WELCHOL Drug Patent Profile

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

Welchol is a drug marketed by Cosette and is included in four NDAs.

The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Welchol

A generic version of WELCHOL was approved as colesevelam hydrochloride by IMPAX LABS INC on May 16^th, 2018.

Summary for WELCHOL

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	28
Patent Applications:	1,161
Drug Prices:	Drug price information for WELCHOL
What excipients (inactive ingredients) are in WELCHOL?	WELCHOL excipients list
DailyMed Link:	WELCHOL at DailyMed

See drug prices for WELCHOL

See drug sales revenues for WELCHOL

Recent Clinical Trials for WELCHOL

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

Sponsor	Phase
Entera Health, Inc	Phase 2
Valeant Pharmaceuticals International, Inc.	Phase 4
Bausch Health Americas, Inc.	Phase 4

See all WELCHOL clinical trials

Pharmacology for WELCHOL

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

Paragraph IV (Patent) Challenges for WELCHOL

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 WELCHOL

WELCHOL is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	WELCHOL	colesevelam hydrochloride	BAR, CHEWABLE;ORAL	210895-001	Apr 3, 2019		DISCN	Yes	No
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009	AB	RX	Yes	Yes
Cosette	WELCHOL	colesevelam hydrochloride	CAPSULE;ORAL	021141-001	May 26, 2000		DISCN	No	No
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009		DISCN	Yes	No
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	AB	RX	Yes	Yes

Expired US Patents for WELCHOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	WELCHOL	colesevelam hydrochloride	CAPSULE;ORAL	021141-001	May 26, 2000
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009
Cosette	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009

International Patents for WELCHOL

See the table below for patents covering WELCHOL around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	60225908
World Intellectual Property Organization (WIPO)	02085382
Cyprus	1119486
Brazil	0209134
Australia	2002257145
Greece	3031702
Portugal	764177

Supplementary Protection Certificates for WELCHOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0764174	SPC013/2004	Ireland		SPC013/2004: 20050912, EXPIRES: 20190309
0764174	SPC/GB04/031	United Kingdom		PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310
0764174	CA 2004 00027	Denmark
0764174	91100	Luxembourg		91100, EXPIRES: 20190310
0764174	C300159	Netherlands		PRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
0764174	300159	Netherlands		300159, 20150605, EXPIRES: 20190309
0764174	04C0021	France		PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310

WELCHOL Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Welchol

Introduction to Welchol

Welchol, also known as colesevelam HCl, is a medication used to treat high cholesterol and type 2 diabetes. It belongs to the class of bile acid sequestrants, which work by binding to bile acids in the intestine and preventing them from being reabsorbed into the bloodstream.

Market Size and Sales

As of 2018, Welchol had significant market presence, with annual U.S. sales of approximately $526 million for the 12 months ending February 2018, according to IQVIA™[1].

Generic Competition

The market dynamics for Welchol shifted significantly with the introduction of generic versions. In May 2018, Amneal Pharmaceuticals received FDA approval and launched a generic version of Welchol, marking a first-to-market opportunity. This move was expected to enhance Amneal's generic portfolio and provide patients with a more affordable treatment option[1].

Impact of Generic Entry

The entry of generic versions typically leads to a reduction in market share and revenue for the branded product. After the launch of generic colesevelam HCl, the sales of the branded Welchol would likely have declined as patients and healthcare providers opted for the more affordable generic alternative.

Financial Performance of Branded vs. Generic

For branded pharmaceutical companies, the loss of patent protection and the subsequent entry of generics can significantly impact financial performance. In contrast, generic pharmaceutical companies like Amneal often see an increase in revenue and market share as they capitalize on the demand for cost-effective treatments.

Market Trends in Dyslipidemia Drugs

The broader market for dyslipidemia drugs, which includes medications like Welchol, is influenced by several trends. The global dyslipidemia drugs market is expected to grow, driven by increasing prevalence of lifestyle-related diseases and the need for effective cholesterol management. This market is forecasted to exhibit growth from 2024 to 2031, with regional variations in market size and growth rates[4].

