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:	133
Patent Applications:	3,910
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
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-002	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	TABLET;ORAL	014214-004	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	014214-002	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-005	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	NEGGRAM	nalidixic acid	SUSPENSION;ORAL	017430-001	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
Sweden	306741
Netherlands	6705466
Belgium	611000
Netherlands	6705465
Brazil	6134479
Belgium	767505
Germany	1445153	1,2,3,4,5,6-HEXAHYDRO-3-(3-METHYL-2BUTENYL)-6,11-DIMETHYL-8-HYDROXY-2,6METHANO-3-BENZAZOCIN, SEINE SAEUREADDITIONSSALZE UND VERFAHREN ZU IHRER HERSTELLUNG

NEGGRAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NegGram

Introduction to NegGram

NegGram, also known as nalidixic acid, is an antibacterial drug primarily effective against Gram-negative bacteria, with minor activity against Gram-positive bacteria. It is administered orally and is used to treat various bacterial infections.

Clinical Use and Pharmacology

NegGram is rapidly absorbed from the gastrointestinal tract, partially metabolized in the liver, and excreted through the kidneys. The drug and its active metabolite, hydroxynalidixic acid, exhibit antibacterial activity, with peak serum levels occurring one to two hours after administration[4].

Market Position

Competitive Landscape

The antibacterial drug market is highly competitive, with numerous alternatives available, including oral, injectable, and transdermal systems. NegGram faces competition from other antibacterial drugs that may offer more reliable or effective outcomes in certain conditions. This competitive pressure can limit the market share of NegGram and other topical or oral antibacterial drugs[3].

Regulatory Landscape

The development and commercialization of NegGram, like other pharmaceuticals, are heavily regulated. Stringent rules concerning the safety and efficacy of novel drug formulations can sometimes delay commercialization, posing a significant burden on pharmaceutical companies, especially those with limited resources[3].

Financial Trajectory

Revenue and Sales

Historical data on NegGram's sales is not as readily available as that for newer or more widely used drugs. However, the financial performance of pharmaceutical companies that produce antibacterial drugs can provide some insights. For instance, the overall market for antibacterial drugs is influenced by factors such as the prevalence of bacterial infections, resistance to antibiotics, and regulatory approvals.

Cost and Pricing

The cost of NegGram can vary based on the region, healthcare system, and availability of generic versions. Generally, the pricing of antibacterial drugs is influenced by production costs, research and development investments, and market demand.

Challenges and Opportunities

Resistance to Antibiotics

One of the significant challenges facing NegGram and other antibacterial drugs is the increasing resistance to antibiotics. This resistance can reduce the effectiveness of these drugs, leading to a decline in their use and sales[4].

Technological Advancements

Technological advancements in drug formulations and delivery systems present opportunities for NegGram. Innovations in drug delivery, such as improved oral formulations or combination therapies, could enhance the drug's efficacy and convenience, potentially increasing its market share[3].

Side Effects and Safety Concerns

NegGram is associated with several side effects, including reversible subjective visual disturbances, headache, dizziness, and vertigo. Rare but serious side effects include toxic psychosis and convulsions, particularly in patients with predisposing factors such as epilepsy or cerebral arteriosclerosis[4].

Market Trends

Increasing Incidences of Bacterial Infections

The rising incidence of bacterial infections, including those resistant to antibiotics, drives the demand for effective antibacterial drugs like NegGram. However, this trend is also complicated by the need for responsible use to prevent further resistance[3].

Preference for Non-Invasive Therapeutics

While NegGram is an oral drug, the broader trend towards non-invasive therapeutics can influence its market position. Patients increasingly prefer drug delivery systems that are convenient and avoid the complexities of injections or other invasive methods[3].

Regional Analysis

The market for antibacterial drugs, including NegGram, varies by region. North America, with its sophisticated healthcare infrastructure and substantial R&D investments, is a significant market. However, emerging markets in regions like APAC also present growth opportunities due to increasing healthcare spending and a growing preference for advanced therapeutic options[3].

Key Players and Market Share

NegGram is one of the products in the portfolio of companies that specialize in antibacterial drugs. Key players in the broader pharmaceutical market include companies like Bayer AG, Novartis AG, and GlaxoSmithKline PLC. The market share of NegGram would depend on its competitive positioning within the antibacterial segment and the overall strategy of its manufacturer[3].

Future Outlook

The future outlook for NegGram is influenced by several factors, including the development of antibiotic resistance, technological advancements in drug delivery, and regulatory changes. Here are some key points:

• Antibiotic Resistance: The ongoing challenge of antibiotic resistance will continue to impact the effectiveness and market position of NegGram.
• Technological Innovations: Improvements in drug formulations and delivery systems could enhance the drug's efficacy and market appeal.
• Regulatory Environment: Changes in regulatory policies and safety guidelines will continue to shape the market dynamics for NegGram and other antibacterial drugs[3].

Key Takeaways

• Competitive Landscape: NegGram operates in a highly competitive market with various alternatives available.
• Regulatory Challenges: Stringent regulations can delay commercialization and impact market growth.
• Technological Advancements: Innovations in drug delivery can enhance the drug's efficacy and market position.
• Antibiotic Resistance: Increasing resistance to antibiotics is a significant challenge.
• Regional Variations: Market dynamics vary by region, with North America and emerging markets presenting different opportunities.

FAQs

Q: What is NegGram primarily used for? A: NegGram, or nalidixic acid, is primarily used to treat bacterial infections, particularly those caused by Gram-negative bacteria.

Q: How is NegGram administered? A: NegGram is administered orally.

Q: What are the common side effects of NegGram? A: Common side effects include reversible subjective visual disturbances, headache, dizziness, and vertigo. Rare but serious side effects include toxic psychosis and convulsions.

Q: What are the key challenges facing NegGram in the market? A: Key challenges include antibiotic resistance, competitive pressure from alternative drug delivery systems, and stringent regulatory requirements.

Q: How does the regulatory environment impact NegGram? A: The regulatory environment can delay commercialization and impact market growth due to stringent rules concerning the safety and efficacy of novel drug formulations[3][4].

Sources

1. Wikipedia - Nalidixic acid
2. Seeking Alpha - Financial Collapse And Further Headwinds Ahead (NASDAQ:NEGG)
3. GlobeNewswire - Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031
4. FDA - NegGram Caplets - accessdata.fda.gov