COREG Drug Patent Profile

Which patents cover Coreg, and when can generic versions of Coreg launch?

Coreg is a drug marketed by Waylis Therap and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in COREG 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

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

Summary for COREG

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Patent Applications:	4,283
Drug Prices:	Drug price information for COREG
What excipients (inactive ingredients) are in COREG?	COREG excipients list
DailyMed Link:	COREG at DailyMed

See drug prices for COREG

See drug sales revenues for COREG

Pharmacology for COREG

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

US Patents and Regulatory Information for COREG

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	carvedilol	TABLET;ORAL	020297-004	May 29, 1997	AB	RX	Yes	No
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	AB	RX	Yes	No	8,101,209*PED				Y
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995	AB	RX	Yes	No
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	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	AB	RX	Yes	No
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995	AB	RX	Yes	Yes

Expired US Patents for COREG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	RE40000*PED
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995	RE40000*PED
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995	5,902,821*PED
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995	5,760,069*PED
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-004	May 29, 1997	4,503,067*PED
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995	4,503,067*PED

International Patents for COREG

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

Country	Patent Number	Title	Estimated Expiration
Finland	791142
Finland	70406
Australia	4718196
Spain	479396
Luxembourg	88320
China	1185106

Market Dynamics and Financial Trajectory for COREG (Carvedilol)

Last updated: July 30, 2025

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Introduction

COREG, the brand name for carvedilol, is a non-selective beta-blocker with alpha-blocking activity primarily prescribed for managing heart failure, hypertension, and myocardial infarction. Since its approval by the FDA in 1995, COREG has established itself as a crucial therapeutic agent in cardiovascular medicine. Understanding its market dynamics and financial trajectory involves analyzing global demand, competitive landscape, regulatory factors, and patent statuses.

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Market Overview

Global Cardiovascular Disease Burden

The rising prevalence of hypertension and heart failure globally fuels demand for carvedilol-containing therapies. According to the World Health Organization (WHO), cardiovascular diseases (CVDs) account for approximately 17.9 million deaths annually, underscoring the ongoing need for effective treatments like COREG [1]. The aging population and lifestyle changes further augment the market size, especially in North America, Europe, and emerging markets.

Prescription Trends and Therapeutic Positioning

COREG’s dual action on beta and alpha receptors offers a significant advantage over selective beta-blockers, providing superior benefits in systolic heart failure management. Its inclusion in treatment guidelines from the American Heart Association (AHA) and European Society of Cardiology (ESC) sustains steady prescription volumes. However, competition from generics and alternative therapies influences market share.

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Market Dynamics

Competitive Landscape

The market faces intense competition primarily from generic carvedilol products and branded alternatives like Coreg CR (extended-release formulation). Major pharmaceutical companies such as Mylan, Teva, and Lupin manufacture cost-effective generics, putting pressure on pricing and margins. Innovator brands like Pfizer, which originally marketed Coreg, have transitioned their focus post patent expiration. The impending patent cliffs for carvedilol (original patent expired in the early 2010s) have significantly impacted revenue streams.

Regulatory and Patent Considerations

Patents protect innovative formulations and specific dosing technologies. Since the early 2010s, patent exclusivity for Coreg expired in several jurisdictions, leading to the proliferation of generics. Regulatory agencies monitor quality and bioequivalence standards, making market entry accessible but also highly competitive. Recent developments in extended-release formulations (Coreg CR) benefit from exclusivity periods, creating niche markets.

Pricing and Reimbursement Policies

Pricing strategies vary globally. In developed markets, healthcare payers and insurance frameworks tend to favor generics due to cost savings, exerting downward pressure on prices. Conversely, in emerging markets, higher out-of-pocket expenses limit access, constraining growth. Reimbursement policies directly impact prescribing behavior and market size.

Innovation and New Clinical Indications

While carvedilol remains primarily for cardiovascular indications, ongoing research into its neuroprotective and anti-inflammatory properties could expand its therapeutic portfolio. Such developments, if approved, may alter market dynamics favorably.

