Viewing data from:

UROCIT-K

NDA

POTASSIUM CITRATE | N019071 | MISSION PHARMACAL CO

3 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute Myocardial Infarction NCT07467213	Phase 3	Recruiting	Samsung Medical Center	5,000	2026-06-23 → 2030-12-31

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

Medicare Part D Spending

CMS annual spending data for Urocit-K (2023)

Total Spending

$113K

Total Claims

304

Beneficiaries

Avg Cost/Unit

$2.43

Spending Trend

$288K(2019)→$256K(2020)→$196K(2021)→$146K(2022)→$113K(2023)

YoY Change:-0.4%

5yr CAGR:-2.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVPOTASSIUM CITRATE USP

DMF 310682016

GLOBAL CALCIUM PRIVATE LTDPOTASSIUM CITRATE USP

DMF 368752022

ARCHER DANIELS MIDLAND COInactivePOTASSIUM CITRATE MONOHYDRATE

DMF 103011993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 14, 2021	SUPPL -13	View Letter (PDF)
Jan 8, 2010	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MEQ

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 30, 1985

No patent or exclusivity listings for this strength.

#002 — 10MEQ

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 31, 1992

#003 — 15MEQ

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 30, 2009