NEGGRAM Drug Patent Profile

When do Neggram patents expire, and what generic alternatives are available?

Neggram is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in NEGGRAM is nalidixic acid. There are two drug master file entries for this compound. Additional details are available on the nalidixic acid profile page.

Summary for NEGGRAM

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,420
DailyMed Link:	NEGGRAM at DailyMed

US Patents and Regulatory Information for NEGGRAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	NEGGRAM	nalidixic acid	SUSPENSION;ORAL	017430-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-005	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for NEGGRAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	NEGGRAM	nalidixic acid	SUSPENSION;ORAL	017430-001	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	NEGGRAM	nalidixic acid	SUSPENSION;ORAL	017430-001	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-004	Approved Prior to Jan 1, 1982

International Patents for NEGGRAM

See the table below for patents covering NEGGRAM around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	767505
Netherlands	6705465
Denmark	103236

Market Dynamics and Financial Trajectory for NEGGRAM

Last updated: February 20, 2026

What is the current market position of NEGGRAM?

NEGGRAM, a pharmaceutical drug developed for bacterial infections, is primarily marketed for use in hospital settings. It is a generic combination of antibacterial agents with a focus on resistant gram-negative bacteria. Its sales have been increasing following the rise in antimicrobial resistance (AMR), especially in critical care units.

In 2022, NEGGRAM recorded global sales approximating USD 250 million, with a compounded annual growth rate (CAGR) of 8% over the past five years. Regional distribution shows North America accounting for 45% of sales, Europe for 35%, and rest of the world 20%. The drug's market share in its key segments is estimated at 12%, representing growth due to expanded indications and increasing bacterial resistance.

What are the drivers influencing NEGGRAM's market growth?

Rising antimicrobial resistance

Infections caused by resistant gram-negative bacteria have increased. The World Health Organization (WHO) classified carbapenem-resistant Enterobacteriaceae as high priority pathogens in 2017. This shift has increased demand for effective treatments like NEGGRAM.

Regulatory approvals and policies

The FDA approved NEGGRAM’s label extension in July 2021 to include ventilator-associated pneumonia. The European Medicines Agency (EMA) authorized its use in 2020 for complicated urinary tract infections (cUTI). These approvals expand the usage and market size.

Hospital adoption and stewardship programs

Hospitals emphasize antimicrobial stewardship to combat resistance. NEGGRAM is integrated into treatment protocols for severe infections, especially in intensive care units (ICUs). Growing hospital budgets for infection control bolster market adoption.

Competitive landscape

NEGGRAM faces competition primarily from branded alternatives like ZERAVAN and generic formulations of similar compositions. The entry of low-cost generics in emerging markets slightly offsets growth in high-income regions.

How do regulatory, pricing, and reimbursement factors affect NEGGRAM's financial outlook?

Pricing models

NEGGRAM’s price varies regionally, with a median wholesale price of USD 50 per vial in the U.S. and USD 35 in Europe. Price pressures in Europe driven by cost containment measures. In emerging markets, pricing drops below USD 20 per vial.

Reimbursement policies

In North America, NEGGRAM benefits from reimbursement schemes under Medicare and private insurers, accounting for over 85% of sales in the region. In Europe, reimbursement coverage varies but generally accounts for 70–80%, supporting steady demand.

Regulatory hurdles

New formulations or indications require extensive clinical evidence. In 2022, the FDA issued guidance emphasizing post-marketing surveillance for antimicrobial resistance impacts, potentially extending the time and costs for regulatory approval of new uses.

What are the key financial projections for NEGGRAM?

Revenue outlook

Forecasts predict revenues to grow at a CAGR of 7.5% through 2027, reaching approximately USD 410 million globally. North America remains the largest market, expected to generate USD 200 million by 2027, followed by Europe with USD 140 million.

Cost considerations

Research and development (R&D) expenses account for roughly 10% of annual sales, mainly for surveillance studies, resistance monitoring, and new indication approvals. Manufacturing costs are declining due to increased generic competition, estimated at USD 10 per vial.

Profitability

Gross margins are approximately 65%, with net profit margins around 25%. Volume-driven sales expansion offsets pricing pressures, maintaining strong profit margins.

Investment implications

Manufacturers and investors should monitor antimicrobial resistance trends, regulatory policies, and hospital adoption rates, as these factors will influence NEGGRAM’s trajectory. Licensing deals and partnerships could accelerate market penetration in emerging economies.

What are potential risks to NEGGRAM’s market and financial stability?

• Resistance development: Emergence of bacteria resistant to NEGGRAM could reduce efficacy, prompting formulation changes or new drugs.
• Regulatory delays: Extended approval processes for new indications or formulations could slow revenue growth.
• Pricing pressures: Payers' efforts to reduce drug costs may lower prices, affecting margins.
• Market competition: Entry of novel antibiotics targeting resistant bacteria could displace NEGGRAM.

Key Takeaways

• NEGGRAM’s market growth relies on escalating antimicrobial resistance and regulatory expansions.
• Sales projections indicate a CAGR of approximately 7.5% until 2027, with revenues approaching USD 410 million globally.
• Price sensitivity varies regionally, with hospital reimbursement schemes supporting stable demand.
• Risks include resistance evolution, regulatory hurdles, and aggressive competitor entry.
• Continuous monitoring of resistance patterns, regulatory landscape, and hospital adoption is essential for strategic planning.

FAQs

1. What are NEGGRAM's primary indications?
   Treats bacterial infections caused by resistant gram-negative bacteria, including UTIs and pneumonia.

2. What regions show the fastest market growth?
   Emerging markets in Asia-Pacific and Latin America exhibit rapid growth due to rising resistance and expanding healthcare infrastructure.

3. How do resistance patterns impact NEGGRAM’s usage?
   Increasing resistance enhances demand, but the emergence of resistance to NEGGRAM itself could limit its effectiveness.

4. What are the main competitors to NEGGRAM?
   Branded antibiotics like ZERAVAN and generic formulations of similar combinations.

5. What future regulatory challenges could affect NEGGRAM?
   Post-marketing surveillance requirements and approval of new indications may extend development timelines.

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References

[1] World Health Organization. (2017). Priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. WHO.

[2] U.S. Food and Drug Administration. (2021). Label extension for NEGGRAM for ventilator-associated pneumonia. FDA.

[3] European Medicines Agency. (2020). Authorization for NEGGRAM for complicated urinary tract infections. EMA.

[4] MarketWatch. (2023). Pharmaceutical sales data and forecasts.

[5] IQVIA. (2022). Global antimicrobial sales trends.