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
Clinical Trials:	7
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
Centro Hospitalar e Universitário de Coimbra, E.P.E.	N/A
University of Coimbra	N/A
Hospital da Senhora da Oliveira	Early Phase 1

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
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006

International Patents for PYLERA

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

Country	Patent Number	Title	Estimated Expiration
Canada	1330759	METHODE DE TRAITEMENT D'AFFECTIONS GASTRO-INTESTINALES (METHOD FOR THE TREATMENT OF GASTRO INTESTINAL DISORDERS)
World Intellectual Property Organization (WIPO)	8903219
Poland	192541
Italy	1296980	CAPSULA DOPPIA COME FORMA FARMACEUTICA PER LA SOMMINISTRAZIONE DI PRINCIPI ATTIVI IN TERAPIE MULTIPLE
Portugal	1037614
Norway	329126

PYLERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pylera

Introduction

Pylera, a patented three-in-one capsule triple therapy, is designed for the eradication of Helicobacter pylori (H. pylori), a bacterium primarily responsible for gastric and duodenal ulcers. Here, we delve into the market dynamics and financial trajectory of Pylera, exploring its pricing, market performance, and the broader context of the H. pylori infection market.

Market Context

The H. pylori infection market is a significant segment within the pharmaceutical industry, driven by the prevalence of H. pylori infections. As of 2021, the total diagnosed prevalent cases of H. pylori infections in the 7MM (the United States, EU5, and Japan) were approximately 321.9 million, contributing to a market size of USD 3.41 billion[4].

Product Overview

Pylera is part of the bismuth quadruple therapy regimen, which includes metronidazole, tetracycline, bismuth subsalicylate, and an acid reducer like omeprazole. It was approved by the FDA on September 28, 2006, for the treatment of H. pylori infection and duodenal ulcers[5].

Pricing and Cost

Without insurance, Pylera is relatively expensive, costing about $1,180 for a 10-day treatment regimen, which translates to approximately $120 per day. This cost does not include the additional expense of omeprazole, which is typically prescribed alongside Pylera, adding another $60 to the total cost[2].

Insurance Coverage

Insurance coverage for Pylera varies widely. Some health plans cover it under high drug tiers, while others, including many Medicare and Medicaid plans, do not cover it at all. Uninsured patients can explore patient assistance programs, prescription discount cards, or generic alternatives to reduce costs[2].

Market Performance

Historically, the market for H. pylori agents has seen moderate growth. Between 2002 and 2006, the US sales of H. pylori agents ranged from $123 million to $145 million, with a slight increase over the years[1].

Competitive Landscape

Pylera operates in a competitive market with other combination therapies such as Talicia, Omeclamox-Pak, and Voquezna Dual and Triple Pak. These products have been approved in recent years and are vying for market share. For instance, Talicia, another FDA-approved product for H. pylori eradication, is also marketed by RedHill Biopharma, the same company that commercializes Pylera[3][4].

Financial Trajectory

RedHill Biopharma, the company behind Pylera, has faced financial challenges. Despite commercializing several GI-related products, including Pylera and Talicia, the company has incurred significant losses. In 2019, RedHill Biopharma reported a net loss of approximately $42.3 million, and as of December 31, 2019, the company had an accumulated deficit of about $208.4 million. The company's ability to sustain its business operations depends on successfully commercializing its current and future products[3].

Market Growth and Challenges

The H. pylori infection market is expected to grow at a CAGR of 1.9% from 2019 to 2032, driven by recent approvals of combination therapies and changing treatment paradigms. However, the market is heavily skewed due to the widespread availability of generics, which affects the sales of approved therapies and limits market growth[4].

Regulatory and Post-Marketing Oversight

The FDA plays a crucial role in overseeing the safety and effectiveness of drugs like Pylera. Despite its approval, the FDA has requested post-marketing studies to gather more information. However, weaknesses in the FDA's monitoring and enforcement processes have been identified, which can impact the long-term market performance of such drugs[5].

Key Takeaways

• Market Size and Growth: The H. pylori infection market was valued at USD 3.41 billion in 2021 and is expected to grow at a CAGR of 1.9% until 2032.
• Pricing and Cost: Pylera is priced around $1,180 for a 10-day treatment without insurance, with additional costs for accompanying medications.
• Insurance Coverage: Coverage varies widely, with some plans covering Pylera under high drug tiers while others do not cover it at all.
• Competitive Landscape: Pylera competes with other combination therapies like Talicia and Voquezna Dual and Triple Pak.
• Financial Performance: RedHill Biopharma faces financial challenges despite commercializing several GI-related products.

FAQs

Q: What is Pylera used for? Pylera is used for the eradication of Helicobacter pylori (H. pylori) infections, which are the main cause of gastric and duodenal ulcers.

Q: How much does Pylera cost without insurance? Without insurance, Pylera costs approximately $1,180 for a 10-day treatment regimen.

Q: Is Pylera covered by insurance? Insurance coverage for Pylera varies widely. Some plans cover it under high drug tiers, while others, including many Medicare and Medicaid plans, do not cover it at all.

Q: What are the generic alternatives to Pylera? The individual components of Pylera (metronidazole, tetracycline, and bismuth subsalicylate) are available in generic forms or over the counter.

Q: How does Pylera fit into the broader H. pylori infection market? Pylera is part of a competitive market with other combination therapies and faces challenges due to the widespread availability of generics, which affects market growth.

Sources

1. MM+M: Pylera - MM+M - Medical Marketing and Media
2. SingleCare: How much is Pylera without insurance? - SingleCare
3. EDGAR Online: RedHill Biopharma Ltd. (Form: 20-F, Received - EDGAR Online
4. PR Newswire: Helicobacter pylori Infection Market to Exhibit Growth at a Paltry ...
5. GAO: New Drug Approval: FDA Needs to Enhance Its ...