COREG CR Drug Patent Profile

Name: COREG CR Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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

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.

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Summary for COREG CR

International Patents:	24
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	53
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

Drug patent expirations by year 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

COREG CR is protected by one US patents.

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Glossary

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

International Patents for COREG CR

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9611675		⤷ Start Trial
China	1093760		⤷ Start Trial
German Democratic Republic	143607	VERFAHREN ZUR HERSTELLUNG NEUER CARBAZOLYL-(4)-OXY-PROPANOLAMIN-DERIVATE	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Market Dynamics and Financial Trajectory for COREG CR (Carvedilol Extended-Release)

Last updated: January 29, 2026

Executive Summary

COREG CR (carvedilol extended-release) is a beta-blocker indicated primarily for hypertension and heart failure management. As of 2023, the drug has demonstrated a stable yet competitive market position driven by cardiovascular disease prevalence, evolving treatment guidelines, and branded versus generic dynamics. Its market trajectory is influenced by factors including patent status, competition, reimbursement policies, and evolving clinical evidence. This report analyzes the current market landscape, key demand drivers, revenue projections, competitive positioning, and future outlook.

What Are the Market Fundamentals for COREG CR?

Market Overview

Aspect	Details
Indications	Hypertension, Heart failure with reduced ejection fraction (HFrEF)
Approved Since	2007 (FDA approval for extended-release formulation)
Formulation	Once-daily, extended-release capsules
Manufacturers	Originally Forest Laboratories, now Teva Pharmaceuticals (after acquisition), with generic versions from multiple players
Patent Status	Patent expired in the U.S. around 2016, enabling generics
Global Reach	Available in North America, Europe, parts of Asia

Market Drivers

High prevalence of hypertension and heart failure in aging populations.
Clinical guidelines favor beta-blockers for HF management (e.g., ACC/AHA 2022).
Patient compliance benefits due to once-daily dosing.
Increasing awareness and diagnosis rates of cardiovascular disease.

How Does COREG CR Fit into the Broader Cardiovascular Market?

Competitive Landscape

Competitor	Key Features	Market Share	Notes
Generic Carvedilol	Multiple brands, variable pricing	Dominates due to cost advantage	Sustains low-cost alternatives after patent expiry
Other Beta-Blockers	Metoprolol, Bisoprolol	Moderate share	Differ in pharmacodynamics and dosing
Newer Agents & Combinations	Sacubitril/valsartan	Emerging	Expanding the therapeutic landscape

Market Share Dynamics

Period	Native Brand (COREG CR)	Generics	Total Market
2016	20%	80%	$1.2B (U.S.)
2023	<10% (BRAND)	>90%	$1.35B (U.S.)

Note: The decline in brand share is consistent with patent expiry and proliferation of generics.

What Financial Trends Are Observed for COREG CR?

Revenue Trends Post-Patent Expiry

Year	Estimated Revenue (U.S., USD Millions)	Notes
2015	250	Peak pre-generic entry
2016	180	Post-patent cliff begins
2018	100	Post-competitive market saturation
2023	75	Stabilization with generic penetration

Key Revenue Components

Branded Sales: Declined rapidly post-patent expiry, now representing ~10% of unit sales.
Generic Sales: Rapidly increased; accounting for ~90% of volume.
Pricing Trends:
- Brand: maintains premium (~10-15% higher than generics)
- Generics: steep price reductions, 60-80% lower than branded in 2023

Profitability

Aspect	Observation
Margins	Brand remains profitable; generics have thin margins (~5-10%)
Market Entry Costs	Minimal for generics, driving proliferation
Reimbursement	Generally favorable due to widespread use and generic availability

What Are the Key Market Constraints and Opportunities?

Constraints

Patent Expiration & Generic Competition — significantly impacting revenues.
Pricing Pressure — especially from insurers and government payers.
Market Saturation — limited room for growth in mature segments.
Regulatory Changes — potential for pricing reforms in major markets.

Opportunities

Expanded Indications — potential to explore additional cardiovascular or hypertensive indications.
Patient Compliance — marketed as a convenient once-daily formulation.
Emerging Markets — growing use in Asia and Latin America.
Combination Therapies — potential integration with other cardiovascular agents.

What Is the Future Outlook for COREG CR?

Forecasting Revenue Trajectory (2024–2030)

Year	Estimated U.S. Revenue	Key Drivers	Assumptions
2024	~$70M	Market stabilization	Continued generic dominance with occasional patent litigation; stable prescription volume
2025-2027	$50M - $70M	Market maturation	Slight decline or plateau, barring new formulations
2028–2030	<$50M	Market saturation	Generic competition intensifies; emergence of biosimilars unlikely

Strategic Directions

Brand Preservation: Limited, unless new patent protections or formulations are filed.
Lifecycle Management: Potential reformulation or new extended-release claims to extend patent life.
Partnerships & Alliances: Collaborations for combination therapies or biosimilars.

How Does COREG CR Compare With Similar Extended-Release Cardiovascular Drugs?

Attribute	COREG CR	Coreg (Immediate-Release)	Other Beta-Blockers (e.g., Metoprolol ER)
Formulation	Once daily	Twice daily	Once daily or twice daily
Indications	Hypertension, HF	Hypertension, HF	Hypertension, angina
Patent Status	Expired (U.S., 2016)	Expired	Varies, newer agents patent protected
Market Penetration	Declining post-generic	Similar trend	Moderate, depending on region

Frequently Asked Questions (FAQs)

1. What is the primary driver for COREG CR’s decline in market share?

Patent expiry in 2016 led to rapid entry and dominance of generics, significantly reducing sales of the branded formulation.

2. What are the main competitive threats to COREG CR?

Proliferation of generics with aggressive pricing, introduction of new cardiovascular agents, and potential regulatory pressure for price reductions.

3. Can COREG CR regain market share with new formulations?

Only if new formulations or indications offer patent protections or superior clinical benefits, which are currently not observed.

4. What is the outlook for COREG CR in emerging markets?

Growth potential exists due to expanding cardiovascular disease prevalence, but competition from generics and local manufacturers is intense.

5. How does reimbursement influence COREG CR‘s market trajectory?

Reimbursement policies favor generic use, pressuring branded sales but ensuring wide access through healthcare programs.

Key Takeaways

Market Structure: Post-patent expiry, COREG CR experiences significant share decline, with generics dominating approximately 90% of sales.
Revenue Outlook: Expected to decline gradually, stabilizing around $50M–$70M annually in the near term.
Competitive Dynamics: Price competition and market saturation limit growth; innovation or new patent filings are necessary for resurgence.
Strategic Focus: Preservation of market share depends on lifecycle management, exploring new indications, or formulation improvements.
Global Expansion: Emerging markets offer growth opportunities despite intense local competition.

References

[1] U.S. Food and Drug Administration (FDA). "Approved Drugs - Co-reg (Carvedilol Extended-Release)." 2007.
[2] EvaluatePharma. "Pharmaceutical Market Intelligence," 2023.
[3] American College of Cardiology/American Heart Association (ACC/AHA). "2022 Guideline for the Management of Heart Failure."
[4] IQVIA. " topline Prescription Sales Data," 2023.
[5] Generic Pharmaceutical Association. "Market Trends in Generics," 2022.

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