Zortress Drug Patent Profile
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Which patents cover Zortress, and what generic alternatives are available?
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. Nine 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.
Summary for Zortress
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 66 |
Patent Applications: | 4,495 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Zortress |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for Zortress |
What excipients (inactive ingredients) are in Zortress? | Zortress excipients list |
DailyMed Link: | Zortress at DailyMed |
Recent Clinical Trials for Zortress
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Early Phase 1 |
M.D. Anderson Cancer Center | Early Phase 1 |
University of Cincinnati | Phase 4 |
Pharmacology for Zortress
Drug Class | Kinase Inhibitor mTOR Inhibitor Immunosuppressant |
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors |
Physiological Effect | Decreased Immunologic Activity |
Anatomical Therapeutic Chemical (ATC) Classes for Zortress
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-004 | Aug 10, 2018 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-002 | Apr 20, 2010 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-003 | Apr 20, 2010 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | 021560-003 | Apr 20, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-001 | Apr 20, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-003 | Apr 20, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-001 | Apr 20, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-001 | Apr 20, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 | no | 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 |
---|---|---|---|
United Kingdom | 9705684 | ⤷ Try a Trial | |
Turkey | 9800045 | ⤷ Try a Trial | |
Hungary | 9501016 | ⤷ Try a Trial | |
Cyprus | 2125 | O-alkylated rapamycin derivatives and their use particularly as immunosuppressants | ⤷ Try a Trial |
Australia | 4819293 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Zortress
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2269604 | C02269604/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS (40-O-(2-HYDROXYETHYL)-RAPAMYCIN); REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 59174 17.11.2009 |
0663916 | 04C0012 | France | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718 |
0663916 | CA 2004 00020 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS |
3143995 | 34/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538 IDF DER ENTSCHEIDUNG DER KOMMISSION C (2016) 3286 (MITTEILUNG) 20160530 |
2269604 | CA 2016 00060 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-006 20090805 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |