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Last Updated: August 19, 2022

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.

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Drug patent expirations by year for RAPAMUNE
Drug Prices for RAPAMUNE

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Recent Clinical Trials for RAPAMUNE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
West China HospitalPhase 2
Haukeland University HospitalPhase 2
National Institute of Neurological Disorders and Stroke (NINDS)Phase 2

See all RAPAMUNE clinical trials

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

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

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