PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER Drug Patent Profile

When do Pepcid Preservative Free In Plastic Container patents expire, and what generic alternatives are available?

Pepcid Preservative Free In Plastic Container is a drug marketed by Merck Sharp Dohme and is included in one NDA.

The generic ingredient in PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER 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 In Plastic Container

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

Summary for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	10
Patent Applications:	6,033
DailyMed Link:	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER at DailyMed

US Patents and Regulatory Information for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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 IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994

International Patents for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

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

Country	Patent Number	Title	Estimated Expiration
Denmark	157132
U.S.S.R.	876056	METHOD OF PRODUCING GUANIDINOTHIAZOLE COMPOUNDS
Australia	5597580
Spain	8103070
Germany	3008056
Japan	S6157830
Portugal	70899

PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Famotidine (Pepcid)

Introduction

Famotidine, commonly known by the brand name Pepcid, is a histamine-2 receptor blocker used to treat various digestive conditions, including gastroesophageal reflux disease (GERD), ulcers, and heartburn. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global market for GERD drugs and devices, which includes famotidine, is significant and growing. As of 2020, the global GERD drugs and devices market size was USD 5.21 billion, and it is expected to reach USD 6.28 billion by 2028, registering 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 Prevalence of GERD

The rising prevalence of gastrointestinal diseases such as GERD is a major driver. This increase is attributed to changing lifestyles, including higher stress levels, excessive intake of alcohol, aerated drinks, and fast food, particularly among younger generations[3].

Growing Geriatric Population

The global geriatric population is increasing, and this demographic is more prone to gastrointestinal disorders, thereby boosting the demand for famotidine and other GERD treatments[3].

Self-Medication and Generic Drugs

There is a growing trend towards self-medication and an increasing demand for generic and over-the-counter (OTC) drugs for gastrointestinal disorders. Famotidine, being available in both prescription and OTC forms, benefits from this trend[3].

Regional Growth

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

Market Segments

By Type

Famotidine is available in various forms, including oral tablets, oral liquid solutions, and solutions for IV injection. The oral tablet segment, particularly the 20 mg and 40 mg strengths, accounts for a significant share of the market. The availability of both prescription and OTC versions of these tablets contributes to their market dominance[2].

By Region

The global famotidine market is segmented by region, with North America and Europe being major markets. However, the Asia Pacific region is projected to grow at the fastest rate due to the factors mentioned above[1][3].

Financial Aspects

Cost Factors

The cost of famotidine can vary based on several factors, including the form of the drug (tablet, liquid solution, or IV injection), the dosage, treatment plan, pharmacy used, and insurance coverage. For instance, the cost of 20 mg and 40 mg tablets can differ significantly depending on whether they are prescription or OTC versions[2].

Insurance and Cost Savings

Insurance coverage plays a crucial role in determining the cost of famotidine. Patients with insurance may have lower out-of-pocket costs compared to those paying out of pocket. Additionally, cost savings programs, coupons, and generic versions can reduce the financial burden on patients[2].

Combination Therapies

Famotidine is sometimes used in combination with other drugs, such as ibuprofen (in the form of Duexis), which can affect the overall cost. The cost of combination therapies can vary based on whether the patient is using a brand-name or generic version and their insurance coverage[2].

Competitive Landscape

The market for famotidine is competitive, with several brand-name and generic versions available. Key players in the GERD drugs and devices market include manufacturers of famotidine and other related treatments. The availability of generic versions, such as Famotidine Prolepha, which is bioequivalent to Pepcid, adds to the competition[4].

Technological and Regulatory Trends

Bioequivalence and Stability

Generic formulations of famotidine must demonstrate bioequivalence to the innovator product. Studies have shown that generic versions, such as Famotidine Prolepha, meet the bioequivalence criteria and have satisfactory stability data, ensuring their safety and efficacy[4].

Regulatory Approvals

Regulatory approvals are crucial for the market entry of new formulations. For example, the marketing authorization for Famotidine Prolepha was granted after demonstrating essential similarity with the reference product, Pepcid[4].

Emerging Uses

Chronic Heart Failure

Research suggests that famotidine may have potential benefits in slowing the progression of chronic heart failure (CHF). While this use is still in the preliminary stages and requires further testing, it could open up new market opportunities for famotidine[5].

Challenges and Restraints

Side Effects and Safety Concerns

Like any medication, famotidine can have side effects and safety concerns, particularly with long-term use. These factors can impact patient compliance and market growth.

Market Saturation

The GERD drugs and devices market is relatively saturated, with many established brands and generic options available. This saturation can make it challenging for new entrants to gain significant market share.

Key Takeaways

• The global GERD drugs and devices market, including famotidine, is expected to grow to USD 6.28 billion by 2028.
• Key drivers include the increasing prevalence of GERD, a growing geriatric population, and a trend towards self-medication and generic drugs.
• The Asia Pacific region is projected to register the fastest revenue CAGR.
• The cost of famotidine varies based on form, dosage, treatment plan, and insurance coverage.
• Generic versions and combination therapies play a significant role in the market.
• Emerging uses, such as in chronic heart failure, could expand the market for famotidine.

FAQs

Q: What are the common forms of famotidine available in the market? A: Famotidine is available in oral tablets, oral liquid solutions, and solutions for IV injection[2].

Q: How does the cost of famotidine vary? A: The cost of famotidine can vary based on the form of the drug, dosage, treatment plan, pharmacy used, and insurance coverage[2].

Q: What are the key drivers of the GERD drugs and devices market? A: Key drivers include the increasing prevalence of GERD, a growing geriatric population, and a trend towards self-medication and generic drugs[3].

Q: Which region is expected to grow the fastest in the GERD drugs and devices market? A: The Asia Pacific region is projected to register the fastest revenue CAGR in the global GERD drugs and devices market[3].

Q: Can famotidine be used for conditions other than GERD? A: Preliminary research suggests that famotidine may help slow the progression of chronic heart failure, but more testing is needed to confirm this use[5].

Sources

1. Cognitivemarketresearch.com: Famotidine Market Report 2024 (Global Edition)
2. Medicalnewstoday.com: Famotidine cost 2024: Coupons and more
3. Biospace.com: GERD Drugs and Devices Market Size to Reach USD 6.28 Billion in 2028
4. Geneesmiddeleninformatiebank.nl: Public Assessment Report Scientific discussion Famotidine
5. Acc.org: Heartburn Drug May Help to Slow Progression of Chronic Heart Failure