APRISO Drug Patent Profile
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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.
Summary for APRISO
International Patents: | 16 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 181 |
Clinical Trials: | 3 |
Patent Applications: | 3,192 |
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 |
Recent Clinical Trials for APRISO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bausch Health Americas, Inc. | Phase 1 |
Valeant Pharmaceuticals International, Inc. | Phase 1 |
University of Michigan | N/A |
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
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 |
>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 |
---|---|---|---|
Eurasian Patent Organization | 201100565 | КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ КИШЕЧНИКА С ИСПОЛЬЗОВАНИЕМ ГРАНУЛИРОВАННОГО МЕЗАЛАМИНА | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2010040113 | ⤷ Try a Trial | |
South Africa | 201102442 | COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |