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Last Updated: April 9, 2025

PROBENECID W/ COLCHICINE Drug Patent Profile


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Which patents cover Probenecid W/ Colchicine, and when can generic versions of Probenecid W/ Colchicine launch?

Probenecid W/ Colchicine is a drug marketed by Lederle and Watson Labs and is included in two NDAs.

The generic ingredient in PROBENECID W/ COLCHICINE is colchicine; probenecid. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the colchicine; probenecid profile page.

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Summary for PROBENECID W/ COLCHICINE
US Patents:0
Applicants:2
NDAs:2
Clinical Trials:2
DailyMed Link:PROBENECID W/ COLCHICINE at DailyMed
Drug patent expirations by year for PROBENECID W/ COLCHICINE
Recent Clinical Trials for PROBENECID W/ COLCHICINE

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

SponsorPhase
Chinese University of Hong KongPhase 2
Mutual Pharmaceutical Company, Inc.Phase 1

See all PROBENECID W/ COLCHICINE clinical trials

US Patents and Regulatory Information for PROBENECID W/ COLCHICINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Watson Labs PROBENECID W/ COLCHICINE colchicine; probenecid TABLET;ORAL 083221-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lederle PROBENECID W/ COLCHICINE colchicine; probenecid TABLET;ORAL 086954-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Probenecid with Colchicine

Introduction

Probenecid and colchicine, a combination drug, has been a cornerstone in the treatment of gout and other related conditions. This article delves into the market dynamics and financial trajectory of this drug, highlighting key trends, challenges, and future outlook.

Historical Context and FDA Approval

Colchicine, a key component of the probenecid and colchicine combination, was first approved by the FDA in 1961 as part of the combination drug ColBenemid, which included probenecid for the chronic treatment of gout[5].

Mechanism of Action and Clinical Use

Probenecid acts as a uricosuric agent, inhibiting the tubular reabsorption of urate and increasing its urinary excretion, thereby reducing serum urate levels. Colchicine, with its antigout activity, is used to prevent gout attacks rather than cure the disease. The combination is effective in managing gout symptoms and is also considered for its potential cardiovascular benefits[2][3].

Market Size and Growth

The global colchicine market, which includes the probenecid and colchicine combination, is projected to grow significantly. By 2030, the market is expected to reach USD 1,558.9 million, expanding at a CAGR of 6.56% from 2024 to 2030. This growth is driven by the increasing incidence of gout among the geriatric population and the drug's established efficacy in mitigating acute gout symptoms[3].

Price Trends and Spending

A significant factor influencing the market dynamics is the price trend of colchicine. Following the approval of Colcrys in 2009, the price of colchicine skyrocketed from $0.10 to $5 per pill. This price hike led to a substantial increase in public spending on colchicine. Medicaid spending on single-ingredient colchicine rose by 2833% between 2008 and 2017, with 58% of this increase attributed to price increases alone[1][4].

Impact of Generic and Authorized Generics

The introduction of generic and authorized generic versions of colchicine in 2015 marginally reduced prices but did not significantly lower the cost compared to the brand-name drug, Colcrys. Generic colchicine prices were around $5.13 per pill in 2017, still considerably higher than the pre-Colcrys prices[1][4].

Public Spending and Budget Implications

Public spending on colchicine has grown exponentially, with Medicare spending on colchicine increasing by 19% from $258 million to $308 million between 2012 and 2017. The substantial price hikes and increased uptake of colchicine have nearly doubled public-payer and beneficiary spending on gout drugs from $439 million to $872 million over the same period[4].

Challenges and Market Volatility

The colchicine market faces significant challenges due to price fluctuations. These fluctuations are driven by changes in manufacturing costs, regulatory developments, and market dynamics. This volatility poses financial strain on patients and healthcare organizations, making it essential to establish more stable pricing structures[3].

Competitive Landscape

The market for probenecid and colchicine is competitive, with several key players including Endo International plc, Camber Pharmaceuticals, Wockhardt, and Takeda Pharmaceuticals U.S.A., Inc. These companies play a crucial role in shaping the market through their pricing strategies and product offerings[3].

Geographical Distribution

The colchicine market is global, with significant presence in regions such as the U.S., Europe, APAC, and South America. The U.S. is the largest market for colchicine, driven by the high prevalence of gout and the drug's established therapeutic benefits[3].

Future Outlook and Research Directions

The future of the probenecid and colchicine market looks promising, with ongoing research exploring its broader therapeutic potential, particularly in addressing inflammation-related cardiovascular conditions. Clinical studies and trials are paving the way for its consideration in preventing cardiovascular events, signifying a paradigm shift in its application[3].

Key Takeaways

  • The global colchicine market is expected to grow at a CAGR of 6.56% from 2024 to 2030.
  • Price hikes following the approval of Colcrys significantly increased public spending on colchicine.
  • Generic and authorized generic versions have marginally reduced prices but not to pre-Colcrys levels.
  • The market faces challenges due to price volatility, impacting patient access and healthcare budgets.
  • Ongoing research is exploring colchicine's potential in cardiovascular diseases.

FAQs

What is the primary use of the probenecid and colchicine combination?

The primary use of the probenecid and colchicine combination is to treat gout by reducing serum urate levels and preventing gout attacks.

How has the price of colchicine changed over the years?

The price of colchicine increased significantly after the approval of Colcrys in 2009, rising from $0.10 to $5 per pill, and remained high even with the introduction of generic versions.

What are the key drivers of the colchicine market growth?

The key drivers include the increasing incidence of gout among the geriatric population and the drug's established efficacy in mitigating acute gout symptoms.

How does the probenecid component work in the combination drug?

Probenecid acts as a uricosuric agent, inhibiting the tubular reabsorption of urate and increasing its urinary excretion, thereby reducing serum urate levels.

What are the potential cardiovascular benefits of colchicine?

Colchicine is being explored for its potential in reducing inflammation associated with cardiovascular diseases, which could lead to its use in preventing cardiovascular events.

Cited Sources:

  1. JAMA Internal Medicine: "Prolonged Increases in Public-Payer Spending and Prices After Market Exclusivity for Colchicine in the US"[1]
  2. Drugs.com: "Probenecid Colchicine: Package Insert / Prescribing Info"[2]
  3. IndustryARC: "Colchicine Market - Forecast(2024 - 2030)"[3]
  4. ACR Abstracts: "From a Potential Solution to Part of the Problem - Analysis of Spending and Price Trends for Brand-Name and Generic Colchicine and Other Gout Medications"[4]
  5. FDA: "204820Orig1s000 - AdminCorres"[5]

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