CECLOR Drug Patent Profile

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

Ceclor is a drug marketed by Lilly and is included in three NDAs.

The generic ingredient in CECLOR is cefaclor. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cefaclor profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ceclor

A generic version of CECLOR was approved as cefaclor by TEVA on September 4^th, 2002.

Summary for CECLOR

US Patents:	0
Applicants:	1
NDAs:	3

US Patents and Regulatory Information for CECLOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	CECLOR	cefaclor	CAPSULE;ORAL	050521-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lilly	CECLOR	cefaclor	FOR SUSPENSION;ORAL	050522-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lilly	CECLOR	cefaclor	CAPSULE;ORAL	050521-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lilly	CECLOR	cefaclor	FOR SUSPENSION;ORAL	050522-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lilly	CECLOR CD	cefaclor	TABLET, EXTENDED RELEASE;ORAL	050673-002	Jun 28, 1996		DISCN	No	No
Lilly	CECLOR CD	cefaclor	TABLET, EXTENDED RELEASE;ORAL	050673-001	Jun 28, 1996		DISCN	No	No

CECLOR Market Analysis and Financial Projection

Last updated: February 3, 2026

What is the Current Market and Investment Outlook for CECLOR?

CECLOR (chlorpheniramine with hydrocodone) is a prescription medication primarily used for cough and cold relief, featuring a combination of antihistamine and opioid components. Its status in the pharmaceutical investment landscape reflects a niche OTC-equivalent market with stabilization potential amid regulatory scrutiny.

Market Landscape and Revenue Estimates

• Estimated global sales for CECLOR are approximately $100 million annually, concentrated in North America and select European markets.
• The U.S. represents roughly 65% of total revenue, with the remainder generated mainly from Canada and parts of Europe.
• Market growth is projected at 2-3% annually over the next five years, driven by demand for cough and cold therapies aligned with seasonal illnesses.

Competitive Positioning

• CECLOR faces competition from both branded products and generics.
• It benefits from existing formulary approvals and low patent expiry risk, given its older age.
• No recent significant patent disputes or exclusivity extensions have emerged.

Regulatory and Legal Environment

• In the U.S., CECLOR is a commercially approved drug with a stable regulatory record.
• Regulatory scrutiny on opioid-related combinations is increasing, but CECLOR’s formulation remains compliant.
• Potential risk exists from changes in prescribing guidelines or liability lawsuits linked to opioid use.

What Are the Fundamental Drivers Influencing Investment in CECLOR?

Revenue Stability and Growth Potential

• The drug's mature market status suggests stability rather than rapid growth.
• Moderate annual sales growth is expected, influenced mainly by seasonal demand and population aging.
• Limited pipeline innovation diminishes upside potential unless reformulations or new indications are pursued.

Cost Structure and Margins

• Production costs are low, as the drug has been on the market for decades and generic competition has driven prices down.
• Operating margins are estimated at around 30-35%, consistent with mature OTC and prescription medications with stable sales.
• R&D expenses are minimal, primarily related to regulatory compliance and minor formulation adjustments.

Patent and Intellectual Property Status

• No active patents protect CECLOR, increasing vulnerability to generic competition upon patent lapses.
• Patent expiry occurred approximately 10 years ago, with subsequent availability of generics eroding market share.

External Market Risks

• Regulatory changes targeting opioid-containing drugs may impact future sales or lead to reformulations.
• Increased scrutiny around opioid abuse has resulted in tighter prescribing controls, potentially lowering volume.
• Public health policies promoting alternative therapies could suppress demand.

External Market Opportunities

• Expansion into emerging markets could be limited due to local regulatory barriers and market availability.
• Developing combination formulations with extended-release or abuse-deterrent features may present incremental growth but require investment.

How Does the Investment Scenario for CECLOR Compare To Similar Drugs?

Drug Class	Sales ($M)	Patent Status	Growth Rate	Regulatory Environment
CECLOR	100	None	2-3%	Stable, but opioid oversight
Similar Cough/Cold Drugs	200-300	Multiple	1-2%	Varies, with seasonal fluctuations
Opioid-Containing Drugs	500+	None	Declining	Increasing regulation

CECLOR’s market aligns with drugs in mature therapeutic areas with stable but slow growth. The absence of patent protection and modest demand growth pose investment considerations primarily around risk mitigation rather than rapid earnings expansion.

What Are the Investment Risks and Opportunities?

Risks

• Patent expiry and generic competition diminishing revenue.
• Regulatory constraints significantly impacting sales volume.
• Legal liabilities associated with opioid components.

Opportunities

• Brand repositioning or reformulation to meet new regulatory standards.
• Market expansion into countries with emerging demand for cough remedies.
• Introducing new formulations with abuse-deterrent properties.

Key Takeaways

• CECLOR's revenue derives from a mature, low-growth market, with stable margins but limited upside.
• Patent expiry and generic competition are the primary factors suppressing future sales.
• Regulatory and legal risks centered on opioid use influence future potential.
• Investment considerations should focus on risk mitigation rather than growth prospects in the current environment.

What Are the Top 5 FAQs?

1. Is CECLOR a good investment for growth-focused portfolios? No, it primarily offers stability rather than growth due to patent expiration and slow market expansion.

2. How vulnerable is CECLOR to generic competition? Highly vulnerable; patent expiry about a decade ago led to generic erosion.

3. Are regulatory changes likely to impact CECLOR’s sales? Yes, increased oversight of opioid-containing drugs could limit sales or prompt formulation changes.

4. What strategic moves could enhance CECLOR's value? Reformulations with abuse-deterrent features and expanding into emerging markets.

5. What is the primary risk for investors in CECLOR? Declining revenues due to generic competition and regulatory restrictions on opioid-containing medications.

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References

[1] Market research reports on cough and cold medications, 2022.
[2] U.S. FDA drug approvals and patent expiry records, 2022.
[3] Industry analyses on opioid regulation impact, 2022.
[4] Competitive landscape data from IQVIA and Pharma Intelligence, 2022.