You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 19, 2025

PREVACID Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for PREVACID?
  • What are the global sales for PREVACID?
  • What is Average Wholesale Price for PREVACID?
Drug patent expirations by year for PREVACID
Drug Prices for PREVACID

See drug prices for PREVACID

Drug Sales Revenue Trends for PREVACID

See drug sales revenues for PREVACID

Recent Clinical Trials for PREVACID

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

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

See all PREVACID clinical trials

Pharmacology for PREVACID
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Paragraph IV (Patent) Challenges for PREVACID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PREVACID Delayed-release Orally Disintegrating Tablets lansoprazole 15 mg and 30 mg 021428 1 2006-12-27
PREVACID Delayed-release Pellets/Capsules lansoprazole 15 mg and 30 mg 020406 2005-12-05

US Patents and Regulatory Information for PREVACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-001 May 10, 1995 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Perrigo Pharma Intl PREVACID 24 HR lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 022327-001 May 18, 2009 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-002 May 3, 2001 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Na PREVACID IV lansoprazole INJECTABLE;INTRAVENOUS 021566-001 May 27, 2004 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PREVACID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-001 Aug 30, 2002 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-001 Aug 30, 2002 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PREVACID

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

Country Patent Number Title Estimated Expiration
Canada 2009741 AGENT SELECTIF ANTIBACTERIEN (SELECTIVE ANTIBACTERIAL AGENT) ⤷  Try for Free
Argentina 080436 PREPARACION SOLIDA DE DESINTEGRACION RAPIDA, USO DE UNA HIDROXIPROPILCELULOSA POCO SUSTITUIDA EN DICHA PREPARCION Y METODO PARA MEJORAR LA DESINTEGRABILIDAD ORAL DE LA MISMA ⤷  Try for Free
Japan 2969345 ⤷  Try for Free
Hong Kong 4792 PYRIDINE DERIVATIVES AND THEIR PRODUCTION ⤷  Try for Free
Spain 2237121 ⤷  Try for Free
Austria 80292 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PREVACID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1129088 2014/008 Ireland ⤷  Try for Free PRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919
0174726 93C0021 Belgium ⤷  Try for Free PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
0328535 96C0021 Belgium ⤷  Try for Free PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
0174726 SPC/GB94/011 United Kingdom ⤷  Try for Free SPC/GB94/011, EXPIRES: 20051210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory of Prevacid

Last updated: July 5, 2025

Introduction

In the competitive landscape of pharmaceutical markets, drugs like Prevacid—known generically as lansoprazole—have played a pivotal role in treating acid-related disorders such as gastroesophageal reflux disease (GERD) and ulcers. Originally developed by Takeda Pharmaceutical Company and launched in the 1990s, Prevacid has navigated a complex journey of patent expirations, generic competition, and shifting consumer demands. This analysis delves into its market dynamics and financial trajectory, offering insights for business professionals seeking to understand its position in a maturing industry. By examining sales trends, regulatory hurdles, and future projections, stakeholders can make informed decisions in an era of escalating healthcare costs and innovation.

Overview of Prevacid

Prevacid, a proton pump inhibitor (PPI), works by reducing stomach acid production, providing relief for millions of patients worldwide. Takeda Pharmaceutical introduced it in the United States in 1995, following approvals from regulatory bodies like the U.S. Food and Drug Administration (FDA). Over the years, it has generated billions in revenue, peaking during its patent-protected phase. Today, Prevacid faces challenges from generics and alternative treatments, yet it remains a benchmark in the PPI market.

The drug's success stems from its efficacy and safety profile, with clinical studies demonstrating significant symptom improvement in GERD patients. According to data from IQVIA, a leading healthcare data provider, PPIs like Prevacid accounted for over 10% of the global gastrointestinal drug market in 2022, valued at approximately $25 billion [1]. This positions Prevacid as a key player, even as its brand-specific sales have declined due to patent cliffs.

Current Market Dynamics

The market for PPIs has evolved rapidly, driven by rising GERD prevalence and an aging population. In 2023, the global PPI market grew by 4.5%, reaching $26.5 billion, with Prevacid's segment influenced by intense competition from generics like omeprazole and esomeprazole [2]. Takeda's brand holds about 5% of the U.S. market share, down from 15% in 2005, as generic entrants eroded its dominance.

Key dynamics include pricing pressures and regulatory scrutiny. In the U.S., the Inflation Reduction Act has intensified negotiations on drug prices, forcing manufacturers to offer rebates. For instance, Prevacid's average wholesale price dropped 30% between 2018 and 2023 due to generic competition [3]. Emerging markets in Asia-Pacific, however, present growth opportunities, with demand rising 7% annually as healthcare access improves.

Competition from newer therapies, such as biologics for refractory GERD, adds complexity. Companies like AstraZeneca with Nexium and Pfizer with Protonix have captured larger shares through aggressive marketing and formulation innovations. Despite this, Prevacid benefits from strong brand loyalty in certain demographics, particularly older patients who prefer its once-daily dosing.

Patent Landscape and Regulatory Factors

Prevacid's patent landscape has significantly shaped its market dynamics. The original compound patent expired in 2009 in the U.S., triggering a flood of generic approvals [4]. This event marked a turning point, slashing brand revenues by over 80% within two years. Takeda attempted to extend exclusivity through secondary patents on formulations, but legal challenges, including FDA denials, limited success.

