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
University of Coimbra	N/A
Centro Hospitalar e Universitário de Coimbra, E.P.E.	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	6,350,468
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

International Patents for PYLERA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1034897
New Zealand	226437	PHARMACEUTICAL COMPOSITIONS FOR TREATMENT OF GASTROINTESTINAL DISORDERS CONTAINING A BISMUTH COMPOUND AND ANTIBIOTICS
Portugal	1037614
European Patent Office	1037614	DOUBLE CAPSULE POUR ADMINISTRER DES PRINCIPES ACTIFS SELON UNE POLYTHERAPIE (A DOUBLE CAPSULE FOR THE ADMINISTRATION OF ACTIVE PRINCIPLES IN MULTIPLE THERAPIES)
Italy	MI972788
Poland	341737

PYLERA Market Analysis and Financial Projection

Last updated: April 29, 2026

PYLERA Market Dynamics and Financial Trajectory

What is PYLERA’s commercial footprint?

PYLERA is a branded, fixed-dose combination regimen of bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride used for Helicobacter pylori (H. pylori) eradication in adults. The product is marketed by Allergan (AbbVie) in the United States, where it is positioned as an alternative to other H. pylori eradication regimens (including clarithromycin-based therapies in markets where available).

From a market-structure standpoint, PYLERA competes in a mature and guideline-driven category where demand depends on:

• Guideline inclusion (first-line vs alternative regimens)
• Antibiotic resistance patterns affecting regimen selection
• Formulary positioning and managed care contracting
• Price pressure from generic alternatives and competitors

How do prescribing guidelines shape demand?

H. pylori eradication is a guideline-led market with periodic shifts in preferred regimens based on resistance. In the US, the standard-of-care has moved over time toward regimens designed to work despite macrolide resistance, with heavy reliance on local susceptibility data and stewardship considerations.

PYLERA’s economic demand is therefore sensitive to how often it is treated as:

• An alternative regimen when other combinations are not appropriate, or
• A preferred regimen in specific clinical pathways where tetracycline and metronidazole-based approaches align with resistance and tolerability profiles.

Guideline frameworks also influence uptake because payers track clinical guideline concordance for prior authorization and coverage.

Source positioning: US FDA labeling for PYLERA provides dosing and clinical-use framing for H. pylori eradication therapy. PYLERA’s package labeling is the reference point for regimen use in payer adjudication and prescriber workflow. [1]

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What market dynamics drive PYLERA’s sales trajectory?

How does resistance and regimen switching affect PYLERA?

H. pylori resistance trends typically favor regimens that avoid or de-emphasize antibiotics with high resistance rates. This dynamic can create periodic demand swings across competing regimens. For PYLERA specifically:

• The regimen includes metronidazole and tetracycline, antibiotics whose effectiveness can differ by region and resistance patterns.
• Clinical selection often responds to macrolide resistance constraints, which can redirect use toward non-clarithromycin strategies.

When clinicians shift away from clarithromycin-based regimens due to resistance, multi-drug regimens like PYLERA can gain relative pull, but the pull is not stable because competitors and guideline recommendations also evolve.

Regimen dependence: Clinical use is anchored to labeled indications, dosing schedules, and eradication assessment requirements, as reflected in FDA-approved prescribing information. [1]

What role does payer formularies play?

PYLERA’s adoption is constrained by typical formulary levers:

• Tier placement (brand vs non-preferred)
• Step edits (use of other eradication therapies before brand)
• Prior authorization triggers tied to diagnosis and guideline concordance
• Quantity limits due to the short course nature of therapy

Because PYLERA is taken as a short course for eradication, repeat dosing is typically limited to:

• Re-treatment after failure or intolerance
• Test-of-cure–driven pathways that determine subsequent management

That structure makes sales particularly sensitive to formulary status. Any shift toward less-expensive generic equivalents or preferred alternatives can produce immediate revenue compression.

How does generic competition influence pricing power?

PYLERA is a branded regimen in a therapeutically substitutable category. Even when exact fixed-dose products are not identical, payers and clinicians can route to:

• Alternative regimens with different antibiotic combinations
• Generic component strategies (where clinically feasible)

This market structure typically produces long-run pricing pressure for brands as:

• Competitors gain preferred formulary status
• Net price erodes faster than volume can compensate

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What does PYLERA’s financial trajectory look like?

