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Last Updated: January 17, 2022

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ZORTRESS Drug Patent 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.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Zortress

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

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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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis ZORTRESS everolimus TABLET;ORAL 021560-004 Aug 10, 2018 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it 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 ZORTRESS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 ⤷  Try it Free ⤷  Try it Free
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 ⤷  Try it Free ⤷  Try it Free
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 ⤷  Try it Free ⤷  Try it Free
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 ⤷  Try it Free ⤷  Try it Free
>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
2269603 122015000094 Germany ⤷  Try it Free PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
3143995 122019000051 Germany ⤷  Try it Free PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/007 EU/1/09/538/008 EU/1/09/538/009 EU/1/09/538/010 20160526
3342411 C03342411/01 Switzerland ⤷  Try it Free PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 17.01.2012
3351246 122019000102 Germany ⤷  Try it Free PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
>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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