BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride and what is the scope of patent protection?

Bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride is the generic ingredient in two branded drugs marketed by Ingenus Pharms Llc, Ph Health, and Labs Juvise, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	3
Clinical Trials:	3
DailyMed Link:	BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

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

Sponsor	Phase
American University of Beirut Medical Center	Phase 4
The University of Texas Health Science Center, Houston	Phase 4
Forest Laboratories	Phase 3

See all BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE clinical trials

Pharmacology for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Drug Class

Bismuth Nitroimidazole Antimicrobial Tetracycline-class Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A02BX	Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

D06AA	Tetracycline and derivatives
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01XD	Imidazole derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

Paragraph IV (Patent) Challenges for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

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 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ingenus Pharms Llc	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	217511-001	Jul 3, 2023	AB	RX	No	No
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	AB	RX	Yes	Yes
Ph Health	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	205770-001	Mar 6, 2023	AB	RX	No	No

Expired US Patents for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

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

Market dynamics and financial trajectory for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

Last updated: April 24, 2026

What is the commercial product footprint and why does it matter?

Bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride is a fixed-dose, multi-drug regimen used primarily to eradicate Helicobacter pylori (H. pylori) in specified combinations. In market terms, this product behaves like an “alignment compound” therapy: unit demand tracks (1) H. pylori diagnosis and guideline-driven eradication rates, (2) payer coverage rules for combination therapies, and (3) competition from alternative H. pylori regimens (e.g., optimized bismuth-based quadruple therapies, concurrent PPI-amoxicillin regimens where available, and regional generics).

Financial trajectory typically follows a pattern common to older H. pylori regimens:

• High early share when branded formulations anchor dosing simplicity, then
• Margin compression as generics expand, followed by
• Stabilization where prescribers stay within labeled regimen constructs and pharmacies drive substitution.

How do the market dynamics shape pricing, volume, and margins?

Demand drivers

The core demand engine is H. pylori eradication rather than broad indication breadth. Key dynamics that affect annual prescription volume:

• Diagnosis rate and test-and-treat intensity: eradication programs and endoscopy pathways determine top-of-funnel prescription growth.
• Guideline alignment and regimen selection: bismuth-based approaches tend to hold share where clarithromycin resistance is a concern, which shifts preference toward bismuth-containing regimens and away from older clarithromycin-based triple therapies.
• Resistance evolution: metronidazole efficacy can be impacted by resistance; tetracycline resistance is less common, but regimen performance affects physician confidence and repeat prescribing.
• Switching costs: when payers enforce step edits or require documentation, clinicians often revert to the “covered set” of regimens.

Supply and competitive structure

The regimen’s financial path is dominated by generic availability:

• Combination regimens reduce pharmacy dispensing friction and can win market share at pharmacy counter level even after brand erosion.
• Therapy switching happens when payers reprice and formularies change, especially if competing bismuth-based or PPI-including regimens are cheaper or more favored.

Pricing and reimbursement dynamics

For older, multi-generic regimens:

• List price is not the metric; net price depends on rebate intensity, wholesaler pricing, and payer formularies.
• Rebate pressure increases as multiple AB-rated competitors exist with similar therapeutic claims.
• Outcomes-based contracting is uncommon at this regimen level; economics remain driven by pricing tiers and utilization management.

What is the financial trajectory pattern for this class of regimen?

Baseline trajectory (typical lifecycle mechanics)

Across older H. pylori regimen portfolios, the financial curve usually shows:

1. Early plateau: branded anchor product captures volume due to prescriber familiarity.
2. Rapid revenue erosion: generic entry compresses unit prices; gross-to-net spreads shrink.
3. Stabilization: when competitors are many and pricing floors are reached, the market becomes a volume game.
4. Re-acceleration pockets: guideline shifts or resistance patterns can raise total bismuth-based regimen usage, even as the overall regimen remains commoditized.

What changes trajectory in practice

Revenue and profitability swing with:

• Formulary moves (tier placement, prior authorization triggers, quantity limits).
• Pack size and dispensing structure (once-daily convenience vs multi-dose schedule).
• Supply continuity: shortages can temporarily lift pricing and favor in-stock NDCs.

How is this regimen positioned versus alternatives?

Competitive set

This regimen competes mainly with:

• Other bismuth-based quadruple regimens (often including a PPI and two antibiotics plus bismuth)
• Non-bismuth regimens using different antibiotic combinations depending on geography and resistance patterns
• Regional guideline variants that alter antibiotic selection (e.g., clarithromycin-based where resistance permits, or other optimized strategies)

Competitive advantage levers

When the regimen performs well clinically and is covered:

• It wins on covered status and availability through multiple generic sources.
• It can win prescriber behavior when packaging/dosing is familiar and when resistance considerations push selection toward bismuth-based approaches.

Where it loses

• Net price falls toward generic parity.
• If a competing regimen is preferred on payer formularies at a lower tier, utilization shifts quickly.

What metrics and financial markers investors track for this product group?

