PEPCID PRESERVATIVE FREE Drug Patent Profile

When do Pepcid Preservative Free patents expire, and when can generic versions of Pepcid Preservative Free launch?

Pepcid Preservative Free is a drug marketed by Merck and Merck Sharp Dohme and is included in two NDAs.

The generic ingredient in PEPCID PRESERVATIVE FREE is famotidine. There are eighteen drug master file entries for this compound. One hundred and forty-four suppliers are listed for this compound. Additional details are available on the famotidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pepcid Preservative Free

A generic version of PEPCID PRESERVATIVE FREE was approved as famotidine by FRESENIUS KABI USA on April 16^th, 2001.

Summary for PEPCID PRESERVATIVE FREE

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	10
Patent Applications:	6,638
DailyMed Link:	PEPCID PRESERVATIVE FREE at DailyMed

US Patents and Regulatory Information for PEPCID PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	PEPCID PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	019510-004	Nov 4, 1986		DISCN	Yes	No
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994		DISCN	Yes	No

Expired US Patents for PEPCID PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PEPCID PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	019510-004	Nov 4, 1986

International Patents for PEPCID PRESERVATIVE FREE

See the table below for patents covering PEPCID PRESERVATIVE FREE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1134836	METHODE DE PREPARATION DE NOUVEAUX GUANIDINOTHIAZOLES (PROCESS FOR PREPARING NOVEL GUANIDINOTHIAZOLE COMPOUNDS)
Germany	3008056
Spain	489222
Greece	67011
Sweden	444317	NYA GUANIDINOTIAZOLFORENINGAR SAMT FARMACEUTISKA KOMPOSITIONER DERAV

PEPCID PRESERVATIVE FREE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PEPCID (Famotidine)

Introduction

PEPCID, commonly known by its generic name famotidine, is a widely used medication for treating gastroesophageal reflux disease (GERD) and other gastrointestinal disorders. Here, we will delve into the market dynamics and financial trajectory of famotidine, highlighting key factors, trends, and projections.

Market Size and Growth

The global market for GERD drugs and devices, which includes famotidine, has been experiencing steady growth. As of 2020, the global GERD drugs and devices market size was USD 5.21 billion, and it is projected to reach USD 6.28 billion by 2028, growing at a CAGR of 2.3% during the forecast period of 2021-2028[3].

Key Market Drivers

Several factors are driving the growth of the famotidine market:

Increasing Geriatric Population

The rise in the geriatric population worldwide is a significant driver, as older adults are more prone to gastrointestinal diseases such as GERD[3].

Changing Lifestyles

Lifestyle changes, including increased stress levels, excessive intake of alcohol, aerated drinks, and fast food, particularly among younger generations, contribute to the growing prevalence of GERD[3].

Growing Demand for OTC and Generic Medications

There is an increasing trend towards self-medication and a growing demand for over-the-counter (OTC) and generic medications for gastrointestinal disorders. This trend benefits famotidine, which is available in both prescription and OTC forms[3].

Advances in Drug Delivery Systems

Research into new drug delivery systems, such as solid lipid nanoparticles (SLNs), has shown promising results in enhancing the oral bioavailability of famotidine. For instance, studies have demonstrated a 2.06-fold increase in oral bioavailability when famotidine is dispersed in SLNs compared to commercial formulations[4].

Market Segmentation

The GERD drugs and devices market is segmented based on several criteria:

Drug Type

The market is segmented into H2 receptor antagonists (like famotidine), proton pump inhibitors, and antacids. In 2020, the antacids segment dominated the market, but H2 receptor antagonists like famotidine remain a significant segment due to their effectiveness and widespread use[3].

Route of Administration

Famotidine is available in various forms, including oral tablets and injections. The oral route is the most common, but intravenous injections are also used, particularly in hospital settings[5].

Regional Analysis

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

Financial Performance

The financial performance of famotidine is closely tied to the overall GERD drugs and devices market. Here are some key financial indicators:

Revenue Share

Famotidine, as part of the H2 receptor antagonist segment, contributes significantly to the revenue of the GERD drugs market. While antacids dominated the market in 2020, famotidine's steady demand ensures it remains a profitable segment[3].

