AXID Drug Patent Profile

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

Axid is a drug marketed by Smithkline Beecham, Braintree, and Haleon Us Holdings. and is included in three NDAs.

The generic ingredient in AXID is nizatidine. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nizatidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Axid

A generic version of AXID was approved as nizatidine by EPIC PHARMA LLC on July 5^th, 2002.

Summary for AXID

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	82
Patent Applications:	4,807
DailyMed Link:	AXID at DailyMed

Paragraph IV (Patent) Challenges for AXID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXID	Oral Solution	nizatidine	15 mg/mL	021494	1	2008-05-14

US Patents and Regulatory Information for AXID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988		DISCN	No	No
Haleon Us Holdings	AXID AR	nizatidine	TABLET;ORAL	020555-001	May 9, 1996		OTC	Yes	Yes
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988		DISCN	No	No

Expired US Patents for AXID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988
Braintree	AXID	nizatidine	SOLUTION;ORAL	021494-001	May 25, 2004

International Patents for AXID

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	42728
Denmark	164056
Australia	7594581

AXID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of H2 Receptor Antagonists: A Focus on Axid

Introduction

H2 receptor antagonists are a class of drugs widely used for the treatment of acid reflux diseases and peptic ulcers. One of the notable drugs in this category is Axid, which has been a part of the market landscape for several decades. This article will delve into the market dynamics and financial trajectory of H2 receptor antagonists, with a specific focus on Axid.

Market Overview of H2 Receptor Antagonists

The H2 receptor antagonist market is projected to grow from USD 4.21 billion in 2024 to USD 6.36 billion by 2031, at a compound annual growth rate (CAGR) of 6.1%[1].

Historical Context of Axid

Axid, also known as nizatidine, was introduced into the market after the pioneering H2 receptor antagonist, Tagamet (cimetidine), and the highly successful Zantac (ranitidine). When Axid entered the market, it faced significant competition from these established brands. Despite this, Axid managed to capture a modest market share.

Market Share and Sales

By the end of the sample period in May 1993, Axid held about a 9% market share, significantly lower than Zantac’s 55% and Tagamet’s 21%[4]. This indicates that while Axid was not as dominant as its predecessors, it still maintained a presence in the market.

Factors Influencing Market Dynamics

Increasing Prevalence of Gastroesophageal Reflux Disease

The growing prevalence of acid reflux diseases and peptic ulcers drives the demand for H2 receptor antagonists. However, this demand is also met by other classes of drugs, such as proton pump inhibitors (PPIs), which have become preferred for long-term management[1].

Generic Competition

The loss of patent exclusivity for many H2 receptor antagonists, including Axid, has led to the entry of generic versions. This has resulted in declining sales and profits for brand-name drugs. For instance, twelve quarters after generic entry, 18% of drugs had average per-unit reimbursement less than 50% of the original branded-drug reimbursement[5].

Regulatory Challenges

Strict regulatory processes have increased the costs and time involved in drug development and approval. This has made it challenging for new H2 receptor antagonists to enter the market, further impacting the financial trajectory of existing drugs like Axid[1].

Regional Market Performance

North America

North America, with a dominant market share of 36.9%, is a key region for H2 receptor antagonists. The strong presence of leading pharmaceutical companies and a highly developed healthcare infrastructure contribute to this dominance. However, the shift towards generic drugs and PPIs has affected the sales of brand-name H2 receptor antagonists in this region[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for H2 receptor antagonists. Factors such as modernizing healthcare systems, increasing healthcare spending, and the presence of prominent generic drug manufacturers in countries like India and China drive this growth. However, Axid, being an older drug, may not benefit as significantly from these trends as newer or more innovative treatments might[1].

Financial Trajectory of Axid

Sales Performance

Axid's sales peaked shortly after its introduction but declined as other competitors entered the market. By the end of the 1990s, Axid's market share had stabilized but remained relatively low compared to other H2 receptor antagonists. The financial performance of Axid has been impacted by the generic competition and the preference for PPIs in long-term acid reflux management[4].

Pricing Dynamics

The pricing of Axid has been influenced by the entry of generic versions. The real price of Axid, like other H2 receptor antagonists, has decreased over time. For example, the price of Tagamet, another H2 receptor antagonist, decreased from about $1 per day at entry to $0.80 per day when Zantac entered the market. Similar pricing pressures have affected Axid[4].

Market Opportunities and Challenges

Research and Development

The market for H2 receptor antagonists, including Axid, faces challenges in terms of research and development. Finding new therapeutic areas and undergoing additional clinical trials are crucial for growth in this maturing market. However, the high costs and time involved in these processes pose significant barriers[1].

Novel Drug Delivery Formulations

The approval and launch of novel drug delivery formulations, such as orally disintegrating tablets, offer opportunities for growth. These formulations can enhance patient compliance and satisfaction, potentially reviving interest in older drugs like Axid[1].

Key Players and Competitive Landscape

Major Pharmaceutical Companies

Companies like AstraZeneca, GlaxoSmithKline (GSK), Pfizer Inc., and Johnson & Johnson are key players in the H2 receptor antagonist market. These companies have the infrastructure and resources to develop new formulations and maintain market presence despite generic competition[1].

Future Outlook

Market Growth Projections

Despite the challenges, the H2 receptor antagonist market is expected to witness steady growth over the forecast period. The increasing prevalence of gastrointestinal disorders and the ongoing modernization of healthcare systems in emerging markets will drive this growth[1].

Impact of Generic Drugs

The shift towards generic drugs will continue to affect the financial trajectory of brand-name H2 receptor antagonists like Axid. However, the large patient pool and the need for effective treatments will ensure that these drugs remain relevant, albeit with reduced market share and profits[1].

Key Takeaways

• The H2 receptor antagonist market, including Axid, is driven by the increasing prevalence of acid reflux diseases and peptic ulcers.
• Generic competition and the preference for PPIs are significant challenges.
• Novel drug delivery formulations offer opportunities for growth.
• The Asia Pacific region is the fastest-growing market for H2 receptor antagonists.
• Strict regulatory processes and high development costs are barriers to new drug entries.

FAQs

What is the current market size of H2 receptor antagonists?

The H2 receptor antagonist market is estimated to be valued at USD 4.21 billion in 2024[1].

What is the projected growth rate of the H2 receptor antagonist market?

The market is expected to grow at a CAGR of 6.1% from 2024 to 2031[1].

Why is Axid's market share lower compared to other H2 receptor antagonists?

Axid's market share is lower due to the strong competition from pioneering drugs like Tagamet and Zantac, as well as the subsequent entry of other competitors like Pepcid[4].

How has generic competition affected Axid's sales?

Generic competition has led to a decline in Axid's sales and profits, as generic versions offer cheaper alternatives to brand-name drugs[1].

What are the key regions driving the growth of the H2 receptor antagonist market?

North America and the Asia Pacific region are the key drivers of growth, with North America being the dominant region and the Asia Pacific being the fastest-growing[1].

Sources

1. Coherent Market Insights: H2 Receptor Antagonist Market Size & Share Analysis - Growth Trends.
2. Eli Lilly and Company: Answers for Shareholders 2005.
3. PR Newswire: Psychedelic Drugs Market to Grow by USD 1.37 Billion from 2024.
4. MIT: CONSUMPTION EXTERNALITIES AND DIFFUSION IN THE MARKET FOR H2-ANTAGONIST DRUGS.
5. ResearchGate: Firm- and Drug-Specific Patterns of Generic Drug Payments by US Medicaid Programs 1991-2008.