PREPOPIK Drug Patent Profile
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Which patents cover Prepopik, and when can generic versions of Prepopik launch?
Prepopik is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-two patent family members in twenty-five countries.
The generic ingredient in PREPOPIK 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 Prepopik
There have been seven 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 PREPOPIK
International Patents: | 32 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 5 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PREPOPIK |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PREPOPIK |
DailyMed Link: | PREPOPIK at DailyMed |
Recent Clinical Trials for PREPOPIK
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Cleveland Clinic | Phase 4 |
Ferring Pharmaceuticals | Phase 4 |
Ferring Pharmaceuticals | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for PREPOPIK
Paragraph IV (Patent) Challenges for PREPOPIK
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PREPOPIK | Oral Solution | citric acid; magnesium oxide; sodium picosulfate | 10 mg, 3.5 g, and 12 g | 202535 | 1 | 2014-05-21 |
US Patents and Regulatory Information for PREPOPIK
PREPOPIK is protected by two US patents.
Patents protecting PREPOPIK
Granular compositions of sodium picosulphate and potassium bicarbonate and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Granular compositions of magnesium oxide and citric acid and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ferring Pharms Inc | PREPOPIK | citric acid; magnesium oxide; sodium picosulfate | FOR SOLUTION;ORAL | 202535-001 | Jul 16, 2012 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ferring Pharms Inc | PREPOPIK | citric acid; magnesium oxide; sodium picosulfate | FOR SOLUTION;ORAL | 202535-001 | Jul 16, 2012 | DISCN | Yes | No | ⤷ 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 PREPOPIK
When does loss-of-exclusivity occur for PREPOPIK?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 08309287
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0818541
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 02152
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1406457
Estimated Expiration: ⤷ Try a Trial
Patent: 1820859
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0180215
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 07526
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 07526
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 38174
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4500
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 54873
Estimated Expiration: ⤷ Try a Trial
Patent: 11500549
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 06
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 07526
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 10003588
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 3899
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 07526
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 07526
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 73332
Estimated Expiration: ⤷ Try a Trial
Patent: 10112483
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 290670
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 07526
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1002131
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1330096
Estimated Expiration: ⤷ Try a Trial
Patent: 1381263
Estimated Expiration: ⤷ Try a Trial
Patent: 100072020
Estimated Expiration: ⤷ Try a Trial
Patent: 130105757
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 59716
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 18352
Estimated Expiration: ⤷ Try a Trial
Patent: 0924759
Estimated Expiration: ⤷ Try a Trial
United Kingdom
Patent: 05953
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 PREPOPIK around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200924759 | Process for the manufacture of a pharmaceutical product | ⤷ Try a Trial |
Denmark | 2207526 | ⤷ Try a Trial | |
Brazil | PI0818541 | Processo para a produção de um produto farmacêutico | ⤷ Try a Trial |
Lithuania | 2207526 | ⤷ Try a Trial | |
Japan | 2011500549 | ⤷ Try a Trial | |
Slovenia | 2207526 | ⤷ Try a Trial | |
Jordan | 3406 | عملية لتصنيع منتج صيدلاني يشتمل على حمض الستريك ،أكسيد ماغنسيوم، بيكربونات بوتاسيوم وبيكو كبريتات صوديوم، تركيبة صيدلانية تشتمل على حبيبات متحصل عليها بواسطة هذه العملية ومنتجات وسيطة منها (PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE PRODUCTS THEREOF) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |