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Last Updated: December 23, 2024

QUESTRAN Drug Patent Profile


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When do Questran patents expire, and when can generic versions of Questran launch?

Questran is a drug marketed by Bristol Myers and Apothecon and is included in three NDAs.

The generic ingredient in QUESTRAN is cholestyramine. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Questran

A generic version of QUESTRAN was approved as cholestyramine by EPIC PHARMA LLC on August 15th, 1996.

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Summary for QUESTRAN
US Patents:0
Applicants:2
NDAs:3
Clinical Trials: 9
DailyMed Link:QUESTRAN at DailyMed
Drug patent expirations by year for QUESTRAN
Recent Clinical Trials for QUESTRAN

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

SponsorPhase
Centre Hospitalier Universitaire de NiceN/A
National Cancer Institute (NCI)Phase 1
City of Hope Medical CenterPhase 1

See all QUESTRAN clinical trials

US Patents and Regulatory Information for QUESTRAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers QUESTRAN cholestyramine POWDER;ORAL 016640-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon QUESTRAN cholestyramine TABLET;ORAL 073403-002 Dec 27, 1999 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers QUESTRAN cholestyramine POWDER;ORAL 016640-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon QUESTRAN cholestyramine TABLET;ORAL 073403-001 Apr 28, 1994 DISCN No No ⤷  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

QUESTRAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: QUESTRAN

Introduction to QUESTRAN

QUESTRAN, also known as cholestyramine, is a bile acid sequestrant used primarily for the treatment of hypercholesterolemia and pruritus associated with liver diseases. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The cholestyramine market, which includes QUESTRAN, has been experiencing steady growth. As of 2023, the market size was estimated at USD 186.60 million and is expected to reach USD 196.08 million in 2024, growing at a Compound Annual Growth Rate (CAGR) of 5.42% to reach USD 270.03 million by 2030[3].

Growth Drivers

Several factors are driving the growth of the cholestyramine market:

  • Increasing Awareness and Diagnosis: Growing awareness and diagnosis of hypercholesterolemia, particularly in developing regions, are boosting demand for cholestyramine[3].
  • Healthcare Expenditure: Increased healthcare expenditure and government initiatives aimed at reducing cardiovascular risks are also contributing to market growth[3].
  • Prevalence of Cardiovascular Diseases: The rising prevalence of cardiovascular diseases among adults and the aging population further fuels the demand for bile acid sequestrants like cholestyramine[3].

Market Restraints

Despite the growth, there are several challenges that the market faces:

  • Patient Habits and Preferences: Slowly evolving patient habits and preferences can hinder the uptake of cholestyramine. Patients may prefer other treatments or have difficulty adhering to the regimen[3].
  • Regulatory Challenges: Regulatory compliance issues and the slow pace of approvals can slow down market expansion[3].
  • Limited Awareness: Limited awareness among healthcare professionals about the benefits of cholestyramine can also act as a restraint[3].

Market Opportunities

There are several opportunities that can be leveraged to further grow the market:

  • Digital Marketing: Digital marketing campaigns can enhance patient awareness of the benefits of cholestyramine[3].
  • Alternative Therapy: Cholestyramine can be positioned as an alternative therapy for statin-intolerant populations, offering a new market segment[3].
  • Nutraceuticals Market: There is potential for cholestyramine to be used in the nutraceuticals market as a fiber supplement alternative[3].

Competitive Landscape

The market for bile acid sequestrants, including QUESTRAN, is competitive. Key players are focusing on innovative formulations and strategic partnerships to maintain their market position.

  • CHEPLAPHARM: For instance, CHEPLAPHARM acquired the worldwide rights for QUESTRAN from Bristol-Myers Squibb, strengthening its portfolio and global presence[5].
  • Par Pharmaceutical: Par Pharmaceutical Companies, Inc. received final approval from the FDA to market generic versions of QUESTRAN, which helped in expanding the market reach[1].

Distribution and Accessibility

Hospital pharmacies are expected to hold a significant share of the bile acid sequestrants market, including QUESTRAN, due to their role in providing specific care and therapy, especially for patients with heart conditions. This segment is predicted to hold around 38% of the market share by 2036[4].

Regional Analysis

The market for bile acid sequestrants varies by region:

  • North America: This region is expected to hold the highest position due to the high usage of cholestyramine in treating pruritus in liver cirrhosis patients. For example, multiple case series and randomized controlled trials have shown that cholestyramine is effective in reducing pruritus symptoms[4].
  • Europe: The European market is also expected to grow substantially, driven by the increasing prevalence of type 2 diabetes and cardiovascular disorders in the region[4].

Financial Performance

The financial performance of companies involved in the cholestyramine market is significant:

  • Revenue: The market size and revenue projections indicate a steady increase. For example, the cholestyramine market is expected to grow from USD 186.60 million in 2023 to USD 270.03 million by 2030[3].
  • Acquisitions and Partnerships: Companies like CHEPLAPHARM have made significant acquisitions and partnerships to strengthen their position in the market. For instance, CHEPLAPHARM's acquisition of QUESTRAN rights from Bristol-Myers Squibb was a strategic move to expand its portfolio[5].

Challenges in Supply Chain and Distribution

Despite the growth opportunities, the market faces challenges in achieving sustainable supply chain operations and ensuring the accessibility of cholestyramine products. Global disruptions and regulatory hurdles can impact the distribution and availability of these products[3].

Innovative Formulations and Digital Health

To overcome some of the market challenges, there is a focus on developing innovative formulations that enhance patient compliance, such as powdered or liquid forms for easier ingestion. Additionally, leveraging digital health tools for patient adherence and personalized medication can unlock further market potential[3].

Key Takeaways

  • The cholestyramine market, including QUESTRAN, is growing steadily driven by increasing awareness of hypercholesterolemia and government healthcare initiatives.
  • The market faces challenges such as patient adherence issues, regulatory compliance, and limited awareness among healthcare professionals.
  • Opportunities lie in digital marketing, alternative therapies, and the nutraceuticals market.
  • Hospital pharmacies play a crucial role in the distribution of these drugs.
  • Regional markets, especially North America and Europe, are significant due to high usage and prevalence of related health conditions.

FAQs

What is QUESTRAN used for?

QUESTRAN, or cholestyramine, is primarily used for the treatment of primary hypercholesterolemia and pruritus associated with liver diseases.

Who are the key players in the cholestyramine market?

Key players include Par Pharmaceutical Companies, Inc. and CHEPLAPHARM, which have made significant contributions through acquisitions and product development.

What are the growth drivers for the cholestyramine market?

Growth drivers include increasing awareness and diagnosis of hypercholesterolemia, increased healthcare expenditure, and the growing prevalence of cardiovascular diseases.

What challenges does the cholestyramine market face?

The market faces challenges such as slowly evolving patient habits, regulatory compliance issues, and limited awareness among healthcare professionals.

How is the market expected to grow in the future?

The cholestyramine market is expected to grow at a CAGR of 5.42% to reach USD 270.03 million by 2030, driven by innovative formulations, digital health tools, and expanding therapeutic applications.

Cited Sources:

  1. Par Pharmaceutical Companies, Inc. Receives Final Approval To Market Generic Questran(R) Powder And Questran(R) Light Powder For Oral Suspension. Biospace, 2005.
  2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee. Oregon Health Authority, 2020.
  3. Cholestyramine Market Size & Share 2025-2030. 360 Research Reports, December 2024.
  4. Bile Acid Sequestrants Market Size & Share | Growth Report 2036. Research Nester, December 2023.
  5. CHEPLAPHARM Arzneimittel GmbH Company History. CHEPLAPHARM, January 2023.

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