CEFTIN Drug Patent Profile

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Which patents cover Ceftin, and when can generic versions of Ceftin launch?

Ceftin is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in CEFTIN is cefuroxime axetil. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ceftin

A generic version of CEFTIN was approved as cefuroxime axetil by CHARTWELL RX on July 29^th, 2005.

Summary for CEFTIN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	55
Patent Applications:	1,361
Drug Prices:	Drug price information for CEFTIN
DailyMed Link:	CEFTIN at DailyMed

See drug prices for CEFTIN

See drug sales revenues for CEFTIN

US Patents and Regulatory Information for CEFTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	CEFTIN	cefuroxime axetil	FOR SUSPENSION;ORAL	050672-001	Jun 30, 1994		DISCN	Yes	No
Glaxosmithkline	CEFTIN	cefuroxime axetil	TABLET;ORAL	050605-002	Dec 28, 1987		DISCN	Yes	No
Glaxosmithkline	CEFTIN	cefuroxime axetil	FOR SUSPENSION;ORAL	050672-002	Apr 29, 1997		DISCN	Yes	No

Ceftin Market Dynamics, Patent Expiration, Generic Competition, and Financial Trajectory

Last updated: November 2, 2026

Ceftin, the brand name for cefuroxime axetil, is a mature oral cephalosporin antibiotic with no meaningful U.S. brand franchise remaining. The product received FDA approval in 1987 and now competes primarily through generic cefuroxime axetil tablets and oral suspension. Its commercial trajectory moved from branded growth in the 1990s to broad generic substitution after loss of market exclusivity. GSK does not report Ceftin as a separate current revenue line, so standalone sales and profit figures are unavailable in public company disclosures. [1][2]

What is Ceftin and how is it used?

Ceftin is an oral prodrug that is converted to cefuroxime after absorption. It belongs to the second-generation cephalosporin class.

Product attribute	Ceftin
Active ingredient	Cefuroxime axetil
Drug class	Second-generation cephalosporin
Original U.S. sponsor	Glaxo, later GlaxoSmithKline
FDA dosage forms	Tablets and oral suspension
Primary route	Oral
Main indications	Bacterial infections, including respiratory, sinus, skin, urinary-tract and certain sexually transmitted infections
FDA approval	1987
Current U.S. status	Generic competition; brand product is not a significant commercial franchise
Biosimilar relevance	None; Ceftin is a small-molecule drug

The FDA-approved labeling covers adult and pediatric use for selected infections caused by susceptible bacteria. Treatment decisions depend on bacterial susceptibility, infection site, patient factors and antimicrobial stewardship policies. [3]

When did Ceftin lose market exclusivity?

Ceftin lost practical market exclusivity after generic cefuroxime axetil products entered the U.S. market. The original product is now well beyond the standard small-molecule patent and regulatory-exclusivity periods.

Ceftin exclusivity timeline

Period	Commercial event	Market effect
1987	FDA approval of Ceftin	GSK obtained branded market access
Late 1980s-1990s	Brand expansion across oral infection indications	Prescription growth and physician familiarity
1990s-2000s	Patent and regulatory exclusivity periods expired	ANDA-based generic entry became possible
2000s onward	Multiple generic cefuroxime axetil suppliers	Rapid erosion of branded pricing and share
Current market	Generic cefuroxime axetil supply	Limited or no standalone value attributable to the Ceftin brand

The precise patent chronology is less commercially important today because the original exclusivity period has long expired and generic products are established in the market. FDA’s Orange Book is the principal source for current patent and exclusivity listings for approved drugs. [4]

What patents protect Ceftin?

Ceftin was historically protected by patents covering cefuroxime chemistry, cefuroxime axetil, pharmaceutical compositions and related manufacturing technology. Those rights are no longer a material barrier to ordinary U.S. generic entry.

No active U.S. patent estate currently gives the Ceftin brand meaningful market protection comparable to a newly launched branded drug. The commercial barriers are instead:

• Generic approval and bioequivalence requirements.
• Manufacturing economics for cefuroxime axetil.
• Supply reliability for the active pharmaceutical ingredient.
• Hospital, pharmacy and payer substitution practices.
• Formulation stability, taste and reconstitution requirements for suspension products.

Are there active Ceftin formulation patents?

Ceftin tablets and suspension were historically supported by formulation and manufacturing know-how, but formulation complexity does not preserve brand exclusivity after the relevant patents expire. Generic manufacturers may enter by using non-infringing formulations that meet FDA quality and bioequivalence standards.

The oral suspension presents greater technical complexity than tablets because manufacturers must control particle characteristics, reconstitution performance, stability, palatability and dosing uniformity. That can reduce the number of active suppliers without creating legally enforceable brand exclusivity.

What is the Orange Book status of Ceftin?

