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Last Updated: January 21, 2021

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AFINITOR DISPERZ Drug Profile

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Which patents cover Afinitor Disperz, and when can generic versions of Afinitor Disperz launch?

Afinitor Disperz is a drug marketed by Novartis Pharm and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and forty-nine patent family members in forty-five countries.

The generic ingredient in AFINITOR DISPERZ is everolimus. There are twelve drug master file entries for this compound. Additional details are available on the everolimus profile page.

US ANDA Litigation and Generic Entry Outlook for Afinitor Disperz

A generic version of AFINITOR DISPERZ was approved as everolimus by HIKMA on April 12th, 2018.

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Drug patent expirations by year for AFINITOR DISPERZ
Drug Prices for AFINITOR DISPERZ

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Recent Clinical Trials for AFINITOR DISPERZ

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 3

See all AFINITOR DISPERZ clinical trials

Paragraph IV (Patent) Challenges for AFINITOR DISPERZ
Tradename Dosage Ingredient NDA Submissiondate
AFINITOR DISPERZ TABLET, FOR SUSPENSION;ORAL everolimus 203985 2016-12-30

US Patents and Regulatory Information for AFINITOR DISPERZ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX 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 AFINITOR DISPERZ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AFINITOR DISPERZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2269604 PA2016035 Lithuania   Start Trial PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
3143995 2019C/528 Belgium   Start Trial PRODUCT NAME: EVEROLIMUS OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001, 003, 004, 006-010 (C(2016)3286) 20160530
0663916 2010/001 Ireland   Start Trial PRODUCT NAME: EVEROLIMUS; NAT REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803; FIRST REGISTRATION NO/DATE: 18960 018691 18962 18693 18694 18695. 20030718
2269604 93320 Luxembourg   Start Trial PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS
0663916 C300154 Netherlands   Start Trial PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Mallinckrodt
Harvard Business School
AstraZeneca
Dow

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