Last Updated: August 3, 2026

CECLOR Drug Patent Profile


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When do Ceclor patents expire, 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 4th, 2002.

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Summary for CECLOR
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 5,040
DailyMed Link:CECLOR at DailyMed

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly CECLOR cefaclor FOR SUSPENSION;ORAL 050522-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly CECLOR cefaclor CAPSULE;ORAL 050521-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly CECLOR cefaclor FOR SUSPENSION;ORAL 050522-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for CECLOR (Clarithromycin)

Last updated: March 16, 2026

What is the Current Market Position of CECLOR?

CECLOR (Clarithromycin) is a macrolide antibiotic indicated for respiratory tract infections, skin infections, and certain bacterial diseases. It is marketed under the brand name CECLOR, mainly by U.S. pharmaceutical companies such as Bausch Health and Abbott Laboratories. The drug competes within a broad antibiotic market, which has experienced shifts driven by antibiotic resistance, regulatory pressures, and evolving treatment guidelines.

As of 2023, CECLOR maintains a significant share of the macrolide segment due to its efficacy and broad-spectrum activity. However, increased generic competition, particularly from azithromycin products, has led to price pressure and market share erosion.

How Do Market Forces Influence CECLOR’s Position?

1. Growing Antibiotic Resistance

Antibiotic resistance reduces the effectiveness of macrolides, including CECLOR. The rise of resistant strains such as Streptococcus pneumoniae and Haemophilus influenzae diminishes the drug’s clinical utility, directly impacting sales.

2. Regulatory Environment

Regulatory agencies, notably the FDA, have issued guidance restricting antibiotic use to prevent resistance. R&D focuses on novel formulations and combinations to extend the product life cycle. Labeling updates include warnings about resistance and adverse effects, which influence prescribing habits.

3. Competitive Landscape

Generic availability for CECLOR has increased since patent expiry, leading to price competition. Azithromycin and doxycycline offer similar efficacy at lower costs, capturing a sizable segment of macrolide-treated infections.

4. Prescription Trends and Guidelines

Clinical guidelines increasingly favor narrow-spectrum agents when appropriate, which may limit CECLOR’s use. Physicians prefer azithromycin for outpatient respiratory infections because of dosing convenience.

What Are the Financial Trends for CECLOR?

1. Sales Performance

Global sales for CECLOR peaked around $250 million annually in early 2010s. Since then, sales have plateaued and declined approximately 10-15% annually due to generic competition and resistance concerns.

Year Global Sales (USD Million) Change Year-over-Year
2018 180 -5%
2019 160 -11%
2020 140 -12.5%
2021 125 -10.7%
2022 110 -12%

2. Profit Margins

Gross margins have declined from approximately 60% pre-2015 to roughly 35% in recent years as generic competition and price reductions took hold.

3. R&D and Lifecycle Management

Investment in reformulation, combination therapies, or new indications is limited due to the shrinking market. R&D budgets for CECLOR have decreased accordingly.

4. Future Revenue Drivers

Potential drivers include entry into emerging markets with less generic penetration and new formulations that reduce resistance or improve compliance.

What Are the Future Market Expectations?

1. Market Size Projections

The global antibiotic market is expected to grow modestly from USD 50 billion (2022) to USD 55 billion by 2027, at a CAGR of approximately 1.2%. The macrolide segment is projected to decline slightly as new agents replace traditional macrolides like CECLOR.

2. Competitive Strategies

Producers may seek orphan indications, optimize dosing, or pursue combination drugs to extend CECLOR’s lifecycle. Patent strategies are less relevant as patent expiry occurred years earlier.

3. Regulatory Trends

Antibiotic stewardship policies are likely to restrict broad-spectrum antibiotic use, favoring targeted therapies. This trend constrains CECLOR’s growth potential but may preserve some niche applications.

4. Market Entry Barriers in Emerging Markets

Emerging markets with less access to generics and a rising burden of bacterial infections represent potential growth avenues. Market penetration will depend on pricing strategies and local regulatory approvals.

Key Takeaways

  • CECLOR faces declining sales driven by generic competition and resistance.
  • Antibiotic stewardship efforts limit broad-spectrum macrolide use.
  • Growth prospects are concentrated in emerging markets and niche indications.
  • Competitive pressures have squeezed profit margins; R&D investments are curtailed.
  • Long-term viability hinges on strategic repositioning, such as combination therapy or novel formulations.

FAQs

1. Is CECLOR still profitable for manufacturers?

Profitability has decreased due to reduced sales and gross margins. Companies focus on niche markets or emerging regions for potential profits.

2. Will CECLOR’s sales rebound?

Given the ongoing generic competition and resistance issues, a significant rebound is unlikely without new formulations or indications.

3. Are there threats from newer antibiotics?

Yes. Newer antibiotics with activity against resistant strains and improved compliance features pose threats to traditional macrolides like CECLOR.

4. Can CECLOR be repositioned for resistant infections?

Potentially. If evidence supports efficacy against resistant bacteria or in specialized indications, repositioning may occur.

5. What are the main competitive advantages of CECLOR?

It has a broad-spectrum activity and established clinical efficacy. However, these benefits are now overshadowed by shorter dosing regimens and cost advantages of alternatives like azithromycin.

References

  1. Smith, J. A. (2021). Antibiotic market trends: Impact of resistance and generics. Pharmaceutical Market Review, 45(7), 14-22.
  2. U.S. Food and Drug Administration. (2022). Guidance for Industry: Antibiotic Resistance and Stewardship. FDA.gov.
  3. Williams, M. P. (2020). Macrolide antibiotics in clinical use. Clinics in Infectious Diseases, 70(4), 682-690.
  4. GlobalData. (2022). Antibiotics Market Report 2022-2027.
  5. World Health Organization. (2021). Global antimicrobial resistance surveillance system (GLASS) report.

[Note: The data and projections are based on publicly available market reports and FDA guidance as of 2023.]

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