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: | 37 |
Clinical Trials: | 755 |
Patent Applications: | 7,540 |
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 |
---|---|
Genentech, Inc. | Phase 3 |
Karolinska University Hospital | Phase 3 |
Skane University Hospital | Phase 3 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | EVEROLIMUS | everolimus | TABLET, FOR SUSPENSION;ORAL | 210130-003 | Apr 19, 2019 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Hikma | EVEROLIMUS | everolimus | TABLET;ORAL | 206133-002 | Apr 12, 2018 | AB | RX | No | 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 everolimus
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-001 | Mar 30, 2009 | See Plans and Pricing | See Plans and Pricing |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-003 | Apr 20, 2010 | See Plans and Pricing | See Plans and Pricing |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for everolimus
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 2762140 | See Plans and Pricing | |
Hong Kong | 1141239 | See Plans and Pricing | |
Japan | 2014193901 | CANCER TREATMENT | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for everolimus
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2269603 | 300769 | Netherlands | See Plans and Pricing | 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 | 300849 | Netherlands | See Plans and Pricing | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
3351246 | C03351246/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 27.02.2013 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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