AFINITOR Drug Patent Profile

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 five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-nine patent family members in thirty-one countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Afinitor

A generic version of AFINITOR was approved as everolimus by HIKMA on April 12^th, 2018.

Summary for AFINITOR

International Patents:	229
US Patents:	4
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	175
Patent Applications:	4,445
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AFINITOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AFINITOR
What excipients (inactive ingredients) are in AFINITOR?	AFINITOR excipients list
DailyMed Link:	AFINITOR at DailyMed

See drug prices for AFINITOR

Recent Clinical Trials for AFINITOR

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

Sponsor	Phase
M.D. Anderson Cancer Center	Early Phase 1
The Lilabean Foundation for Pediatric Brain Cancer Research	Phase 1
Pediatric Brain Tumor Foundation	Phase 1

See all AFINITOR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for AFINITOR

L01EG	Mammalian target of rapamycin (mTOR) kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for AFINITOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AFINITOR	Tablets	everolimus	2.5 mg, 5 mg, and 7.5 mg	022334	1	2014-12-10
AFINITOR	Tablets	everolimus	10 mg	022334	1	2014-06-18

US Patents and Regulatory Information for AFINITOR

AFINITOR is protected by one US patents and one FDA Regulatory Exclusivity.

Patents protecting AFINITOR

FDA Regulatory Exclusivity protecting 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	AB	RX	Yes	Yes					Y
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012	AB	RX	Yes	Yes
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No					Y
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012	AB	RX	Yes	No					Y

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	022334-003	Jul 9, 2010
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012

International Patents for AFINITOR

See the table below for patents covering AFINITOR around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1198946
Japan	2014177469	CANCER TREATMENT
Poland	191933
United Kingdom	0523658
Lithuania	3342411

Supplementary Protection Certificates for AFINITOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3143995	122019000051	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/007 EU/1/09/538/008 EU/1/09/538/009 EU/1/09/538/010 20160526
3143995	PA2019511	Lithuania		PRODUCT NAME: EVEROLIMUZAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/09/538/001, 003, 004, 006-010 20160526
0663916	CA 2004 00020	Denmark		PRODUCT NAME: EVEROLIMUS
3351246	122019000102	Germany		PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
2269603	300769	Netherlands		PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/001, 003, 004 EN 006-010 (C(2012)5347) 20120725