You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

UROCIT-K Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Urocit-k patents expire, and when can generic versions of Urocit-k launch?

Urocit-k is a drug marketed by Mission Pharma and is included in one NDA.

The generic ingredient in UROCIT-K is potassium citrate. There are two hundred and forty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the potassium citrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Urocit-k

A generic version of UROCIT-K was approved as potassium citrate by RISING on June 9th, 2006.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for UROCIT-K?
  • What are the global sales for UROCIT-K?
  • What is Average Wholesale Price for UROCIT-K?
Summary for UROCIT-K
Drug patent expirations by year for UROCIT-K
Drug Prices for UROCIT-K

See drug prices for UROCIT-K

Recent Clinical Trials for UROCIT-K

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Texas Southwestern Medical CenterEarly Phase 1

See all UROCIT-K clinical trials

Pharmacology for UROCIT-K

US Patents and Regulatory Information for UROCIT-K

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mission Pharma UROCIT-K potassium citrate TABLET, EXTENDED RELEASE;ORAL 019071-001 Aug 30, 1985 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mission Pharma UROCIT-K potassium citrate TABLET, EXTENDED RELEASE;ORAL 019071-002 Aug 31, 1992 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mission Pharma UROCIT-K potassium citrate TABLET, EXTENDED RELEASE;ORAL 019071-003 Dec 30, 2009 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

UROCIT-K Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Urocit-K

Introduction

Urocit-K, a potassium citrate extended-release tablet, is a crucial medication in the treatment of kidney stone conditions, particularly renal tubular acidosis. Understanding its market dynamics and financial trajectory is essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Clinical Significance and Mechanism of Action

Urocit-K works by increasing urinary citrate and pH, making the urine less conducive to the crystallization of stone-forming salts like calcium oxalate, calcium phosphate, and uric acid. The medication modifies the renal handling of citrate, raising urinary citrate levels without significantly altering serum citrate levels[1][4][5].

Market Size and Growth

The global potassium citrate market, which includes Urocit-K, is projected to grow steadily. As of 2023, the market value is estimated at USD 705.23 million, with a forecasted growth to USD 947.77 million by 2033, representing a Compound Annual Growth Rate (CAGR) of 3%[3].

Geographic Distribution

The demand for potassium citrate is highest in the Asia-Pacific region, with China being a major producer and exporter. The United States is a significant market for exported potassium citrate supplements from China[3].

Driving Factors

Several factors drive the growth of the potassium citrate market:

  • Growing Awareness of Health Benefits: Increasing awareness about the benefits of low sodium levels in food and beverages contributes to the demand for potassium citrate.
  • Processed Food Industry Growth: The expansion of the processed food industry, which often uses potassium citrate as a preservative and flavor enhancer, also drives market growth.
  • End-Use Industries: The growth of end-use industries such as food, beverages, and pharmaceuticals further propels the market[3].

Competitive Landscape

The global potassium citrate market includes several major players. While specific financial data for Urocit-K is not readily available, the overall market competition is intense, with multiple manufacturers vying for market share.

Financial Performance of Pharmaceutical Sector

The financial performance of pharmaceutical companies can be influenced by various factors, including regulatory changes, market demand, and economic conditions. For instance, the COVID-19 pandemic had a significant impact on the pharmaceutical sector, with many companies experiencing fluctuations in revenue and operating expenses due to changes in market conditions and regulatory policies[2].

Revenue and Sales Projections

While specific revenue and sales projections for Urocit-K are not available, the overall market growth indicates a positive financial trajectory. The steady increase in market value from USD 705.23 million in 2023 to USD 947.77 million by 2033 suggests that Urocit-K, as part of the potassium citrate market, will continue to generate significant revenue.

Dosage and Pricing

The effectiveness and pricing of Urocit-K are closely tied to its dosage. A typical dosage of 60 mEq/day raises urinary citrate by approximately 400 mg/day and increases urinary pH by about 0.7 units. The pricing strategy for Urocit-K would need to balance the therapeutic benefits with market competition and patient affordability[1][4][5].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of pharmaceutical products. Urocit-K, like other medications, must comply with stringent regulatory requirements. Any changes in regulatory policies or approval processes can significantly impact the market dynamics and financial performance of the drug.

Clinical Studies and Effectiveness

Clinical studies on Urocit-K, although non-randomized and non-placebo controlled, have shown its effectiveness in raising urinary citrate levels and preventing kidney stone formation. The results of these studies contribute to the drug's market acceptance and financial viability[1].

Patient Compliance and Market Demand

Patient compliance with Urocit-K treatment is critical for its market success. The medication's ability to maintain a higher, more constant level of urinary citrate throughout the day enhances patient compliance and drives market demand.

Key Takeaways

  • Market Growth: The potassium citrate market, including Urocit-K, is expected to grow at a CAGR of 3% from 2023 to 2033.
  • Geographic Focus: Asia-Pacific, particularly China, is a key region for production and export.
  • Driving Factors: Growing awareness of health benefits, processed food industry growth, and end-use industries drive the market.
  • Financial Trajectory: The market's steady growth indicates a positive financial outlook for Urocit-K.
  • Regulatory Compliance: Adherence to regulatory requirements is essential for the drug's market success.

FAQs

Q: What is the primary use of Urocit-K? A: Urocit-K is primarily used to treat kidney stone conditions, particularly renal tubular acidosis, by increasing urinary citrate and pH.

Q: How does Urocit-K work? A: Urocit-K works by modifying the renal handling of citrate, raising urinary citrate levels and increasing urinary pH, which makes the urine less conducive to stone formation.

Q: What is the projected market value of the potassium citrate market by 2033? A: The global potassium citrate market is projected to reach USD 947.77 million by 2033.

Q: Which region has the highest demand for potassium citrate? A: The Asia-Pacific region, particularly China, has the highest demand for potassium citrate.

Q: What factors drive the growth of the potassium citrate market? A: Growing awareness of health benefits, processed food industry growth, and the expansion of end-use industries drive the market growth.

Cited Sources

  1. RxList - Urocit-K (Potassium Citrate Extended-Release Tablets)
  2. HSBC Continental Europe - 2020 Annual Report
  3. Future Market Insights - Potassium Citrate Market Size, Share & Trends – 2033
  4. Drugs.com - Urocit-K: Package Insert / Prescribing Information
  5. FDA - UROCIT-K Label[1][2][3][4][5]

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.