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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 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. Five suppliers are listed for this compound. 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
Suppliers / Packagers:	5
Bulk Api Vendors:	35
Clinical Trials:	724
Patent Applications:	7,574
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

See drug prices for everolimus

Recent Clinical Trials for everolimus

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

Sponsor	Phase
Hoffmann-La Roche	Phase 1/Phase 2
Second Affiliated Hospital of Guangzhou Medical University	N/A
The Hospital for Sick Children	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.

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
Par Pharm	EVEROLIMUS	everolimus	TABLET;ORAL	207934-001	Dec 9, 2019	AB	RX	No	No
Par Pharm	EVEROLIMUS	everolimus	TABLET;ORAL	207934-004	Dec 9, 2020	AB	RX	No	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009		RX	Yes	No
Mylan	EVEROLIMUS	everolimus	TABLET;ORAL	212936-004	Jun 8, 2020		DISCN	No	No
Mylan	EVEROLIMUS	everolimus	TABLET, FOR SUSPENSION;ORAL	210130-001	Apr 19, 2019		DISCN	No	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012		RX	Yes	Yes
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No					Y

Expired US Patents for everolimus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012

International Patents for everolimus

Country	Patent Number	Estimated Expiration
Brazil	0207378
Japan	6349476
New Zealand	542273
Argentina	026102
Austria	365051
Lithuania	3143995
New Zealand	527781

Supplementary Protection Certificates for everolimus

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3342411	LUC00148	Luxembourg		PRODUCT NAME: EVEROLIMUS; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-008 20110830
2269604	PA2016035	Lithuania		PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
2269603	CA 2015 00058	Denmark		PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
3143995	300992	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3351246	CA 2019 00056	Denmark		PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
3351246	301018	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3143995	2019C/528	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION