroscopicus, >=95% (HPLC), powder |
| Rapamycin from Streptomyces hygroscopicus, Vetec(TM) reagent grade, >=95% |
| Rapamycin, VETRANAL(TM), analytical standard |
| Rapamycin,Sirolimus,Rapamune |
| RL03960 |
| S-7759 |
| S1039 |
| SCHEMBL3463 |
| SILA 9268A |
| Sirolimus |
| Sirolimus (RAPAMUNE) |
| Sirolimus [USAN:BAN:INN] |
| Sirolimus [USAN:INN:BAN] |
| Sirolimus solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| sirolimusum |
| Supralimus |
| SYN1185 |
| Tox21_110870 |
| Tox21_112750 |
| UNII-W36ZG6FT64 |
| UNM-0000358684 |
| W36ZG6FT64 |
| Wy 090217 |
| WY-090217 |
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 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for RAPAMUNE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | ➤ Sign Up | ➤ Sign Up |
| Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | ➤ Sign Up | ➤ Sign Up |
| Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | ➤ Sign Up | ➤ Sign Up |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for RAPAMUNE
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 0.5 mg | ➤ Subscribe | 2010-08-25 |
| ➤ Subscribe | Tablets | 1 mg and 2 mg | ➤ Subscribe | 2009-12-17 |
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