Colesevelam hydrochloride - Generic Drug Details

What are the generic sources for colesevelam hydrochloride and what is the scope of freedom to operate?

Colesevelam hydrochloride is the generic ingredient in two branded drugs marketed by Cosette, Alkem Labs Ltd, Glenmark Pharms Ltd, Impax, Watson Labs Inc, Beijing Tide Pharm, Bionpharma, Chartwell Rx, Dr Reddys, Impax Labs Inc, Invagen Pharms, Inventia, United Res Labs, Zhejiang Jingxin, and Zydus Pharms, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for colesevelam hydrochloride. Sixteen suppliers are listed for this compound.

Summary for colesevelam hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	21
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	47
What excipients (inactive ingredients) are in colesevelam hydrochloride?	colesevelam hydrochloride excipients list
DailyMed Link:	colesevelam hydrochloride at DailyMed

Recent Clinical Trials for colesevelam hydrochloride

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

Sponsor	Phase
St. Boniface Hospital	Phase 1/Phase 2
Spanish Breast Cancer Research Group	Phase 2
Puma Biotechnology, Inc.	Phase 2

See all colesevelam hydrochloride clinical trials

Pharmacology for colesevelam hydrochloride

Drug Class	Bile Acid Sequestrant
Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for colesevelam hydrochloride

Anticholesteremic Agents

Anatomical Therapeutic Chemical (ATC) Classes for colesevelam hydrochloride

C10AC	Bile acid sequestrants
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for COLESEVELAM HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
WELCHOL	Powder for Oral Suspension	colesevelam hydrochloride	1.875 g/Packet and 3.75 g/Packet	022362	1	2010-04-09
WELCHOL	Tablets	colesevelam hydrochloride	625 mg	021176	1	2009-07-01

US Patents and Regulatory Information for colesevelam hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	210889-001	Oct 5, 2018	AB	RX	No	No
Chartwell Rx	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	201354-001	Dec 17, 2020		DISCN	No	No
Glenmark Pharms Ltd	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	FOR SUSPENSION;ORAL	202190-001	Jul 16, 2018		RX	No	No
Watson Labs Inc	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	200830-001	Sep 2, 2020		DISCN	No	No
Bionpharma	COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	208670-001	Sep 13, 2019	AB	RX	No	No

Expired US Patents for colesevelam hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009	5,919,832*PED
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	5,607,669*PED
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	6,784,254*PED
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	5,693,675*PED
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	6,433,026*PED

Colesevelam hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Colesevelam Hydrochloride

Introduction to Colesevelam Hydrochloride

Colesevelam hydrochloride is a nonabsorbed lipid-lowering agent, primarily used to reduce low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia. It is available in both tablet and powder forms and is marketed under the brand name Welchol, as well as in generic versions[2][3].

Market Size and Growth

The global colesevelam hydrochloride market has been experiencing significant growth, driven by increasing demand for effective lipid-lowering agents. As of 2022, the market size was valued at a substantial amount, and it is expected to expand at a notable Compound Annual Growth Rate (CAGR) during the forecast period of 2024-2031[1].

Competitive Environment

The market for colesevelam hydrochloride is characterized by a competitive environment, with both brand-name and generic versions available. The brand-name version, Welchol, tends to be more expensive due to the higher costs associated with its initial approval and development. However, generic versions of colesevelam hydrochloride offer a more affordable alternative, making the drug more accessible to a wider patient population[2].

Factors Influencing Market Dynamics

Increasing Prevalence of Hypercholesterolemia

The rising prevalence of hypercholesterolemia and associated cardiovascular diseases is a key driver of the market. As more patients are diagnosed and treated for high LDL cholesterol, the demand for effective lipid-lowering agents like colesevelam hydrochloride increases[3].

Combination Therapies

Colesevelam hydrochloride is often used in combination with other lipid-lowering agents, such as HMG-CoA reductase inhibitors (statins) and ezetimibe. This combination therapy approach has been shown to be more effective than monotherapy, further boosting the market demand[3][5].

Regulatory Approvals and Guidelines

Regulatory approvals and clinical guidelines play a crucial role in shaping the market. For instance, the inclusion of colesevelam hydrochloride in treatment guidelines for primary hypercholesterolemia and type 2 diabetes supports its market growth[2][3].

