DrugPatentWatch Database Preview
RAPAMUNE Drug Profile
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. Nine suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for RAPAMUNE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 53 |
| Clinical Trials: | 110 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RAPAMUNE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RAPAMUNE |
| DailyMed Link: | RAPAMUNE at DailyMed |
Recent Clinical Trials for RAPAMUNE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ohio State University | Phase 2 |
| PTEN Research | Phase 2 |
| University of Pennsylvania | Phase 2 |
Recent Litigation for RAPAMUNE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Par Pharmaceutical, Inc. v. Twi Pharmaceuticals, Inc. | 2014-04-01 |
| LUPIN ATLANTIS HOLDINGS S.A. v. APOTEX INC. | 2011-03-18 |
| Pfizer Inc. v. Watson Pharmaceuticals Inc. | 2010-04-28 |
Pharmacology for RAPAMUNE
| Drug Class | mTOR Inhibitor Immunosuppressant Kinase Inhibitor |
| Mechanism of Action | mTOR Inhibitors Protein Kinase Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Synonyms for RAPAMUNE
| (-)-Rapamycin |
| 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 |
| ACN-035837 |
| AK544290 |
| AKOS015850976 |
| AKOS015961618 |
| Antibiotic AY 22989 |
| AS-11687 |
| AY 22989 |
| AY-22989 |
| BC207597 |
| BDBM36609 |
| BDBM50064359 |
| BIDD:PXR0165 |
| BiomolKI2_000084 |
| BRD-K84937637-001-04-0 |
| BRD-K84937637-001-06-5 |
| 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 |
| GTPL6031 |
| HMS2089A21 |
| HMS3403F11 |
| HSDB 7284 |
| HY-10219 |
| LCP-Siro |
| LS-143290 |
| MFCD00867594 |
| MLS006010168 |
| MolPort-003-959-433 |
| MS-R001 |
| NCGC00021305-05 |
| NCGC00021305-06 |
| NCGC00021305-07 |
| NCGC00181146-01 |
| NSC 226080 |
| NSC226080 |
| Perceiva |
| PubChem16645 |
| Q-201659 |
| QFJCIRLUMZQUOT-HPLJOQBZSA-N |
| R0097 |
| RAP |
| RAPA |
| 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 |
| SMR004701276 |
| Supralimus |
| SYN1185 |
| Tox21_110870 |
| Tox21_112750 |
| UNII-W36ZG6FT64 |
| UNM-0000358684 |
| W36ZG6FT64 |
| Wy 090217 |
| WY-090217 |
| ZINC169289388 |
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 | 021110-004 | Jan 25, 2010 | Start Trial | Start Trial |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | Start Trial | Start Trial |
| 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 | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
