Last Updated: May 3, 2026

CECLOR Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 4th, 2002.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for CECLOR?
  • What are the global sales for CECLOR?
  • What is Average Wholesale Price for CECLOR?
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 ⤷  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
Lilly CECLOR CD cefaclor TABLET, EXTENDED RELEASE;ORAL 050673-002 Jun 28, 1996 DISCN No 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

CECLOR (cefaclor): Investment Scenario and Fundamentals Analysis

Last updated: April 25, 2026

What is CECLOR and where does it fit in the value chain?

CECLOR is a brand of cefaclor, an oral second-generation cephalosporin antibiotic. In commercial terms, it is positioned in acute bacterial infection treatment segments where prescriber switching and payer formularies drive volume more than differentiation.

Core business drivers

  • Generic erosion: CECLOR faces sustained price and margin pressure as cefaclor has long transitioned to generic supply.
  • Channel dynamics: Antibiotics are typically won on contracting, formulary access, and net price rather than clinical differentiation at this stage.
  • Manufacturing/quality: For an older antibiotic, supply reliability, FDA compliance history, and cost of goods are central to sustaining share after generic entry.
  • Regulatory and stewardship: Antibiotics are subject to tightening utilization patterns driven by resistance concerns and stewardship.

What is CECLOR’s market fundamentals outlook?

Volume and pricing dynamics

Because cefaclor is widely available as generics, CECLOR’s investment case depends on the ability to:

  • Maintain contracted shelf access
  • Defend net pricing through rebate and distribution terms
  • Avoid supply disruptions that force payer switching to other cephalosporins

Practical implication for investors: In mature antibiotics, CECLOR’s revenue growth usually depends less on new clinical adoption and more on retention of formulary position and working capital and supply execution.

Competitive set (same class, substitute products)

CECLOR competes primarily with:

  • Other oral cephalosporins (e.g., cefdinir, cefprozil, cefixime class substitutes depending on indication)
  • Narrow and broad-spectrum antibiotic substitutes chosen by formularies and stewardship protocols
  • Generic versions of cefaclor and therapeutically substitutable beta-lactams

Key indicator set for fundamentals monitoring

For a mature antibiotic brand, the “fundamentals” lens shifts to metrics that predict resilience:

  • Net price trend (invoice price minus rebates, chargebacks, and payer programs)
  • Utilization trend in acute outpatient antibiotic settings
  • Share stability vs. switching to newer oral options
  • Supply continuity (OTIF, batch release performance)
  • Wholesale inventory levels (signal of stocking vs. restocking)

What does the patent and exclusivity landscape imply for investment risk?

CECLOR’s long-standing status means the near-term investment risk is dominated by:

  • No meaningful brand exclusivity after generic availability
  • Follow-on generic competition (label, formulation, and sourcing diversity)

From an investment perspective, that changes the valuation framework from “patent-protected growth” to “defend cash flow through execution.”

Regulatory status and label anchoring

CECLOR corresponds to cefaclor and is authorized for bacterial infections where cephalosporins are clinically appropriate per labeled indications. The investment relevance is that the label stays stable in mature antibiotics while the market shifts to lower-cost generics and therapeutically adjacent options.

How do historical safety communications and class risk affect demand?

CECLOR is a cephalosporin. Beta-lactams carry class-level demand sensitivities:

  • Allergic reactions (including hypersensitivity concerns)
  • Diarrhea and antibiotic-associated gastrointestinal events
  • Rare severe cutaneous reactions and hematologic effects reported across beta-lactams
  • Increased scrutiny in stewardship due to resistance and unnecessary antibiotic use

Investment effect: Safety communications do not typically eliminate an existing market for established generics, but they can shift prescribing patterns at the margin, affecting brand share if the product is not the lowest-cost contracted option.

What is the investment scenario for CECLOR as a cash-flow asset?

Base-case investment scenario (execution-led)

  • Revenue: Flat to modest decline due to generic price pressure
  • Margin: Constrained unless CECLOR holds contracted net prices and avoids volume-share dilution
  • Cash flow: More sensitive to supply continuity, rebate/chargeback structure, and working capital management than to R&D catalysts

Where upside can still exist

  • Contract renewals that sustain share at favorable net pricing
  • Stable acquisition/production costs
  • Avoidance of manufacturing interruptions or FDA compliance events

Bear-case scenario (generic commoditization and utilization pressure)

  • Net price compresses further as payers increase generic substitution
  • Volume declines as prescribers move to other cephalosporins or alternative beta-lactams
  • Margin deterioration from unfavorable rebate structures or higher COGS

Bull-case scenario (temporary formulary re-anchoring or supply gap)

  • Short-term share gain if competitor supply tightens or distribution constraints arise
  • Stabilization of net pricing through payer contracting strategy
  • Lower-than-expected utilization decline due to local prescribing patterns

What fundamentals should drive an underwriting model?

