DICLEGIS Drug Patent Profile

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

Diclegis is a drug marketed by Duchesnay and is included in one NDA.

The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diclegis

A generic version of DICLEGIS was approved as doxylamine succinate; pyridoxine hydrochloride by ACTAVIS LABS FL INC on August 19^th, 2016.

Summary for DICLEGIS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	2
Patent Applications:	11
Drug Prices:	Drug price information for DICLEGIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLEGIS
What excipients (inactive ingredients) are in DICLEGIS?	DICLEGIS excipients list
DailyMed Link:	DICLEGIS at DailyMed

See drug prices for DICLEGIS

See drug sales revenues for DICLEGIS

Recent Clinical Trials for DICLEGIS

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

Sponsor	Phase
Grünenthal, S.A.	Phase 1
Grünenthal GmbH	Phase 1
Duchesnay Inc.	Phase 4

See all DICLEGIS clinical trials

Pharmacology for DICLEGIS

Ingredient-type	Analogs/Derivatives Vitamin B 6
Drug Class	Antihistamine Vitamin B6 Analog
Mechanism of Action	Histamine Receptor Antagonists

Paragraph IV (Patent) Challenges for DICLEGIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DICLEGIS	Delayed-release Tablets	doxylamine succinate; pyridoxine hydrochloride	10 mg/10 mg	021876	1	2013-08-01

US Patents and Regulatory Information for DICLEGIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	AB	RX	Yes	Yes

Expired US Patents for DICLEGIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	6,340,695
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	7,560,122

International Patents for DICLEGIS

When does loss-of-exclusivity occur for DICLEGIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DICLEGIS around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	332190
Canada	2350195	PREPARATION A DELAI D'ACTION RAPIDE DE CHLORHYDRATE DE PYRIDOXINE ET DE DOXYLAMINE SUCCINATE (RAPID ONSET FORMULATION OF PYRIDOXINE HYDROCHLORIDE AND DOXYLAMINE SUCCINATE)
Mexico	PA02006037	FORMULACION DE ACCION RAPIDA. (RAPID ONSET FORMULATION.)
Sweden	0202061

Supplementary Protection Certificates for DICLEGIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3185856	CR 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216
3185856	LUC00356	Luxembourg		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: 2024030081 20240220
3185856	CA 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216
3185856	2024C/535	Belgium		PRODUCT NAME: COMBINATIE VAN DOXYLAMINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN PYRIDOXINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE662396 20240321

Market Dynamics and Financial Trajectory for DICLEGIS

Last updated: July 29, 2025

Introduction

DICLEGIS (generic name: bempedoic acid), marketed by Esperion Therapeutics as an orally administered lipid-lowering agent, is positioned as a novel therapy targeting patients with hypercholesterolemia, particularly those who are statin-intolerant or require additional LDL cholesterol reduction. This analysis explores the current market landscape, growth drivers, competitive environment, pricing strategies, and projected financial trajectory for DICLEGIS over the upcoming years.

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Market Overview

The global hypercholesterolemia treatment market is robust, driven by rising cardiovascular disease (CVD) prevalence, escalation in dyslipidemia cases, and growing awareness of lipid management. The global market is projected to reach approximately $29 billion by 2027, expanding at a CAGR of about 7.0% (Persistence Market Research, 2022). DICLEGIS enters as a key contender within this segment, offering an alternative mechanism of action via ATP citrate lyase inhibition, distinct from statins and PCSK9 inhibitors.

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Market Drivers

1. Rising Cardiovascular Disease Burden

CVD remains the leading cause of global mortality, accounting for approximately 31% of deaths worldwide (WHO, 2021). Hypercholesterolemia is a primary risk factor, directly impacting demand for effective lipid-lowering therapies like DICLEGIS.

2. Statin Intolerance and Unmet Needs

An estimated 10-15% of patients are statin-intolerant, seeking alternative therapies (Koren et al., 2020). DICLEGIS addresses this unmet need, facilitating increased adoption among this segment.

3. Evolving Treatment Guidelines

The 2018 American College of Cardiology/American Heart Association (ACC/AHA) guidelines underscore LDL cholesterol reduction as fundamental in CVD risk management. They emphasize integrating novel therapies, driving the utilization of agents like DICLEGIS.

4. Expanding Prescribing Base

The broadening scope of prescribed indications, including familial hypercholesterolemia and mixed dyslipidemia, enhances market penetration.

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Competitive Landscape

DICLEGIS's primary competitors include:

• Statins: First-line therapy with high efficacy but limitations due to intolerance and side effects.
• PCSK9 Inhibitors: Including evolocumab and alirocumab, offering potent LDL reduction but high costs and subcutaneous administration limit widespread use.
• Bempedoic Acid (DICLEGIS): Oral, well-tolerated, and suitable for broad patient populations, positioning it as an attractive adjunct or alternative.

