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AFINITOR DISPERZ Drug Profile

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Which patents cover Afinitor Disperz, and when can generic versions of Afinitor Disperz launch?

Afinitor Disperz is a drug marketed by Novartis Pharm and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and twenty-one patent family members in forty-five countries.

The generic ingredient in AFINITOR DISPERZ is everolimus. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the everolimus profile page.

Summary for AFINITOR DISPERZ

International Patents:	321
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	29
Patent Applications:	6,548
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AFINITOR DISPERZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AFINITOR DISPERZ
DailyMed Link:	AFINITOR DISPERZ at DailyMed

Pharmacology for AFINITOR DISPERZ

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 AFINITOR DISPERZ

Antineoplastic Agents

Immunosuppressive Agents

Synonyms for AFINITOR DISPERZ

1245613-55-1

159351-69-6

351E696

40-O-(2-hydroxyethyl)-rapamycin

42-O-(2-Hydroxyethyl)rapamycin

9HW64Q8G6G

Afinitor

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

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

US Patents and Regulatory Information for AFINITOR DISPERZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012		RX	Yes	No					Y
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012		RX	Yes	Yes
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012		RX	Yes	No					Y
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012		RX	Yes	No					Y

Expired US Patents for AFINITOR DISPERZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012
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

Paragraph IV (Patent) Challenges for AFINITOR DISPERZ

Drugname	Dosage	Strength	RLD	Date
	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg

International Patents for AFINITOR DISPERZ

Country	Patent Number	Estimated Expiration
Finland	109540
Poland	348333
South Korea	100695846
Canada	2145383

Supplementary Protection Certificates for AFINITOR DISPERZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC001/2010	Ireland		SPC001/2010: 20101001, EXPIRES: 20180717
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
0663916	SPC/GB10/003	United Kingdom		PRODUCT NAME: EVEROLIMUS; REGISTERED: SE SE 18690-18695 20030718; UK EU/1/09/538/001 20090803; UK EU/1/09/538/002 20090803; UK EU/1/09/538/003 20090803; UK EU/1/09/538/004 20090803; UK EU/1/09/538/005 20090803; UK EU/1/09/538/006 20090803