The Orange Book identifies approved drug products, therapeutic-equivalence evaluations, patent information and exclusivity data. Ceftin’s historical reference-listed-drug status allowed generic manufacturers to rely on the brand product as the reference for abbreviated new drug applications. [4]

The current commercial significance of the listing is limited because:

1. Ceftin is an old small-molecule product.
2. Generic cefuroxime axetil products have been marketed for years.
3. No current brand patent barrier prevents routine generic competition.
4. The brand does not have the pricing power associated with a protected reference product.

The FDA’s Orange Book remains the controlling source for any product-specific patent listing or current therapeutic-equivalence designation. A company assessing a new ANDA would need to review the live Orange Book entry and FDA approval history at the time of filing.

Which companies challenge or compete with Ceftin?

Ceftin’s competitive field consists primarily of generic manufacturers rather than branded challengers. Generic cefuroxime axetil has been supplied by multiple companies over time, including manufacturers with U.S. ANDA portfolios and contract manufacturing relationships.

The relevant competitors fall into four groups:

Competitor group	Competitive mechanism
Generic tablet manufacturers	Price competition and pharmacy substitution
Generic suspension manufacturers	Differentiation through pediatric supply and availability
Other oral antibiotics	Clinical substitution based on infection type, resistance and guidelines
Intravenous cephalosporins	Use in hospitalized or more severe infections

Ceftin also competes indirectly with amoxicillin-clavulanate, oral cephalosporins, macrolides, fluoroquinolones and other antibiotics. The choice is driven less by brand identity than by local resistance patterns, diagnosis, allergy history, dosing convenience, adverse effects and payer restrictions.

What is the financial trajectory of Ceftin?

Ceftin’s financial trajectory follows the standard lifecycle of a mature small-molecule antibiotic.

Branded growth phase

Following approval, Ceftin benefited from physician adoption, expansion into additional indications and the commercial infrastructure of Glaxo. Its value was linked to brand recognition, sales-force promotion and the clinical utility of an oral second-generation cephalosporin.

Loss-of-exclusivity phase

Generic entry materially changed the economics. Once multiple manufacturers supplied cefuroxime axetil, the market shifted from branded promotion to price-based procurement. Pharmacies and payers had strong incentives to substitute generic products, reducing:

• Net price per prescription.
• Brand prescription volume.
• Promotional return on investment.
• Contribution margin.
• Strategic value of the Ceftin name.

Mature generic phase

GSK’s public reporting does not provide a current standalone Ceftin revenue figure. Ceftin is not identified as a material growth product in GSK’s current reporting structure, which is focused on vaccines, specialty medicines and other major pharmaceutical franchises. [1]

The absence of a separate reported revenue line indicates that Ceftin no longer has material visibility in GSK’s consolidated commercial portfolio. It does not establish zero sales, because residual brand prescriptions or licensing income could exist. It does establish that Ceftin is not a separately disclosed financial driver.

Revenue exposure assessment

Financial metric	Current assessment
Brand revenue	Not separately disclosed
Generic market revenue	Distributed among multiple manufacturers
Brand gross-margin potential	Low relative to protected products
Pricing power	Minimal
Promotional spending rationale	Limited
Revenue growth outlook	Mature or declining
Acquisition value	Primarily supply-chain or portfolio value, not exclusivity value

What generic entry risks exist for Ceftin?

Generic entry risk is no longer prospective for Ceftin. It is an established market condition.

Generic launch scenarios

Scenario	Likely result
Additional tablet entrant	Further price pressure and lower incumbent share
Additional suspension entrant	Improved pediatric supply but lower pricing
Supplier exit	Temporary shortages or price stabilization
API disruption	Short-term availability pressure across manufacturers
Brand relaunch	Difficult economics without differentiation or supply advantage
New delivery technology	Limited commercial value unless it improves adherence, tolerability or dosing

The main risk for generic manufacturers is not patent litigation. It is margin compression, procurement concentration, manufacturing costs and intermittent shortages. For the former brand sponsor, the principal risk is continued loss of residual prescriptions to lower-cost alternatives.

What regulatory issues affect Ceftin?

Ceftin is regulated as a conventional small-molecule prescription drug. Generic versions generally use the ANDA pathway, which requires pharmaceutical equivalence and bioequivalence to the reference product rather than a new clinical-efficacy program. [5]

Key regulatory considerations include:

• Demonstrating the correct strength and dosage form.
• Meeting dissolution and quality specifications.
• Establishing bioequivalence for tablets.
• Controlling reconstitution and stability for suspension.
• Maintaining current labeling and safety information.
• Complying with current good manufacturing practice requirements.
• Managing antimicrobial stewardship and resistance concerns.

Cefuroxime axetil products may be affected by FDA manufacturing inspections, warning letters, recalls and drug-shortage conditions. These factors can influence market share more quickly than patent rights in a mature generic category.

Does Ceftin face biosimilar risk?

No. Biosimilar risk does not apply to Ceftin because cefuroxime axetil is a chemically synthesized small molecule, not a biologic. The relevant competitive pathway is generic substitution under the ANDA system.

