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Last Updated: July 4, 2020

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RAPAMUNE Drug 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. Ten suppliers are listed for this compound. Additional details are available on the sirolimus profile page.

US ANDA 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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Drug patent expirations by year for RAPAMUNE
Drug Prices for RAPAMUNE

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Recent Clinical Trials for RAPAMUNE

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SponsorPhase
City of Hope Medical CenterPhase 2
Dana-Farber Cancer InstitutePhase 1
Walter K. KraftPhase 1

See all RAPAMUNE clinical trials

Paragraph IV (Patent) Challenges for RAPAMUNE
Tradename Dosage Ingredient NDA Submissiondate
RAPAMUNE TABLET;ORAL sirolimus 021110 2010-09-28
RAPAMUNE TABLET;ORAL sirolimus 021110 2010-08-25
RAPAMUNE TABLET;ORAL sirolimus 021110 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   Start Trial   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 DISCN Yes No   Start Trial   Start Trial   Start 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 021110-003 Feb 23, 2004   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999   Start Trial   Start Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RAPAMUNE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0763039 PA2008009,C0763039 Lithuania   Start Trial PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0401747 CA 2001 00025 Denmark   Start Trial
0648494 C300055 Netherlands   Start Trial 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   Start Trial PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001-005 20010313; FIRST REGISTRATION: IKS55243 20000926
0763039 122008000023 Germany   Start Trial PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039 PA2008009 Lithuania   Start Trial PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0648494 SPC/GB01/037 United Kingdom   Start Trial PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Express Scripts
Johnson and Johnson
Harvard Business School
McKinsey

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