SIROLIMUS - Generic Drug Details
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What are the generic sources for sirolimus and what is the scope of freedom to operate?
Sirolimus
is the generic ingredient in four branded drugs marketed by Nobelpharma, Aadi, Pf Prism Cv, Amneal, Apotex, MSN, Novitium Pharma, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms, and is included in thirteen NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sirolimus has one hundred and forty-nine patent family members in thirty-two countries.
There are twenty-one drug master file entries for sirolimus. Eighteen suppliers are listed for this compound.
Summary for SIROLIMUS
International Patents: | 149 |
US Patents: | 5 |
Tradenames: | 4 |
Applicants: | 12 |
NDAs: | 13 |
Drug Master File Entries: | 21 |
Finished Product Suppliers / Packagers: | 18 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 680 |
Patent Applications: | 3,693 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
Mirati Therapeutics Inc. | Phase 1/Phase 2 |
Aadi Bioscience, Inc. | Phase 1/Phase 2 |
Melanoma and Skin Cancer Trials Limited | Phase 3 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alkem Labs Ltd | SIROLIMUS | sirolimus | TABLET;ORAL | 214753-003 | Mar 12, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Msn | SIROLIMUS | sirolimus | SOLUTION;ORAL | 216728-001 | Jan 19, 2023 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Aadi | FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312-001 | Nov 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | 021110-003 | Feb 23, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for SIROLIMUS
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 108024999 | 治疗上皮样细胞肿瘤的方法 (METHODS OF TREATING EPITHELIOID CELL TUMORS) | ⤷ Try a Trial |
Lithuania | 2419732 | ⤷ Try a Trial | |
Japan | 2017061537 | プリオンを含まないナノ粒子組成物および方法 (PRION-FREE NANOPARTICLE COMPOSITIONS AND METHODS) | ⤷ Try a Trial |
Ukraine | 118645 | СПОСІБ КОМБІНОВАНОЇ ТЕРАПІЇ РАКУ НАНОЧАСТИНКАМИ, ЩО МІСТЯТЬ РАПАМІЦИН І АЛЬБУМІН | ⤷ Try a Trial |
European Patent Office | 4051241 | COMPOSITIONS PHARMACEUTIQUES D'ALBUMINE ET DE RAPAMYCINE (PHARMACEUTICAL COMPOSITIONS OF ALBUMIN AND RAPAMYCIN) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SIROLIMUS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0763039 | 122008000023 | Germany | ⤷ Try a Trial | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | C300348 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | SPC/GB08/025 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119 |
0401747 | SPC/GB01/036 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313 |
0648494 | C00648494/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: SIROLIMUS; REGISTRATION NO/DATE: IKS 55243 20000926 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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