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-seven 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for APRISO?
- What are the global sales for APRISO?
- What is Average Wholesale Price for APRISO?
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: | 3,492 |
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 |
![APRISO drug patent expirations Drug patent expirations by year for APRISO](/p/graph/s/t/APRISO-patent-expirations.png)
![Drug Prices for APRISO](/p/graph/drug-price/APRISO.png)
![Drug Sales Revenue Trends for APRISO](/p/graph/drug-sales-revenues/APRISO.png)
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2010040021 | ⤷ Sign Up | |
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) | ⤷ Sign Up |
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) | ⤷ Sign Up |
Eurasian Patent Organization | 022886 | СПОСОБ ПОДДЕРЖАНИЯ РЕМИССИИ ЯЗВЕННОГО КОЛИТА У ПАЦИЕНТОВ (METHOD OF MAINTAINING REMISSION OF ULCERATIVE COLITIS IN PATIENTS) | ⤷ Sign Up |
Germany | 59808642 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |