OMEPRAZOLE - Generic Drug Details

What are the generic drug sources for omeprazole and what is the scope of freedom to operate?

Omeprazole is the generic ingredient in eight branded drugs marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Norvium Bioscience, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Astrazeneca, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Aurobindo Pharma Ltd, L Perrigo Co, Spil, Covis, P And L, Perrigo R And D, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Sciegen Pharms Inc, Zydus, Zydus Pharms, Salix, Riley Consumer, and Azurity, and is included in fifty-four NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has thirteen patent family members in eight countries.

There are one hundred and thirty-one drug master file entries for omeprazole. Ninety-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for OMEPRAZOLE

International Patents:	13
US Patents:	9
Tradenames:	8
Applicants:	37
NDAs:	54
Drug Master File Entries:	131
Finished Product Suppliers / Packagers:	98
Raw Ingredient (Bulk) Api Vendors:	225
Clinical Trials:	445
Patent Applications:	6,785
Drug Prices:	Drug price trends for OMEPRAZOLE
Drug Sales Revenues:	Drug sales revenues for OMEPRAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMEPRAZOLE
What excipients (inactive ingredients) are in OMEPRAZOLE?	OMEPRAZOLE excipients list
DailyMed Link:	OMEPRAZOLE at DailyMed

See drug prices for OMEPRAZOLE

See drug sales revenues for OMEPRAZOLE

Recent Clinical Trials for OMEPRAZOLE

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

Sponsor	Phase
Jacobio Pharmaceuticals Co., Ltd.	Phase 1
Hospital Clinico Universitario de Santiago	Phase 4
Complejo Hospitalario de Navarra	Phase 4

See all OMEPRAZOLE clinical trials

Generic filers with tentative approvals for OMEPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		40MG	CAPSULE, DELAYED REL PELLETS;ORAL
		20MG	CAPSULE, DELAYED REL PELLETS;ORAL
		10MG	CAPSULE, DELAYED REL PELLETS;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for OMEPRAZOLE

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

Medical Subject Heading (MeSH) Categories for OMEPRAZOLE

Anti-Ulcer Agents

Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OMEPRAZOLE

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for OMEPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMEPRAZOLE	Delayed-release Tablets	omeprazole	20 mg	022032	1	2015-06-03

US Patents and Regulatory Information for OMEPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	079182-002	Apr 19, 2013	AB	RX	No	No
Dr Reddys	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204068-001	Jul 15, 2016	AB	RX	No	No
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	205545-001	Jul 27, 2016	AB	RX	No	No
L Perrigo Co	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	216096-001	May 24, 2022		OTC	No	No
Anda Repository	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	212587-001	Apr 30, 2020	AB	RX	No	No

Expired US Patents for OMEPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998

International Patents for OMEPRAZOLE

Country	Patent Number	Title	Estimated Expiration
Israel	147232	STABLE BENZIMIDAZOLE FORMULATION
Australia	5423200
World Intellectual Property Organization (WIPO)	2017216789
Israel	130602
European Patent Office	1187599	FORMULATION DE BENZIMIDAZOLE STABLE (STABLE BENZIMIDAZOLE FORMULATION)

Supplementary Protection Certificates for OMEPRAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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

OMEPRAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omeprazole

Introduction to Omeprazole

Omeprazole, a proton pump inhibitor (PPI), is a widely used medication for treating various acid-related gastrointestinal disorders, including gastroesophageal reflux disease (GERD), ulcers, and esophagitis. The market for omeprazole is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The global omeprazole market has demonstrated substantial growth in recent years. As of 2023, the market was valued at approximately $2.17 billion and is expected to increase to $2.34 billion in 2024, reflecting a compound annual growth rate (CAGR) of 7.6%[1][3].

By 2028, the market is forecasted to grow to $3.15 billion at a CAGR of 7.7%, driven by factors such as favorable reimbursement policies, the transition from H2 blockers to PPIs, and increased health literacy initiatives[1].

Drivers of Market Growth

Several factors are driving the growth of the omeprazole market:

Increasing Gastrointestinal Disorders

The rising prevalence of gastrointestinal disorders, such as GERD, is a significant driver. GERD affects approximately 20% of adults in Western societies, making it one of the most widespread gastrointestinal conditions[4].

Aging Population

The aging population is another key factor, as older individuals are more prone to gastrointestinal issues that require PPI therapy[3].

Growing Awareness About PPIs

Increased awareness among healthcare professionals and patients about the benefits of PPI therapy has led to higher prescription rates and greater consumer demand for omeprazole[3].

Technological Advancements

Technological advancements in drug delivery systems and the introduction of generic versions have made omeprazole more affordable and widely available[3].