Financial Trajectory

Cost and Pricing

The cost of colesevelam hydrochloride can vary based on several factors, including the form of the drug (tablet or powder), treatment plan, insurance coverage, and the pharmacy used. Generally, the generic version is more cost-effective compared to the brand-name version, Welchol[2].

Insurance Coverage and Financial Assistance

Insurance coverage significantly influences the financial trajectory of the drug. Patients with health insurance may have lower out-of-pocket costs, while those without insurance may need to explore other financial assistance options, such as mail-order pharmacies and online resources[2].

Long-Term Cost Savings

Strategies to lower long-term costs include obtaining a 90-day supply of the drug, which can reduce the number of pharmacy visits and potentially lower costs. Using mail-order pharmacies is another option that can help in cost savings[2].

Market Trends and Projections

Growing Demand for Generic Versions

The demand for generic versions of colesevelam hydrochloride is expected to rise due to their cost-effectiveness and equivalent efficacy to brand-name versions. This trend is likely to continue as more patients and healthcare providers opt for generic medications to manage healthcare costs[2].

Expanding Use in Combination Therapies

The use of colesevelam hydrochloride in combination with other lipid-lowering agents is expected to increase, driven by clinical evidence showing improved outcomes with combination therapy. This expansion will contribute to the overall growth of the market[3][5].

Impact of Clinical Trials and Guidelines

Clinical trials and updated guidelines will continue to influence the market. For example, studies like the HOPE-3 trial, which demonstrate the efficacy of lipid-lowering therapies in diverse patient populations, will support the broader adoption of colesevelam hydrochloride[5].

Regional Analysis

The market for colesevelam hydrochloride is not uniform across all regions. Factors such as healthcare infrastructure, regulatory environments, and patient demographics vary, influencing the market dynamics in different regions. For instance, regions with higher prevalence of cardiovascular diseases and better healthcare access are likely to see higher demand for the drug[1].

Challenges and Opportunities

Compliance and Adverse Effects

One of the challenges associated with traditional bile acid sequestrants is compliance due to adverse effects like constipation. However, colesevelam hydrochloride has been shown to have fewer adverse effects, which can improve patient compliance and drive market growth[3].

Financial Barriers

Despite the availability of generic versions, financial barriers can still limit access to colesevelam hydrochloride. Efforts to improve insurance coverage and financial assistance programs can help mitigate these barriers and expand the market[2].

Key Takeaways

• Market Growth: The global colesevelam hydrochloride market is expected to grow significantly due to increasing demand for lipid-lowering agents.
• Competitive Environment: The market is competitive, with both brand-name and generic versions available, offering different pricing options.
• Combination Therapies: The use of colesevelam hydrochloride in combination with other lipid-lowering agents is a key market driver.
• Financial Trajectory: The cost of the drug varies based on several factors, and strategies like obtaining a 90-day supply can help in cost savings.
• Regional Variations: Market dynamics vary across regions due to differences in healthcare infrastructure and patient demographics.

FAQs

Q: What is colesevelam hydrochloride used for? A: Colesevelam hydrochloride is used to lower LDL cholesterol in patients with primary hypercholesterolemia and to treat type 2 diabetes[2][3].

Q: Does colesevelam hydrochloride come in different forms? A: Yes, it is available in both oral tablet and powder forms[2].

Q: How does the cost of colesevelam hydrochloride vary? A: The cost varies based on the form of the drug, treatment plan, insurance coverage, and the pharmacy used[2].

Q: Can colesevelam hydrochloride be used in combination with other medications? A: Yes, it is often used in combination with HMG-CoA reductase inhibitors (statins) and ezetimibe to achieve better lipid-lowering outcomes[3][5].

Q: What are some strategies to lower the long-term costs of colesevelam hydrochloride? A: Strategies include obtaining a 90-day supply and using mail-order pharmacies to reduce costs[2].

Sources

1. Colesevelam Hydrochloride Market 2024-2031 (Size and Share) by Competitive Environment, New Updates, and Regional Analysis. Southeast News Channel Nebraska.
2. Colesevelam cost 2024: Coupons and more. Medical News Today.
3. Colesevelam hydrochloride. PubMed.
4. Global Colesevelam Hydrochloride Market Size, Trends and Forecast. Market Research Intellect.
5. Pot·pour·ri. National Lipid Association.