LANSOPRAZOLE - Generic Drug Details

What are the generic drug sources for lansoprazole and what is the scope of patent protection?

Lansoprazole is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Breckenridge, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Natco, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Wockhardt, Xiromed, Zydus Hlthcare, Takeda Pharms Usa, Perrigo Pharma Intl, Takeda Pharms Na, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, and Zydus Pharms, and is included in thirty-seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lansoprazole has three patent family members in three countries.

There are fifty-six drug master file entries for lansoprazole. Seventy-one suppliers are listed for this compound.

Summary for LANSOPRAZOLE

International Patents:	3
US Patents:	2
Tradenames:	7
Applicants:	31
NDAs:	37
Drug Master File Entries:	56
Finished Product Suppliers / Packagers:	71
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	181
Patent Applications:	6,962
Drug Prices:	Drug price trends for LANSOPRAZOLE
Drug Sales Revenues:	Drug sales revenues for LANSOPRAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LANSOPRAZOLE
What excipients (inactive ingredients) are in LANSOPRAZOLE?	LANSOPRAZOLE excipients list
DailyMed Link:	LANSOPRAZOLE at DailyMed

See drug prices for LANSOPRAZOLE

See drug sales revenues for LANSOPRAZOLE

Recent Clinical Trials for LANSOPRAZOLE

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

Sponsor	Phase
Fu Jen Catholic University Hospital	Phase 4
Hospital Clinico Universitario de Santiago	Phase 4
Complejo Hospitalario de Navarra	Phase 4

See all LANSOPRAZOLE clinical trials

Pharmacology for LANSOPRAZOLE

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors
Physiological Effect	Inhibition Gastric Acid Secretion

Medical Subject Heading (MeSH) Categories for LANSOPRAZOLE

Anti-Ulcer Agents

Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LANSOPRAZOLE

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 LANSOPRAZOLE

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 LANSOPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Inventia	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	205868-001	Aug 30, 2017	AB	RX	No	No
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003		DISCN	No	No
Hetero Labs Ltd Iii	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	203083-002	May 18, 2020	AB	RX	No	No
Alkem Labs Ltd	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	207394-002	Jan 18, 2019	AB	RX	No	No
Macleods Pharms Ltd	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	208671-002	Nov 4, 2024	AB	RX	No	No
Hetero Labs Ltd Iii	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	203083-001	May 18, 2020	AB	RX	No	No

Expired US Patents for LANSOPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	6,749,864
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001	6,749,864
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	6,328,994*PED
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	7,399,485*PED
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	4,628,098*PED
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	4,689,333

International Patents for LANSOPRAZOLE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016174664
European Patent Office	3288556	COMPOSITIONS À DÉSINTÉGRATION PAR VOIE ORALE (ORALLY DISINTEGRATING COMPOSITIONS)
Israel	255048	הרכבים המתפוררים בפה (Orally disintegrating compositions)

Supplementary Protection Certificates for LANSOPRAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0174726	93C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
1129088	2014/008	Ireland		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
0328535	96C0021	Belgium		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

LANSOPRAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lansoprazole

Introduction to Lansoprazole

Lansoprazole is a proton pump inhibitor (PPI) widely used to treat various gastrointestinal disorders, including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Its efficacy in reducing stomach acid and promoting healing of the gastrointestinal lining has made it a preferred treatment option.

Global Market Size and Growth

The global lansoprazole market is experiencing significant growth. As of 2023, the market was valued at approximately USD 385.16 million and is projected to reach USD 409.81 million in 2024. By 2032, the market is expected to grow to USD 651.9 million, with a compound annual growth rate (CAGR) of 6.4% during the forecast period[1][4].

Drivers of Market Growth

Several factors are driving the growth of the lansoprazole market:

Increasing Prevalence of Gastrointestinal Disorders

The rising incidence of GERD, gastric ulcers, and other gastrointestinal conditions is a major driver. This increase is partly due to lifestyle factors, aging populations, and improved diagnostic techniques[1][2].

Rising Healthcare Spending and Awareness

High healthcare expenditure, particularly in North America, and growing awareness of the need for early diagnosis and treatment of acid-related conditions are significant contributors to market growth[1].

Adoption of Over-the-Counter (OTC) Formulations

The increasing adoption of OTC lansoprazole formulations has surged demand. Consumers prefer convenient, self-managed healthcare solutions, leading to a higher demand for OTC medications[1].

Advancements in Drug Formulations

Improvements in drug formulations, such as delayed-release and orally disintegrating tablets, have enhanced patient compliance and satisfaction. These innovations are further driving market growth[1].

Market Trends

Several trends are shaping the lansoprazole market:

Preference for Generic Formulations

There is a growing preference for generic lansoprazole due to its cost-effectiveness compared to branded formulations. This trend is particularly noticeable in price-sensitive markets[1].

Combination Drugs

The development of combination drugs containing lansoprazole and other active ingredients is gaining traction. These formulations offer enhanced therapeutic benefits and convenience for patients managing multiple conditions[1].

