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Last Updated: December 22, 2024

PREVACID 24 HR Drug Patent Profile


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Which patents cover Prevacid 24 Hr, and when can generic versions of Prevacid 24 Hr launch?

Prevacid 24 Hr is a drug marketed by Perrigo Pharma Intl and is included in one NDA.

The generic ingredient in PREVACID 24 HR is lansoprazole. There are fifty-six drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the lansoprazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prevacid 24 Hr

A generic version of PREVACID 24 HR was approved as lansoprazole by MYLAN PHARMS INC on November 10th, 2009.

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Summary for PREVACID 24 HR
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 162
Clinical Trials: 42
Patent Applications: 3,973
What excipients (inactive ingredients) are in PREVACID 24 HR?PREVACID 24 HR excipients list
DailyMed Link:PREVACID 24 HR at DailyMed
Drug patent expirations by year for PREVACID 24 HR
Recent Clinical Trials for PREVACID 24 HR

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

SponsorPhase
Janssen Research & Development, LLCPhase 1
McGill University Health CenterPhase 4
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 4

See all PREVACID 24 HR clinical trials

Pharmacology for PREVACID 24 HR
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion

US Patents and Regulatory Information for PREVACID 24 HR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo Pharma Intl PREVACID 24 HR lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 022327-001 May 18, 2009 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PREVACID 24 HR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prevacid 24HR

Introduction

Prevacid 24HR, a proton pump inhibitor (PPI) containing the active ingredient lansoprazole, has been a significant player in the over-the-counter (OTC) market for treating frequent heartburn. Here, we delve into the market dynamics and financial trajectory of this drug.

FDA Approval and Market Entry

In May 2009, Novartis received FDA approval for Prevacid 24HR to be sold over-the-counter, marking the first OTC PPI treatment for frequent heartburn since 2003[1][4].

Clinical Efficacy and Usage

Prevacid 24HR is clinically proven to provide 24-hour relief from frequent heartburn, defined as heartburn occurring two or more days per week. It works by stopping the release of acid into the stomach and is effective for both day and night relief. Clinical trials have shown that it provides more heartburn-free days and nights compared to placebo, with 88% of users satisfied with the treatment[4].

Market Availability and Distribution

Upon its launch, Prevacid 24HR was made available in over 100,000 retail locations across the United States, including pharmacies, drug stores, supermarkets, and mass merchandisers. This widespread availability was a key factor in its market penetration[4].

Financial Performance

In the year preceding its OTC approval, Prevacid achieved $3.37 billion in annual sales in the U.S. as a prescription medication. The transition to OTC status was expected to drive strong incremental growth for the OTC Digestive Health category[1][4].

Acquisition and Ownership Changes

In 2019, Perrigo Company plc acquired the branded OTC rights to Prevacid 24HR from GlaxoSmithKline. This acquisition was part of Perrigo's strategy to expand its self-care portfolio and leverage its existing infrastructure and manufacturing expertise to enhance the value of the Prevacid brand[2].

Competitive Landscape

Prevacid 24HR operates in a competitive market dominated by various acid suppression treatments, including antacids, H2 antagonists, and other PPIs. However, as the first and only OTC PPI in its original formulation, Prevacid 24HR holds a unique position. The lack of branded competition in the OTC PPI segment has contributed to its market success[2][4].

Consumer Impact and Quality of Life

Frequent heartburn significantly affects the quality of life for sufferers. Prevacid 24HR's ability to provide consistent, long-term relief has made it a preferred choice for many consumers. The drug's effectiveness in reducing heartburn symptoms has improved the overall well-being of its users[4].

Pricing Strategy

At its launch, Prevacid 24HR was priced at an average retail price of $11.99, making it an affordable option for consumers seeking long-term heartburn relief. This pricing strategy helped in making the product accessible to a wide audience[4].

Future Outlook and Growth Potential

The acquisition by Perrigo is expected to accelerate brand and category growth. Perrigo's extensive U.S. customer network and innovation pipeline in the gastrointestinal category are seen as key drivers for future success. The company's ability to leverage its existing infrastructure and manufacturing expertise is anticipated to enhance the value of the Prevacid brand[2].

Regulatory and Patent Considerations

While Prevacid 24HR's patent status is not directly mentioned, the broader context of PPIs and their patent lifecycles is relevant. Generally, PPIs like lansoprazole have seen their patents expire, leading to generic competition. However, the brand's strong market presence and consumer loyalty have helped maintain its market share[3].

Key Takeaways

  • FDA Approval: Prevacid 24HR received FDA approval for OTC sale in 2009.
  • Clinical Efficacy: It provides 24-hour relief from frequent heartburn with high user satisfaction.
  • Market Availability: Widely available in over 100,000 retail locations.
  • Financial Performance: Achieved significant sales as a prescription medication and expected to drive growth in the OTC market.
  • Ownership Changes: Acquired by Perrigo in 2019 to expand its self-care portfolio.
  • Competitive Landscape: Unique position as the first and only OTC PPI in its original formulation.
  • Consumer Impact: Improves quality of life by providing consistent heartburn relief.
  • Pricing Strategy: Priced affordably to make it accessible to a wide audience.
  • Future Outlook: Expected to grow under Perrigo's management and infrastructure.

FAQs

What is Prevacid 24HR used for?

Prevacid 24HR is used to treat frequent heartburn, defined as heartburn occurring two or more days per week.

How does Prevacid 24HR work?

It works by stopping the release of acid into the stomach, providing 24-hour relief from heartburn.

Who are the current owners of Prevacid 24HR?

Perrigo Company plc acquired the branded OTC rights to Prevacid 24HR from GlaxoSmithKline in 2019.

Where is Prevacid 24HR available?

It is available in over 100,000 retail locations across the United States, including pharmacies, drug stores, supermarkets, and mass merchandisers.

How much does Prevacid 24HR cost?

At its launch, it was priced at an average retail price of $11.99.

What makes Prevacid 24HR unique in the market?

It is the first and only OTC PPI in its original formulation, providing a unique position in the market.

Sources

  1. FDA Approves Prevacid 24HR for OTC Market - Supermarket News
  2. Perrigo Advances Consumer Self-Care Growth Strategy With Acquisition of Prevacid24HR - PR Newswire
  3. CORPORATE OVERVIEW - Phathom Pharma
  4. Novartis Corporation Launches Prevacid(R)24HR Over-the-Counter - BioSpace

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