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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 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 seven NDAs. There are eight 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-one patent family members in forty-eight countries.

There are twelve drug master file entries for everolimus. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for everolimus

International Patents:	381
US Patents:	8
Tradenames:	4
Applicants:	6
NDAs:	7
Drug Master File Entries:	12
Suppliers / Packagers:	2
Bulk Api Vendors:	29
Clinical Trials:	708
Patent Applications:	7,525
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
CoImmune	Phase 2
M.D. Anderson Cancer Center	Early Phase 1
Transplant Genomics, Inc.	Phase 4

See all everolimus clinical trials

Recent Litigation for everolimus

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Point.360, a California Corporation	2017-10-10
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.	2017-06-30
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.	2017-04-07

See all everolimus litigation

PTAB Litigation

Petitioner	Date
Hikma Pharmaceuticals PLC	2018-01-17
Breckenridge Pharmaceutial, Inc.	2017-06-12
West-Ward Pharmaceuticals International Limited	2017-03-13

See all everolimus litigation

Generic filers with tentative approvals for EVEROLIMUS

Applicant	Application No.	Strength	Dosage Form
		2.5MG	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

Synonyms for everolimus

1245613-55-1

159351-69-6

351E696

40-O-(2-hydroxyethyl)-rapamycin

42-O-(2-Hydroxyethyl)rapamycin

9HW64Q8G6G

Afinitor

Afinitor Disperz

AK323674

AKOS015850977

AS-16971

AT-22180

BDBM50088378

BRD-K13514097-001-01-2

BRD-K13514097-001-05-3

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

Everolimus; RAD001; SDZ-RAD

everolimusum

EX-A2057

GTPL5889

HKVAMNSJSFKALM-GKUWKFKPSA-N

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

ZINC169677008

Zortress

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

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
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012

International Patents for everolimus

Country	Patent Number	Estimated Expiration
European Patent Office	1413581
Argentina	036643
Czech Republic	302210
New Zealand	622710
Japan	3805625

Supplementary Protection Certificates for everolimus

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2269604	2016C/075	Belgium		DETAILS LICENCE: LICENCE, ENREGISTREMENT D'UNE NOUVELLE LICENCE
2269604	CA 2016 00060	Denmark		PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-006 20090805
0663916	14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN); NAT. REGISTRATION NO/DATE: 1-25271;1-25272; 1-25275,1-25276. 20040302; FIRST REGISTRATION: SE 18690;18691;18692; 18693;18694;18695. 20030718
2269603	92880	Luxembourg		PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (AFINITOR); AUTHORISATION NUMBER AND DATE: EU/1/09/538/001,003,004 ET 006-010 - AFINITOR
3351246	301018	Netherlands		PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/538/001-008 (C(2012)5347) 20120725