RAPAMUNE Drug Patent 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. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rapamune
A generic version of RAPAMUNE was approved as sirolimus by ZYDUS PHARMS on January 8th, 2014.
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Questions you can ask:
- What is the 5 year forecast for RAPAMUNE?
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- What is Average Wholesale Price for RAPAMUNE?
Summary for RAPAMUNE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 233 |
| Patent Applications: | 2,713 |
| Drug Prices: | Drug price information for RAPAMUNE |
| What excipients (inactive ingredients) are in RAPAMUNE? | RAPAMUNE excipients list |
| DailyMed Link: | RAPAMUNE at DailyMed |
Recent Clinical Trials for RAPAMUNE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Stanford University | Phase 1/Phase 2 |
| Markus Mapara | Phase 1/Phase 2 |
| ITB-Med LLC | Phase 1/Phase 2 |
Pharmacology for RAPAMUNE
| Drug Class | Kinase Inhibitor mTOR Inhibitor Immunosuppressant |
| Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | AB | RX | Yes | 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 |
Expired US Patents for RAPAMUNE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083-001 | Sep 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for RAPAMUNE
| 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 RAPAMUNE
See the table below for patents covering RAPAMUNE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1108529 | ⤷ Sign Up | |
| Netherlands | 300055 | ⤷ Sign Up | |
| Japan | H08501073 | ⤷ Sign Up | |
| Czech Republic | 9301316 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RAPAMUNE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0648494 | C300055 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SIROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; NATL. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: CH CH/55243 20000926 |
| 0648494 | 01C0037 | France | ⤷ Sign Up | PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001-005 20010313; FIRST REGISTRATION: IKS55243 20000926 |
| 0648494 | C00648494/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SIROLIMUS; REGISTRATION NO/DATE: IKS 55243 20000926 |
| 0648494 | SPC020/2001 | Ireland | ⤷ Sign Up | SPC020/2001: 20050808, EXPIRES: 20150925 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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