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Last Updated: April 1, 2025

CHOLESTYRAMINE LIGHT Drug Patent Profile


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

Cholestyramine Light is a drug marketed by Alkem Labs Ltd, Endo Operations, Epic Pharma Llc, Macleods Pharms Ltd, Tagi, Teva, Teva Pharms, and Zydus Pharms. and is included in eight NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Cholestyramine Light

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

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Summary for CHOLESTYRAMINE LIGHT
Drug patent expirations by year for CHOLESTYRAMINE LIGHT
Recent Clinical Trials for CHOLESTYRAMINE LIGHT

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

SponsorPhase
Centre Hospitalier Universitaire de NiceN/A
Eli Lilly and CompanyPhase 1
Loxo Oncology, Inc.Phase 1

See all CHOLESTYRAMINE LIGHT clinical trials

Pharmacology for CHOLESTYRAMINE LIGHT
Drug ClassBile Acid Sequestrant
Mechanism of ActionBile-acid Binding Activity

US Patents and Regulatory Information for CHOLESTYRAMINE LIGHT

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Teva CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 074348-002 May 28, 1998 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva Pharms CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 074555-002 Sep 30, 1998 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Endo Operations CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 077203-002 Aug 26, 2005 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Macleods Pharms Ltd CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 209109-001 Oct 31, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Macleods Pharms Ltd CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 209109-002 Oct 31, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alkem Labs Ltd CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 211799-001 Oct 19, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alkem Labs Ltd CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 211799-002 Oct 19, 2021 AB RX 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 7 of 7 entries

Cholestyramine Light: Market Dynamics and Financial Trajectory

Introduction

Cholestyramine Light, a formulation of the bile acid sequestrant cholestyramine, is a crucial medication in the management of hypercholesterolemia, bile acid diarrhea, and itching caused by bile duct blockage. This article delves into the market dynamics and financial trajectory of Cholestyramine Light, highlighting its current status, growth prospects, and the challenges it faces.

Market Size and Growth

The Cholestyramine market, which includes Cholestyramine Light, is projected to experience significant growth. As of 2023, the market size was estimated at USD 186.60 million, expected to increase to USD 196.08 million in 2024, and reach USD 270.03 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.42%[1].

Product Types and Applications

Cholestyramine Light is available in various forms, including granules, pellets, and powder. Its primary applications include bile acid sequestration and the treatment of hyperlipidemia. Additionally, it is used to alleviate symptoms such as chronic diarrhea post-surgery and pruritus related to liver disease[1][4].

End-User and Distribution Channels

The end-users of Cholestyramine Light predominantly include patients within the pharmaceutical and healthcare sectors, particularly those with gastrointestinal and liver conditions. The distribution channels for this medication involve pharmacies, hospitals, and online platforms. However, recent shortages in Canada, attributed to production disruptions and increased demand, have affected its availability[3].

Market Drivers

Several factors drive the growth of the Cholestyramine Light market:

  • Increasing Awareness and Diagnosis: Growing awareness and diagnosis of hypercholesterolemia, especially in developing regions, contribute to the demand for cholesterol-lowering medications like Cholestyramine Light[1].
  • Healthcare Expenditure and Government Initiatives: Increased healthcare expenditure and government initiatives aimed at reducing cardiovascular risks also boost the market[1].
  • Growing Prevalence of Cardiovascular Diseases: The rising prevalence of cardiovascular diseases among adults and the aging population further fuels the demand for this medication[1].

Market Restraints

Despite the growth drivers, several challenges hinder the market expansion:

  • Patient Habits and Preferences: Slowly evolving patient habits and preferences can hinder the uptake of Cholestyramine Light. Some patients may prefer alternative treatments with fewer side effects[1].
  • Regulatory Challenges: Stringent regulatory guidelines pose barriers to new market entrants and can slow down the expansion of existing players[1].
  • Limited Awareness Among Healthcare Professionals: Limited awareness among healthcare professionals about the benefits of Cholestyramine Light can also restrict its adoption[1].

Market Opportunities

There are several opportunities that can be leveraged to enhance the market for Cholestyramine Light:

  • Digital Marketing Campaigns: Enhancing patient awareness through digital marketing campaigns can increase the adoption of Cholestyramine Light[1].
  • Alternative Therapy in Statin-Intolerant Populations: Cholestyramine Light can serve as an alternative therapy for patients who are intolerant to statins, a common cholesterol-lowering medication[1].
  • Growth in Nutraceuticals Market: There is potential for Cholestyramine Light to be marketed as a fiber supplement alternative in the nutraceuticals market[1].

