MAXIPIME Drug Patent Profile

When do Maxipime patents expire, and when can generic versions of Maxipime launch?

Maxipime is a drug marketed by Hospira Inc and is included in one NDA.

The generic ingredient in MAXIPIME is cefepime hydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Maxipime

A generic version of MAXIPIME was approved as cefepime hydrochloride by ACS DOBFAR on March 20^th, 2008.

Summary for MAXIPIME

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	6
Patent Applications:	7,154
Drug Prices:	Drug price information for MAXIPIME
DailyMed Link:	MAXIPIME at DailyMed

See drug prices for MAXIPIME

Recent Clinical Trials for MAXIPIME

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Assiut University	Phase 2/Phase 3
Yasser Esmat Mohammed	Phase 2/Phase 3
Acellena Contract Drug Research and Development	Phase 2

See all MAXIPIME clinical trials

US Patents and Regulatory Information for MAXIPIME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira Inc	MAXIPIME	cefepime hydrochloride	INJECTABLE;INJECTION	050679-002	Jan 18, 1996		DISCN	Yes	No
Hospira Inc	MAXIPIME	cefepime hydrochloride	INJECTABLE;INJECTION	050679-003	Jan 18, 1996		DISCN	Yes	No
Hospira Inc	MAXIPIME	cefepime hydrochloride	INJECTABLE;INJECTION	050679-001	Jan 18, 1996		DISCN	Yes	No

MAXIPIME Market Dynamics and Financial Trajectory: Cefepime, Generic Competition, and Commercial Outlook

Last updated: August 18, 2026

MAXIPIME is the original branded formulation of cefepime, a fourth-generation cephalosporin antibiotic. Its commercial trajectory has shifted from branded hospital sales to a mature, multisupplier generic market. Core patent protection and regulatory exclusivity have expired, and no material current revenue stream is publicly reported for the MAXIPIME brand. Commercial value now resides primarily in generic cefepime injection, hospital supply reliability, government procurement, and infection-driven demand.

What is MAXIPIME and how is cefepime used?

MAXIPIME contains cefepime hydrochloride, a parenteral cephalosporin used for serious bacterial infections. The drug is administered intravenously or intramuscularly and is used in hospitals for conditions including:

• Pneumonia, including hospital-acquired and bacterial pneumonia
• Febrile neutropenia and empiric treatment of high-risk infections
• Complicated and uncomplicated urinary tract infections
• Complicated skin and skin-structure infections
• Complicated intra-abdominal infections in combination with metronidazole
• Severe infections caused by susceptible Gram-negative and Gram-positive organisms

Cefepime has activity against many Enterobacterales and Pseudomonas aeruginosa strains. Its clinical value is constrained by antimicrobial resistance, local susceptibility patterns, renal dosing requirements, and the risk of neurotoxicity in patients with impaired renal function. The FDA label requires dose adjustment in renal impairment and identifies encephalopathy, myoclonus, and seizures as important safety risks associated with excessive exposure.[1]

MAXIPIME was originally developed and commercialized by Bristol-Myers Squibb. The product received U.S. approval in the 1990s and became an established inpatient antibiotic before generic cefepime entered the market.

What is the current market status of MAXIPIME?

MAXIPIME is commercially mature and no longer has the economic profile of a protected branded pharmaceutical.

Market attribute	Current position
Active ingredient	Cefepime hydrochloride
Therapeutic class	Fourth-generation cephalosporin
Primary dosage form	Injectable powder for solution
Main setting	Hospital and institutional care
U.S. market structure	Generic-dominated
Core patent position	Expired
FDA exclusivity	Expired
Retail exposure	Limited
Revenue disclosure	No material standalone MAXIPIME revenue reported by the originator
Main commercial drivers	Hospital purchasing, tenders, supply reliability, resistance patterns, and shortages

MAXIPIME competes with generic cefepime products supplied by multiple manufacturers. In this market, prescribers and hospital pharmacies often select products through formulary contracts, group purchasing organizations, distributor arrangements, and government tenders rather than through brand preference.

The brand can retain residual clinical recognition, but that recognition does not usually translate into premium pricing. Hospitals generally treat cefepime as a multisource injectable generic.

When did MAXIPIME lose exclusivity?

MAXIPIME lost its principal commercial protection after the expiration of its original patent and regulatory exclusivity. Generic cefepime products subsequently entered the U.S. market, eliminating the originator’s ability to maintain a sustained branded price premium.

The exact commercial impact of generic entry was greater than the impact of a single patent expiry because hospital injectables are typically exposed to rapid price competition once several approved suppliers become available. Cefepime has no active market exclusivity comparable to a newly approved antibacterial product.

MAXIPIME exclusivity timeline

Period	Commercial event	Market effect
1990s	FDA approval and branded launch	Establishment of cefepime as a hospital antibiotic
Early commercial period	MAXIPIME supplied primarily by the originator	Branded pricing and formulary adoption
Generic-entry period	FDA-approved generic cefepime injections become available	Price erosion and supplier substitution
Mature generic period	Multiple manufacturers compete for institutional contracts	Commodity pricing and procurement-driven share
Current market	Cefepime demand continues, but MAXIPIME has limited standalone economic relevance	Value shifts to manufacturing scale and supply continuity

No active patent-based barrier prevents generic cefepime competition in the United States. Patent rights that once protected the product are no longer the principal determinant of market access.

What patents protect MAXIPIME?

The commercially important MAXIPIME patent estate is no longer a meaningful barrier to generic cefepime entry.

Composition and active-ingredient protection

Cefepime was protected by historical compound and development patents. Those rights expired after the statutory patent term, including any applicable adjustments or extensions. Generic manufacturers have been able to develop and market cefepime injection without needing a license from the originator for the expired core technology.

Formulation patents

Cefepime injection is a relatively conventional sterile powder product. Formulation and manufacturing patents may cover specific excipient systems, container configurations, reconstitution characteristics, or processes, but those rights do not prevent competition with standard cefepime products once the core drug protection has expired.

The most relevant formulation barriers today are technical and regulatory rather than patent-based. Manufacturers must demonstrate sterile manufacturing capability, product stability, compatibility, container closure integrity, and acceptable performance after reconstitution.

Method-of-use patents

Historical method-of-use protection for cefepime has limited current commercial significance. Treatment indications reflected in the FDA label are generally available to generic manufacturers through the abbreviated new drug application pathway, subject to applicable labeling and patent certification requirements.

Any remaining method-of-use patent would need to be evaluated product by product in FDA Orange Book listings and court records. There is no widely recognized active method-of-use patent that protects the broader cefepime hospital market from generic competition.

What is the Orange Book status of MAXIPIME?

The Orange Book framework is relevant to MAXIPIME because generic cefepime applicants used the abbreviated new drug application pathway. The product’s core patents and regulatory exclusivities are expired, so Orange Book-listed rights do not create a current barrier to generic cefepime supply.

MAXIPIME’s commercial status should be distinguished from the approval status of cefepime generics. A discontinued or commercially inactive brand does not imply that cefepime has lost FDA approval. FDA-approved generic cefepime products remain available from multiple suppliers, although individual products may be discontinued, temporarily unavailable, or subject to manufacturing changes.

The practical Orange Book conclusion is:

1. MAXIPIME has no current exclusivity that supports premium branded pricing.
2. Generic cefepime applicants can compete through ANDAs.
3. Any product-specific patent listing must be reviewed against the relevant NDA or ANDA record.
4. FDA approval of generic cefepime is separate from continued commercial promotion of the MAXIPIME brand.

Which companies compete with MAXIPIME?

The competitive market is composed primarily of generic injectable cefepime suppliers. Manufacturers and labelers have included large hospital-product companies, specialty generic manufacturers, and contract manufacturing organizations.

Representative competitive groups include:

• Fresenius Kabi
• Hikma Pharmaceuticals
• Sandoz and other Novartis-related generic operations
• Eugia or Aurobindo-affiliated entities
• Qilu Pharmaceutical
• WG Critical Care
• Sagent Pharmaceuticals and successor operations
• Other ANDA holders and contract suppliers

The exact supplier set changes as companies discontinue products, transfer abbreviated applications, adjust manufacturing networks, or respond to shortages.

Competitive differentiation

Cefepime products are generally differentiated by:

• Approved vial strengths
• Single-dose and pharmacy bulk presentations
• Reconstitution instructions
• Shelf life and storage requirements
• Availability of premixed or ready-to-administer presentations
• Contract pricing
• Back-order performance
• Manufacturing-site reliability
• Ability to supply government and group-purchasing contracts

Clinical differentiation among FDA-approved generic cefepime injections is limited when products meet applicable quality and bioequivalence requirements. Procurement performance often has greater commercial importance than brand positioning.

How strong is the MAXIPIME patent estate?

The current patent estate is weak as a commercial defense because the principal composition and product protections have expired.

Patent-estate factor	Assessment
Core compound protection	Expired
Regulatory exclusivity	Expired
Generic substitution risk	Very high
Formulation differentiation	Limited
Manufacturing know-how	Relevant but generally nonexclusive
Litigation leverage	Low for the originator
Pricing power	Low
Supply-chain value	High relative to patent value

Manufacturing know-how still matters. Sterile beta-lactam production requires validated facilities, containment controls, aseptic processing, quality systems, and reliable supply of active pharmaceutical ingredient. These requirements can limit the number of dependable suppliers, but they do not recreate patent exclusivity.

The main barrier to entry is therefore operational. A company may obtain FDA approval yet remain commercially weak if it cannot maintain production, meet demand spikes, or secure hospital contracts.

What generic entry risks exist for MAXIPIME?

Generic entry risk is no longer prospective. It has already materialized and defines the market.

The principal risks to the MAXIPIME brand are:

• Therapeutic substitution by generic cefepime
• Hospital formulary exclusion
• Contracting pressure from group purchasing organizations
• Limited physician sensitivity to the originator brand
• Low willingness to pay for branded injectable cefepime
• Product discontinuation by the originator
• Replacement by other broad-spectrum hospital antibiotics where clinically appropriate

For generic manufacturers, the main commercial risks are different:

• Price compression after additional entrants
• FDA manufacturing observations
• Drug shortages
• Dependence on a small number of API suppliers
• Hospital contract losses
• Antimicrobial stewardship restrictions
• Reduced demand from lower infection volumes or narrower prescribing

What is the financial trajectory of MAXIPIME?

MAXIPIME’s financial trajectory follows the standard life cycle of an injectable small-molecule antibiotic:

1. Branded launch and hospital adoption
2. Expansion through infectious-disease and oncology-related use
3. Patent expiry and generic entry
4. Rapid price erosion
5. Decline in originator sales
6. Mature generic market with low unit margins
7. Revenue concentration among reliable suppliers

Bristol-Myers Squibb does not report MAXIPIME as a material standalone revenue product in its recent public financial disclosures. The company’s financial reporting is organized around larger brands and business segments, and MAXIPIME is no longer a significant contributor to consolidated revenue.[2]

Financial profile by market phase

Phase	Revenue characteristic	Margin profile
Branded exclusivity	Higher price per vial and stronger hospital brand recognition	Attractive branded margins
Early generic competition	Rapid volume migration and price reduction	Margin compression
Mature generic market	High unit volume but low average selling price	Low to moderate margins
Shortage periods	Temporary price and volume improvement for available suppliers	Volatile
Current originator position	Minimal or undisclosed standalone revenue	No meaningful strategic pricing power

Public financial data generally do not isolate global cefepime sales by manufacturer. Generic companies report portfolios or business segments rather than product-level revenue. As a result, the cefepime market can be assessed through FDA approvals, shortage records, procurement activity, hospital demand, and company commentary, but not through a reliable publicly reported global revenue series for MAXIPIME itself.

What market factors determine cefepime demand?

Cefepime demand is linked to hospital utilization rather than consumer prescription growth.

Clinical demand

Demand rises when hospitals treat:

• Severe Gram-negative infections
• Suspected Pseudomonas infections
• Febrile neutropenia
• Hospital-acquired pneumonia
• Complicated urinary and intra-abdominal infections

Use is constrained by antimicrobial stewardship programs, which seek to limit unnecessary broad-spectrum antibiotic exposure. Resistance patterns also affect local formulary placement. Cefepime may gain use when susceptibility data support it, but can lose share to carbapenems, piperacillin-tazobactam, ceftazidime, newer beta-lactam/beta-lactamase inhibitor combinations, or other agents.

Supply and procurement

Injectable cefepime is exposed to hospital supply-chain risk. A manufacturing interruption, API shortage, quality investigation, or regulatory action can move volume rapidly among suppliers. During shortage periods, manufacturers with available inventory can gain temporary share, but those gains may not persist after supply normalizes.

Hospitals usually evaluate cefepime suppliers on delivered cost, fill rate, back-order history, quality record, vial configuration, and contract terms. This makes supply reliability a central commercial asset.

How does MAXIPIME compare with competing antibiotics?

Drug	Class	Typical competitive role	Commercial position
Cefepime	Fourth-generation cephalosporin	Broad hospital Gram-negative coverage, including many Pseudomonas strains	Mature generic
Piperacillin-tazobactam	Penicillin plus beta-lactamase inhibitor	Broad empiric inpatient therapy	Mature generic
Ceftazidime	Third-generation cephalosporin	Gram-negative and Pseudomonas coverage	Mature generic
Meropenem	Carbapenem	Serious resistant Gram-negative infections	Generic, often reserved
Cefiderocol	Siderophore cephalosporin	Selected highly resistant Gram-negative infections	Newer branded product
Ceftolozane-tazobactam	Cephalosporin plus beta-lactamase inhibitor	Resistant Pseudomonas and complicated infections	Branded or specialty-priced
Cefepime-enmetazobactam	Cephalosporin combination	Selected resistant bacterial infections	Newer competitive category

Cefepime remains economically competitive because generic pricing is low and hospital familiarity is high. Newer agents can command higher prices but are generally reserved for resistant infections or defined clinical circumstances.

What patent litigation and Paragraph IV challenges affect MAXIPIME?