Competitive Landscape

The competitive landscape for dyslipidemia drugs is highly competitive, with multiple players offering both branded and generic products. Companies like Daiichi Sankyo, which has a portfolio of cardiovascular drugs, also compete in this space by focusing on innovative products and life-cycle management strategies to maintain market share[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. Changes in FDA approval requirements, healthcare reforms, and drug price revisions can all impact the financial trajectory of drugs like Welchol. For instance, regulatory changes in the U.S. and other countries can affect the pricing and reimbursement of these medications[1][3].

Patient Affordability and Access

The availability of generic versions of Welchol has improved patient affordability and access to cholesterol management treatments. This shift is aligned with broader healthcare trends that emphasize cost-effectiveness and patient-centric care.

Financial Trajectory Post-Generic Entry

After the generic entry, the financial trajectory for the branded Welchol would likely involve a decline in sales revenue. Here are some key points to consider:

• Revenue Decline: The introduction of generic colesevelam HCl would lead to a significant decline in revenue for the branded product.
• Market Share: The market share of the branded Welchol would decrease as generic versions capture a larger portion of the market.
• Cost Savings: Patients and healthcare systems would benefit from cost savings associated with generic medications, which could lead to increased adoption and usage.
• Competitive Strategies: The original manufacturer might employ various strategies such as price adjustments, marketing campaigns, or bundling with other products to maintain some level of market share.

Industry Expert Insights

Industry experts often highlight the importance of life-cycle management and strategic planning in the face of generic competition. For example, Daiichi Sankyo's approach to maximizing sales of established products and introducing new global products demonstrates a proactive strategy to mitigate the impact of generic entries[3].

Illustrative Statistics

• Annual U.S. sales of Welchol: Approximately $526 million (2018)[1].
• Generic entry impact: Expected significant decline in branded product sales post-generic launch.
• Global dyslipidemia drugs market growth: Forecasted to grow from 2024 to 2031, driven by increasing prevalence of lifestyle-related diseases[4].

Key Takeaways

• The introduction of generic versions of Welchol significantly impacts the market dynamics and financial trajectory of the branded product.
• Generic competition leads to reduced sales and market share for the branded product.
• The broader dyslipidemia drugs market is expected to grow, driven by increasing demand for cholesterol management treatments.
• Regulatory changes and patient affordability play crucial roles in shaping the market.

FAQs

What is Welchol used for?

Welchol, or colesevelam HCl, is used to treat high cholesterol and type 2 diabetes. It works by binding to bile acids in the intestine and preventing them from being reabsorbed into the bloodstream.

How did the introduction of generic Welchol affect the market?

The introduction of generic Welchol led to a significant decline in sales and market share for the branded product, as patients and healthcare providers opted for the more affordable generic alternative.

What is the current market size for dyslipidemia drugs?

The global dyslipidemia drugs market is forecasted to grow from 2024 to 2031, driven by increasing prevalence of lifestyle-related diseases. The exact market size varies by region and year.

How do regulatory changes impact the financial trajectory of drugs like Welchol?

Regulatory changes, such as FDA approval requirements and drug price revisions, can significantly impact the pricing, reimbursement, and overall financial performance of drugs like Welchol.

What strategies do pharmaceutical companies employ to manage the impact of generic competition?

Companies may employ strategies such as price adjustments, marketing campaigns, life-cycle management, and introducing new global products to maintain market share and mitigate the impact of generic entries.

Sources

1. Amneal Pharmaceuticals, Inc. - "Amneal Announces FDA Approval and Launch of Generic Welchol (Colesevelam HCl) Tablets, 625 mg" - PR Newswire, May 17, 2018.
2. HilleVax - "HilleVax Reports Second Quarter 2024 Financial Results and Provides Business Update" - August 8, 2024.
3. Daiichi Sankyo Co., Ltd. - "Annual Report 2010" - July 31, 2008.
4. iHealthcareAnalyst - "Dyslipidemia Drugs Market and Forecast 2024-2031".
5. Gilead Sciences - "Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results" - February 6, 2024.