PEPCID COMPLETE Drug Patent Profile

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

Pepcid Complete is a drug marketed by J And J Consumer Inc and is included in one NDA.

The generic ingredient in PEPCID COMPLETE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for PEPCID COMPLETE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	35
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEPCID COMPLETE
What excipients (inactive ingredients) are in PEPCID COMPLETE?	PEPCID COMPLETE excipients list
DailyMed Link:	PEPCID COMPLETE at DailyMed

Recent Clinical Trials for PEPCID COMPLETE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2/Phase 3
United States Department of Defense	Phase 2
Leidos Life Sciences	Phase 2

See all PEPCID COMPLETE clinical trials

Pharmacology for PEPCID COMPLETE

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

Paragraph IV (Patent) Challenges for PEPCID COMPLETE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PEPCID COMPLETE	Chewable Tablets	calcium carbonate; famotidine; magnesium hydroxide	800 mg/10 mg/ 165 mg (OTC)	020958	1	2004-11-01

US Patents and Regulatory Information for PEPCID COMPLETE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000		OTC	Yes	Yes

Expired US Patents for PEPCID COMPLETE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000

International Patents for PEPCID COMPLETE

See the table below for patents covering PEPCID COMPLETE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2267503	PROCEDES ET COMPOSITIONS POUR LA PREVENTION ET LE TRAITEMENTDES BRULURES D'ESTOMAC (METHODS AND COMPOSITIONS FOR PREVENTING AND TREATING HEARTBURN)
Denmark	157132
Japan	H06316536	TASTE-MASKING AND SUSTAINED-RELEASE FILM FOR MEDICINE
Spain	2088550
Australia	7723491
U.S.S.R.	876056	METHOD OF PRODUCING GUANIDINOTHIAZOLE COMPOUNDS

Supplementary Protection Certificates for PEPCID COMPLETE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	300962	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
2365988	2018C/006	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2957286	1990003-4	Sweden		PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721
2365988	LUC00061	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286	SPC/GB19/003	United Kingdom		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 20170721

PEPCID COMPLETE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pepcid Complete (Famotidine)

Introduction

Pepcid Complete, which contains the active ingredient famotidine, is a widely used medication for treating gastrointestinal disorders such as gastroesophageal reflux disease (GERD), peptic ulcer disease, and heartburn. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The famotidine market, which includes Pepcid Complete, has been experiencing significant growth. As of 2023, the famotidine market was valued at USD 6.7 billion and is projected to reach USD 13.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.6% from 2024 to 2031[3].

Key Market Drivers

Several factors are driving the growth of the famotidine market:

Increasing Prevalence of Gastrointestinal Disorders

The rising incidence of GERD, peptic ulcers, and other gastrointestinal diseases is a major driver. Changing lifestyles, including increased stress levels and the consumption of fast food, aerated drinks, and alcohol, particularly among younger generations, contribute to this trend[1][3].

Shift Away from Proton Pump Inhibitors (PPIs)

There is a growing awareness of the long-term risks associated with PPIs, leading patients and medical providers to opt for famotidine due to its perceived safety profile and lower risk of side effects[5].

Growing Demand for Over-the-Counter (OTC) Medications

The availability of famotidine in OTC formulations has increased its accessibility and demand. Consumers are increasingly seeking efficient and easily accessible remedies for gastrointestinal issues, which has boosted the market for famotidine[3][5].

Generic and Affordable Alternatives

The emergence of generic versions of famotidine has made the medication more affordable and accessible, further driving market growth[5].

Market Segmentation

The famotidine market is segmented based on several criteria:

Application

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome
• Heartburn
• Indigestion[3]

Product Form

• Famotidine tablets
• Famotidine injection
• Famotidine oral suspension[3]

Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle East and Africa[3]

Regional Market Performance

The Asia-Pacific region is expected to register the fastest revenue CAGR in the global GERD drugs and devices market, including famotidine. 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[1].

Competitive Landscape

The market for famotidine is competitive, with several key players:

• Merck & Co.
• Johnson & Johnson
• Teva Pharmaceuticals
• Novartis
• Mylan
• Hikma Pharmaceuticals
• Glenmark Pharmaceuticals
• Lupin
• Perrigo
• Sun Pharmaceutical[3]

Financial Trajectory

The financial trajectory of the famotidine market is robust, with significant growth projected over the next few years.

Revenue Projections

The market is expected to grow from USD 6.7 billion in 2023 to USD 13.5 billion by 2031, indicating a substantial increase in revenue[3].

Investment and Funding

The pharmaceutical industry is witnessing increased investments in research and development to enhance famotidine formulations and delivery systems. This investment is expected to further boost the market's growth[5].

Cost and Revenue Analysis

Setting up a famotidine manufacturing plant involves significant capital investment, but the returns are promising. The project economics include detailed insights into capital investments, operating expenses, income and expenditure projections, and expected Return on Investment (ROI) and Net Present Value (NPV)[5].

Market Dynamics

The market dynamics for famotidine are influenced by several factors:

Increasing Geriatric Population

The aging population is more prone to digestive problems, which increases the demand for famotidine and other gastrointestinal medications[1][3].

Lifestyle Changes

Changes in lifestyle, including diet and stress levels, are contributing to the rising incidence of gastrointestinal disorders, thereby driving the demand for famotidine[1][3].

Regulatory Environment

The regulatory environment, particularly the approval and oversight of generic versions of famotidine, plays a crucial role in the market's growth. Regulatory bodies ensure the safety and efficacy of these medications, which helps in building consumer trust[5].

"The rising incidence of gastrointestinal problems like GERD, ulcers, and heartburn, are propelling the expansion of the famotidine market. The market is expanding due to the rising need for easily accessible and efficient over-the-counter therapies."[3]

Key Takeaways

• The famotidine market, including Pepcid Complete, is expected to grow significantly, driven by the increasing prevalence of gastrointestinal disorders and a shift away from PPIs.
• The market is segmented based on application, product form, and geography, with the Asia-Pacific region showing the fastest growth.
• Key players in the market include major pharmaceutical companies, and the competitive landscape is influenced by the availability of generic versions.
• The financial trajectory indicates robust growth, with significant revenue projections and investments in research and development.

FAQs

What is the projected market size of the famotidine market by 2031?

The famotidine market is expected to reach USD 13.5 billion by 2031, growing at a CAGR of 7.6% from 2024 to 2031[3].

What are the main drivers of the famotidine market?

The main drivers include the increasing prevalence of gastrointestinal disorders, a shift away from PPIs, growing demand for OTC medications, and the emergence of generic alternatives[3][5].

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

The Asia-Pacific region is expected to register the fastest revenue CAGR in the global GERD drugs and devices market[1].

Who are the key players in the famotidine market?

Key players include Merck & Co., Johnson & Johnson, Teva Pharmaceuticals, Novartis, Mylan, and others[3].

What is the impact of lifestyle changes on the demand for famotidine?

Lifestyle changes, including increased stress levels and the consumption of fast food, aerated drinks, and alcohol, contribute to the rising incidence of gastrointestinal disorders, thereby driving the demand for famotidine[1][3].

How does the availability of generic versions affect the market for famotidine?

The availability of generic versions makes famotidine more affordable and accessible, contributing to market growth through increased affordability and accessibility[5].