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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 everolimus patent protection?

Everolimus is the generic ingredient in four branded drugs marketed by Novartis Pharm, Novartis, and West-ward Pharms Int, and is included in four NDAs. There are ten 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 fifty-nine patent family members in forty-eight countries.

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

Summary for everolimus

International Patents:	359
US Patents:	10
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	12
Suppliers / Packagers:	1
Bulk Api Vendors:	22
Clinical Trials:	662
Patent Applications:	8,045
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for everolimus
DailyMed Link:	everolimus at DailyMed

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

Synonyms for everolimus

(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-((1R)-2-((1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo(

(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,35R)-1,18-dihydroxy-12-{(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.

(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-((1R)-2-((1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-10,21-dimet

(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-3-{(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-9,10,12,13,14,21,22,23,24,25,26,2

1245613-55-1

159351-69-6

351E696

40-O-(2-hydroxyethyl)-rapamycin

42-O-(2-Hydroxyethyl)rapamycin

9HW64Q8G6G

Afinitor

Afinitor Disperz

AKOS015850977

AS-16971

AT-22180

BDBM50088378

BRD-K13514097-001-01-2

C53H83NO14

CAS-159351-69-6

Certican

CHEBI:68478

CHEMBL1908360

CS-0064

DB01590

dihydroxy-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxy-cyclohexyl]-1-methyl-ethyl]-dimethoxy-hexamethyl-[?]pentone

DSSTox_CID_20599

DSSTox_GSID_40599

DSSTox_RID_79508

DTXSID0040599

Everolimus - RAD001

Everolimus (INN)

Everolimus [USAN:INN:BAN]

Everolimus [USAN]

Everolimus solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material

Everolimus, analytical standard

everolimusum

HSDB 8255

HY-10218

LS-143292

MolPort-003-847-342

NCGC00167512-01

NSC733504

NVP-RAD-001

PubChem20048

Q-101413

RAD

RAD 001

RAD-001

RAD-001C

RAD001

Rapamycin, 42-O-(2-hydroxyethyl)-

RL02051

SCHEMBL4378

SDZ-RAD

Tox21_112510

UNII-9HW64Q8G6G

V2036

Votubia

XIENCE V

Zortress

Tentative approvals for EVEROLIMUS

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

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	022334-004	Mar 30, 2012		RX	Yes	No					Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009		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	022334-001	Mar 30, 2009		RX	Yes	No

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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 Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012

Non-Orange Book US Patents for everolimus

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,440,990	O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants
6,605,613	Macrolides
6,852,729	Macrolides
7,572,804	Macrolides

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International Patents for everolimus

Country	Document Number	Estimated Expiration
Slovakia	285256
Japan	2015061868
New Zealand	256026
Israel	229156

Supplementary Protection Certificates for everolimus

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10/001	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
2016000094	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
0663916/01	Switzerland		PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005
/2016	Austria		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805