Everolimus - Generic Drug Details
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What are the generic sources for everolimus and what is the scope of freedom to operate?
Everolimus
is the generic ingredient in four branded drugs marketed by Novartis Pharm, Mylan, Novartis, Alkem Labs Ltd, Biocon Pharma, Breckenridge, Hikma, Par Pharm, and Teva Pharms Usa, and is included in fourteen NDAs. There are five patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Everolimus has two hundred and seventy-seven patent family members in thirty-eight countries.
There are twelve drug master file entries for everolimus. Eight suppliers are listed for this compound.
Summary for everolimus
International Patents: | 277 |
US Patents: | 5 |
Tradenames: | 4 |
Applicants: | 9 |
NDAs: | 14 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 773 |
Patent Applications: | 7,099 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for everolimus |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for everolimus |
What excipients (inactive ingredients) are in everolimus? | everolimus excipients list |
DailyMed Link: | everolimus at DailyMed |
Recent Clinical Trials for everolimus
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Nationwide Children's Hospital | Phase 2 |
University of Miami | Phase 2 |
University of Wisconsin, Madison | Phase 2 |
Pharmacology for everolimus
Drug Class | Kinase Inhibitor mTOR Inhibitor Immunosuppressant |
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors P-Glycoprotein Inhibitors |
Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for everolimus
Anatomical Therapeutic Chemical (ATC) Classes for everolimus
Paragraph IV (Patent) Challenges for EVEROLIMUS
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AFINITOR DISPERZ | Tablets for Oral Suspension | everolimus | 2 mg, 3 mg and 5 mg | 203985 | 1 | 2016-12-30 |
AFINITOR | Tablets | everolimus | 2.5 mg, 5 mg, and 7.5 mg | 022334 | 1 | 2014-12-10 |
AFINITOR | Tablets | everolimus | 10 mg | 022334 | 1 | 2014-06-18 |
ZORTRESS | Tablets | everolimus | 0.25 mg, 0.5 mg, and 0.75 mg | 021560 | 3 | 2013-09-30 |
US Patents and Regulatory Information for everolimus
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Alkem Labs Ltd | EVEROLIMUS | everolimus | TABLET;ORAL | 214138-003 | Nov 26, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Breckenridge | EVEROLIMUS | everolimus | TABLET;ORAL | 205432-001 | May 20, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | EVEROLIMUS | everolimus | TABLET, FOR SUSPENSION;ORAL | 210130-002 | Apr 19, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | EVEROLIMUS | everolimus | TABLET, FOR SUSPENSION;ORAL | 210130-003 | Apr 19, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-001 | Mar 30, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Breckenridge | EVEROLIMUS | everolimus | TABLET;ORAL | 205426-002 | Mar 5, 2021 | AB | RX | No | 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 everolimus
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-001 | Mar 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-003 | Apr 20, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-001 | Apr 20, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 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 everolimus
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 everolimus
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Morocco | 29966 | TRAITEMENT DES TUMEURS NEUROENDOCRINES | ⤷ Try a Trial |
Norway | 20190290 | ⤷ Try a Trial | |
Denmark | 2269603 | ⤷ Try a Trial | |
Japan | 2009516671 | ⤷ Try a Trial | |
European Patent Office | 1954269 | TRAITEMENT DES TUMEURS NEUROENDOCRINES (NEUROENDOCRINE TUMOR TREATMENT USING MTOR INHIBITORS) | ⤷ Try a Trial |
Denmark | 3351246 | ⤷ Try a Trial | |
Israel | 191475 | שימוש ב- 40-o-(2-hydroxyethyl)-rapamycin להכנת תרופה לטיפול בגידולים נוירואנדוקריניים בלבלב (Use of 40-o-(2-hydroxyethyl)-rapamycin for the manufacture of a medicament for the treatment of pancreatic neuroendocrine tumors) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for everolimus
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 132016000127697 | Italy | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AFINITOR); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/09/538/001-006, 20090805 |
3342411 | PA2020503 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538 20110824 |
2269603 | CA 2015 00058 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725 |
2269603 | 300769 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/001, 003, 004 EN 006-010 (C(2012)5347) 20120725 |
2269604 | 93320 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS |
3342411 | 301032 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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