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
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
Braintree	AXID	nizatidine	SOLUTION;ORAL	021494-001	May 25, 2004		DISCN	Yes	No

Expired US Patents for AXID

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

International Patents for AXID

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	15987	IMPROVEMENTS IN OR RELATING TO 2,4-DISUBSTITUTED THIAZOLE DERIVATIVES
Norway	813334
Denmark	435181
World Intellectual Property Organization (WIPO)	2004009077

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AXID

Last updated: July 27, 2025

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Introduction

AXID (nizatidine) is an over-the-counter (OTC) and prescription medication historically used for the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, and other acid-related disorders. As a histamine-2 receptor antagonist (H2RA), AXID shares its class with drugs like ranitidine and famotidine. Recent market shifts, regulatory changes, and evolving consumer preferences substantially influence the drug’s market dynamics and financial trajectory.

This analysis examines the current landscape of AXID, its competitive positioning, regulatory environment, market trends, and future outlook, with insights valuable for stakeholders considering investment, licensing, or strategic development.

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Market Overview and Historical Context

AXID was introduced in the 1980s and gained significant market share as a safer alternative to older medications such as cimetidine. It became available both via prescription and OTC, expanding its accessibility. Its mechanism—selective H2 receptor blockade—effectively reduces gastric acid secretion, maintaining its therapeutic relevance.

Until early 2020, AXID exhibited consistent sales, buoyed by familiarity among clinicians and patients, alongside minimal generic competition. However, recent events, notably the recall of ranitidine in 2019 due to contamination concerns, caused a surge in demand for alternative H2 modulators, positioning drugs like AXID as potential substitutes.

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Market Dynamics

Regulatory Shifts and Safety Concerns

The pharmaceutical landscape for AXID has been significantly influenced by regulatory agencies' safety evaluations. The U.S. Food and Drug Administration (FDA) issued warnings regarding potential carcinogenic nitrosamine impurities in some H2RAs, including ranitidine. While AXID has not faced similar recalls, increased regulatory scrutiny around safety and quality control has been observed.

Additionally, the global move away from longstanding medications due to safety concerns has pressured manufacturers to ensure rigorous testing, impacting production costs and regulatory timelines.

Competitive Landscape

The rise of proton pump inhibitors (PPIs) like omeprazole and lansoprazole has challenged H2RAs, including AXID, particularly for acid suppression efficacy. PPIs exhibit superior potency and longer duration of action, leading to their dominance in the treatment hierarchy for GERD and erosive esophagitis.

Nevertheless, H2RAs maintain market relevance due to their favorable safety profile, lower cost, and reduced drug-drug interactions compared to PPIs. This niche sustains market segments, especially among populations requiring maintenance therapy or those contraindicated for PPIs.

Generic and OTC Market Trends

The patent expirations of original formulations of AXID around 2000 have resulted in extensive generic availability, driving down prices. The OTC availability further expanded user access, but also intensified price competition.

Recent manufacturing consolidations and supply chain disruptions—exacerbated by COVID-19—have occasionally led to shortages of H2RAs, impacting sales and availability, especially in the OTC segment.

Emerging Therapeutic Trends

Innovative therapeutics such as alginate-based formulations, novel acid reducers, and advanced probiotics are emerging as alternatives for acid-related disorders. These trends, coupled with patient preference shifts toward natural remedies, could influence demand for traditional medications like AXID.

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Financial Trajectory and Market Projections

Current Revenue and Market Share

Preliminary data indicates that AXID’s global revenues have experienced a decline over the past decade owing to the ascendancy of PPIs and generics' commoditization. However, in niche segments—such as maintenance therapy, elderly care, and OTC markets—AXID retains a modest but stable share.

In 2021, estimates suggest global sales in the range of $200-$300 million, predominantly driven by the OTC segment and in markets with limited PPI penetration.

