Viewing data from:

CLENPIQ

NDA

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE | N209589 | FERRING PHARMACEUTICALS INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2026

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Today

Jun. 26, 2034

Jun. 23, 2034

Jun. 23, 2034

Jan. 27, 2038

Jun. 23, 2034

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Ferring Pharmaceuticals Inc. et al v. Alkem Laboratories Ltd. 1:2025cv00810 3 patentsANDA 220428sodium picosulfate, magnesium oxide, and anhydrous citric acid	D. Del.	2025-07-02	Terminated 2025-12-01	—
Ferring Pharmaceuticals Inc. et al v. Lupin Inc. 1:2019cv00913 2 patentsANDA 213029sodium picosulfate, magnesium oxide, and anhydrous citric acid	D. Del.	2019-05-16	Terminated 2021-07-12	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.5183

per ml

Lowest NADAC/Unit

$0.5183

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
55566680001CLENPIQ 175 ML SOLUTION	$0.5183	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$101.60

Highest Price

$101.60

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
55566-6800-01CLENPIQ 350ML	$101.60	FSS	Ferring Pharmaceuticals, Inc.	12/31/2026
55566-6800-01CLENPIQ 350ML	$101.60	Big4	Ferring Pharmaceuticals, Inc.	12/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Clenpiq (2024)

Total Spending

$26.3M

Total Claims

154,263

Beneficiaries

149,396

Avg Cost/Unit

$0.49

Spending Trend

$4.0M(2019)→$4.1M(2020)→$11.8M(2021)→$19.6M(2022)→$33.2M(2023)→$26.3M(2024)

YoY Change:-5.5%

5yr CAGR:+1.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Aug 30, 2023	SUPPL -15	View Letter (PDF)
Aug 31, 2022	SUPPL -14	View Letter (PDF)
Oct 30, 2019	SUPPL -6	View Letter (PDF)
Aug 12, 2019	SUPPL -5	View Letter (PDF)
Dec 1, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 12GM/BOT;3.5GM/BOT;10MG/BOT

RLD

5 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Nov 28, 2017

Patents (5) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9827231	Jun 26, 2034	—	—	Yes		—
10624879	Jun 23, 2034	—	—	Yes	—	—
11191753	Jun 23, 2034	—	—	—		—
12458634	Jan 27, 2038	—	—	Yes	—	—
12576072	Jun 23, 2034	—	—	Yes		—