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Last Updated: January 31, 2023

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 Strength NDA ANDAs Submitted Submissiondate
ZORTRESS Tablets everolimus 0.25 mg, 0.5 mg, and 0.75 mg 021560 3 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-004 Aug 10, 2018 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 AB RX 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 ZORTRESS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 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 ZORTRESS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Novartis Europharm Limited Afinitor everolimus EMEA/H/C/001038
Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.Neuroendocrine tumours of pancreatic originAfinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.Neuroendocrine tumours of gastrointestinal or lung originAfinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.Renal-cell carcinomaAfinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Authorised no no no 2009-08-02
Novartis Europharm Limited Votubia everolimus EMEA/H/C/002311
Renal angiomyolipoma associated with tuberous sclerosis complex (TSC), , Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery., , The evidence is based on analysis of change in sum of angiomyolipoma volume., , Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC), , Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery., , The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease‑related symptoms, has not been demonstrated.,
Authorised no no yes 2011-09-02
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ZORTRESS

See the table below for patents covering ZORTRESS around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0839028 DISPERSIONS SOLIDES DE RAPAMYCINE (SOLID DISPERSIONS OF RAPAMYCIN) See Plans and Pricing
Chile 2003002715 See Plans and Pricing
Hungary 9900391 See Plans and Pricing
Brazil 9609537 See Plans and Pricing
Denmark 0839028 See Plans and Pricing
Cyprus 2125 O-alkylated rapamycin derivatives and their use particularly as immunosuppressants See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZORTRESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663916 04C0012 France See Plans and Pricing PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718
2269604 132016000127697 Italy See Plans and Pricing PRODUCT NAME: EVEROLIMUS O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AFINITOR); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/09/538/001-006, 20090805
3143995 122019000051 Germany See Plans and Pricing 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
3351246 122019000102 Germany See Plans and Pricing PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
0663916 SPC001/2010 Ireland See Plans and Pricing SPC001/2010: 20101001, EXPIRES: 20180717
0663916 91104 Luxembourg See Plans and Pricing 91104, EXPIRES: 20180718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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