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Financial Trajectory

Historical Revenue Trends

Pfizer’s core sales of Coreg peaked prior to patent expiration, with revenues approaching several hundred million USD annually. Post-patent expiry, revenues declined sharply, giving way to generic competition, which eroded profit margins and revenue [2]. For instance, Pfizer’s global carvedilol sales fell from over $700 million in the early 2000s to significantly lower figures post-2012.

Impact of Generics and Market Penetration

The proliferation of generics led to a substantial decline in branded drug revenues. Mylan and Teva, among others, captured market share by offering low-cost alternatives, often priced at 80-90% less than branded versions. These dynamics have resulted in a stable but subdued revenue trajectory for carvedilol in mature markets, shifting focus towards emerging markets and formulations with extended-release features to regain profitability.

Emerging Markets and Access Strategies

Emerging economies like India, China, and Latin America exhibit growing demand due to expanding healthcare infrastructure. Generic manufacturers often dominate these regions, propelled by lower manufacturing costs and local patent laws. Strategic partnerships and licensing agreements in these markets bolster revenue but typically at lower margins.

Future Outlook

Forecasts predict a plateau in carvedilol sales in developed markets due to patent expiry and stiff competition but anticipate steady growth in emerging markets. Innovation in pharmacokinetics, such as novel delivery mechanisms, could rejuvenate interest. Additionally, the inclusion of carvedilol in combination therapies for resistant hypertension may create new revenue streams.

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Key Market Drivers

• Growing CVD prevalence drives consistent demand.
• Patent expirations lead to increased generic competition.
• Pricing and reimbursement policies influence access and sales.
• Formulation innovations (e.g., extended-release versions) may sustain profitability.
• Global health initiatives promote access in emerging markets.

Challenges

• Price erosion due to widespread generic availability.
• Regulatory hurdles in new formulations.
• Market saturation in mature regions.
• Limited therapeutic innovation compared to emerging drug candidates.

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Conclusion

COREG's market dynamics are emblematic of a mature, generic-dominant pharmaceutical segment. While established as a mainstay in cardiovascular therapy, patent expiration and commoditization have shifted revenue focus toward cost-competitive generics and emerging markets. Future growth hinges on innovating formulations, exploring new indications, and expanding access in developing regions. Stakeholders must balance competitive pressures with potential pipeline innovations to optimize the drug’s financial trajectory.

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Key Takeaways

• The expiration of key patents on carvedilol significantly shifted market share from branded to generic manufacturers.
• Cost pressures from generics dominate developed markets, while emerging markets offer growth opportunities.
• Formulation innovations like extended-release versions can mitigate revenue decline.
• Regulatory status and reimbursement policies critically influence market accessibility.
• Investment in new clinical research could unlock additional therapeutic uses, enhancing future revenue streams.

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FAQs

1. How has patent expiry affected COREG’s market share?
Patent expiration led to a surge in generic carvedilol products, sharply reducing branded sales and market share for the original manufacturer, Pfizer, while increasing overall market volume through lower-cost alternatives.

2. What are the main competitive threats to COREG today?
The primary threats include commoditization by multiple generic manufacturers, price competition, and limited innovation. Patent-protected extended-release formulations and new combination therapies could provide competitive advantages.

3. Is there potential for COREG in new therapeutic areas?
Emerging research suggests possible neuroprotective and anti-inflammatory benefits, but these indications are not yet approved clinically, limiting near-term commercial impact.

4. How do reimbursement policies influence COREG sales?
In developed countries, favorable reimbursement for generics sustains access but compresses margins. Conversely, restrictive or limited coverage hampers sales expansion, especially in lower-income regions.

5. What strategies could revitalize COREG’s market presence?
Innovating formulations, securing new regulatory approvals for additional indications, expanding access in emerging markets, and differentiation through pharmacokinetic advancements can help restore growth potential.

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Sources:

[1] World Health Organization. Cardiovascular diseases (CVDs) Fact Sheet. 2022.
[2] Pfizer Annual Reports and Market Analyses, 2010-2022.