1) Pricing and contracting

Model net revenue using:

  • Net price per unit trend (assume annual compression consistent with mature generic antibiotics)
  • Rebate and chargeback rate stability vs. payer tightening
  • Distribution mix (institutional vs. retail, where applicable)

2) Unit demand and mix

Track:

  • Outpatient antibiotic dispensing trends in relevant respiratory and ENT segments (where cephalosporins are used)
  • Share vs. adjacent oral cephalosporins
  • Seasonality patterns for upper respiratory infections

3) Cost of goods and supply

Underwrite:

  • Manufacturing yield and batch release performance
  • Supplier and raw material cost volatility
  • Inventory and expiration risk management

4) Compliance and quality

Include:

  • FDA inspection outcomes
  • Changes in manufacturing sites or scale-up events
  • Recalls or quality alerts (if they occur)

What evidence anchors CECLOR’s regulatory identity?

CECLOR is cefaclor-based and tied to labeling and U.S. drug authorization. For institutional and investor diligence, anchor the product to authoritative label and FDA drug listings.

  • CECLOR label and prescribing information: provides the official approved indications, dosing, contraindications, and safety section. (FDA label access) [1]
  • FDA’s drug product and label repositories: used to confirm current label content and regulatory status. [2]

What are the key diligence questions investors should answer (and what to expect)?

Even with generic commoditization, investors diligence these areas for cash-flow durability:

  1. Is CECLOR’s net share stable within its payer footprint?
    Expectation: share tends to erode slowly unless contracting is favorable.

  2. Does the brand maintain a defensible net price vs. lowest-cost generic equivalents?
    Expectation: net price compresses, but favorable rebates and contracts can slow erosion.

  3. Is there supply resilience across manufacturing and distribution?
    Expectation: antibiotics can show volatility during supply chain disruption; resilience is a margin and revenue stabilizer.

  4. Are there any active risk signals in safety communications tied to cefaclor?
    Expectation: class risks exist; demand impact depends on severity and payer prescribing guidance.

Market and regulatory references investors should rely on

Label and official drug information

  • CECLOR prescribing information and label updates in FDA repositories [1][2]

FDA drug product databases

  • Use FDA label and drug listing sources to verify product identifiers, label versions, and authorized status. [2]

Key Takeaways

  • CECLOR (cefaclor) is a mature, generic-pressured antibiotic where the investment case is fundamentally about net pricing, contracted share, and supply reliability rather than patent-protected growth.
  • Underwrite through a cash-flow defense model: pricing discipline, contracting, distribution execution, and manufacturing quality dominate outcomes.
  • The central risk is continued generic commoditization and utilization shifts driven by antibiotic stewardship, which typically reduce both volume and margin over time.
  • Diligence should anchor to FDA label content and drug listing records, then translate those into a model built around net revenue retention and COGS/supply resilience.

FAQs

  1. Is CECLOR protected by meaningful near-term exclusivity?
    It is a mature antibiotic brand after cefaclor’s generic transition; investment expectations should treat near-term exclusivity as non-central to growth.

  2. What most influences CECLOR’s profitability in a generic market?
    Net pricing after rebates and chargebacks, plus COGS and manufacturing/supply continuity.

  3. How should investors benchmark CECLOR against competitors?
    Compare to therapeutically substitutable oral cephalosporins and the lowest-cost contracted generic options within relevant formularies.

  4. Does safety information materially change CECLOR demand?
    Class-level beta-lactam safety issues can shift prescribing at the margin, but demand is usually governed primarily by contracting and substitution.

  5. What diligence artifact best anchors CECLOR’s regulatory identity?
    The official FDA label/prescribing information and FDA drug listing records for the authorized product.


References (APA)

[1] U.S. Food and Drug Administration. (n.d.). CECLOR (cefaclor) prescribing information. FDA. https://www.accessdata.fda.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drug products. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.