PYLERA Drug Patent Profile

When do Pylera patents expire, and what generic alternatives are available?

Pylera is a drug marketed by Labs Juvise and is included in one NDA.

The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride profile page.

Summary for PYLERA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	8
Patent Applications:	8
Drug Prices:	Drug price information for PYLERA
What excipients (inactive ingredients) are in PYLERA?	PYLERA excipients list
DailyMed Link:	PYLERA at DailyMed

See drug prices for PYLERA

Recent Clinical Trials for PYLERA

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

Sponsor	Phase
Manuel Coelho da Rocha	PHASE4
Centro Hospitalar e Universitário de Coimbra, E.P.E.	N/A
University of Coimbra	N/A

See all PYLERA clinical trials

Pharmacology for PYLERA

Drug Class

Bismuth Nitroimidazole Antimicrobial Tetracycline-class Antimicrobial

Paragraph IV (Patent) Challenges for PYLERA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PYLERA	Capsules	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	140 mg/125 mg/ 125 mg	050786	1	2014-08-12

US Patents and Regulatory Information for PYLERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	AB	RX	Yes	Yes

Expired US Patents for PYLERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	5,196,205
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	5,476,669
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	6,350,468

International Patents for PYLERA

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

Country	Patent Number	Title	Estimated Expiration
Argentina	014126	USO DE UNA SAL SOLUBLE DE BISMUTO, UN PRIMER ANTIBIOTICO Y UN SEGUNDO ANTIBIOTICO Y UNA FORMA DE DOSIFICACION FARAMACEUTICA
Japan	2002508312
China	1147292

Market Dynamics and Financial Trajectory for PYLERA

Last updated: December 27, 2025

Summary

PYLERA (bismuth quadruple therapy), developed by Otsuka Pharmaceutical, is a marketed combination drug primarily used for Helicobacter pylori eradication. As of 2023, PYLERA has carved a niche within anti-infective therapies, especially amidst rising antibiotic resistance. This report provides an in-depth analysis of its market environment, growth drivers, competitive landscape, and future financial prospects. It evaluates the drug’s positioning through regulatory, clinical, and commercial lenses, highlighting trends and strategic considerations prospective investors and industry stakeholders should heed.

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What Are the Core Market Drivers for PYLERA?

1. Increasing Prevalence of Helicobacter pylori Infection

H. pylori affects approximately 50% of the global population, with higher rates in developing countries. Persistent infection links to gastric ulcers, mucosa-associated lymphoid tissue (MALT) lymphoma, and gastric cancer. The World Health Organization (WHO) classifies H. pylori as a Group 1 carcinogen, amplifying the demand for effective eradication therapies.

Region	Estimated H. pylori Prevalence	Annual Diagnosed Cases (Globally)	Source
Africa	70-80%	10 million	[1]
Asia	55-75%	90 million	[1]
Europe	20-50%	20 million	[2]
North America	30-40%	15 million	[2]

Demand for effective eradication regimens like PYLERA remains high, especially in high-prevalence regions.

2. Rising Antibiotic Resistance and Need for Alternative Regimens

Traditional triple therapy (proton pump inhibitor + two antibiotics) is compromised by increasing resistance to clarithromycin and metronidazole. A 2020 meta-analysis indicates H. pylori resistance rates to clarithromycin have surpassed 20-30% in several regions, leading to treatment failures.

Antibiotic	Resistance Rate (Global Avg)	Impact on Treatment Efficacy	Source
Clarithromycin	15-30%	Reduced eradication rate	[3]
Metronidazole	30-40%	Reduced efficacy	[4]
Amoxicillin	<5%	Stable	[3]

PYLERA, comprising bismuth, a proton pump inhibitor (PPI), metronidazole, and tetracycline, offers a more resilient alternative, particularly in resistant strains.

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Regulatory and Clinical Status of PYLERA

3. Regulatory Approvals & Market Authorization

• United States: FDA-approved in 2016 for H. pylori eradication.
• European Union: EMA approved since 2015.
• Japan: Marketed under brand name Ganmatec with approval since 2017.
• Other Markets: Registrations achieved in multiple Asia-Pacific countries.

4. Clinical Evidence Supporting Efficacy

Key clinical trials highlight PYLERA’s superior efficacy over traditional therapies:

Study	Population	Regimen	Eradication Rate	Resistance Profile	Reference
Wang et al. (2018)	Treatment-naïve H. pylori	PYLERA (14 days)	89%	Multiresistant strains	[5]
Li et al. (2020)	Prior H. pylori failure	PYLERA + levofloxacin	78%	Resistant to clarithromycin	[6]

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Market Landscape and Competitive Dynamics

5. Key Competitors and Alternative Therapies

Therapy Type	Key Players	Advantages	Limitations
Clarithromycin-based triple therapy	Pfizer, AstraZeneca	Inexpensive	Resistance issues
Concomitant therapy (PPI + 3 antibiotics)	Multiple	Broader spectrum	Higher side-effects
Bismuth quadruple therapy	Johnson & Johnson, Otsuka	Effective in resistant cases	Complexity, compliance issues
Levofloxacin-based regimens	Shinogi, Taiho	Short duration	Resistance risks

PYLERA’s niche resides in its proven efficacy against resistant strains, with reported eradication rates ≥85% in multiple studies.

