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Everolimus - Generic Drug Details

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What are the generic drug sources for everolimus and what is the scope of patent protection?

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 nine 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 ninety-seven patent family members in forty-eight countries.

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

Summary for everolimus

International Patents:	397
US Patents:	7
Tradenames:	4
Applicants:	6
NDAs:	9
Drug Master File Entries:	12
Bulk Api Vendors:	34
Clinical Trials:	720
Patent Applications:	5,697
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for everolimus
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for everolimus
DailyMed Link:	everolimus at DailyMed

See drug prices for everolimus

Recent Clinical Trials for everolimus

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

Sponsor	Phase
Fondazione per la Medicina Personalizzata	Phase 2
National Cancer Institute, France	Phase 2
King Chulalongkorn Memorial Hospital	N/A

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.

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
Mylan	EVEROLIMUS	everolimus	TABLET, FOR SUSPENSION;ORAL	210130-001	Apr 19, 2019		DISCN	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012		RX	Yes	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No
Hikma	EVEROLIMUS	everolimus	TABLET;ORAL	207486-002	Jun 8, 2020	AB	RX	No	No
Mylan	EVEROLIMUS	everolimus	TABLET;ORAL	212936-001	Jun 8, 2020	AB	RX	No	No

Expired US Patents for everolimus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012

International Patents for everolimus

Country	Patent Number	Estimated Expiration
Italy	1319701
Israel	202155
United Kingdom	0601082
Cyprus	1117164
Norway	20121113
Hong Kong	1141239

Supplementary Protection Certificates for everolimus

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2269604	PA2016035	Lithuania		PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
3143995	2019C/528	Belgium		PRODUCT NAME: EVEROLIMUS OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001, 003, 004, 006-010 (C(2016)3286) 20160530
0663916	2010/001	Ireland		PRODUCT NAME: EVEROLIMUS; NAT REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803; FIRST REGISTRATION NO/DATE: 18960 018691 18962 18693 18694 18695. 20030718
2269604	93320	Luxembourg		PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS
0663916	C300154	Netherlands		PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
3143995	LUC00122	Luxembourg		PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001, 003, 004, 006-010 20160530