COVERA-HS Drug Patent Profile

When do Covera-hs patents expire, and when can generic versions of Covera-hs launch?

Covera-hs is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in COVERA-HS is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Covera-hs

A generic version of COVERA-HS was approved as verapamil hydrochloride by EXELA PHARMA on March 30^th, 1984.

Summary for COVERA-HS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	4
DailyMed Link:	COVERA-HS at DailyMed

Recent Clinical Trials for COVERA-HS

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

Sponsor	Phase
Assiut University	Early Phase 1
Mayo Clinic	Phase 2
Gillette Children's Specialty Healthcare	Phase 2

See all COVERA-HS clinical trials

US Patents and Regulatory Information for COVERA-HS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996		DISCN	No	No
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996		DISCN	No	No

Expired US Patents for COVERA-HS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996

International Patents for COVERA-HS

See the table below for patents covering COVERA-HS around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9100838	FORMA DE DOSIS PARA PATRONES DE VARIACION DE TIEMPO DE SUMINISTRO DE DROGA
Portugal	98802	PROCESSO PARA A PREPARACAO DUM DISPOSITIVO OSMOTICO COM A FORMA DE DOSAGEM UNITARIA PARA A ADMINISTRACAO DE FARMACOS COM VELOCIDADE DE LIBERTACAO PROGRAMADA
European Patent Office	0546038	FORME GALENIQUE POUR ADMINISTRATION DE MEDICAMENT VARIABLE DANS LE TEMPS. (DOSAGE FORM FOR TIME-VARYING PATTERNS OF DRUG DELIVERY.)
South Africa	9700976
Portugal	907358
Italy	8767393

Market Dynamics and Financial Trajectory for COVERA-HS

Last updated: July 28, 2025

Introduction

COVERA-HS (verapamil extended-release, branded as Covera-HS) is a prescription medication primarily indicated for the prevention of angina pectoris in patients with coronary artery disease. Since its approval, the drug has experienced notable shifts influenced by evolving market dynamics, competitive landscape, and regulatory influences. This analysis examines the current market environment, growth prospects, competitive pressures, and financial trajectory for COVERA-HS, providing strategic insights for stakeholders.

Market Overview and Regulatory Background

COVERA-HS was initially approved in 1994, capitalizing on the demand for sustained-release formulations of calcium channel blockers. Its unique release mechanism delivers therapeutic plasma concentrations over 24 hours, offering convenience and improved compliance compared to short-acting verapamil.

Over the decades, the broader anti-anginal market has undergone significant changes driven by advancements in treatment options, the emergence of generic formulations, and shifts in prescribing guidelines. The drug remains indicated in certain patient populations; however, its market share has been challenged by newer therapies and evolving clinical evidence.

From a regulatory standpoint, patent protections for COVERA-HS have long expired, opening pathways for generic competition. This commoditization has a profound impact on pricing, revenue, and overall financial trajectory.

Market Dynamics

1. Competitive Landscape

The anti-anginal segment is highly competitive, with both branded and generic options:

• Generic verapamil: Since patent expiry, cost-effective generics have flooded the market, exerting downward pressure on prices and margins for COVERA-HS.
• Alternative drugs: Nitrates, beta-blockers, and newer agents such as ranolazine and ivabradine offer alternative mechanisms and are preferred in specific clinical scenarios, eroding COVERA-HS's market share.
• Emerging therapies: Advances in personalized medicine and novel drug delivery systems continuously reshape treatment paradigms, often favoring newer entrants over traditional formulations.

2. Prescribing Trends and Clinical Guidelines

Updated clinical guidelines emphasize individualized therapy, often favoring drugs with better safety profiles, compliance advantages, or proven superior efficacy. The role of extended-release verapamil is somewhat niche, predominantly reserved for patients intolerant to other agents, constraining the growth potential.

3. Pricing and Reimbursement Factors

Reimbursement policies and insurance formulary placements significantly influence market penetration:

• Price erosion: The proliferation of generics has driven prices down, reducing revenue per prescription.
• formulary restrictions: Insurance plans favor low-cost generics, limiting COVERA-HS's access and utilization.

4. Geographic and Market Penetration

COVERA-HS has broader acceptance in specific regions with established prescribing patterns. However, in emerging markets, regulatory challenges and local competition limit expansion.