Regulatory Approvals

Regulatory bodies continue to approve new formulations and expanded indications for omeprazole, further boosting market growth[3].

Over-the-Counter (OTC) Market

The OTC market for omeprazole is particularly robust. PL Developments recently received FDA approval for its omeprazole magnesium tablet, a product comparable to Prilosec OTC. This approval makes PLD the only provider of omeprazole OTC produced in the United States. The OTC market for omeprazole in the U.S. is valued at approximately $550 million annually, with commercial shipments expected to commence in early 2025[2][5].

Financial Trajectory of Key Players

PL Developments (PLD)

PLD's financial health and growth trajectory have been significantly enhanced by the FDA approval for omeprazole OTC and the successful refinancing of its corporate debt. The company completed an exchange offer for $350 million of its outstanding Senior Secured Notes, which has improved its financial flexibility and positioned it for continued growth and strategic investments[5].

Market Concentration and Competition

The omeprazole market is characterized by medium market concentration, with several global and regional players competing for market share. Key players include Bayer AG, Novartis, Pfizer, Procter & Gamble, and Teva. These companies are engaging in strategic initiatives such as mergers and acquisitions, partnerships, and product launches to capture market share[4].

Regional Market Dynamics

The Asia Pacific region is expected to be the fastest-growing market for omeprazole, while North America remains the largest market. The regional dynamics are influenced by factors such as healthcare infrastructure, regulatory environments, and consumer preferences[4].

Challenges and Opportunities

Challenges

Despite the growth, the omeprazole market faces challenges such as disruptions in the pharmaceutical supply chain and government interventions affecting drug prices. Additionally, changes in disease patterns, such as the increased incidence of gastric cancers, present both challenges and opportunities for market expansion[1].

Opportunities

The market offers lucrative opportunities for stakeholders, particularly with the introduction of new formulations and expanded indications. Personalized treatment approaches and rising consumer preference for self-care products are also driving growth[1].

Illustrative Statistics

• The global omeprazole market is expected to grow from $2.17 billion in 2023 to $3.15 billion by 2028, at a CAGR of 7.7%[1].
• The OTC market for omeprazole in the U.S. is valued at approximately $550 million annually[2][5].
• GERD affects approximately 20% of adults in Western societies[4].

Quotes from Industry Experts

"Receiving FDA approval for omeprazole OTC is a significant achievement for our organization," said Evan Singer, President of PLD. "This accomplishment not only highlights our team's dedication and expertise in bringing complex products to market, but it also reinforces our role as a comprehensive supply partner for our customers."[5]

Highlight from Original Source

"The successful consummation of the Exchange Offer is a strong affirmation of PLD's financial health and growth trajectory," said Asaph Naaman, Chief Financial Officer. "This achievement reflects our focus on operational efficiencies, free cash flow generation, and building strong relationships with external stakeholders. We are now well-positioned to capitalize on future opportunities and continue our upward momentum."[5]

Key Takeaways

• The global omeprazole market is projected to grow significantly, driven by factors such as increasing gastrointestinal disorders, aging population, and growing awareness about PPIs.
• The OTC market for omeprazole is robust, with PL Developments being the only U.S.-based provider of omeprazole OTC.
• Key players are engaging in strategic initiatives to capture market share, and the market is expected to see sustained growth due to technological advancements and regulatory approvals.
• Regional dynamics, particularly in the Asia Pacific and North America, play a crucial role in market growth.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the global omeprazole market? A: As of 2023, the global omeprazole market was valued at approximately $2.17 billion[1].

Q: What is the projected growth rate of the omeprazole market? A: The market is forecasted to grow at a CAGR of 7.7% from 2023 to 2028[1].

Q: Who are the key players in the omeprazole market? A: Key players include Bayer AG, Novartis, Pfizer, Procter & Gamble, and Teva[4].

Q: What is the significance of the FDA approval for PL Developments' omeprazole OTC? A: The FDA approval makes PLD the only provider of omeprazole OTC produced in the United States, underscoring the company's capabilities in developing and manufacturing complex consumer healthcare products[2][5].

Q: What are the main drivers of the omeprazole market growth? A: The main drivers include increasing gastrointestinal disorders, an aging population, growing awareness about PPIs, technological advancements, and regulatory approvals[1][3][4].

Sources:

1. Global Omeprazole Market Overview And Statistic For 2024-2033 - EIN Presswire
2. PL Developments receives FDA approval for over-the-counter omeprazole - Drug Store News
3. Omeprazole Market | Growth | Share | Size | Trends and Forecast - Reanin
4. Omeprazole And Antihistamine Market Size & Share Analysis - Mordor Intelligence
5. PL Developments Announces FDA Approval for Omeprazole OTC ANDA and Successful Corporate Debt Refinancing - PR Newswire