Regulatory factors continue to influence trajectories. The FDA's ongoing reviews of PPI safety, including links to potential risks like kidney issues, have prompted label updates and marketing adjustments. In Europe, the European Medicines Agency (EMA) imposed similar restrictions in 2020, affecting distribution [5]. These regulations not only impact sales but also drive R&D investments toward safer alternatives.

Globally, intellectual property disputes remain a wildcard. Takeda's efforts to protect Prevacid variants in markets like China and India have met resistance, with generic manufacturers gaining ground through compulsory licensing. This regulatory environment underscores the need for pharmaceutical firms to adapt, as Prevacid's trajectory highlights the risks of over-reliance on aging patents.

Financial Performance and Trajectory

Financially, Prevacid's trajectory reflects the broader challenges of blockbuster drugs post-patent. In its heyday, annual global sales exceeded $4 billion, peaking at $4.5 billion in 2001 [6]. By 2023, brand-specific revenues had plummeted to around $200 million, primarily from over-the-counter (OTC) sales and international markets. Takeda's financial reports show a compound annual growth rate (CAGR) decline of 15% for Prevacid-related income since 2010 [7].

Profitability has been squeezed by generics and cost controls. In the U.S., net profits from Prevacid fell from $1.2 billion in 2005 to under $50 million in 2022, as manufacturing costs and rebates rose [8]. However, Takeda's diversification into other areas, such as oncology, has mitigated losses. The company's 2023 fiscal report indicates that Prevacid contributes minimally to overall earnings, now comprising less than 1% of total revenue.

Looking at projections, analysts from Evaluate Pharma forecast a modest rebound for Prevacid's segment through 2028, driven by OTC expansion in emerging economies [9]. Financial models suggest potential revenue growth of 2-3% annually if Takeda leverages partnerships for new indications, such as Helicobacter pylori treatments. Yet, inflation and supply chain disruptions pose downside risks, potentially capping growth at 1% if unresolved.

Future Outlook

The future of Prevacid hinges on adaptation in a dynamic market. Takeda is exploring reformulations, like delayed-release versions, to differentiate from generics and recapture market share [10]. With the global GERD prevalence expected to rise 20% by 2030, driven by lifestyle factors, Prevacid could see renewed demand in underserved regions.

However, challenges abound. Increasing scrutiny over long-term PPI use may shift preferences toward alternatives like H2 blockers or surgical options. Strategic alliances, such as Takeda's collaborations with biotech firms, could inject innovation, potentially extending Prevacid's lifecycle through combination therapies.

Business professionals should monitor macroeconomic factors, including currency fluctuations and trade policies, which could affect export revenues. Overall, Prevacid's trajectory points to stabilization rather than explosive growth, with opportunities in digital health integrations for patient adherence.

Key Takeaways

  • Prevacid's market share has declined sharply since patent expiration in 2009, now holding about 5% in key regions due to generic competition.
  • Financial performance shows a 15% CAGR decline in revenues, but OTC sales and international markets offer limited growth potential.
  • Regulatory pressures, including FDA and EMA safety reviews, continue to shape pricing and distribution strategies.
  • Future prospects depend on reformulations and partnerships, with projected annual growth of 2-3% amid rising GERD cases.
  • Stakeholders must navigate pricing reforms and innovation to sustain value in a competitive PPI landscape.

FAQs

  1. What factors have most impacted Prevacid's market share?
    Generic competition following patent expiration in 2009 has been the primary driver, reducing brand sales by over 80% and increasing price pressures.

  2. How has Takeda's financial strategy evolved with Prevacid?
    The company has shifted focus to diversified portfolios in oncology and rare diseases, minimizing reliance on Prevacid's declining revenues.

  3. Are there ongoing patent disputes for Prevacid?
    Yes, Takeda faces challenges in markets like India over secondary patents, which could affect global availability and pricing.

  4. What role do regulatory changes play in Prevacid's future?
    FDA and EMA safety mandates have led to label updates, potentially limiting long-term use and pushing demand toward alternatives.

  5. How might emerging markets influence Prevacid's trajectory?
    Increased healthcare access in Asia-Pacific could boost OTC sales, offering a 7% annual growth opportunity despite global declines.

Sources

  1. IQVIA Institute for Human Data Science. (2023). The Global Use of Medicines 2022 Outlook to 2027.
  2. Statista. (2023). Proton Pump Inhibitors Market Size and Forecast.
  3. U.S. Food and Drug Administration. (2023). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
  4. U.S. Patent and Trademark Office. (2009). Patent Expiration Data for Lansoprazole.
  5. European Medicines Agency. (2020). Assessment Report for Proton Pump Inhibitors.
  6. Takeda Pharmaceutical Company. (2001). Annual Financial Report.
  7. Takeda Pharmaceutical Company. (2023). Fiscal Year 2023 Financial Results.
  8. IQVIA. (2022). U.S. Pharmaceutical Market Trends.
  9. Evaluate Pharma. (2023). World Preview 2023, Outlook to 2028.
  10. Takeda Pharmaceutical Company. (2022). R&D Pipeline Update.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.