PRILOSEC Drug Patent Profile

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

Prilosec is a drug marketed by Astrazeneca and Covis and is included in three NDAs.

The generic ingredient in PRILOSEC 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

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

Summary for PRILOSEC

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	225
Clinical Trials:	51
Patent Applications:	3,924
Drug Prices:	Drug price information for PRILOSEC
Drug Sales Revenues:	Drug sales revenues for PRILOSEC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRILOSEC
What excipients (inactive ingredients) are in PRILOSEC?	PRILOSEC excipients list
DailyMed Link:	PRILOSEC at DailyMed

See drug prices for PRILOSEC

See drug sales revenues for PRILOSEC

Recent Clinical Trials for PRILOSEC

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 clinical trials

Pharmacology for PRILOSEC

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

US Patents and Regulatory Information for PRILOSEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995		DISCN	Yes	No
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-001	Mar 20, 2008		RX	Yes	No
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989		DISCN	Yes	No
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998		DISCN	Yes	No

Expired US Patents for PRILOSEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	6,191,148*PED
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	6,150,380*PED
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	4,853,230*PED
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	6,147,103*PED

International Patents for PRILOSEC

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	43694
Sweden	9201297
Norway	960067
Austria	94063

Supplementary Protection Certificates for PRILOSEC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0005129	SPC/GB99/015	United Kingdom		SPC/GB99/015, EXPIRES: 20021115
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214

PRILOSEC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prilosec (Omeprazole)

Introduction to Prilosec (Omeprazole)

Prilosec, commonly known by its generic name omeprazole, is a proton pump inhibitor (PPI) widely used for treating gastroesophageal reflux disease (GERD), peptic ulcers, and other gastric disorders. Here, we will delve into the market dynamics and financial trajectory of omeprazole.

Market Size and Growth Projections

The omeprazole market is part of the broader proton pump inhibitors (PPIs) market, which is experiencing significant growth. As of 2023, the omeprazole market size was valued at USD 1.06 billion and is expected to grow to USD 2.38 billion by 2036, with a compound annual growth rate (CAGR) of more than 6.4% during the forecast period from 2024 to 2036[1].

Driving Factors

Several factors are driving the growth of the omeprazole market:

Increasing Prevalence of Chronic Diseases

The global rise in chronic diseases such as cancer, diabetes, and respiratory ailments is a significant driver. According to the World Health Organization (WHO), these diseases are expected to account for 90% of all global fatalities by 2050, contributing to the increased demand for omeprazole[1].

Growing Incidence of GERD and Peptic Ulcers

The increasing incidence of GERD and peptic ulcers, particularly in regions like North America, is another key factor. In the US, for example, around 4.5 million individuals are affected by peptic ulcers annually, and about 10% of the population suffers from duodenal ulcers[1].

Shift to Over-the-Counter (OTC) Availability

The shift from prescription-only to OTC availability of PPIs, including omeprazole, has made these medications more accessible to a wider audience, driving market growth[3].

Product Launches and Innovations

New product launches, such as the generic omeprazole delayed-release capsules by Xiromed LLC, are also propelling the market forward. These launches provide therapeutic equivalents to branded drugs, making omeprazole more affordable and accessible[3].

Regional Market Dynamics

North America

North America is anticipated to hold the largest share of the omeprazole market, with an estimated 59.3% share during the forecast period. The prevalence of H. pylori infection and peptic ulcers in this region, particularly in the US, contributes significantly to this dominance[1].

Asia Pacific

The Asia Pacific region, excluding Japan, is expected to emerge as one of the fastest-growing markets due to large patient pools, rising healthcare expenditure, and expanding medical insurance coverage in many countries[4].

Financial Performance of Key Players

AstraZeneca

AstraZeneca, a major player in the pharmaceutical industry, has seen strong performance in its therapy areas, including those relevant to omeprazole. While AstraZeneca's total revenue increased by 6% in 2023, excluding COVID-19 medicines, the revenue grew by 15%, reflecting the robust demand for other therapeutic areas[5].

Challenges and Limitations

Side Effects and Generic Alternatives

Long-term use of omeprazole has been associated with side effects such as increased risk of fractures, pneumonia, hypomagnesemia, and vitamin B12 deficiency. Additionally, the availability of cheaper generic alternatives poses competition to branded drugs, which can hamper market growth[3][4].

COVID-19 Impact

The COVID-19 pandemic had a temporary impact on the PPI market, as patients were advised to reduce their use of these medications unless absolutely necessary. However, as the pandemic subsided, the market has seen a favorable growth trajectory[3].

Market Competition

The proton pump inhibitors market, including omeprazole, is moderately fragmented with key players like AstraZeneca, Bayer AG, and Pfizer competing for market share. These companies are focusing on research, development, and strategic initiatives to introduce new formulations and enhance their market presence[3].

Future Outlook

The omeprazole market is expected to continue its growth trajectory driven by the increasing prevalence of GERD, rising geriatric population, and growing healthcare expenditure in emerging nations. New product launches and the shift towards OTC availability will further propel the market. However, the market must navigate challenges such as patent expirations and the rise of generic alternatives[1][3][4].

Key Takeaways

• The omeprazole market is projected to grow significantly, reaching USD 2.38 billion by 2036.
• North America is expected to dominate the market due to high incidence rates of GERD and peptic ulcers.
• The shift to OTC availability and new product launches are key drivers of market growth.
• Side effects and generic alternatives pose challenges to the market.
• The Asia Pacific region is expected to be a fast-growing market due to increasing healthcare expenditure and medical insurance coverage.

FAQs

Q: What is the current market size of omeprazole?

The omeprazole market size was valued at USD 1.06 billion in 2023[1].

Q: What is the expected CAGR of the omeprazole market from 2024 to 2036?

The omeprazole market is expected to grow at a CAGR of more than 6.4% from 2024 to 2036[1].

Q: Which region is expected to dominate the omeprazole market?

North America is anticipated to hold the largest share of the omeprazole market during the forecast period[1].

Q: What are the main drivers of the omeprazole market growth?

The main drivers include the increasing prevalence of chronic diseases, growing incidence of GERD and peptic ulcers, and the shift to OTC availability[1][3].

Q: What challenges does the omeprazole market face?

The market faces challenges such as side effects associated with long-term use, the rise of generic alternatives, and the impact of COVID-19 on medication usage[3][4].

Sources:

1. Research Nester: Omeprazole Market Size & Share | Growth Forecasts 2036
2. AstraZeneca: Full year and Q4 2022 results
3. Mordor Intelligence: Proton Pump Inhibitors Market Size (2024
4. Coherent Market Insights: Proton Pump Inhibitors Market - Price, Size, Share & Growth
5. AstraZeneca: FY and Q4 2023 results Strong growth and pipeline momentum with three new medicines approved since the third quarter