PREVACID Drug Patent Profile

Which patents cover Prevacid, and what generic alternatives are available?

Prevacid is a drug marketed by Takeda Pharms Usa, Takeda Pharms Na, and Perrigo Pharma Intl. and is included in six NDAs.

The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.

Summary for PREVACID

US Patents:	0
Applicants:	3
NDAs:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	42
Patent Applications:	4,013
Drug Prices:	Drug price information for PREVACID
Drug Sales Revenues:	Drug sales revenues for PREVACID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREVACID
What excipients (inactive ingredients) are in PREVACID?	PREVACID excipients list
DailyMed Link:	PREVACID at DailyMed

See drug prices for PREVACID

See drug sales revenues for PREVACID

Recent Clinical Trials for PREVACID

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

Sponsor	Phase
Janssen Research & Development, LLC	Phase 1
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
McGill University Health Center	Phase 4

See all PREVACID clinical trials

Pharmacology for PREVACID

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors
Physiological Effect	Inhibition 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
Perrigo Pharma Intl	PREVACID 24 HR	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	022327-001	May 18, 2009		OTC	Yes	Yes
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001		DISCN	No	No
Takeda Pharms Na	PREVACID IV	lansoprazole	INJECTABLE;INTRAVENOUS	021566-001	May 27, 2004		DISCN	Yes	No
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	AB	RX	Yes	Yes
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001		DISCN	No	No

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	021428-001	Aug 30, 2002	7,431,942*PED
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	7,399,485*PED
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	7,875,292*PED
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	5,013,743*PED
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	4,689,333

International Patents for PREVACID

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200100285	Rapidly disintegrable solid preparation.
Australia	666666
Japan	2000344660	RAPIDLY DISINTEGRATING SOLID PREPARATION
Cyprus	1110988
Spain	8607288
Denmark	1561458

Supplementary Protection Certificates for PREVACID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0174726	SPC/GB94/011	United Kingdom		SPC/GB94/011, EXPIRES: 20051210
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
0174726	93C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211

PREVACID Market Analysis and Financial Projection Experimental

Proton Pump Inhibitors Market Dynamics and Financial Trajectory: Focus on Prevacid

Introduction to Proton Pump Inhibitors (PPIs)

Proton pump inhibitors (PPIs) are a class of drugs widely used to treat acid reflux diseases, peptic ulcers, and other gastric disorders. Among these, Prevacid (lansoprazole) is a prominent medication that has been a staple in the treatment of gastrointestinal issues.

Market Size and Growth

The global proton pump inhibitors market, which includes Prevacid, is estimated to be valued at USD 12.70 billion in 2024 and is expected to reach USD 16.32 billion by 2029, growing at a CAGR of 5.14% during the forecast period[1][4].

Regional Market Dynamics

North America

North America currently dominates the proton pump inhibitors market, including Prevacid, due to a high prevalence of GERD and other gastrointestinal disorders. The region's favorable reimbursement policies and high healthcare spending in the U.S. and Canada contribute to its dominant market share. However, the market is also subject to pricing pressures from generic versions and competitive brands[1][4].

Asia Pacific

The Asia Pacific region, excluding Japan, is emerging as the fastest-growing market for proton pump inhibitors. This growth is driven by large patient pools, rising healthcare expenditures, and expanding medical insurance coverage in countries like India, China, and Japan. Local companies in these markets are strengthening their presence through cost-effective generic versions, which can impact the sales of branded drugs like Prevacid[1][4].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the proton pump inhibitors market, including Prevacid. Research indicated that PPI use was associated with a slightly increased risk of COVID-19 infection and poor outcomes in patients with COVID-19. This led to reduced consumption of PPIs during the pandemic. However, as the pandemic subsided, the market is expected to recover and show favorable growth[1].

Patent Expiration and Generic Competition

One of the significant challenges facing Prevacid and other PPIs is the expiration of patents. When major drugs like Prevacid lose their patent exclusivity, generic manufacturers can produce affordable copies, leading to increased competition and downward pressure on prices. For instance, the patents on Prevacid (lansoprazole) have expired, allowing generic versions to enter the market, which has reduced the sales of the branded product[1][4].

Market Exclusivity and Rx-to-OTC Switches

The FDA provides three-year market exclusivity for firms that make the first Rx-to-OTC switch with a given drug. This exclusivity can significantly impact the market dynamics. For example, if a company like Takeda Pharmaceuticals, the manufacturer of Prevacid, had introduced an OTC version earlier, it could have earned higher profits prior to patent expiration due to the first-mover advantage. However, the value of OTC market exclusivity at patent expiration can also drive decisions to delay OTC entry to fence off competition from generic products[3].