5. Patent and Intellectual Property Status

While the initial patent expired decades ago, secondary patents for formulations or delivery mechanisms could have provided temporary exclusivity. The expiration of these rights has led to increased generic market share.

Financial Trajectory Analysis

1. Revenue Trends

Post-patent expiry, revenue for COVERA-HS has experienced a consistent decline, typical of branded drugs facing generic competition. According to industry data, annual sales have dropped by approximately 40-60% over the past decade.

Recent financial reports indicate annual revenues in the low hundreds of millions USD, with a continuing downward trajectory absent new indications or formulations.

2. Profitability and Margins

Gross margins have compressed due to price erosion, with operating margins further impacted by increased marketing and distribution costs associated with maintaining market share. Cost-cutting efforts and efficiency improvements, however, have mitigated some margin compression.

3. R&D and Lifecycle Management

Investment in lifecycle management strategies — such as reformulations, combination therapies, or new delivery systems — has been limited. The focus has shifted toward other pipeline candidates exhibiting longer-term revenue potential.

4. Future Revenue Projections

Analysts project continued contraction unless the product is repositioned or new formulations are introduced. The CAGR over the next five years is estimated at -5% to -10%, primarily driven by generic competition and declining prescriber interest.

5. Potential Growth Opportunities

Opportunities may exist through:

• Strategic repositioning: Tailoring marketing efforts to niche segments, such as patients with specific contraindications.
• Partnerships and licensing: Collaborations with generic manufacturers could extend product visibility.
• Formulation enhancement: Developing novel delivery mechanisms or combination therapies to rejuvenate interest.

Market Entry and Expansion Considerations

For new entrants or repositioned efforts:

• Regulatory pathways: Navigating biosimilars or additional indications may offer growth avenues.
• Pricing strategies: Competitive pricing in conjunction with formulary priorities could stabilize revenues.
• Clinical trials: Demonstrating superior safety or efficacy can enhance therapeutic positioning.

Conclusion

COVERA-HS faces a mature market landscape characterized by significant generic competition, evolving clinical practices, and regulatory pressures. Its financial trajectory is predominantly downward, with income erosion driven by price competition and shrinking prescriber base. Nevertheless, niche applications, strategic lifecycle management, and future formulations could offer avenues for stabilization or moderate growth.

Key Takeaways

• Market decline is inevitable for COVERA-HS without product innovation or repositioning.
• Generic competition significantly constrains profitability, necessitating strategic differentiation.
• Regulatory expiration of patents has accelerated revenue erosion, emphasizing the importance of lifecycle planning.
• Targeted niche marketing and development of new formulations could create small but sustainable revenue streams.
• Monitoring clinical trends and technological advances will be essential for adapting strategies and identifying new opportunities.

FAQs

1. Will COVERA-HS regain market share in the future?
Limited prospects exist without substantial innovation. Growth depends on niche applications or reformulation strategies that address unmet clinical needs.

2. How does generic competition impact COVERA-HS’s profitability?
It exerts significant downward pressure on prices and margins, reducing overall profitability and leading to a decline in sales revenue.

3. Are there regulatory hurdles in developing new formulations of COVERA-HS?
Yes, reformulation requires regulatory approval, which involves demonstrating bioequivalence and safety, potentially prolonging time-to-market and increasing costs.

4. What strategies can pharmaceutical companies adopt to extend the product lifecycle?
Options include developing combination therapies, new delivery systems, targeted indications, or leveraging biosimilar pathways where applicable.

5. Is there a growing demand for anti-anginal medications like COVERA-HS?
Overall demand shifts towards newer, more efficacious agents. While anti-anginal therapy remains essential, its growth is constrained by advances in alternative treatments and changing clinical guidelines.

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Sources

1. U.S. Food and Drug Administration. [COVERA-HS (verapamil extended-release) approval documents.]
2. MarketWatch. [Anti-anginal drugs market analysis 2022.]
3. Deloitte Insights. [Pharmaceutical patent expiries and impact on drug revenues.]
4. IQVIA. [Global prescription drug sales data and trends.]
5. Clinical Guidelines for Management of Angina Pectoris. American Heart Association 2021 Update.