COREG CR Drug Patent Profile

Which patents cover Coreg Cr, and what generic alternatives are available?

Coreg Cr is a drug marketed by Waylis Therap and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has twenty-four patent family members in fourteen countries.

The generic ingredient in COREG CR is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Coreg Cr

A generic version of COREG CR was approved as carvedilol phosphate by SUN PHARM INDUSTRIES on October 25^th, 2017.

Summary for COREG CR

International Patents:	24
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	61
Drug Prices:	Drug price information for COREG CR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COREG CR
What excipients (inactive ingredients) are in COREG CR?	COREG CR excipients list
DailyMed Link:	COREG CR at DailyMed

See drug prices for COREG CR

See drug sales revenues for COREG CR

Pharmacology for COREG CR

Drug Class	alpha-Adrenergic Blocker beta-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists

Paragraph IV (Patent) Challenges for COREG CR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COREG CR	Extended-release Capsules	carvedilol phosphate	10 mg and 20 mg	022012	1	2008-03-18
COREG CR	Extended-release Capsules	carvedilol phosphate	40 mg	022012	1	2007-12-21
COREG CR	Extended-release Capsules	carvedilol phosphate	80 mg	022012	1	2007-11-19

US Patents and Regulatory Information for COREG CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	AB	RX	Yes	No	8,101,209*PED				Y
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	AB	RX	Yes	No	8,101,209*PED				Y
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	AB	RX	Yes	No	8,101,209*PED				Y

Expired US Patents for COREG CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	4,503,067*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	7,268,156*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	4,503,067*PED

International Patents for COREG CR

See the table below for patents covering COREG CR around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04003367	FORMULACION ORAL MICROPARTICULADA GALENICA PARA LA LIBERACION RETRASADA Y CONTROLADA DE PRINCIPIOS ACTIVOS FARMACEUTICOS. (GALENIC MICROPARTICULATE ORAL FORMULATION.)
Germany	2960553
South Africa	9508762

Market Dynamics and Financial Trajectory for COREG CR (Carvedilol CR)

Last updated: July 27, 2025

Introduction

COREG CR, a fixed-dose extended-release formulation of carvedilol, plays a pivotal role in managing heart failure, hypertension, and other cardiovascular conditions. As a cornerstone therapy, its market trajectory is influenced by evolving clinical guidelines, regulatory frameworks, competitive landscapes, and demographic trends. This analysis examines the market dynamics and financial outlook for COREG CR, providing strategic insights for industry stakeholders.

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1. Pharmacological Profile and Therapeutic Positioning

COREG CR is a controlled-release formulation of carvedilol, a non-selective beta-adrenergic blocker with alpha-1 blocking properties. Its extended-release profile ensures sustained plasma concentration, enhancing patient adherence and reducing dosing frequency. The drug demonstrates efficacy in reducing mortality and hospitalization in heart failure with reduced ejection fraction (HFrEF) and offers antihypertensive benefits.

Its distinct pharmacokinetics—once-daily dosing—differentiate it from immediate-release counterparts, fostering adherence and improving clinical outcomes. These features position COREG CR as an attractive option in the cardiovascular therapeutic landscape, aligning with guideline recommendations that favor simplified regimens.

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2. Market Dynamics

a. Rising Prevalence of Cardiovascular Diseases

According to the World Health Organization (WHO), cardiovascular diseases (CVDs) continue to be the leading cause of global mortality, accounting for approximately 17.9 million deaths annually [1]. The aging global population and lifestyle factors—sedentary habits, unhealthy diets, increased obesity—escalate the burden of hypertension and heart failure. This rising prevalence sustains demand for effective therapies like COREG CR.

b. Regulatory Approvals and Guidelines

The incorporation of carvedilol into heart failure management guidelines by the American Heart Association (AHA) and European Society of Cardiology (ESC) bolsters its market outlook [2]. Regulatory authorities have approved COREG CR in multiple markets, endorsing its safety and efficacy profile, which stimulates prescription volume.

c. Competitive Landscape

While COREG CR benefits from brand recognition and clinical validation, the market faces competition from other beta-blockers, such as metoprolol succinate and bisoprolol, which also have generic versions. The entry of generic carvedilol formulations has exerted pricing pressure, impacting revenue streams for the branded COREG CR.

d. Patent Status and Intellectual Property

The original patent for COREG CR has expired or is nearing expiration in several jurisdictions, leading to increased generic competition. However, formulations with unique extended-release technologies may still be under patent protection, offering exclusivity in certain markets and affecting the financial trajectory.

e. Adoption Factors and Prescription Trends

Physician familiarity, patient adherence benefits, and insurance reimbursement influence prescribing patterns. The preference for once-daily dosing favors COREG CR, though cost considerations may sway clinicians toward generic alternatives.

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3. Market Opportunities and Challenges

Opportunities:

• Expansion into Emerging Markets: Rapid urbanization and increasing healthcare infrastructure facilitate access to cardiovascular therapies. Market entry via strategic partnerships can tap into these regions’ growth potential.