Competitive Landscape

Major companies in the GERD drugs and devices market include pharmaceutical giants that produce and market famotidine. These companies often have diversified portfolios that help mitigate the impact of generic competition and ensure steady revenue streams[3].

Challenges and Opportunities

Despite the growth prospects, the famotidine market faces several challenges and opportunities:

Generic Competition

The entry of generic versions of famotidine can impact the market share of branded products. However, this also presents an opportunity for companies to expand their generic portfolios and capture a larger market share[1].

Regulatory Environment

Changes in regulatory environments, particularly regarding the approval and marketing of OTC drugs, can affect the sales of famotidine. For instance, the successful transition of prescription drugs to OTC status can significantly boost sales, as seen with other products like alli, the first OTC weight loss aid approved by the FDA[2].

Research and Development

Investments in R&D are crucial for developing new and advanced formulations of famotidine. Innovations like SLNs can enhance the drug's bioavailability and patient compliance, offering a competitive edge in the market[4].

Consumer Behavior and Preferences

Consumer behavior plays a significant role in the market dynamics of famotidine:

Self-Medication

The trend towards self-medication is increasing, with more consumers opting for OTC medications for gastrointestinal issues. This trend is driven by convenience and the availability of effective OTC options like famotidine[3].

Preference for Minimally Invasive Treatments

There is a growing preference for minimally invasive surgeries and treatments, which can impact the demand for drugs like famotidine. However, famotidine remains a first-line treatment for many GERD patients due to its efficacy and safety profile[3].

Regional Market Analysis

The regional performance of the famotidine market varies:

Asia Pacific

This region is expected to register the fastest revenue CAGR due to the increasing prevalence of GERD, rising diagnostic and surgical procedures, and a growing demand for OTC and generic medications[3].

North America and Europe

These regions also contribute significantly to the market, driven by a high prevalence of GERD and a well-established healthcare infrastructure. However, these markets are more mature and may experience slower growth compared to the Asia Pacific region[3].

Key Takeaways

• Market Growth: The GERD drugs and devices market, including famotidine, is expected to grow at a CAGR of 2.3% from 2021 to 2028.
• Key Drivers: Increasing geriatric population, changing lifestyles, and growing demand for OTC and generic medications are key drivers.
• Market Segmentation: The market is segmented by drug type, route of administration, and region, with antacids currently dominating but H2 receptor antagonists like famotidine remaining significant.
• Financial Performance: Famotidine contributes significantly to the revenue of the GERD drugs market, with steady demand ensuring profitability.
• Challenges and Opportunities: Generic competition and regulatory changes present both challenges and opportunities for market growth.

FAQs

1. What is the projected market size of the GERD drugs and devices market by 2028?

   • The global GERD drugs and devices market is expected to reach USD 6.28 billion by 2028[3].

2. Which segment dominated the GERD drugs market in 2020?

   • The antacids segment dominated the market in 2020, but H2 receptor antagonists like famotidine remain a significant segment[3].

3. What is the impact of solid lipid nanoparticles (SLNs) on famotidine?

   • SLNs have shown a 2.06-fold increase in the oral bioavailability of famotidine compared to commercial formulations[4].

4. Which region is expected to register the fastest revenue CAGR in the GERD drugs and devices market?

   • The Asia Pacific region is projected to register the fastest revenue CAGR during the forecast period[3].

5. What are the key factors driving the growth of the famotidine market?

   • Key factors include the increasing geriatric population, changing lifestyles, and growing demand for OTC and generic medications[3].

Sources

1. Cognitivemarketresearch.com: Famotidine Market Report 2024 (Global Edition)
2. GSK Annual Report 2007: Summary review of operations and financial statements
3. Emergen Research: GERD Drugs and Devices Market Size to Reach USD 6.28 Billion in 2028
4. Wiley Online Library: Fabrication, Characterization, and In Vivo Evaluation of Famotidine
5. DailyMed: Famotidine Injection in GALAXY Plastic ContainerRx Only