APRISO Drug Patent Profile

Which patents cover Apriso, and what generic alternatives are available?

Apriso is a drug marketed by Valeant Pharms Intl and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in thirteen countries.

The generic ingredient in APRISO is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Apriso

A generic version of APRISO was approved as mesalamine by PADAGIS ISRAEL on September 17^th, 2004.

Summary for APRISO

International Patents:	16
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	3
Patent Applications:	4,129
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for APRISO
Drug Sales Revenues:	Drug sales revenues for APRISO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APRISO
What excipients (inactive ingredients) are in APRISO?	APRISO excipients list
DailyMed Link:	APRISO at DailyMed

See drug prices for APRISO

See drug sales revenues for APRISO

Recent Clinical Trials for APRISO

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

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 1
Bausch Health Americas, Inc.	Phase 1
University of Michigan	N/A

See all APRISO clinical trials

Pharmacology for APRISO

Drug Class

Aminosalicylate

Paragraph IV (Patent) Challenges for APRISO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APRISO	Extended-release Capsules	mesalamine	0.375 g	022301	1	2012-04-03

US Patents and Regulatory Information for APRISO

APRISO is protected by one US patents.

Patents protecting APRISO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms Intl	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	AB	RX	Yes	Yes

Expired US Patents for APRISO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008
Valeant Pharms Intl	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008
Valeant Pharms Intl	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008
Valeant Pharms Intl	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008
Valeant Pharms Intl	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008
Valeant Pharms Intl	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008

International Patents for APRISO

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0977557
China	102238868	Compositions and methods for the treatment of bowel diseases with granulated mesalamine
Japan	5740306
European Patent Office	2334178	COMPOSITIONS ET PROCÉDÉS PERMETTANT DE TRAITER LES MALADIES INTESTINALES À L AIDE DE MÉSALAMINE GRANULÉE (COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE)
Canada	2739465	COMPOSITIONS ET PROCEDES PERMETTANT DE TRAITER LES MALADIES INTESTINALES A L'AIDE DE MESALAMINE GRANULEE (COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE)
Portugal	977557