Financial Performance of Key Players

Companies like Takeda Pharmaceuticals, which manufacture Prevacid, have seen varied financial performances. While the generic competition has reduced the sales of branded PPIs, these companies are investing heavily in research and development to launch new products and maintain market share. For instance, the launch of new generic versions, such as Xiromed LLC's Omeprazole Delayed-Release Capsules, has helped in propelling the growth of the market[1].

Consumer Behavior and Market Shifts

The increasing shift from prescription to OTC drugs is driving the growth of the proton pump inhibitors market. Consumers are more likely to switch to OTC versions of drugs like Prevacid rather than opting for prescription versions. This shift is driven by increased awareness about treatment options and the convenience of OTC availability[1][3].

Adverse Effects and Market Challenges

Long-term use of PPIs, including Prevacid, has been linked to several adverse effects such as increased risk of fractures, pneumonia, hypomagnesemia, and vitamin B12 deficiency. These side effects can hamper the market growth as patients and healthcare providers become more cautious about the long-term use of these medications[1][4].

New Research and Market Opportunities

Despite the challenges, there are opportunities for growth in the proton pump inhibitors market. New research on dual therapy drugs and the development of novel products are expected to leverage market opportunities. The focus on emerging markets and the strong pipeline of new drug candidates also offer potential for future growth[1][4].

Key Players and Competitive Landscape

Major players in the proton pump inhibitors market include Bayer AG, Pfizer Inc., Takeda Pharmaceuticals, Cadila Pharmaceuticals, and AstraZeneca. These companies are investing in new product launches, marketing campaigns, and strategic partnerships to maintain their market share and drive growth[1].

Regulatory Environment

The regulatory environment, particularly the FDA's policies on market exclusivity and Rx-to-OTC switches, plays a crucial role in shaping the market dynamics. Companies must navigate these regulations to maximize their profits and market presence[3].

Consumer Awareness and Healthcare Spending

Increasing consumer awareness about gastrointestinal disorders and the growing healthcare expenditure in emerging nations are driving the demand for proton pump inhibitors. The adoption of sedentary lifestyles and the consumption of spicy and oily foods, which can trigger acid reflux, also contribute to the market growth[1][4].

Example: Impact of Nexium's Patent Expiration

The patent expiration of Nexium (esomeprazole), another popular PPI, led to an immediate decline in sales for the branded product as generic versions entered the market. This scenario is likely to repeat with other PPIs, including Prevacid, as their patents expire and generic competition increases[4].

Conclusion

The proton pump inhibitors market, including Prevacid, is complex and influenced by various factors such as patent expirations, generic competition, regulatory policies, and consumer behavior. Despite the challenges, the market is expected to grow driven by increasing prevalence of gastrointestinal disorders, rising healthcare expenditures, and new research on dual therapy drugs.

Key Takeaways

• The global proton pump inhibitors market is projected to grow at a CAGR of 5.14% from 2024 to 2029.
• North America dominates the market, but the Asia Pacific region is the fastest-growing segment.
• Patent expirations and generic competition significantly impact the market dynamics.
• The shift from prescription to OTC drugs is driving market growth.
• Adverse effects of long-term PPI use are a concern but do not significantly deter market growth.
• New research and emerging markets offer opportunities for future growth.

FAQs

1. What is the current market size of the proton pump inhibitors market? The proton pump inhibitors market size is estimated at USD 12.70 billion in 2024[1].

2. How is the COVID-19 pandemic affecting the proton pump inhibitors market? The COVID-19 pandemic led to reduced consumption of PPIs due to associated health risks, but the market is expected to recover as the pandemic subsides[1].

3. What is the impact of patent expiration on branded PPIs like Prevacid? Patent expiration leads to generic competition, reducing the sales of branded products and putting downward pressure on prices[1][4].

4. Which region is the fastest-growing market for proton pump inhibitors? The Asia Pacific region, excluding Japan, is the fastest-growing market for proton pump inhibitors[1][4].

5. What are the major challenges facing the proton pump inhibitors market? Major challenges include patent expirations, generic competition, adverse effects of long-term use, and regulatory policies[1][4].

Sources

1. Mordor Intelligence: Proton Pump Inhibitors Market - PPIS - Size, Share & Analysis
2. PR Newswire: Perrigo Reports Third Quarter 2024 Financial Results From Continuing Operations
3. AEAWEB: Does Market Exclusivity Improve Access to Drugs? The Case of US
4. Coherent Market Insights: Proton Pump Inhibitors Market - Price, Size, Share & Growth