NEXIUM 24HR Drug Patent Profile

Which patents cover Nexium 24hr, and when can generic versions of Nexium 24hr launch?

Nexium 24hr is a drug marketed by Astrazeneca Lp and is included in two NDAs.

The generic ingredient in NEXIUM 24HR is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and ten suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexium 24hr

A generic version of NEXIUM 24HR was approved as esomeprazole magnesium by IVAX SUB TEVA PHARMS on January 26^th, 2015.

Summary for NEXIUM 24HR

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	162
Patent Applications:	1,346
Drug Sales Revenues:	Drug sales revenues for NEXIUM 24HR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXIUM 24HR
What excipients (inactive ingredients) are in NEXIUM 24HR?	NEXIUM 24HR excipients list
DailyMed Link:	NEXIUM 24HR at DailyMed

See drug sales revenues for NEXIUM 24HR

Recent Clinical Trials for NEXIUM 24HR

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

Sponsor	Phase
Alexandria University	Phase 3
Nanfang Hospital of Southern Medical University	Phase 4
Liaocheng People's Hospital	Phase 1

See all NEXIUM 24HR clinical trials

Pharmacology for NEXIUM 24HR

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

Paragraph IV (Patent) Challenges for NEXIUM 24HR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXIUM 24HR	Delayed-release Capsules	esomeprazole magnesium	20 mg	204655		2014-04-24

US Patents and Regulatory Information for NEXIUM 24HR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014		OTC	Yes	Yes
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015		OTC	Yes	Yes

Expired US Patents for NEXIUM 24HR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014

International Patents for NEXIUM 24HR

See the table below for patents covering NEXIUM 24HR around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	9915087
Algeria	2495	Formule nouvelle de l'oméprazole-s.
Norway	950263
Slovakia	284837
Sweden	9302396

Supplementary Protection Certificates for NEXIUM 24HR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	1290006-4	Sweden		PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	122012000017	Germany		PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
0984957	CA 2012 00035	Denmark

NEXIUM 24HR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NEXIUM 24HR

Introduction

NEXIUM 24HR, a proton pump inhibitor (PPI) marketed by Pfizer, has significantly impacted the over-the-counter (OTC) antacid market since its introduction in 2014. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Entry and Impact

In May 2014, Pfizer launched NEXIUM 24HR, marking a significant shift in the OTC antacid category. This launch followed an agreement between AstraZeneca and Pfizer in August 2012, where Pfizer acquired the global rights to market NEXIUM for OTC indications[2][4].

Immediate Market Impact

The introduction of NEXIUM 24HR led to a substantial increase in retail dollar sales for the OTC acid blocker category. It contributed to a nearly 30% increase in incremental retail dollar sales year over year, amounting to about $10.1 million in the months of June and July 2014 alone. This also added $2.5 million in margin dollars to the OTC drug channel, given an average retailer margin of 24.7%[1].

Competitive Landscape

Response from Competitors

The launch of NEXIUM 24HR had a profound impact on its competitors. Prilosec, a leading OTC acid blocker at the time, did not immediately adjust its promotional strategy, allowing NEXIUM 24HR to quickly dominate the market. As a result, dollar sales of NEXIUM’s competitors dropped by an average of 19% in the two months following its introduction[1].

Market Share and Dominance

NEXIUM 24HR quickly surpassed Prilosec in sales, becoming the dominant brand in the OTC antacids category by July 2014. The total OTC acid blocker units increased by 570,714 year over year, with NEXIUM 24HR accounting for 691,325 of these units. This indicates that NEXIUM not only added new consumers to the category but also drew sales away from other brands[1].

Financial Implications

Revenue and Margins

The financial performance of NEXIUM 24HR has been robust. The drug provided an additional 5.5% more in margin per unit compared to Prilosec, benefiting retailers significantly. Pfizer’s acquisition of the global rights for OTC NEXIUM included an upfront payment of $250 million to AstraZeneca, along with potential milestone and royalty payments based on product launches and sales[2].

