PEPCID AC Drug Patent Profile

When do Pepcid Ac patents expire, and what generic alternatives are available?

Pepcid Ac is a drug marketed by J And J Consumer Inc and is included in three NDAs.

The generic ingredient in PEPCID AC 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 Ac

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

Summary for PEPCID AC

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	35
Patent Applications:	7,161
What excipients (inactive ingredients) are in PEPCID AC?	PEPCID AC excipients list
DailyMed Link:	PEPCID AC at DailyMed

Recent Clinical Trials for PEPCID AC

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

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

See all PEPCID AC clinical trials

Pharmacology for PEPCID AC

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

US Patents and Regulatory Information for PEPCID AC

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 AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998		DISCN	Yes	No
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999		OTC	No	No
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007		OTC	Yes	Yes

Expired US Patents for PEPCID AC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999	4,283,408*PED
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007	5,075,114*PED
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995	5,854,267*PED

International Patents for PEPCID AC

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

Country	Patent Number	Title	Estimated Expiration
Germany	69109163
Portugal	96837	DISPOSITIVO E PROCESSO PARA A PREPARACAO DE MEDICAMENTOS REVESTIDOS APERFEICOADOS
Denmark	157132

PEPCID AC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pepcid AC

Introduction

Pepcid AC, a medication containing famotidine, has been a significant player in the over-the-counter (OTC) antacid market since its transition from a prescription-only drug in the 1990s. Here, we will delve into the market dynamics and financial trajectory of Pepcid AC, highlighting its impact, growth, and competitive landscape.

Historical Context

Pepcid AC was first introduced as an OTC medication in 1995, following FDA approval for Johnson & Johnson/Merck Consumer Pharmaceuticals to produce and market a low-dosage version of the drug. This move was seen as a major event in the treatment of heartburn and acid indigestion, marking a significant shift in the antacid market[1].

Market Demand

The demand for Pepcid AC is driven by the high prevalence of gastrointestinal issues such as heartburn, acid indigestion, and ulcers. Over 50% of U.S. households have at least one person suffering from these conditions, creating a substantial market for effective OTC remedies[1].

Competitive Landscape

Upon its introduction, Pepcid AC entered a competitive market dominated by antacids and other H2 blockers like Tagamet. The competition was anticipated to be fierce, with potential pricing wars and marketing battles to capture market share. However, Pepcid AC's unique selling point – its ability to control stomach acid production rather than just neutralizing it – gave it a competitive edge[1].

Marketing and Sales Strategies

The launch of Pepcid AC was supported by substantial marketing efforts, including print and broadcast advertising campaigns. Retailers like Save Mart and Supervalu planned extensive promotional activities, such as full-page ads, floor shippers, and in-store signs, to attract customers. The strategy focused on highlighting Pepcid AC's long-lasting relief and gastroenterologist recommendations to build consumer trust and loyalty[1][4].

Financial Performance

The financial performance of Pepcid AC has been robust. In the first year after its OTC launch, the product was expected to exceed revenue goals, with projected revenues significantly above initial targets. By 2020, the Pepcid AC brand and its generic equivalents had U.S. sales of approximately $211 million for the twelve months ending in August 2020[5].

Market Growth and Projections

The famotidine market, which includes Pepcid AC, is expected to grow significantly. Valued at $6.7 billion in 2023, the market is projected to reach $13.5 billion by 2031, growing at a CAGR of 7.6% from 2024 to 2031. This growth is driven by increasing incidence of gastrointestinal disorders, rising customer preference for efficient OTC remedies, and advancements in pharmaceutical formulations and delivery systems[3].

Impact on Retailers

The introduction of Pepcid AC has been beneficial for retailers, attracting more customers to their health and beauty care (HBC) departments. Retailers like Big Y and Supervalu's Southeast division have seen increased traffic and sales due to the product's popularity. The availability of Pepcid AC in both antacid and pharmacy sections has helped retailers compete with discount and chain drug stores[1].

Competitive Positioning

Pepcid AC's competitive positioning is strengthened by its unique features, such as lasting four times longer than traditional antacids and its ability to treat heartburn and stomach upset effectively. The product's name, "Acid Controller," reinforces its market position. Additionally, recommendations from gastroenterologists have added credibility and trust among consumers[4].

Challenges and Future Outlook

Despite its success, Pepcid AC faces ongoing challenges, including competition from other H2 blockers and the need to maintain market share. The withdrawal of other antacids like ranitidine has created opportunities for Pepcid AC to fill therapy gaps in the market. Future growth will depend on continued marketing efforts, consumer awareness, and the introduction of new formulations and delivery systems[5].

Key Takeaways

• High Demand: Over 50% of U.S. households have at least one person suffering from heartburn and acid indigestion.
• Competitive Edge: Pepcid AC controls stomach acid production, offering long-lasting relief.
• Strong Marketing: Extensive advertising and promotional activities have supported its launch and growth.
• Robust Financials: Sales of $211 million in the twelve months ending August 2020.
• Market Growth: Projected to grow at a 7.6% CAGR from 2024 to 2031.
• Retail Impact: Increased traffic and sales for retailers in the HBC departments.

FAQs

Q: What is Pepcid AC used for? A: Pepcid AC is used to treat occasional heartburn, acid indigestion, and sour stomach in people aged 16 and older.

Q: How does Pepcid AC differ from traditional antacids? A: Unlike traditional antacids that neutralize stomach acid, Pepcid AC works to control the production of stomach acid.

Q: What was the initial market response to Pepcid AC's OTC launch? A: The launch was highly anticipated, with retailers expecting strong profits and increased traffic in their HBC departments.

Q: What are the projected market growth figures for the famotidine market? A: The famotidine market is expected to grow from $6.7 billion in 2023 to $13.5 billion by 2031, at a CAGR of 7.6%.

Q: How has the withdrawal of other antacids impacted Pepcid AC's market position? A: The withdrawal of antacids like ranitidine has created therapy gaps that Pepcid AC can fill, potentially increasing its market share.

Sources

1. Supermarket News - "Sweet Time Expected With OTC Pepcid AC"
2. PR Newswire - "Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS"
3. Market Research Intellect - "Famotidine Market Size, Share and Trends [2024-2031]"
4. Course Hero - "Pepcid AC: Racing to the OTC Market Business Case Analysis"
5. BioSpace - "Dr. Reddy's announces the re-launch of over-the-counter famotidine tablets USP 10 mg and 20 mg store brand equivalent of Pepcid AC in the U.S. market"