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Last Updated: March 28, 2024

RAPAMUNE Drug Patent Profile


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When do Rapamune patents expire, and when can generic versions of Rapamune launch?

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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Paragraph IV (Patent) Challenges for RAPAMUNE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RAPAMUNE Tablets sirolimus 0.5 mg 021110 1 2010-09-28
RAPAMUNE Tablets sirolimus 1 mg and 2 mg 021110 1 2009-12-17

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 ⤷  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
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 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 ⤷  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 021110-001 Aug 25, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 ⤷  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 021110-003 Feb 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 ⤷  Try a Trial ⤷  Try a Trial
>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
Israel 100754 ⤷  Try a Trial
Hungary T64832 ⤷  Try a Trial
Japan 4439590 ⤷  Try a Trial
Finland 108333 ⤷  Try a Trial
Czech Republic 9301316 ⤷  Try a Trial
Mexico 173183 USO DE LA RAPAMICINA PARA LA PREPARACION DE UNA COMPOSICION PARA INHIBIR EL RECHAZO DE TRANSPLANTES DE ORGANOS O TEJIDOS EN UN MAMIFERO QUE LO NECESITA ⤷  Try a Trial
Mexico 9303950 NANOPARTICULAS ANTICANCERIGENAS MODIFICADAS EN SU SUPERFICIE. ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RAPAMUNE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0648494 C00648494/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SIROLIMUS; REGISTRATION NO/DATE: IKS 55243 20000926
0763039 08C0018 France ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 PA2008009,C0763039 Lithuania ⤷  Try a Trial PRODUCT NAME: TEMSIROLIMUSUM; 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
0648494 SPC020/2001 Ireland ⤷  Try a Trial SPC020/2001: 20050808, EXPIRES: 20150925
0648494 SPC/GB01/037 United Kingdom ⤷  Try a Trial PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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