• Combination Therapy Development: Combining carvedilol with other cardiovascular agents could meet unmet clinical needs, enhancing market share.

• Digital Health Integration: Leveraging telemedicine and adherence monitoring tools can promote sustained use of COREG CR, especially in remote or elderly populations.

Challenges:

• Pricing and Reimbursement Pressures: Payers increasingly favor generics, squeezing margins for branded formulations like COREG CR.

• Market Saturation: Mature markets may experience stagnation due to high penetration of existing therapies, necessitating differentiation strategies.

• Patent Expiry Risks: Loss of exclusivity intensifies competition, potentially reducing revenues.

4. Financial Trajectory and Revenue Projections

a. Historical Performance

Data indicates COREG CR's revenue aligns with broader carvedilol sales, though specific figures are often proprietary. Its performance in established markets has remained stable owing to clinical preference and brand loyalty.

b. Forecasting Future Revenue

Projection models incorporate epidemiological trends, competitive dynamics, regulatory status, and pricing. Estimates suggest that global sales of COREG CR could grow modestly at a compound annual growth rate (CAGR) of 2-4% over the next five years, driven primarily by emerging markets and the ongoing burden of CVDs [3].

c. Impact of Patent Expiry and Generics

The imminent patent expiration in key markets risks a sharp decline in brand revenues unless offset by innovative formulations or expanded indications. Price erosion related to generics could reduce profit margins unless counterbalanced by improved manufacturing efficiencies or premium positioning.

d. Strategic Revenue Maximization

Investment in lifecycle management—including clinical trials for new indications, formulation enhancements, and targeted marketing—can sustain revenue streams. Licensing collaborations and co-marketing agreements might also diversify income sources.

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5. Market Entry and Expansion Strategies

• Regulatory Approvals: Obtaining approval in high-growth regions can capitalize on demographic trends.

• Pricing Strategies: Competitive pricing and value-based reimbursement negotiations can mitigate generic competition.

• Clinical Evidence Generation: Conducting comparative effectiveness studies can reinforce clinical superiority or differentiated positioning.

• Patient Engagement: Leveraging digital health for improved adherence enhances long-term market sustainability.

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6. Conclusion

The market dynamics for COREG CR are shaped by a confluence of clinical, economic, and regulatory factors. While rising CVD prevalence underpins growth prospects, patent expiries and intense competition pose significant challenges. Strategic focus on emerging markets, lifecycle management, and advocacy for premium positioning are vital to sustaining and enhancing its financial trajectory.

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Key Takeaways

• Growing Demand: The expanding global burden of heart failure and hypertension sustains demand for carvedilol formulations like COREG CR, especially in aging populations.

• Competitive Challenges: Patent expirations and generic competition require proactive strategies such as formulations innovation and targeted marketing.

• Regional Expansion: Entry into emerging markets offers significant growth opportunities, bolstered by increasing healthcare access and infrastructure.

• Pricing and Reimbursement: Navigating pricing pressures necessitates value-based strategies, emphasizing clinical benefits and adherence advantages.

• Long-term Growth Strategies: Investing in clinical research, digital health integration, and potential new indications can mitigate risks and unlock new revenue streams.

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FAQs

Q1: How does COREG CR compare to immediate-release carvedilol in clinical efficacy?
COREG CR provides sustained plasma levels through its extended-release formulation, which improves patient adherence and maintains comparable efficacy to immediate-release carvedilol in managing heart failure and hypertension. Clinical trials confirm similar outcomes with added convenience [4].

Q2: What impact will patent expiration have on COREG CR’s market share?
Patent expirations typically lead to increased generic competition, lowering prices and reducing branded sales. Companies may counter this by developing new formulations, seeking approval for additional indications, or emphasizing brand loyalty through clinical differentiation.

Q3: Are there opportunities to expand COREG CR's indications?
Potential expansion into indications like left ventricular dysfunction post-myocardial infarction or additional hypertensive subpopulations exists, contingent on clinical trial results and regulatory approval pathways.

Q4: Why is market expansion into emerging economies crucial for COREG CR’s financial outlook?
Emerging markets exhibit rapid growth in CVD prevalence and improving healthcare infrastructure. Entry into these markets offers significant volume growth, compensating for saturation and price pressures in mature markets.

Q5: What competitive strategies can pharmaceutical companies employ to sustain COREG CR’s market position?
Differentiation through clinical data, patient-centered marketing emphasizing adherence benefits, strategic licensing, leveraging digital health tools, and optimizing pricing strategies are key to sustaining competitiveness.

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References:

[1] World Health Organization. (2021). Cardiovascular diseases. [Online] Available: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases

[2] Ponikowski, P., et al. (2016). 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. European Heart Journal, 37(27), 2129–2200.

[3] MarketResearch.com. (2022). Cardiology Drug Market Forecast.

[4] Flattery, M., et al. (2018). Comparative studies of extended-release vs. immediate-release carvedilol. Journal of Cardiac Pharmacology, 72(4), 805–813.