CARTROL Drug Patent Profile

Which patents cover Cartrol, and what generic alternatives are available?

Cartrol is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in CARTROL is carteolol hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carteolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cartrol

A generic version of CARTROL was approved as carteolol hydrochloride by SANDOZ on January 3^rd, 2000.

Summary for CARTROL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	121
DailyMed Link:	CARTROL at DailyMed

US Patents and Regulatory Information for CARTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	CARTROL	carteolol hydrochloride	TABLET;ORAL	019204-001	Dec 28, 1988		DISCN	No	No
Abbvie	CARTROL	carteolol hydrochloride	TABLET;ORAL	019204-002	Dec 28, 1988		DISCN	No	No
Abbvie	CARTROL	carteolol hydrochloride	TABLET;ORAL	019204-003	Dec 28, 1988		DISCN	No	No

Expired US Patents for CARTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	CARTROL	carteolol hydrochloride	TABLET;ORAL	019204-001	Dec 28, 1988
Abbvie	CARTROL	carteolol hydrochloride	TABLET;ORAL	019204-002	Dec 28, 1988
Abbvie	CARTROL	carteolol hydrochloride	TABLET;ORAL	019204-003	Dec 28, 1988

International Patents for CARTROL

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	158176
Australia	475964
Norway	140589
Japan	S48103589
Japan	S5241268
Switzerland	589060

CARTROL Market Analysis and Financial Projection

Last updated: February 17, 2026

What are the current market dynamics for CARTROL?

CARTROL (carteolol hydrochloride) is a beta-blocker primarily approved for the management of angina pectoris. Its market presence is limited relative to other beta-blockers due to its age and patent status. Market dynamics are influenced by the availability of generic options and the drug's positioning within cardiovascular therapy.

Market Size and Growth

• The global beta-blocker market was valued at approximately $9 billion in 2022.
• CAGR from 2023 to 2030 projected at around 2.8%, driven by increasing cardiovascular disease prevalence and expanding indications for existing drugs.
• CARTROL's specific market share is estimated under 1%, constrained by competition from generic formulations of atenolol, metoprolol, and propranolol.

Competitive Landscape

• Generics dominate the beta-blocker segment, limiting revenue for brand-name CARTROL.
• Major players include Novartis, AstraZeneca, and Teva, which market widely used alternatives.
• Cardiovascular therapy trends favor drugs with better side-effect profiles and ease of dosing; CARTROL's unique properties do not significantly differentiate it from existing options.

Regulatory and Reimbursement Environment

• In the U.S., the FDA classifies CARTROL as an archived drug, with limited ongoing regulatory activity.
• Reimbursement is aligned with generics, with no special pricing or coverage advantages.
• International markets are heterogeneous; some prefer newer or more established agents like atenolol or propranolol.

What is the financial trajectory of CARTROL?

Given the limited market share and high generic competition, CARTROL's revenue trajectory is expected to remain flat or decline marginally.

Revenue Trends

• Estimated annual sales: below $50 million globally.
• Sales peaked in the late 1990s shortly after approval but have declined steadily because of generics.
• Year-over-year decline estimated at 5-8% since 2010.

Cost Considerations

• R&D and manufacturing costs are minimal, as the drug is off-patent.
• Marketing expenditure is low, mainly for maintaining existing formulations.
• No substantial investment has been made towards reformulation or new indications in recent years.

Investment and Licensing Opportunities

• Limited interest from major pharmaceutical companies due to low profitability.
• Niche markets or specific patient groups may present opportunities for targeted marketing, but overall financial prospects are weak.

How do patent and regulatory statuses impact future prospects?

• CARTROL's original patent expired in the early 2000s.
• No current patent protections or exclusivities.
• Its status as a non-proprietary, off-patent drug limits future revenue growth.
• Regulatory agencies have shifted focus toward newer agents; no recent approvals or indications are in pipeline.

What are the key forces shaping CARTROL's market and financial future?

• Increasing competition from low-cost generics.
• Growing preference for drugs with improved safety profiles.
• Market consolidation favoring newer agents with broader indications.
• Limited investment from pharmaceutical companies due to low revenue potential.

Summary of Key Data

Factor	Data
Market Value (2022)	~$9 billion (beta-blockers)
CARTROL's Share	<1% (~$50 million annually)
CAGR (2023-2030)	2.8% (overall beta-blocker market)
Revenue Decline	5-8% annually since 2010
Patent Status	Expired (early 2000s)
Key Competitors	Generic atenolol, metoprolol, propranolol

Key Takeaways

• CARTROL’s market is dominated by generics, with a stagnant or declining revenue trajectory.
• Market expansion opportunities are constrained by competition, lack of new formulations, and regulatory disinterest.
• Limited financial incentives restrict investments to extend or reposition the drug.
• Larger cardiovascular market trends favor newer agents with improved safety or broader approvals.
• The drug's future remains confined to niche segments or legacy prescribing practices.

FAQs

1. Why has CARTROL's market share declined over the years?
It faces competition from well-established generics like atenolol and metoprolol, which are cheaper and have broader clinical use.

2. Are there any new formulations or indications for CARTROL?
No recent regulatory filings or developments are associated with new formulations or indications.

3. Does CARTROL have any patent protections remaining?
No. Its patent expired in the early 2000s, leaving it vulnerable to generic competition.

4. How does the global market for beta-blockers compare to the U.S.?
The U.S. has a mature market dominated by generics with minimal growth, similar to most international markets. Some regions might still favor branded drugs, but overall, the landscape is similar.

5. What is the outlook for investing in CARTROL?
Given its limited market and revenue prospects, financial investment would be unattractive. Focus tends to shift toward newer agents with expanded indications or better safety profiles.

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Sources

[1] Market research reports on beta-blocker industry, 2022.
[2] FDA drug approval and patent status databases.
[3] Industry analyses on cardiovascular therapeutics market, 2023.