This distinction matters for valuation. Ceftin does not require analysis of reference-biologic exclusivity, biosimilar interchangeability, patent dance litigation or biologic manufacturing comparability. Its competitive analysis centers on generic approvals, therapeutic equivalence, manufacturing reliability and reimbursement.

What patent litigation affects Ceftin?

Ceftin is not associated with a current high-value patent litigation profile comparable to newer branded drugs. Any historical patent disputes would have concerned the original cefuroxime axetil patent estate, generic entry rights or manufacturing processes. Those issues no longer create a credible long-term barrier to ordinary generic competition.

Current litigation risk is more likely to involve:

• Product liability claims.
• Manufacturing or contamination allegations.
• Supply agreements.
• Antitrust issues involving generic pricing or distribution.
• Regulatory enforcement.

There is no evident commercial basis for a new Paragraph IV litigation campaign against the legacy Ceftin brand. Paragraph IV challenges are relevant when a generic applicant seeks approval before expiration of listed patents. Ceftin’s market is already genericized, so a new Paragraph IV strategy would have limited value unless tied to a newly protected formulation or delivery system. [4][5]

How strong is the Ceftin patent estate?

The legacy patent estate is commercially weak because the product’s core exclusivity has expired and generic substitution is established.

Patent-estate factor	Assessment
Core molecule protection	Expired or commercially exhausted
Composition protection	No material current barrier identified
Formulation protection	Limited practical effect
Method-of-use protection	Limited after broad generic availability
Manufacturing know-how	Potential operational value, not broad market exclusivity
Litigation leverage	Low
Geographic value	Variable by country, but weak in the U.S.

International rights may have had different expiration dates and litigation histories. Country-specific commercial value depends on local patent law, regulatory approval, procurement systems and generic penetration. U.S. conclusions should not be applied automatically to Europe, Japan, emerging markets or private-pay markets.

How does Ceftin compare with newer antibiotics?

Ceftin has a lower commercial risk profile for investors and licensors because its patent cliff has already occurred. It also has limited upside.

Factor	Ceftin	Newly launched branded antibiotic
Patent protection	Largely exhausted	Potentially substantial
Generic competition	Established	Often absent initially
Pricing power	Low	Higher, subject to access controls
Clinical differentiation	Familiar oral cephalosporin	May depend on resistance or spectrum
Regulatory risk	Mature-product compliance	Approval and launch risk
Revenue visibility	Declining or fragmented	Potentially high but uncertain
Litigation exposure	Low patent exposure	Potentially significant

Ceftin can retain clinical relevance where physicians value its established safety profile, oral dosing and coverage profile. Clinical relevance does not translate into brand-level financial power once equivalent generics are widely available.

Key Takeaways

• Ceftin is the legacy brand for cefuroxime axetil, an oral second-generation cephalosporin approved by the FDA in 1987.
• Generic cefuroxime axetil has displaced the branded product in the U.S. market.
• The original patent and regulatory exclusivity periods are commercially exhausted.
• No current Ceftin patent estate creates a meaningful barrier to routine generic entry.
• Formulation and manufacturing complexity may affect supplier numbers, especially for oral suspension, but does not restore brand exclusivity.
• GSK does not separately disclose current Ceftin revenue.
• Ceftin has no biosimilar exposure because it is a small-molecule drug.
• Current market value lies in generic supply, manufacturing reliability and procurement position rather than branded pricing power.
• Future financial growth for the Ceftin brand is unlikely without a differentiated formulation, new delivery system or commercial relaunch.

FAQs

Is Ceftin still available in the United States?

Generic cefuroxime axetil is available in the United States. The branded Ceftin product has limited commercial presence compared with its historical role.

Is cefuroxime axetil the same as Ceftin?

Yes. Ceftin is the original brand name for cefuroxime axetil. Generic cefuroxime axetil products are intended to be therapeutically equivalent when assigned an FDA-equivalent rating.

Can a company launch a new Ceftin generic without a Paragraph IV lawsuit?

Potentially. If no relevant unexpired patents are listed, an applicant can generally pursue an ANDA without making a Paragraph IV certification. The applicable Orange Book entry and patent status control the filing strategy.

Does Ceftin have pediatric market value?

The oral suspension can retain pediatric demand because of dosing flexibility and administration needs. That value is limited by generic competition, supply reliability and the availability of other pediatric antibiotics.

Could Ceftin become valuable through a new formulation?

Only if the formulation delivers a material clinical or commercial advantage, such as improved taste, reduced dosing frequency, better stability or a distinct delivery profile. A reformulation would face new regulatory, patent and market-adoption requirements.

References

1. GSK. (2024). Annual report 2023. https://www.gsk.com/en-gb/investors/annual-report/

2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

3. U.S. Food and Drug Administration. (n.d.). Ceftin prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

5. U.S. Food and Drug Administration. (2024). Abbreviated new drug application (ANDA) process. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda