You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

APRISO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Apriso is a drug marketed by Salix 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-six 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 17th, 2004.

  Try a Trial

Drug patent expirations by year for APRISO
Drug Prices for APRISO

See drug prices for APRISO

Drug Sales Revenue Trends for APRISO

See drug sales revenues for APRISO

Recent Clinical Trials for APRISO

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

SponsorPhase
Valeant Pharmaceuticals International, Inc.Phase 1
Bausch Health Americas, Inc.Phase 1
Food and Drug Administration (FDA)N/A

See all APRISO clinical trials

Pharmacology for APRISO
Drug ClassAminosalicylate
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

Compositions and methods for treatment of bowel diseases with granulated mesalamine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS

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

Expired US Patents for APRISO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for APRISO

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

Country Patent Number Title Estimated Expiration
Japan 4088413 ⤷  Try a Trial
Israel 212057 שימוש בתכשירים המכילים מזלאמין מגורען לשימור ההפוגה בקוליטיס כיבית (Use of compositions comprising granulated mesalamine for maintaining the remission of ulcerative colitis) ⤷  Try a Trial
Australia 2009298139 Compositions and methods for the treatment of bowel diseases with granulated mesalamine ⤷  Try a Trial
Spain 2196556 ⤷  Try a Trial
Eurasian Patent Organization 201100565 КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ КИШЕЧНИКА С ИСПОЛЬЗОВАНИЕМ ГРАНУЛИРОВАННОГО МЕЗАЛАМИНА ⤷  Try a Trial
Austria 241964 ⤷  Try a Trial
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) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.