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Sirolimus - Generic Drug Details
What are the generic drug sources for sirolimus and what is the scope of freedom to operate?
Sirolimus
is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Novitium Pharma, Dr Reddys Labs Ltd, and Zydus Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-one drug master file entries for sirolimus. Nine suppliers are listed for this compound.
Summary for sirolimus
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 21 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 533 |
| Patent Applications: | 8,696 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for sirolimus |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sirolimus |
| DailyMed Link: | sirolimus at DailyMed |
Recent Clinical Trials for sirolimus
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Instituto de Oftalmología Fundación Conde de Valenciana | Early Phase 1 |
| PTEN Research | Phase 2 |
| Ohio State University | Phase 2 |
Recent Litigation for sirolimus
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 sirolimus
| 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 sirolimus
Synonyms for sirolimus
| (-)-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 |
| Rapamune |
| 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 (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 sirolimus
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Ltd | SIROLIMUS | sirolimus | TABLET;ORAL | 201578-002 | Oct 27, 2014 | AB | RX | No | No | 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 | |||
| Dr Reddys Labs Ltd | SIROLIMUS | sirolimus | TABLET;ORAL | 201578-001 | Oct 27, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Novitium Pharma | SIROLIMUS | sirolimus | SOLUTION;ORAL | 211040-001 | Jan 28, 2019 | AA | RX | No | 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 sirolimus
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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