AXID AR Drug Patent Profile

Which patents cover Axid Ar, and when can generic versions of Axid Ar launch?

Axid Ar is a drug marketed by Haleon Us Holdings and is included in one NDA.

The generic ingredient in AXID AR 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 Ar

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

Summary for AXID AR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	27
DailyMed Link:	AXID AR at DailyMed

US Patents and Regulatory Information for AXID AR

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

Expired US Patents for AXID AR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	AXID AR	nizatidine	TABLET;ORAL	020555-001	May 9, 1996

International Patents for AXID AR

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	42728
Denmark	164056
Australia	7594581
Spain	505950

AXID AR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AXID AR

Introduction

AXID AR, a brand of the H2 receptor antagonist nizatidine, has been a significant player in the gastrointestinal drug market, particularly in the treatment of gastroesophageal reflux disease (GERD) and other acid-related disorders. To understand the market dynamics and financial trajectory of AXID AR, it is essential to delve into its history, market competition, regulatory changes, and financial performance.

Historical Context

AXID, introduced in the late 1980s, was one of the later entrants in the H2 receptor antagonist market, following pioneers like Tagamet (cimetidine) and Zantac (ranitidine)[1].

Market Competition

The H2 receptor antagonist market is highly competitive, with several brands vying for market share. When AXID AR transitioned from a prescription (Rx) to an over-the-counter (OTC) drug, it faced intense competition from other OTC versions of H2 antagonists like Pepcid AC, Tagamet HB, and Zantac 75.

Order of Entry and Marketing Effects

The order of entry into the market significantly impacts the success of a drug. In the Rx market, Zantac was able to overcome Tagamet's first-mover advantage through aggressive marketing. However, in the OTC market, the order of entry was different, with Pepcid AC being the first entrant, followed closely by Tagamet HB, Zantac 75, and finally AXID AR. Despite the close timing of their entries into the OTC market, the cumulative marketing intensity and order-of-entry effects still played a crucial role in determining market share[1].

Regulatory Changes

The deregulation of direct-to-consumer (DTC) marketing by the FDA in 1997 had a profound impact on the pharmaceutical industry, including AXID AR. This deregulation allowed pharmaceutical companies to directly advertise their prescription drugs to consumers, which increased marketing efforts and competition in the Rx and subsequently the OTC markets[1].

Financial Performance

Sales and Revenue

AXID AR's financial performance was influenced by its transition from an Rx to an OTC drug. The sales of AXID declined as it lost patent protection in 2002 and faced increased competition from generic and other OTC versions. For instance, Eli Lilly's financial reports indicate that sales of Axid decreased significantly, contributing to a decline in overall sales for certain periods[2].

Impact of Generic Competition

The introduction of generic versions further eroded the market share of AXID AR. Generic drugs, facilitated by the Hatch-Waxman Act, have significantly impacted the pharmaceutical market by increasing competition and reducing prices. This competition has led to lower returns for brand-name drugs like AXID AR[4].

Market Dynamics

GERD Drugs and Devices Market

The global GERD drugs and devices market, which includes H2 receptor antagonists like AXID AR, is expected to grow from USD 5.21 billion in 2020 to USD 6.28 billion by 2028, with a CAGR of 2.3% during the forecast period. Key factors driving this growth include an increasing geriatric population, rising prevalence of GERD, and growing demand for OTC and generic medications[3].

Segment Performance

In the GERD drugs market, the antacids segment dominated in terms of revenue share in 2020, but H2 receptor antagonists like AXID AR remain significant. The market is also driven by increasing awareness of gastrointestinal diseases and the need for early diagnosis and treatment[3].

Regional Market Performance

The Asia Pacific region is expected to register the fastest revenue growth rate in the GERD drugs and devices market, driven by increasing prevalence of gastrointestinal diseases, rising volumes of diagnostic and surgical procedures, and a growing preference for minimally invasive surgeries[3].

Key Takeaways

• Regulatory Impact: Deregulation of DTC marketing and Rx-to-OTC switches have significantly impacted AXID AR's market dynamics.
• Competition: Intense competition from other H2 antagonists and generic versions has affected AXID AR's sales and revenue.
• Market Growth: The GERD drugs and devices market is growing, driven by demographic and lifestyle changes.
• Regional Trends: The Asia Pacific region is a key growth area for GERD treatments.

FAQs

What was the impact of DTC marketing deregulation on AXID AR?

The deregulation of DTC marketing increased competition and marketing efforts, which had a mixed impact on AXID AR. While it enhanced rivalry, it also made it harder for AXID AR to maintain its market share against other aggressively marketed brands.

How did the transition from Rx to OTC affect AXID AR's sales?

The transition to OTC status exposed AXID AR to more direct competition from other OTC H2 antagonists and generic versions, leading to a decline in sales.

What are the key drivers of the GERD drugs and devices market?

Key drivers include an increasing geriatric population, rising prevalence of GERD, changing lifestyles, growing demand for OTC and generic medications, and increasing investments in research and development.

Which region is expected to see the fastest growth in the GERD drugs and devices market?

The Asia Pacific region is projected to register the fastest revenue growth rate due to increasing prevalence of gastrointestinal diseases and growing demand for diagnostic and surgical procedures.

How has generic competition affected AXID AR's financial performance?

Generic competition has significantly reduced the market share and revenue of AXID AR, as generic versions offer cheaper alternatives, eroding the brand's market position.

Sources

1. Margaret Kyle, "Deregulating Direct-to-Consumer Marketing of Prescription Drugs", Journal of Law and Economics, October 2002.
2. Eli Lilly, "Form 10-Q", Investor Relations, September 30, 2002.
3. Emergen Research, "GERD Drugs and Devices Market", January 18, 2022.
4. Congressional Budget Office, "How Increased Competition from Generic Drugs Has Affected Prices and Returns", July 1998.