COREG Drug Patent Profile

When do Coreg patents expire, 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

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

International Patents for COREG

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

Country	Patent Number	Title	Estimated Expiration
Spain	2134588
European Patent Office	0808162	UTILISATION DE COMPOSES DE CARBAZOLE POUR LA MANUFACTURE D'UN MEDICAMENT DESTINE AU TRAITEMENT DE L'INSUFFISANCE CARDIAQUE CONGESTIVE (USE OF CARBAZOLE COMPOUNDS FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF CONGESTIVE HEART FAILURE)
Hong Kong	2385	DERIVATIVES OF CARBAZOLYL-4-OXYPROPANOLAMINE,METHODS FOR THEIR PREPARATION AND MEDICINES CONTAINING THEM
Germany	2815926
Netherlands	930110

Investment Scenario and Fundamentals Analysis for COREG (Carvedilol)

Last updated: February 3, 2026

What is the market position of COREG?

COREG (carvedilol) is a beta-blocker indicated for heart failure, hypertension, and left ventricular dysfunction post-myocardial infarction. It is marketed primarily by Pfizer. As a generic medication, its sales are influenced by patent status, competition, and adoption rates in clinical practice.

What are the current sales and revenue trends?

COREG sales peaked around 2010 to 2012 at approximately $1.0 billion annually in the United States. Since patent expiration in 2007 and subsequent generic entry, sales declined significantly. In 2022, Pfizer reported US sales under $200 million, reflecting market penetration and generic competition.

Year	US Sales (Million USD)	Global Sales (Million USD)
2010	1,039	1,337
2015	275	324
2020	189	227
2022	180	210

The decline continues due to generic competition and market saturation.

What is the patent and regulatory landscape?

COREG's original patent expired in 2007, with the drug becoming generic in the US. Patent protections for formulations or specific uses may extend for certain markets but are limited.

FDA approval for COREG was obtained in 1995. The drug’s primary patents were invalidated or expired, limiting exclusivity. The drug faces competition from multiple generic carvedilol products.

What are the core therapeutic and market drivers?

• Indications: Heart failure with reduced ejection fraction, hypertension, post-myocardial infarction ventricular dysfunction.
• Market size: The US heart failure market exceeds $4 billion (per IQVIA 2022). Hypertension market exceeds $20 billion.
• Clinician preference: Carvedilol’s established guideline role supports ongoing prescribing, though other generics and combination therapies are available.
• Reimbursement: Generally favorable due to generic pricing, limiting margins for branded products.

What are the key risks and opportunities?

Risks:

• Entry of newer, branded beta-blockers with improved efficacy or side-effect profiles.
• Price erosion as generics dominate.
• Patent or regulatory challenges in emerging markets.
• Shrinking market share due to evolving clinical guidelines.

Opportunities:

• Novel formulations or delivery methods that extend patents.
• Use in expanded indications (e.g., heart failure with preserved ejection fraction).
• Growth in emerging markets with increasing cardiovascular disease prevalence.
• Potential for co-formulation with other antihypertensive drugs.

How does competitive landscape affect investment outlook?

• Approximately 15 companies market carvedilol generics in the US.
• The top three account for over 90% of generic sales.
• Pfizer's branded sales represent less than 10% of total carvedilol revenue.
• Innovation in beta-blocker therapy is limited, but some companies invest in targeted formulations or delivery systems.

What are financial valuation considerations?

• Declining sales and margins diminish revenue streams for innovations.
• Licensing or patent extension opportunities are minimal due to expiration.
• Market value is driven by global generics, not branded sales.

Given current market dynamics, COREG does not represent a high-growth asset but offers stability in mature markets with moderate cash flow from established indications.

What is the outlook for new developments?

No recent filings or clinical trials for COREG-specific formulations are publicly reported, indicating limited near-term pipeline activity. Future growth hinges on market expansion or repositioning for new indications.

Key Takeaways

• COREG’s US sales have declined sharply post-patent expiry, now primarily driven by generic sales.
• The market is saturated, with intense price competition among multiple manufacturers.
• Opportunities are limited to formulation innovation or expanded indications.
• The primary risk involves further erosion of market share and low margins.
• Investment potential remains stable in mature markets but lacks growth prospects.

FAQs

1. Will COREG regain market share?
Unlikely, given the dominance of generic competition and limited differentiation.

2. Are there opportunities for patent extensions?
No significant patent protections currently exist; generic competition prevails.

3. Can COREG's indications expand?
Potential exists if new evidence supports additional uses, but no current developments are underway.

4. How does pricing compare globally?
Pricing varies, with high prices maintained in some European markets under patent protections, but generally, generic prices dominate worldwide.

5. Is COREG a viable long-term investment?
In mature markets, it offers limited growth but can generate stable cash flows; long-term value depends on market conditions and strategic innovations.

Sources:

[1] IQVIA, "Pharmaceutical Market Data," 2022.
[2] FDA, "Drug Approvals and Patent Information," 2022.
[3] Pfizer Annual Reports, 2010-2022.