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

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
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-002	Approved Prior to Jan 1, 1982		DISCN	No	No

International Patents for NEGGRAM

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1000506
Netherlands	6705465
Belgium	611000
Sweden	306741

Negative Scenario and Fundamentals Analysis for NEGGRAM

Last updated: February 10, 2026

Overview
NEGGRAM is a pharmaceutical compound under development or certifiable status. This analysis evaluates the drug’s investment potential based on current fundamentals and potential market and regulatory risks.

Market Opportunity and Competitive Landscape

• The primary indication targeted by NEGGRAM influences overall market size. For instance, if intended for an infectious disease, the global market could reach billions, depending on prevalence.
• Competition analysis shows whether other drugs in the same class already dominate or are emerging. If NEGGRAM targets a well-penetrated market with established therapies, market penetration risks increase.
• Patent exclusivity period affects revenue potential. A patent expiring in less than 5 years presents limited lifetime revenue prospects.

Regulatory Risks

• The drug’s regulatory pathway could face hurdles if preclinical or clinical data are insufficient or if safety profiles reveal adverse effects.
• Negative early-phase trial results or failure to meet primary endpoints impact approval prospects.
• Regions such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) have stringent requirements; failure to meet these reduces commercial prospects significantly.

Development and Commercialization Timeline

• Estimated phases: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale validation). Delays at any stage extend time-to-market, increasing costs and lowering the net present value (NPV).
• Regulatory delays or requirement for additional trials raise costs and reduce cash flow projections.

Financial Fundamentals

• R&D costs: Estimated at $50-150 million through clinical phases, depending on the therapeutic area.
• Market entry costs include manufacturing, marketing, and distribution, typically adding 20-30% to development expenses.
• Revenue forecasts are volatile; if NEGGRAM fails clinical or regulatory hurdles, projected revenues collapse. No established market share is assumed unless the drug has already received approval or has significant pre-market sales.

Negative Financial Scenario	Parameter	Impact	Explanation
Clinical trial failure	Significant	Results showing lack of efficacy or safety concerns prevent approval.
Regulatory rejection	Critical	Missing approval deadlines or adverse agency decisions negate commercialization.
Market entry delays	Increased costs	Delays in approval extend cash burn and reduce overall project valuation.
Competitive pressures	Reduced market share	Established therapies with proven efficacy diminish NEGGRAM’s pricing power and adoption.
Patent challenges	Reduced exclusivity	Legal disputes or patent infringements can undermine market advantage.

Key Risks

• Clinical setbacks limit chances of approval; negative trial outcomes are common hurdles in drug development.
• Regulatory authorities may request additional data, increasing R&D expenses and timeline extensions.
• Market size and market dynamics depend heavily on therapeutic area acceptance; if competitors introduce superior therapies, NEGGRAM’s market share diminishes.
• Financial viability hinges on completing development within timeline projections; delays or failures lead to abnormal expenditures and negative cash flows.

Conclusion
Investing in NEGGRAM bears high risk absent positive clinical and regulatory outcomes. The fundamental risks outweigh potential returns if negative results emerge at any development phase. Market penetration becomes unlikely if competitors secure approval earlier or if its efficacy is inferior or unsafe.

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Key Takeaways

• NEGGRAM faces significant risks if clinical trials do not demonstrate safety and efficacy.
• Regulatory delays or rejection could render the investment non-viable.
• Market competition and patent challenges threaten potential revenue streams.
• The development timeline and costs are sensitive to trial outcomes, impacting valuation sharply.
• Negative scenarios emphasize the importance of stringent clinical validation and regulatory strategy.

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Frequently Asked Questions

1. What are the common reasons for clinical trial failure in drugs like NEGGRAM?
Clinical trial failures often occur due to lack of efficacy, unexpected adverse effects, or safety concerns identified during Phase 1 or Phase 2 studies.

2. How does regulatory approval influence NEGGRAM’s market potential?
Without regulatory approval, the drug cannot enter the market, negating revenue opportunities. Approval depends on meeting safety, efficacy, and quality standards set by agencies like the FDA and EMA.

3. What impact does competition have on NEGGRAM’s commercial prospects?
Established therapies with proven efficacy and long market presence diminish NEGGRAM’s chances for rapid market penetration and pricing power, especially if the new drug does not demonstrate clear advantages.

4. How do patent expirations affect NEGGRAM’s revenue potential?
Patent expiry shortens exclusivity, allowing competitors to introduce generics, which suppresses pricing and reduces revenue streams.

5. What are the key steps to mitigate negative investment scenarios for drugs like NEGGRAM?
Focus on comprehensive early-phase data to clarify safety and efficacy, develop a clear regulatory strategy, and engage with key opinion leaders to facilitate market acceptance.