PREVPAC (COPACKAGED) Drug Patent Profile

When do Prevpac (copackaged) patents expire, and when can generic versions of Prevpac (copackaged) launch?

Prevpac (copackaged) is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in PREVPAC (COPACKAGED) is amoxicillin; clarithromycin; lansoprazole. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.

Summary for PREVPAC (COPACKAGED)

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	PREVPAC (COPACKAGED) at DailyMed

US Patents and Regulatory Information for PREVPAC (COPACKAGED)

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	PREVPAC (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	050757-001	Dec 2, 1997		DISCN	Yes	No

Expired US Patents for PREVPAC (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PREVPAC (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	050757-001	Dec 2, 1997	4,628,098*PED
Takeda Pharms Usa	PREVPAC (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	050757-001	Dec 2, 1997	5,433,959*PED
Takeda Pharms Usa	PREVPAC (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	050757-001	Dec 2, 1997	5,093,132*PED
Takeda Pharms Usa	PREVPAC (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	050757-001	Dec 2, 1997	5,013,743*PED

International Patents for PREVPAC (COPACKAGED)

See the table below for patents covering PREVPAC (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8607288
Finland	940951
Hong Kong	188195	Stabilized pharmaceutical composition and its production
Germany	3780045

Supplementary Protection Certificates for PREVPAC (COPACKAGED)

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
0174726	SPC/GB94/011	United Kingdom		SPC/GB94/011, EXPIRES: 20051210

PREVPAC (COPACKAGED) Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for PREVPAC (COPACKAGED)

Introduction to PREVPAC

PREVPAC is a copackaged combination of medications designed to treat duodenal ulcers caused by Helicobacter pylori bacteria. It includes lansoprazole (a proton pump inhibitor), amoxicillin, and clarithromycin, each targeting different aspects of the infection and ulceration process[5].

Market Size and Growth

The proton pump inhibitors (PPIs) market, which includes PREVPAC, is projected to experience significant growth over the coming years. The global PPI market 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].

Key Drivers of Market Growth

Increasing Prevalence of Gastroesophageal Reflux Disease (GERD)

The rising prevalence of GERD and other gastrointestinal disorders is a major driver for the PPI market. GERD affects a significant portion of the population, with approximately 40% of the U.S. population experiencing GERD symptoms, and 10-20% being affected on a weekly basis[1].

Aging Population

The increasing geriatric population is another significant factor. By 2030, it is estimated that 1 in 6 people worldwide will be aged 60 years or over, and by 2050, the world's population of people aged 60 years and older will double to 2.1 billion. This demographic shift is expected to increase the demand for PPIs, as aging is a major risk factor for GERD[1].

Lifestyle Factors

Changing lifestyles, including the consumption of spicy, oily, and fatty foods, as well as smoking and alcohol consumption, contribute to the increasing incidence of GERD and other gastric disorders. These factors are expected to drive the demand for PPIs like PREVPAC[1][4].

Novel Drug Delivery Systems and Product Launches

The development of novel drug delivery systems and new product launches are also driving the market. For instance, the launch of generic versions of PPIs, such as Xiromed LLC's Omeprazole Delayed-Release Capsules, is propelling market growth[1].

Market Segments and Regional Performance

Esomeprazole Segment

Esomeprazole, another PPI, is expected to have a significant share of the revenue due to its widespread use in treating GERD and other disorders involving excessive stomach acid. The shift from prescription-only to over-the-counter (OTC) availability is likely to boost sales of esomeprazole and similar PPIs[1].

North America

North America currently dominates the PPI market and is anticipated to continue this trend. The region's favorable reimbursement policies, high healthcare spending, and strong presence of major pharmaceutical companies contribute to its dominance. However, pricing pressures from generic alternatives may challenge future growth prospects for innovator products in this region[1][4].

Asia Pacific

The Asia Pacific region, excluding Japan, is emerging as the fastest-growing market for PPIs. 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, while international brands are targeting these regions through product licensing and joint ventures[4].