Growth Drivers

• Increased Patients with Acid Disorders: Rising prevalence of GERD and peptic ulcers, driven by obesity and lifestyle factors, sustain demand for acid reducers like AXID.
• OTC Market Expansion: The push for accessible, low-cost medications bolsters OTC sales, especially in emerging markets.
• Product Line Extensions: Formulations such as dual-release tablets or combination therapies with probiotics could enhance market appeal.

Challenges and Risks

• Market Share Erosion: PPI dominance and safety concerns may restrict AXID’s growth.
• Regulatory Risks: Stringent safety evaluations could lead to restrictions or requirement of additional safety data.
• Pricing Pressures: Intense generic competition exerts downward pressure on margins.
• Supply Chain Disruptions: Manufacturing constraints could impact availability, especially in OTC channels.

Future Outlook

Analysts project a compounded annual decline (CAD) rate of approximately 2-4% over the next five years for AXID’s core markets, with potential stabilization in niche segments. However, strategic repositioning through product innovation and market diversification could mitigate declines.

Opportunities include expanding in emerging markets where OTC infrastructure is developing, and leveraging brand loyalty among existing users.

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Strategic Considerations

• Lifecycle Management: Developing new formulations or combination therapies to extend patent life and market appeal.
• Market Diversification: Leveraging AXID’s safety profile to target specific patient populations or for adjunct therapy.
• Regulatory Engagement: Maintaining proactive dialogue with health authorities to pre-empt safety issues and facilitate approvals for new claims.
• Manufacturing Optimization: Ensuring high-quality quality control to retain regulatory confidence and prevent disruptions.

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Conclusion

AXID’s market landscape is characterized by mature generics, regulatory scrutiny, and competition from PPIs. While current revenues stabilize around modest levels, opportunities exist in niche markets and emerging regions. The drug’s future viability hinges on strategic innovations, regulatory navigation, and market adaptation, especially in the context of evolving therapeutic options and safety paradigms.

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Key Takeaways

• AXID remains relevant primarily through its safety profile and OTC availability but faces ongoing challenges from PPI dominance and generics.
• Regulatory safety concerns continue to influence the market, necessitating rigorous quality control and proactive engagement.
• The declining trend in global sales is expected to persist; however, niche markets and emerging markets offer growth opportunities.
• Strategic product development and market diversification are essential to sustain financial performance.
• Cost pressures and supply chain stability are critical considerations for maintaining competitiveness and ensuring patient access.

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FAQs

1. What factors are influencing AXID’s declining market share?
The primary factors include the rise of PPIs due to superior efficacy, safety concerns regarding other H2RAs, and the commoditization of generics leading to price competition. Additionally, changing prescribing preferences and consumer habits favor newer therapies.

2. How do safety concerns impact AXID’s regulatory status?
While AXID has not faced significant recalls, increased scrutiny around nitrosamine impurities and general safety evaluations for H2RAs can lead to restrictions or enhanced labeling, affecting market confidence and demand.

3. Are there any recent innovations or formulations under development for AXID?
Current efforts focus on optimizing existing formulations, exploring combination therapies, and potential novel drug delivery systems to enhance patient adherence and extend lifecycle.

4. What regional markets present the most growth opportunities for AXID?
Emerging markets with expanding OTC infrastructure, rising disease prevalence, and less competition from PPIs present the most promising growth landscape for AXID.

5. Will AXID's market significantly rebound or stabilize in the future?
Given current trends, a substantial rebound is unlikely. However, niche applications, strategic innovations, and market expansion could stabilize revenues and sustain its relevance.

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References

1. U.S. Food and Drug Administration. (2020). "Safety Announcement Regarding Nitrosamine Impurities in Certain Medicines."
2. GlobalData. (2022). "Pharmaceutical Market Analysis: Acid Reducers."
3. IQVIA. (2022). "Prescription and OTC Drug Sales Data."
4. Pfizer. (2019). "Product Lifecycle and Strategic Initiatives for AXID."
5. Statista. (2023). "OTC Pharmaceutical Market Revenue Forecast."