Digital Health Platforms

Digital health platforms are playing a crucial role in promoting patient education and facilitating access to lansoprazole products. Online pharmacy platforms have expanded their product offerings, enhancing accessibility and consumer convenience[1].

Sustainability and Environmental Concerns

Pharmaceutical companies are focusing on sustainable manufacturing processes and eco-friendly packaging to meet regulatory requirements and consumer expectations. This shift towards sustainability is a key trend in the market[1].

Regional Outlook

The lansoprazole market varies significantly across different regions:

North America

North America, particularly the United States, dominates the lansoprazole market due to its advanced healthcare infrastructure and high prevalence of gastrointestinal disorders. The region's strong focus on innovative drug development and high healthcare expenditure are key factors contributing to its market leadership[1][2].

Europe

Europe holds a substantial market share, with countries like Germany, France, and the United Kingdom leading the demand. Stringent regulations and an emphasis on research and development drive innovation in this region[1].

Asia-Pacific

The Asia-Pacific region is expected to witness the fastest growth, driven by increasing healthcare access, rising disposable incomes, and a growing disease burden. China and India are major contributors due to their large populations and growing healthcare needs[1].

Route of Administration and Product Types

The market is segmented based on the route of administration and product types:

Oral Route of Administration

The oral route of administration is expected to hold the largest market share due to patient preference for capsule formulations, the low cost of oral capsules, and the increasing number of manufacturers supplying lansoprazole in capsule forms[2].

Product Types

The market is segmented into capsules, orally disintegrating (OD) tablets, and other formulations. The botulinum toxin segment, though not directly related to lansoprazole's primary use, is also growing rapidly due to its application in reducing wrinkles[2].

Competitive Landscape

The lansoprazole market is highly competitive, with several key players:

Major Players

Companies like Takeda Pharmaceutical, Teva Pharmaceuticals, Sandoz, GSK, Dr. Reddy's, and Pfizer are among the top players. These companies are engaged in research and development, market expansion, and the launch of generic and combination drug formulations[2][4].

Recent Developments

Several recent developments have reshaped the competitive landscape, including the launch of generic versions, research into combination drugs, notable mergers and acquisitions, and the adoption of eco-friendly manufacturing processes[1].

Challenges and Opportunities

Despite the growth, the market faces some challenges:

COVID-19 Impact

The COVID-19 pandemic had a temporary impact on the market as patients were advised to reduce their use of proton pump inhibitors unless absolutely necessary. However, as the pandemic subsides, the market is expected to return to its growth trajectory[3].

Alternative Medications

The availability of alternative medication classes such as H2 blockers and antacids could pose a challenge. However, the efficacy and convenience of lansoprazole are expected to maintain its market position[2].

Financial Trajectory

The financial trajectory of the lansoprazole market is positive, with significant growth projected over the next decade:

• Market Size in 2023: Approximately USD 385.16 million[1].
• Projected Market Size in 2032: USD 651.9 million[1].
• CAGR: 6.4% during the forecast period[1][4].

Key Takeaways

• The global lansoprazole market is driven by the increasing prevalence of gastrointestinal disorders and the adoption of OTC formulations.
• North America leads the market, but the Asia-Pacific region is expected to witness the fastest growth.
• The market is trending towards generic formulations, combination drugs, and sustainable manufacturing practices.
• Key players are focusing on research and development and market expansion to maintain their competitive edge.
• Despite challenges, the market is expected to grow significantly over the next decade.

Frequently Asked Questions

1. What is the current market size of the lansoprazole market?

The global lansoprazole market was valued at approximately USD 385.16 million in 2023[1].

2. What is the projected growth rate of the lansoprazole market?

The market is expected to grow at a CAGR of 6.4% during the forecast period from 2024 to 2032[1][4].

3. Which region dominates the lansoprazole market?

North America, particularly the United States, dominates the lansoprazole market due to its advanced healthcare infrastructure and high prevalence of gastrointestinal disorders[1][2].

4. What are the key trends in the lansoprazole market?

Key trends include the increasing preference for generic formulations, the development of combination drugs, the use of digital health platforms, and a focus on sustainable manufacturing practices[1].

5. Who are the major players in the lansoprazole market?

Major players include Takeda Pharmaceutical, Teva Pharmaceuticals, Sandoz, GSK, Dr. Reddy's, and Pfizer[2][4].

Cited Sources:

1. Global Growth Insights - Lansoprazole Market Size, Growth | CAGR of 6.4 % [https://www.globalgrowthinsights.com/market-reports/lansoprazole-market-103133]
2. Maximize Market Research - Lansoprazole Market: Global Industry Analysis and Forecast [https://www.maximizemarketresearch.com/market-report/lansoprazole-market/74123/]
3. Mordor Intelligence - Proton Pump Inhibitors Market - PPIS - Size, Share & Analysis [https://www.mordorintelligence.com/industry-reports/proton-pump-inhibitors-market]
4. Valuates Reports - Lansoprazole - Market Size [https://reports.valuates.com/market-reports/QYRE-Auto-32M6904/global-lansoprazole]