CLENPIQ Drug Patent Profile
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Which patents cover Clenpiq, and when can generic versions of Clenpiq launch?
Clenpiq is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has thirteen patent family members in ten countries.
The generic ingredient in CLENPIQ is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.
DrugPatentWatch® Generic Entry Outlook for Clenpiq
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for CLENPIQ
International Patents: | 13 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 2 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for CLENPIQ |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLENPIQ |
What excipients (inactive ingredients) are in CLENPIQ? | CLENPIQ excipients list |
DailyMed Link: | CLENPIQ at DailyMed |
Recent Clinical Trials for CLENPIQ
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ferring Pharmaceuticals | Phase 1/Phase 2 |
Ferring Pharmaceuticals | Phase 4 |
The Cleveland Clinic | Phase 4 |
Pharmacology for CLENPIQ
Anatomical Therapeutic Chemical (ATC) Classes for CLENPIQ
Paragraph IV (Patent) Challenges for CLENPIQ
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CLENPIQ | Oral Solution | citric acid; magnesium oxide; sodium picosulfate | 10 mg, 3.5 g, and 12 g | 209589 | 1 | 2019-02-11 |
US Patents and Regulatory Information for CLENPIQ
CLENPIQ is protected by three US patents.
Patents protecting CLENPIQ
Liquid pharmaceutical composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liquid pharmaceutical composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY
Liquid pharmaceutical composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CLEANSING THE LARGE INTESTINE AS A PREPARATION FOR COLONOSCOPY
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ferring Pharms Inc | CLENPIQ | citric acid; magnesium oxide; sodium picosulfate | SOLUTION;ORAL | 209589-001 | Nov 28, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ferring Pharms Inc | CLENPIQ | citric acid; magnesium oxide; sodium picosulfate | SOLUTION;ORAL | 209589-001 | Nov 28, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ferring Pharms Inc | CLENPIQ | citric acid; magnesium oxide; sodium picosulfate | SOLUTION;ORAL | 209589-001 | Nov 28, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for CLENPIQ
When does loss-of-exclusivity occur for CLENPIQ?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 14386903
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 42878
Estimated Expiration: ⤷ Try a Trial
China
Patent: 6456534
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 20835
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 47891
Estimated Expiration: ⤷ Try a Trial
Patent: 17508815
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 6499
Estimated Expiration: ⤷ Try a Trial
Patent: 16011938
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 68882
Estimated Expiration: ⤷ Try a Trial
Patent: 16138577
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1420315
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 07324
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering CLENPIQ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2907324 | ⤷ Try a Trial | |
Canada | 2942878 | COMPOSITION PHARMACEUTIQUE LIQUIDE (LIQUID PHARMACEUTICAL COMPOSITION) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2015141897 | ⤷ Try a Trial | |
Australia | 2014386903 | Liquid pharmaceutical composition | ⤷ Try a Trial |
Russian Federation | 2016138577 | Жидкая фармцевтическая композиция | ⤷ Try a Trial |
South Korea | 101420315 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |