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PREPOPIK

NDA

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE | N202535 | FERRING PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

Today

8450338

Oct. 10, 2028

8481083

Oct. 10, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Ferring Pharmaceuticals Inc. et al v. Hetero USA Inc. et al 1:2019cv00634	D. Del.	2019-04-04	Terminated 2019-07-11	—
Ferring Pharmaceuticals Inc. et al v. Novel Laboratories, Inc. et al 1:2017cv00894	D. Del.	2017-07-05	Terminated 2019-02-01	—
Ferring Pharmaceuticals Inc. et al v. Teva Pharmaceuticals USA, Inc. 1:2017cv00435	D. Del.	2017-04-19	Terminated 2018-01-16	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Ferring Pharmaceuticals, Inc. (Buchanan Ingersoll & Rooney PC) - Citizen Peti... FDA-2013-P-0119 · 8 docket documents Ferring Pharmaceuticals, Inc., through counsel, filed this citizen petition under Federal Food, Drug and Cosmetic Act section 505 and related regulations, requesting that the FDA amend the exclusivity period for Prepopik (citric acid; magnesium oxide; sodium picosulfate) oral solution, approved unde	505(q) Stay Request	2013-02-06	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

7 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy NCT02386449	Phase 4	Completed	Ferring Pharmaceuticals	184	2015-02 → 2015-12
A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy NCT03017235	Phase 3	Completed	Ferring Pharmaceuticals	917	2017-02-20 → 2017-10-12
A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy NCT01984008	Phase 3	Completed	Universal Integrated Corp.	631	2013-10-23 → 2014-06-17
Comparison of Clenpiq vs Golytely Bowel Preparation NCT03198221	Phase 4	Terminated	The Cleveland Clinic	14	2018-07-11 → 2019-03-26
Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation NCT04033250	N/A	UNKNOWN	Rambam Health Care Campus	600	2019-09 → 2020-12
Bowel Preparation in Elective Pediatric Colorectal Surgery NCT03593252	N/A	UNKNOWN	McMaster University	81	2022-01-01 → 2024-01-30
Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.NCT04161599	Phase 4	UNKNOWN	Hospital Universitari Vall d'Hebron Research Institute	968	2022-03-01 → 2024-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Aug 30, 2023	SUPPL -6	View Letter (PDF)
Aug 20, 2018	SUPPL -5	View Letter (PDF)
Jul 17, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Jul 16, 2012

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8450338	Oct 10, 2028	—	—	Yes	—	—
8481083	Oct 10, 2028	—	—	Yes	—	—