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. Fifteen 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.
Summary for RAPAMUNE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 63 |
Clinical Trials: | 229 |
Patent Applications: | 5,041 |
Formulation / Manufacturing: | see details |
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 |
---|---|
West China Hospital | Phase 2 |
Haukeland University Hospital | Phase 2 |
National Institute of Neurological Disorders and Stroke (NINDS) | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for RAPAMUNE
US Patents and Regulatory Information for RAPAMUNE
RAPAMUNE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting RAPAMUNE
TREATMENTOF LYMPHANGIOLEIOMYOMATOSIS (LAM)
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | 021110-003 | Feb 23, 2004 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | See Plans and Pricing | See Plans and Pricing |
>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 | |
>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 |
---|---|---|---|
Germany | 69414810 | See Plans and Pricing | |
Hungary | T64832 | See Plans and Pricing | |
Greece | 3029439 | See Plans and Pricing | |
Singapore | 55104 | Surface modified drug nanoparticles | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 9325190 | See Plans and Pricing | |
Japan | 4439590 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RAPAMUNE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0401747 | CA 2001 00025 | Denmark | See Plans and Pricing | |
0401747 | 25/2001 | Austria | See Plans and Pricing | PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926 |
0648494 | SPC020/2001 | Ireland | See Plans and Pricing | SPC020/2001: 20050808, EXPIRES: 20150925 |
0763039 | PA2008009,C0763039 | Lithuania | See Plans and Pricing | PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0401747 | SPC/GB01/036 | United Kingdom | See Plans and Pricing | PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313 |
0763039 | 08C0018 | France | See Plans and Pricing | PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |