Actonel Drug Patent Profile

When do Actonel patents expire, and when can generic versions of Actonel launch?

Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for Actonel

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	35
Patent Applications:	2,226
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for Actonel
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Actonel
What excipients (inactive ingredients) are in Actonel?	Actonel excipients list
DailyMed Link:	Actonel at DailyMed

See drug prices for Actonel

See drug sales revenues for Actonel

Recent Clinical Trials for Actonel

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

Sponsor	Phase
Dong-A ST Co., Ltd.	Phase 4
Wake Forest University Health Sciences	Phase 3
Weill Medical College of Cornell University	Phase 4

See all Actonel clinical trials

Pharmacology for Actonel

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for ACTONEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACTONEL	Tablets	risedronate sodium	150 mg	020835	1	2008-08-12
ACTONEL	Tablets	risedronate sodium	75 mg	020835	1	2007-09-07
ACTONEL	Tablets	risedronate sodium	5 mg, 30 mg and 35 mg	020835	1	2004-04-23

US Patents and Regulatory Information for Actonel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000		DISCN	Yes	No
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007		DISCN	Yes	No
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998		DISCN	Yes	No

Expired US Patents for Actonel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007

International Patents for Actonel

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1506041	L'ACIDE IBANDRONIQUE POUR LE TRAITEMENT ET LA PREVENTION DE L'OSTEOPOROSE (IBANDRONIC ACID FOR THE TREATMENT AND PREVENTION OF OSTEOPOROSIS)
Netherlands	300223
European Patent Office	0186405	PHARMACEUTICAL COMPOSITIONS CONTAINING GEMINAL DIPHOSPHONATES

Supplementary Protection Certificates for Actonel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1175904	C01175904/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
0998292	PA2006002	Lithuania		PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
1175904	C300292	Netherlands		PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824