There is no current high-value patent litigation or active Paragraph IV dispute that materially changes the U.S. commercial outlook for MAXIPIME. Paragraph IV challenges were relevant during the historical transition from branded cefepime to generic entry. They are no longer the central competitive issue because generic cefepime is established in the market and the original protection has expired.

Any new dispute would more likely concern:

• A specific generic manufacturer’s manufacturing process
• A container or device configuration
• Supply or quality claims
• Product liability
• Hospital contracting
• Regulatory compliance

Such disputes would not ordinarily restore broad exclusivity for cefepime.

Are there licensing deals involving MAXIPIME?

No current licensing arrangement is publicly identified as a material driver of MAXIPIME economics. Historical commercialization was associated with Bristol-Myers Squibb, but the brand’s present commercial value does not appear to depend on an active royalty-bearing license that controls generic cefepime.

Generic manufacturers may use contract manufacturing, API supply agreements, distribution arrangements, and application transfers. These transactions affect individual suppliers but do not create market-wide exclusivity.

What is the geographic coverage of MAXIPIME?

Cefepime has been marketed in multiple jurisdictions under MAXIPIME and other brand or generic names. The economic center of gravity is institutional procurement in the United States and other developed healthcare markets.

Geographic commercial conditions differ:

• United States: multisource generic market with hospital contracting and FDA supply oversight
• Europe: generic hospital market with national reimbursement and tender systems
• Emerging markets: broader brand and generic variation, with local registration and procurement rules
• Low- and middle-income markets: access depends on sterile manufacturing capacity, public tenders, and import controls

Patent expiry has generally made cefepime accessible to multiple manufacturers globally. Local regulatory approval, GMP compliance, and tender qualification remain important market-entry requirements.

What is the outlook for MAXIPIME and cefepime?

The MAXIPIME brand has limited standalone growth potential. The cefepime market should remain stable but mature, with demand supported by continued hospital use and constrained by stewardship and generic pricing.

The most likely commercial trajectory is:

• Flat or declining branded revenue
• Continued generic substitution
• Low average selling prices
• Periodic supply-driven price volatility
• Greater value for manufacturers with dependable sterile capacity
• Limited benefit from additional brand marketing
• Continued clinical relevance in empiric and targeted inpatient therapy

Cefepime is unlikely to generate a new branded-growth cycle without a differentiated delivery system, combination product, or regulatory strategy that creates new exclusivity. The higher-value opportunities are more likely to involve resistant-pathogen combinations, ready-to-administer hospital presentations, or supply-chain consolidation than the legacy MAXIPIME brand.

Key Takeaways

• MAXIPIME is the original branded cefepime injection product.
• Its core patents and regulatory exclusivity have expired.
• Generic cefepime dominates the U.S. hospital market.
• Bristol-Myers Squibb does not publicly report material standalone MAXIPIME revenue in recent filings.
• Current commercial competition centers on price, sterile manufacturing, supply reliability, and hospital contracting.
• The originator patent estate provides little present defensive value.
• Paragraph IV litigation and branded patent disputes are no longer major market drivers.
• Cefepime demand remains tied to severe hospital infections, Pseudomonas coverage, febrile neutropenia, and local resistance patterns.
• Generic suppliers face operational and regulatory barriers, but not meaningful market-wide patent barriers.
• The brand’s financial outlook is declining or immaterial, while generic cefepime remains a stable, low-margin hospital product.

FAQs

Is MAXIPIME still available in the United States?

Cefepime remains available through FDA-approved generic injectable products. Availability of the original MAXIPIME brand can vary by distributor and manufacturer status.

Is cefepime a biologic or a small-molecule drug?

Cefepime is a small-molecule antibacterial drug. Biosimilar regulation does not apply. Competition occurs through generic drug applications rather than biosimilar applications.

Can a generic manufacturer launch cefepime without a MAXIPIME license?

Yes. Generic cefepime manufacturers can rely on the abbreviated new drug application pathway after expiration of applicable patent and exclusivity protections. A license from the originator is not generally required for standard generic entry.

Does cefepime have revenue potential outside the hospital market?

Its principal demand is institutional. Outpatient revenue potential is limited because cefepime requires parenteral administration and is generally used for serious infections managed in hospitals or structured infusion settings.

What could increase the value of a new cefepime product?

A new product could improve commercial value through reduced preparation time, extended stability, ready-to-administer packaging, differentiated combination therapy, improved renal dosing utility, or a regulatory exclusivity strategy. Standard cefepime injection alone has limited pricing power.

References

1. U.S. Food and Drug Administration. (2023). Maxipime (cefepime hydrochloride) for injection prescribing information. FDA.

2. Bristol-Myers Squibb Company. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

4. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. FDA.

5. U.S. Food and Drug Administration. (2024). Drug shortages database. FDA.

6. Centers for Disease Control and Prevention. (2022). COVID-19: U.S. impact on antimicrobial resistance, special report 2022. U.S. Department of Health and Human Services.