SIROLIMUS Drug Patent Profile
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When do Sirolimus patents expire, and what generic alternatives are available?
Sirolimus is a drug marketed by Amneal, Apotex, MSN, Novitium Pharma, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms. and is included in nine NDAs.
The generic ingredient in SIROLIMUS is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sirolimus
A generic version of SIROLIMUS was approved as sirolimus by ZYDUS PHARMS on January 8th, 2014.
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Questions you can ask:
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Summary for SIROLIMUS
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 14 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 687 |
| Patent Applications: | 2,713 |
| Drug Prices: | Drug price information for SIROLIMUS |
| What excipients (inactive ingredients) are in SIROLIMUS? | SIROLIMUS excipients list |
| DailyMed Link: | SIROLIMUS at DailyMed |
Recent Clinical Trials for SIROLIMUS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Case Comprehensive Cancer Center | Phase 2 |
| Stanford University | Phase 1/Phase 2 |
| Aadi Bioscience, Inc. | Phase 2 |
Pharmacology for SIROLIMUS
| Drug Class | Kinase Inhibitor mTOR Inhibitor Immunosuppressant |
| Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for SIROLIMUS
Anatomical Therapeutic Chemical (ATC) Classes for SIROLIMUS
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | SIROLIMUS | sirolimus | SOLUTION;ORAL | 211212-001 | Oct 18, 2019 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | SIROLIMUS | sirolimus | TABLET;ORAL | 214753-002 | Mar 12, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novitium Pharma | SIROLIMUS | sirolimus | SOLUTION;ORAL | 211040-001 | Jan 28, 2019 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for SIROLIMUS
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer Europe MA EEIG | Rapamune | sirolimus | EMEA/H/C/000273 Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued., , Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function., |
Authorised | no | no | no | 2001-03-13 | |
| Plusultra pharma GmbH | Hyftor | sirolimus | EMEA/H/C/005896 Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older. |
Authorised | no | no | yes | 2023-05-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
