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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. Nine 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 25th, 2020.
Summary for RAPAMUNE
Recent Clinical Trials for RAPAMUNE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The University of Texas Health Science Center at San Antonio | Early Phase 1 |
| PTEN Research | Phase 2 |
| Ohio State University | 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 | 021110-002 | Aug 22, 2002 | 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 | 021110-001 | 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 | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
