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AFINITOR Drug Profile

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When do Afinitor patents expire, and what generic alternatives are available?

Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are eight patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in AFINITOR 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

US Patents:	7
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	23
Clinical Trials:	149
Patent Applications:	6,764
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AFINITOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AFINITOR
DailyMed Link:	AFINITOR at DailyMed

Pharmacology for AFINITOR

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

Antineoplastic Agents

Immunosuppressive Agents

Synonyms for AFINITOR

(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 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

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

US Patents and Regulatory Information for AFINITOR

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	203985-003	Aug 29, 2012		RX	Yes	Yes					Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012		RX	Yes	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012		RX	Yes	No					Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009		RX	Yes	Yes					Y

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Expired US Patents for AFINITOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009

Paragraph IV (Patent) Challenges for AFINITOR

Drugname	Dosage	Strength	RLD	Date
	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg
	Tablets	2.5 mg, 5 mg, and 7.5 mg
	Tablets	10 mg

Non-Orange Book US Patents for AFINITOR

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
7,572,804	Macrolides
6,852,729	Macrolides
8,877,771	Treatment of solid tumors with rapamycin derivatives

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International Patents for AFINITOR

Country	Document Number	Estimated Expiration
United Kingdom	0104072
Czech Republic	20032209
Norway	2015010
Norway	332698

Supplementary Protection Certificates for AFINITOR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015041	Lithuania		PRODUCT NAME: EVEROLIMUSUM; REGISTRATION NO/DATE: EU/1/09/538/001, EU/1/09/538/003, EU/1/09/538/004, EU/1/09/538/006-010 20120723
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
00154	Netherlands		PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
/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