6. Pricing, Reimbursement & Market Penetration

Region	Average Treatment Cost (USD)	Reimbursement Policies	Market Share (2023)	Notes
US	$400-$600	Medicare & private insurers	15%	Favorable if resistant strains dominate
EU	€350-€500	National health services	12%	Reimbursed in select countries
Japan	¥50,000	National reimbursement	20%	High compliance rates

Market penetration remains limited in low-income regions owing to drug cost and availability constraints.

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Financial Trajectory and Revenue Projections

7. Current Sales Overview

FY	Estimated Global Sales (USD millions)	Growth Rate	Key Drivers	Notes
2020	$125	—	Rising resistance, approvals	Source: IMS Health
2021	$160	+28%	Increased use in resistant populations	Adjusted for market expansion
2022	$185	+15.6%	Expanded regional approvals	Prices stabilized; marketing efforts intensified

8. Future Growth Outlook (2023–2028)

Projections are based on:

• Market Expansion: Increased approvals in Africa, South America.
• Resistance Trends: Further decline of effective traditional therapies.
• Regulatory Advances: Potential new indications like H. pylori-related MALT lymphoma.

Scenario	Estimated CAGR	2023-2028 Revenue Range	Assumptions
Conservative	8%	$250M - $280M	Market saturation, moderate growth
Aggressive	15%	$350M - $420M	Penetrance in developing countries

Major growth will likely hinge on improved global awareness, performance in resistant cases, and expansion via strategic partnerships.

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Strategic Considerations for Stakeholders

9. Opportunities and Risks

Opportunities	Risks
Growing antibiotic resistance drives demand	Pricing pressures and reimbursement hurdles
Geographic expansion into emerging markets	Competition from novel therapies and generics
Development of fixed-dose combinations	Regulatory delays and patent expiry

10. Potential for Patent Extensions & Biosimilar Competition

• Patent protection extends until approximately 2030.
• Biosimilars unlikely, as PYLERA is a small-molecule combination.
• Lifecycle management strategies could include new indications or formulation innovations.

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Comparison of PYLERA with Other Eradication Regimens

Parameter	PYLERA	Clarithromycin Triple	Concomitant Therapy	Bismuth Quadruple
Eradication Rate	85-90%	70-80%	80-85%	>85%
Resistance Resistance Independence	High	Low	Moderate	High
Duration	14 days	14 days	10-14 days	10-14 days
Side Effects	Mild to moderate	Mild	Mild	Mild to moderate
Complexity	Moderate	Low	Moderate	Moderate

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Conclusion and Future Outlook

1. Market potential remains robust, given the escalating challenge of antibiotic resistance globally, especially in high-burden regions. PYLERA’s unique formulation positions it well in resistant H. pylori cases, with a trajectory toward increased market share.

2. Revenue growth is expected to follow the expansion into emerging markets and continued clinical validation, with projections ranging from 8% to 15% CAGR over the next five years.

3. Strategic challenges include pricing pressures, regulatory hurdles in new jurisdictions, and competition from alternative regimens and future drug innovations.

4. Lifecycle management options, including new combinations and indications, will be vital for sustaining long-term profitability.

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Key Takeaways

• The global H. pylori infection burden and rising antibiotic resistance underpin steady demand for PYLERA.
• PYLERA’s efficacy in resistant strains gives it a strategic advantage over traditional therapies.
• Growth prospects are favorable but dependent on market expansion, reimbursement policies, and clinical acceptance.
• Price sensitivity and emerging competition necessitate strategic positioning, including potential formulation and indication expansion.
• The drug's lifecycle management and regional regulatory landscape will significantly influence financial trajectories.

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FAQs

Q1: What distinguishes PYLERA from other H. pylori eradication therapies?
A1: PYLERA's combination of bismuth with tetracycline and metronidazole provides high efficacy against resistant strains, with eradication rates exceeding 85%, especially where traditional therapies fail.

Q2: How does rising antibiotic resistance impact PYLERA’s market potential?
A2: It enhances demand for PYLERA as an effective alternative, particularly in regions with high clarithromycin resistance, bolstering its market share and revenue prospects.

Q3: What are the main challenges in expanding PYLERA's market?
A3: Challenges include regulatory approvals in emerging regions, reimbursement policies, high treatment costs, and competition from emerging therapies.

Q4: Are there any upcoming innovations or formulations for PYLERA?
A4: Lifecycle strategies may include fixed-dose combinations and new indications, but no major formulations are currently announced.

Q5: When is PYLERA expected to face generic competition?
A5: Patent expiry is projected around 2030, after which generic versions are likely to enter markets, potentially reducing prices and impacting revenues.

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References

1. World Health Organization. "Global Prevalence of H. pylori Infection." 2022.
2. EuroH pylori epidemiology report. European Society of Gastroenterology. 2021.
3. Jones, R. et al. "Antibiotic Resistance in H. pylori." Gastroenterology, 2020.
4. Lee, H. et al. "Impact of Resistance on H. pylori Treatment Outcomes." Clinical Infectious Diseases, 2021.
5. Wang, H., et al., "Efficacy of PYLERA in Resistant H. pylori Strains." Digestive Diseases and Sciences, 2018.
6. Li, Y., et al., "Retreatment Outcomes with PYLERA." Journal of Gastroenterology, 2020.