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Last Updated: January 23, 2021

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ZORTRESS Drug Profile

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

Zortress is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty patent family members in twenty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Zortress

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

  Start Trial

Drug patent expirations by year for ZORTRESS
Drug Prices for ZORTRESS

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Recent Clinical Trials for ZORTRESS

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

SponsorPhase
The Lilabean Foundation for Pediatric Brain Cancer ResearchPhase 1
University of California, San FranciscoPhase 1
Pediatric Brain Tumor FoundationPhase 1

See all ZORTRESS clinical trials

Paragraph IV (Patent) Challenges for ZORTRESS
Tradename Dosage Ingredient NDA Submissiondate
ZORTRESS TABLET;ORAL everolimus 021560 2013-09-30

US Patents and Regulatory Information for ZORTRESS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-004 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 AB 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 ZORTRESS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZORTRESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3351246 122019000102 Germany   Start Trial PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
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 SZ 14/2004 Austria   Start Trial PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN)
3342411 CA 2020 00007 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538 (K(2011)6162) 20110830
3351246 CA 2019 00056 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Medtronic
Baxter
Express Scripts
Harvard Business School

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