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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, Hikma, Par Pharm, and Teva Pharms Usa, and is included in seven NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Everolimus has three hundred and eighty-eight patent family members in forty-eight countries.

There are twelve drug master file entries for everolimus. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for everolimus

International Patents:	388
US Patents:	7
Tradenames:	4
Applicants:	6
NDAs:	7
Drug Master File Entries:	12
Suppliers / Packagers:	4
Bulk Api Vendors:	30
Clinical Trials:	715
Patent Applications:	8,326
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for everolimus
DailyMed Link:	everolimus at DailyMed

Recent Clinical Trials for everolimus

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute, France	Phase 2
Regeneron Pharmaceuticals	Phase 1
Fudan University	Phase 2

See all everolimus clinical trials

Generic filers with tentative approvals for EVEROLIMUS

Applicant	Application No.	Strength	Dosage Form
		7.5MG	TABLET;ORAL
		5MG	TABLET;ORAL
		2.5MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for everolimus

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for everolimus

Antineoplastic Agents

Immunosuppressive Agents

Paragraph IV (Patent) Challenges for EVEROLIMUS

Tradename	Dosage	Ingredient	NDA	Submissiondate
AFINITOR DISPERZ	TABLET, FOR SUSPENSION;ORAL	everolimus	203985	2016-12-30
AFINITOR	TABLET;ORAL	everolimus	022334	2014-12-10
AFINITOR	TABLET;ORAL	everolimus	022334	2014-06-18
ZORTRESS	TABLET;ORAL	everolimus	021560	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	022334-001	Mar 30, 2009	AB	RX	Yes	Yes
Mylan	EVEROLIMUS	everolimus	TABLET, FOR SUSPENSION;ORAL	210130-002	Apr 19, 2019		DISCN	No	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012		RX	Yes	Yes					Y

Expired US Patents for everolimus

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

International Patents for everolimus

Country	Patent Number	Estimated Expiration
Czech Republic	302210
Hungary	0303271
Canada	2732620

Supplementary Protection Certificates for everolimus

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3351246	PA2019521	Lithuania		PRODUCT NAME: REPAMICINO DARINYS, SKIRTAS KIETO NAVIKO, SISIJUSIO SU NEREGULIUOJAMA ANGIOGENEZE, GYDYMUI; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
2269604	122016000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
2269603	PA2015041	Lithuania		PRODUCT NAME: EVEROLIMUSUM; REGISTRATION NO/DATE: EU/1/09/538/001, EU/1/09/538/003, EU/1/09/538/004, EU/1/09/538/006-010 20120723