Financial Trajectory

Revenue Projections

The global PPI market, which includes PREVPAC, is expected to grow from USD 12.70 billion in 2024 to USD 16.32 billion by 2029, at a CAGR of 5.14%. Another estimate suggests the market will be valued at USD 3.81 billion in 2024 and reach USD 5.50 billion by 2031, with a CAGR of 5.4% during this period[1][4].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the PPI market, as patients were advised to reduce their use of PPIs unless absolutely necessary due to associated risks. However, as the pandemic subsided, the market is expected to experience favorable growth[1].

Challenges and Opportunities

Side Effects and Generic Competition

Long-term use of PPIs, including PREVPAC, is associated with adverse effects such as increased risk of fractures, pneumonia, hypomagnesemia, and vitamin B12 deficiency. Additionally, the availability of cheaper generic alternatives poses competition to branded drugs, which can hamper market growth[4].

Patent Expirations

The patent expiration of major PPI drugs can also challenge the market growth of innovator products. However, this also opens opportunities for generic manufacturers to enter the market with cost-effective alternatives[4].

Emerging Markets

The strong pipeline of novel drug candidates and the increasing focus on emerging markets by key players offer new opportunities. International brands are targeting regions like the Asia Pacific through product licensing, joint ventures, and imports, which can drive market growth[4].

Clinical Efficacy and Usage

Treatment of Duodenal Ulcers

PREVPAC is specifically designed to treat duodenal ulcers caused by H. pylori bacteria. The combination of lansoprazole, amoxicillin, and clarithromycin has been shown to be highly effective in eradicating H. pylori and reducing the risk of duodenal ulcer recurrence. Clinical studies have demonstrated that this triple therapy regimen is more effective than dual therapy combinations[2][5].

Dosage and Administration

PREVPAC should be taken exactly as prescribed, before eating, and the entire packet of medicine should be completed to ensure the ulcer heals completely. Patients must inform their doctors about all medications they are taking and any allergies or medical conditions they have[5].

Conclusion

The market dynamics for PREVPAC and other PPIs are driven by the increasing prevalence of GERD, an aging population, and lifestyle factors. Despite challenges such as side effects and generic competition, the market is expected to grow significantly over the next few years. The financial trajectory indicates a steady increase in revenue, with opportunities in emerging markets and through the development of novel drug delivery systems.

Key Takeaways

• The global PPI market is projected to grow from USD 12.70 billion in 2024 to USD 16.32 billion by 2029.
• The increasing prevalence of GERD and the aging population are key drivers of market growth.
• North America dominates the market, but the Asia Pacific region is emerging as the fastest-growing segment.
• PREVPAC is highly effective in treating duodenal ulcers caused by H. pylori bacteria.
• Long-term use of PPIs is associated with adverse effects, and generic competition poses a challenge to branded drugs.

FAQs

What is PREVPAC used for?

PREVPAC is used to treat duodenal ulcers caused by Helicobacter pylori bacteria. It is a combination of lansoprazole, amoxicillin, and clarithromycin[5].

What are the key drivers of the PPI market growth?

The key drivers include the increasing prevalence of GERD, an aging population, and lifestyle factors such as the consumption of spicy and oily foods[1][4].

Which region dominates the PPI market?

North America currently dominates the PPI market due to favorable reimbursement policies, high healthcare spending, and the strong presence of major pharmaceutical companies[1][4].

What are the potential side effects of long-term PPI use?

Long-term use of PPIs is associated with increased risks of fractures, pneumonia, hypomagnesemia, and vitamin B12 deficiency[4].

How does the COVID-19 pandemic impact the PPI market?

The COVID-19 pandemic had a negative impact on the PPI market due to associated risks, but as the pandemic subsided, the market is expected to experience favorable growth[1].

Sources

1. Mordor Intelligence: Proton Pump Inhibitors Market - PPIS - Size, Share & Analysis
2. FDA: PREVPAC Package Insert
3. PubMed: Booming prescription drug expenditure: a population-based study
4. Coherent Market Insights: Proton Pump Inhibitors Market - Price, Size, Share & Growth
5. GI for Kids: Prevpac – lansoprazole, amoxicillin and clarithromycin