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Last Updated: June 14, 2021

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AFINITOR DISPERZ Drug Profile


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When do Afinitor Disperz patents expire, and what generic alternatives are available?

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

This drug has two hundred and twenty-nine patent family members in thirty-five countries.

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

DrugPatentWatch® 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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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   Get Started Free   Get Started Free Y   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX Yes No   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012   Get Started Free   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012   Get Started Free   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012   Get Started Free   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012   Get Started Free   Get Started Free
>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
3351246 PA2019521 Lithuania   Get Started Free PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
3143995 2019C/528 Belgium   Get Started Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
3143995 PA2019511 Lithuania   Get Started Free PRODUCT NAME: EVEROLIMUZAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/09/538/001, 003, 004, 006-010 20160526
3143995 300992 Netherlands   Get Started Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3351246 2019C/550 Belgium   Get Started Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
McKinsey
Mallinckrodt
Harvard Business School
Medtronic

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