Market Challenges

The market faces several challenges that need to be addressed:

  • Supply Chain Disruptions: Achieving sustainable supply chain operations for Cholestyramine Light amidst global disruptions is a significant challenge. Recent shortages in Canada highlight this issue[3].
  • Alternative Therapies and Lifestyle Changes: The influence of alternative therapies and lifestyle changes on the demand for Cholestyramine Light products is another challenge. Patients may opt for lifestyle modifications or other treatments with fewer side effects[1].

Competitive Landscape

The Cholestyramine market is competitive, with several key players including Actylis, Ajanta Pharma Limited, ANI Pharmaceuticals, Inc., Bristol-Myers Squibb Company, and others. These companies are focused on product development, innovation, and strategic partnerships to maintain their market share[1].

Product Development and Innovation

To stay competitive, companies are investing in research and development to enhance patient compliance and expand therapeutic applications. For example, developing powdered or liquid forms of Cholestyramine Light for easier ingestion is a promising area of innovation. Leveraging digital health tools for patient adherence and personalized medication could also unlock further market potential[1].

Financial Performance

The financial performance of the Cholestyramine market is expected to be robust, driven by the increasing demand for cholesterol management and the growing elderly population. However, challenges such as generic competition and the emergence of alternative treatments could impact profitability. Strategic investments in R&D and customer-centric strategies will be crucial for sustained growth[1].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of Cholestyramine Light. Companies must navigate stringent regulatory guidelines to ensure compliance. For instance, the shortage of Cholestyramine in Canada due to production disruptions highlights the importance of regulatory oversight and supply chain management[3].

Patient Compliance and Adherence

Improving patient compliance is essential for the success of Cholestyramine Light. Studies have shown that formulations like Questran Light, which is a low-calorie version of cholestyramine, are equally effective in maintaining lowered plasma cholesterol levels as the standard formulation, making them more appealing to patients[2].

Conclusion

The market for Cholestyramine Light is poised for growth, driven by increasing awareness of hypercholesterolemia, healthcare expenditure, and the growing prevalence of cardiovascular diseases. However, it faces challenges such as regulatory hurdles, patient preferences, and supply chain disruptions. Innovations in product formulation, digital health tools, and strategic partnerships will be key to capitalizing on existing and emerging opportunities.

Key Takeaways

  • The Cholestyramine market is projected to grow to USD 270.03 million by 2030 at a CAGR of 5.42%.
  • Increasing awareness and diagnosis of hypercholesterolemia drive market growth.
  • Regulatory challenges and patient preferences are significant restraints.
  • Innovations in product formulation and digital health tools offer growth opportunities.
  • Supply chain disruptions and alternative therapies are key challenges.

FAQs

Q: What is the primary use of Cholestyramine Light? A: Cholestyramine Light is primarily used to lower elevated serum cholesterol levels in patients with primary hypercholesterolemia and to alleviate symptoms such as bile acid diarrhea and itching caused by bile duct blockage[4].

Q: What are the key drivers of the Cholestyramine market growth? A: Key drivers include increasing awareness and diagnosis of hypercholesterolemia, increased healthcare expenditure, and the growing prevalence of cardiovascular diseases among adults and the aging population[1].

Q: What challenges does the Cholestyramine Light market face? A: The market faces challenges such as regulatory hurdles, slowly evolving patient habits and preferences, limited awareness among healthcare professionals, and supply chain disruptions[1].

Q: How is Cholestyramine Light different from other cholesterol-lowering medications? A: Cholestyramine Light is a bile acid sequestrant that is not absorbed from the digestive tract and can be used as an alternative therapy for patients intolerant to statins. It also has applications beyond cholesterol management, such as treating chronic diarrhea and pruritus[4].

Q: What are the potential opportunities for growth in the Cholestyramine Light market? A: Opportunities include enhancing patient awareness through digital marketing, serving as an alternative therapy for statin-intolerant populations, and growth in the nutraceuticals market as a fiber supplement alternative[1].

Sources

  1. 360iResearch: Cholestyramine Market Size & Share 2025-2030.
  2. PubMed: Comparison of the efficacy of Questran Light, a new formulation of cholestyramine powder.
  3. Canada.ca: Cholestyramine in short supply: Notice.
  4. Drugs.com: Cholestyramine Light: Package Insert / Prescribing Info.

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