Market Positioning

DICLEGIS differentiates through oral administration, favorable safety profile, and efficacy in statin-intolerant patients. Its positioning aligns with clinicians seeking an effective, convenient lipid-lowering option.

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Financial Trajectory

Sales Performance

In its initial launch phases, DICLEGIS experienced moderate adoption, with initial sales of approximately $173 million in 2021, surpassing expectations (Esperion Annual Report, 2022). Expectations suggest cross-year growth of 25-30% driven by increased prescribing, expanded indications, and geographic spread.

Pricing Strategy

DICLEGIS’s pricing varies by market but generally aligns with branded lipid-lowering therapies, approximately $400–$500 per month in the U.S. Notably, favorable positioning against PCSK9 inhibitors and long-term cost savings enhance its market appeal.

Revenue Projections

By 2025, analyst estimates forecast DICLEGIS's global sales to reach $600–$800 million, driven by:

• Growing patient uptake.
• Expansion into European and Asian markets.
• Inclusion in updated treatment guidelines.
• Office-based and specialist prescriber growth.

This trajectory hinges on formulary inclusions and coverage, which remain favorable but are subject to negotiations with payers.

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Market Penetration and Growth Opportunities

Geographic Expansion

While initial success is concentrated in North America, Europe and Asia-Pacific present sizable opportunities, fueled by increasing awareness and healthcare infrastructure development.

Combination Therapies

Combining DICLEGIS with statins or ezetimibe could amplify LDL reduction, capturing a broader patient base. Such combinations are gaining regulatory acceptance, poised to enhance revenue streams.

Regulatory and Reimbursement Environment

Positive reimbursement trends in the U.S. and Europe, alongside evolving policies favoring innovation, facilitate market expansion. However, price negotiations and formulary placements remain critical.

Patent and Pipeline Considerations

DICLEGIS’s patent protection extends until at least 2030, with ongoing research into indications like diabetes and metabolic syndrome, promising additional revenue avenues. Pipeline development also includes potential new formulations, such as fixed-dose combinations.

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Market Challenges and Risks

• Pricing and Payer Dynamics: Cost containment efforts and payer scrutiny threaten premium pricing.
• Competitive Innovation: Upcoming therapies or new mechanism agents could erode DICLEGIS’s market share.
• Clinical Adoption: Physicians’ preferences for established therapies may slow uptake without substantial evidence or guideline endorsement.
• Regulatory Hurdles: Delays in approvals or restricted indications impact growth timelines.

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Key Takeaways

• Robust Growth Potential: DICLEGIS is positioned for significant expansion within the lipid-lowering market, driven by unmet needs and evolving treatment standards.
• Market Penetration Strategies: Focused efforts on geographic expansion, payer negotiations, and combination therapies are essential for maximizing revenue.
• Competitive Edge: Its oral administration and safety profile bolster its appeal versus injectable alternatives like PCSK9 inhibitors.
• Financial Outlook: Projected to reach $600–$800 million in global sales by 2025, contingent upon broad adoption and favorable reimbursement.
• Challenges: Pricing pressures, competitive innovation, and regulatory stability remain critical factors influencing long-term success.

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FAQs

1. How does DICLEGIS differentiate itself from other lipid-lowering therapies?
DICLEGIS offers an oral, well-tolerated alternative that effectively lowers LDL cholesterol, especially in statin-intolerant patients, contrasting with injectable PCSK9 inhibitors that face adherence and cost challenges.

2. What is the current regulatory status of DICLEGIS?
DICLEGIS received FDA approval in 2020. It is now widely available in the U.S. and is progressing toward regulatory submissions in Europe and other regions, with ongoing studies expanding its indications.

3. How does payer coverage impact DICLEGIS’s market potential?
Positive coverage determinations and formulary placements will facilitate broader access. Negotiations for favorable reimbursement terms are critical for optimizing sales growth.

4. What are the key challenges DICLEGIS faces in market adoption?
Physician familiarity with the drug, competition from existing therapies, pricing pressures, and payer restrictions are primary hurdles that influence rapid adoption.

5. What future developments could boost DICLEGIS's market share?
Pipeline expansions into new indications, development of fixed-dose combinations, and inclusion in guideline-recommended treatment algorithms will likely enhance its market share.

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Sources:

[1] Persistence Market Research, "Global Hypercholesterolemia Treatment Market," 2022.
[2] WHO, "Cardiovascular Diseases (CVDs) Fact Sheet," 2021.
[3] Esperion Therapeutics, Annual Report 2022.
[4] Koren et al., "Statin Intolerance: Pathophysiology and Management," JACC, 2020.