What does the latest product-level financial profile indicate?

Public, product-level revenue and prescription share data for PYLERA is not consistently disclosed in a way that allows a clean, year-by-year reconstruction of the brand’s standalone financial trajectory without reliance on proprietary sales reporting. Under a strict analysis requirement, a complete financial trajectory with auditable numeric series cannot be produced from accessible primary disclosures alone.

What can be stated with precision is the corporate disclosure context and product identity:

• PYLERA is an AbbVie-branded H. pylori eradication regimen with FDA labeling.
• The commercial performance is fundamentally constrained by the maturity of the H. pylori market, short-course prescribing, and formulary and resistance-driven regimen switching.

FDA labeling supports that PYLERA is a defined eradication therapy regimen, not a chronic therapy with recurring dosing that would naturally stabilize branded revenue. [1]

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What are the key commercial risk factors to monitor?

How do safety and tolerability affect repeat use and payer coverage?

H. pylori regimens can face discontinuations due to:

• GI intolerance
• Antibiotic-associated adverse effects
• Drug interactions (especially those related to metronidazole)

Labeling-based constraints influence:

• Real-world persistence through completion of therapy
• Rates of eradication failure (which can lead to retreatment)

In a fixed short course, any tolerability issue can reduce completion rates and can indirectly reduce prescription conversion and payer willingness.

FDA prescribing information remains the anchor for adverse-event context and use instructions. [1]

How does test-of-cure practice shift address counts?

Because eradication requires assessment of success, the frequency of repeat testing influences:

• Retreatment volume
• Switching to alternative regimens after failure

If practice patterns prefer specific alternatives after failed eradication, PYLERA’s share can decline even if absolute H. pylori prevalence remains stable.

FDA labeling ties use to eradication treatment, creating a structural dependency between regimen selection and downstream test-of-cure behavior. [1]

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What strategic implications does the market structure create for competitors?

Why do regimen re-allocations matter economically?

In H. pylori, total addressable prescriptions depend less on epidemiology and more on:

• Which regimens are “allowed” by formularies
• Which regimens are “preferred” by guidelines and resistance surveillance
• Which regimens maintain acceptable tolerability and completion rates

For PYLERA, these levers determine whether it stays an accessible alternative or becomes a rarely used option.

This is consistent with how branded eradication therapies behave in mature antibiotic-driven indications: volumes can fall quickly when preferred alternatives emerge or when payer coverage narrows.

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Key Takeaways

• PYLERA is a short-course, guideline-driven H. pylori eradication regimen whose commercial trajectory is structurally exposed to formulary status, resistance-driven regimen switching, and competition. [1]
• Sales sensitivity is high because demand is not recurring and is tied to initial eradication plus downstream test-of-cure and retreatment pathways.
• Pricing power is likely limited long-run in a category with therapeutic substitution and component-level competition dynamics, which typically compress net revenue for brands.
• A numeric year-by-year financial trajectory cannot be fully reconstructed from auditable public disclosures under strict completeness rules; the defensible analysis is rooted in demand mechanics and labeled therapy structure. [1]

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FAQs

1. What is PYLERA used for?
   It is used for eradication of H. pylori in adults as specified in FDA labeling. [1]

2. Why does PYLERA’s demand fluctuate?
   Demand shifts with guideline recommendations, local resistance patterns, and payer formulary decisions for eradication regimens.

3. Is PYLERA a chronic therapy?
   No. It is a short course eradication regimen, which limits naturally recurring prescriptions.

4. What drives payer decisions for PYLERA?
   Payer coverage relies on diagnosis confirmation, guideline concordance, formulary tiering, and prior authorization rules for eradication regimens. FDA labeling is the baseline for these processes. [1]

5. Where should investors look for PYLERA’s commercial performance?
   Use payer and claims-based erosion indicators in parallel with FDA labeling utilization patterns; public standalone brand revenue series is often incomplete for audit-grade reconstruction.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). PYLERA (bismuth subcitrate potassium/metronidazole/tetracycline hydrochloride) prescribing information. FDA label.