Market Size and Growth

The esomeprazole market, which includes NEXIUM 24HR, is anticipated to grow from USD 1,904.40 million in 2024 to USD 2,872.07 million by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period. This growth is driven by factors such as an increasing aging population and changing lifestyles that lead to digestive health issues[3].

Consumer and Retailer Benefits

Increased Accessibility

The transition of NEXIUM from a prescription medication to an OTC drug made it more accessible to consumers. With 60 million adults affected by heartburn, including 15 million who suffer from it daily, the market demand for this product is strong[4].

Retailer Margins

The introduction of NEXIUM 24HR has been beneficial for drug retailers. The increased sales and higher margins per unit have enhanced the overall profitability of the OTC drug channel. Additionally, the competition driven by NEXIUM’s entry has led to more aggressive marketing and promotional strategies, ultimately benefiting consumers through increased choices and potentially lower prices[1].

Competitive Strategies

Private Label and Generic Competition

The success of NEXIUM 24HR has also led to the development of store brand or generic equivalents. For instance, Perrigo received FDA approval for a store brand OTC equivalent of NEXIUM 24HR capsules in 2017, providing consumers with a high-quality, value alternative[5].

Market Trends and Drivers

Rising Gastrointestinal Issues

The increasing incidence of gastroenteritis and other digestive health issues drives the demand for esomeprazole and similar medications. The hectic lifestyles and poor dietary habits of many individuals contribute to the growing need for acid-reducing medications[3].

Research and Development

Ongoing research into the health effects of esomeprazole is expected to provide new growth opportunities in the coming years. This includes exploring new indications and improving the efficacy and safety profile of the drug[3].

Regional Performance

Global Market

North America leads the global esomeprazole market, driven by high consumer awareness and a well-established healthcare system. The global rights acquired by Pfizer allow for a broad market reach, including the United States, Europe, and other regions[3].

Key Takeaways

• Market Dominance: NEXIUM 24HR quickly became the dominant brand in the OTC antacids category.
• Financial Impact: The drug contributed significantly to retail dollar sales and margins for drug retailers.
• Consumer Benefits: Increased accessibility and competition have benefited consumers.
• Market Growth: The esomeprazole market is expected to grow at a CAGR of 5.3% from 2024 to 2032.
• Competitive Landscape: The entry of NEXIUM 24HR has led to competitive responses from other brands and the development of generic equivalents.

FAQs

Q: What was the impact of NEXIUM 24HR on the OTC antacid market?

A: NEXIUM 24HR led to a nearly 30% increase in incremental retail dollar sales year over year and dominated the market, surpassing Prilosec in sales.

Q: How did competitors respond to the launch of NEXIUM 24HR?

A: Competitors like Prilosec did not immediately adjust their promotional strategies, allowing NEXIUM 24HR to gain market share quickly.

Q: What are the key drivers of the esomeprazole market?

A: The market is driven by an increasing aging population, changing lifestyles, and rising cases of gastroenteritis.

Q: How has the transition to OTC affected consumer access to NEXIUM?

A: The transition made NEXIUM more accessible to consumers, particularly those suffering from frequent heartburn.

Q: What is the projected growth of the esomeprazole market?

A: The market is anticipated to grow from USD 1,904.40 million in 2024 to USD 2,872.07 million by 2032, with a CAGR of 5.3%.

Sources

1. Drug Store News: Nexium 24HR's impact: How top brands respond
2. AstraZeneca: AstraZeneca and Pfizer enter agreement for over-the-counter NEXIUM
3. Polaris Market Research: Esomeprazole Market Size, Share, Global Analysis Report 2024-2032
4. BioPharma Dive: Pfizer expands OTC portfolio with launch of OTC Nexium 24HR
5. PR Newswire: Perrigo Announces Final FDA Approval And Settlement For The Store Brand OTC Equivalent Of Nexium 24HR Capsules