PRILOSEC OTC Drug Patent Profile

Which patents cover Prilosec Otc, and what generic alternatives are available?

Prilosec Otc is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in PRILOSEC OTC is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prilosec Otc

A generic version of PRILOSEC OTC was approved as omeprazole magnesium by DR REDDYS LABS LTD on June 5^th, 2009.

Summary for PRILOSEC OTC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	51
Patent Applications:	83
Drug Prices:	Drug price information for PRILOSEC OTC
Drug Sales Revenues:	Drug sales revenues for PRILOSEC OTC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRILOSEC OTC
What excipients (inactive ingredients) are in PRILOSEC OTC?	PRILOSEC OTC excipients list
DailyMed Link:	PRILOSEC OTC at DailyMed

See drug prices for PRILOSEC OTC

See drug sales revenues for PRILOSEC OTC

Recent Clinical Trials for PRILOSEC OTC

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

Sponsor	Phase
Pfizer	Phase 1
Carlos Roberto Simons-Linares	Phase 4
Emory University	Phase 4

See all PRILOSEC OTC clinical trials

Pharmacology for PRILOSEC OTC

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Paragraph IV (Patent) Challenges for PRILOSEC OTC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRILOSEC OTC	Delayed-release Tablets	omeprazole magnesium	20 mg	021229	1	2012-03-30
PRILOSEC OTC	Delayed-release Capsules	omeprazole magnesium	20 mg	021229	1	2007-03-19

US Patents and Regulatory Information for PRILOSEC OTC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003		OTC	Yes	Yes

Expired US Patents for PRILOSEC OTC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	5,753,265
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	6,428,810
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	4,738,974
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	5,900,424

International Patents for PRILOSEC OTC

See the table below for patents covering PRILOSEC OTC around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P950349	MULTIPLE UNIT TABLETED DOSAGE FORM I
Japan	H09502741
Greece	970300015
South Korea	910004579

Supplementary Protection Certificates for PRILOSEC OTC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

PRILOSEC OTC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prilosec OTC

Introduction

Prilosec OTC, a proton pump inhibitor (PPI) developed by Procter & Gamble (P&G), has been a significant player in the over-the-counter (OTC) heartburn medication market since its launch. Here, we delve into the market dynamics and financial trajectory of Prilosec OTC, exploring its launch, market performance, competition, and future outlook.

Launch and Initial Market Performance

Prilosec OTC was launched with a substantial $100 million marketing campaign, which proved highly effective in generating demand. The product quickly became one of the most popular OTC switch products, with demand outstripping supply shortly after its launch. This initial success was attributed to the effective marketing and the widespread prevalence of heartburn among the American population[1].

Supply Chain Challenges

Despite the strong demand, Prilosec OTC faced significant supply chain issues. The product was in short supply, and retailers were managed on an inventory basis. This shortage, which began earlier in the year, became more severe over the following months. AstraZeneca Pharmaceuticals, the supplier of Prilosec OTC to P&G, worked to resolve the supply chain issues, but the shortage was not fully resolved until the end of the year[1].

Market Size and Growth

The market for omeprazole, the active ingredient in Prilosec OTC, is robust. In the United States, retail sales of omeprazole OTC products amount to approximately $550 million annually. This market is expected to grow, driven by factors such as the increasing prevalence of gastroesophageal reflux disease (GERD) and the rising demand for OTC medications[2][3].

Competition in the Market

Prilosec OTC faces significant competition in the heartburn medication market. After losing market exclusivity, other branded PPIs such as Novartis's Prevacid 24HR (lansoprazole) and Merck's Zegerid OTC entered the market. Private-label brands have also gained traction, further increasing competition. To stay competitive, P&G has had to innovate its marketing strategies, including online social media campaigns and sponsorship of various events[4].

Financial Performance

At its peak, Prilosec OTC generated annual sales of around $387 million in 2006. However, with increased competition and the entry of other branded and private-label products, sales have declined. Despite this, the product remains a significant contributor to P&G's consumer healthcare segment. The convenience and cost savings of OTC remedies continue to attract consumers, with research indicating that OTC remedies save consumers an average of $174 annually in prescription and office visits[4].

Market Expansion and New Entrants

The approval of new omeprazole OTC products by other companies, such as PL Developments, further expands the market. PL Developments received FDA approval for its Omeprazole Magnesium Tablet, which is comparable to Prilosec OTC. This development underscores the competitive landscape and the ongoing demand for omeprazole-based products[2].

Regional Market Dynamics

North America is expected to hold a significant share of the omeprazole market, driven by the high prevalence of GERD and other gastrointestinal conditions. The Asia Pacific region is also anticipated to be a fast-growing market, contributing to the overall growth of the omeprazole and antihistamine market[3][5].

Future Outlook

The omeprazole market is projected to grow at a CAGR of 5.70% to 6.4% over the forecast period, driven by increasing cases of chronic diseases and the positive results of clinical trials for omeprazole in treating Helicobacter pylori infections. The market size is expected to expand from $1.06 billion in 2023 to $2.38 billion by 2036[3][5].

Key Takeaways

• Strong Initial Demand: Prilosec OTC saw high demand following its launch, outstripping supply.
• Supply Chain Issues: The product faced significant supply chain challenges, which were gradually resolved.
• Robust Market: The omeprazole OTC market is valued at approximately $550 million annually in the U.S.
• Competition: The market is highly competitive with other branded and private-label products.
• Financial Performance: Prilosec OTC has seen declining sales but remains a significant player.
• Market Growth: The omeprazole market is expected to grow at a CAGR of 5.70% to 6.4% over the forecast period.

FAQs

What was the initial marketing campaign for Prilosec OTC like?

The initial marketing campaign for Prilosec OTC was highly effective, with a $100 million investment that generated significant demand for the product[1].

Why did Prilosec OTC face supply chain issues?

Prilosec OTC faced supply chain issues due to demand outstripping supply shortly after its launch. AstraZeneca Pharmaceuticals worked to resolve these issues, but the shortage persisted for several months[1].

How competitive is the market for heartburn medications?

The market for heartburn medications is highly competitive, with other branded products like Prevacid 24HR and Zegerid OTC, as well as private-label brands, competing with Prilosec OTC[4].

What is the projected growth rate of the omeprazole market?

The omeprazole market is expected to grow at a CAGR of 5.70% to 6.4% over the forecast period, driven by increasing cases of chronic diseases and positive clinical trial results[3][5].

Who are the major players in the omeprazole OTC market?

Major players include Procter & Gamble, Novartis, Merck, and PL Developments, among others. These companies are involved in the development, manufacturing, and distribution of omeprazole OTC products[2][4].

Sources

1. Supermarket News: "PRILOSEC OTC IN SHORT SUPPLY"[1]
2. PR Newswire: "PL Developments Announces FDA Approval for Omeprazole OTC ANDA and Successful Corporate Debt Refinancing"[2]
3. Mordor Intelligence: "Omeprazole And Antihistamine Market Size & Share Analysis"[3]
4. CBS News: "Procter & Gamble Wages That the Medium and its Message Can Save Prilosec OTC"[4]
5. Research Nester: "Omeprazole Market Size & Share | Growth Forecasts 2036"[5]