Because the regimen is mature and likely largely generic-dependent, the strongest financial indicators are:

• Total prescription volume (TRx) by market
• Net price per course of therapy (post-rebate)
• Share of scripts within covered bismuth-based H. pylori options
• Formulary tiering changes (preferred vs non-preferred)
• Inventory stability metrics (in-stock rate, shortage events)
• Gross-to-net trend (rebate intensity shifts with competitive entries)

What market events typically drive multi-quarter financial swings?

1) Generic entries and price drops

Even one additional AB-rated product can reset net pricing. Financially:

• Revenue declines while units remain stable if market stays covered.
• Share redistribution occurs if one supplier is cheaper net or more consistently in stock.

2) Formulary re-contracting

Health plans reprice and rebundle pharmacy economics in annual cycles.

• Expect step changes in volume when the regimen becomes preferred or loses preferred status.
• Net price changes often outpace list price changes.

3) Guideline updates linked to resistance patterns

H. pylori treatment selection changes when resistance data shifts.

• A move toward bismuth-based regimens can raise market share for the bismuth-containing bucket even as individual products remain low-margin.

Which markets and channels matter most?

Geography

H. pylori therapy is a global standard of care, but commercial dynamics vary by:

• Generic adoption and price controls
• Payer formularies and step therapy requirements
• Local antibiotic resistance profiles affecting regimen preference

Channel

• Retail pharmacy is typically dominant for prescription fills.
• Specialty distribution is not the core because the regimen is conventional oral therapy.
• Institutional channels matter in GI/endoscopy settings where bundled outpatient prescriptions are common, but long-term economics still track outpatient fill patterns.

How should business teams forecast revenue and margins for this regimen?

Forecast framework (practical)

1. Forecast H. pylori eradication course volume
   • Use diagnosis and eradication share assumptions.
2. Forecast regimen mix
   • Allocate bismuth-based bucket shares by resistance-driven guideline selection.
3. Forecast net price
   • Model generic pricing drift and rebate compression.
4. Forecast share shifts
   • Add discrete events for formulary changes or major generic supply swings.

Profitability reality

For mature combination regimens:

• Margin is constrained by generic price competition.
• Profit comes from volume retention and supply reliability more than from pricing power.
• Cost of goods and logistics matter because net price compresses while demand stays relatively stable.

What does the “financial trajectory” look like at an investor level?

Revenue

• Trend is usually downward in price, stable or modestly upward in volume, leading to flat-to-slow declining revenue after maturity.
• When policy and resistance shift toward bismuth-based approaches, there can be a temporary rise in regimen usage that offsets price declines.

Operating margin

• Generic-driven margin pressure produces lower EBITDA/operating margins unless the company holds a dominant NDC portfolio position.
• Supply stability reduces write-down risk from expired inventory and prevents loss of covered share.

What are the most important strategic implications for manufacturers and investors?

Manufacturers

• Win with NDC coverage breadth and in-stock reliability.
• Manage price competition via portfolio rationalization and distribution agreements rather than expecting sustainable pricing power.
• Track payer formularies and re-contract cycles tightly because they govern utilization.

Investors

• Treat this regimen category as a cash-flow stable but low-growth segment unless a measurable guideline and payer-driven uplift occurs.
• Value drivers:
  • NDC share retention
  • Net price per course resilience
  • Contracting and supply execution

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Key Takeaways

• This fixed regimen tracks H. pylori eradication demand, not broad chronic disease growth.
• Financial trajectory is typically generic-driven margin compression after early share, followed by stabilization with periodic step changes from formulary and guideline shifts.
• Pricing and profitability depend on net price and rebates, while volume depends on covered status and bismuth-based regimen utilization in the context of antibiotic resistance.
• Forecasting should focus on eradication course volume, regimen mix, net pricing drift, and discrete formulary/supply events.

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FAQs

1. Is the revenue growth for this regimen usually high?
   No. For mature H. pylori combination regimens, revenue usually follows generic-driven price compression with volume stability or modest changes.

2. What most influences utilization for this regimen?
   Payer formulary placement, prior authorization and step edits, and the guideline-driven preference for bismuth-based approaches under local resistance conditions.

3. Does antibiotic resistance materially affect market share?
   Yes. Shifts in resistance patterns can change which regimen clinicians and guideline bodies recommend, moving share within the H. pylori treatment landscape.

4. What is the main margin risk?
   Net price compression from generic competition and rebate pressure; margin can also be harmed by supply disruptions that lead to lost covered share.

5. What is the best leading indicator for near-term financial movement?
   Formulary decisions and contracting cycles, followed by in-stock continuity and any major generic entry events affecting net price.

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References

[1] FDA. Drug Approval Package: bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride (where applicable for specific products). U.S. Food and Drug Administration.
[2] ACG Clinical Guidelines. Recommendations for the treatment of Helicobacter pylori infection (updates and regimen guidance). American College of Gastroenterology.
[3] Maastricht VI/Florence Consensus Report. Management of Helicobacter pylori infection and treatment strategy guidance. European Helicobacter Study Group.
[4] CDC. Helicobacter pylori infection treatment and public health guidance (framework on diagnosis and eradication). Centers for Disease Control and Prevention.
[5] WHO. Helicobacter pylori and peptic ulcer disease information relevant to eradication principles. World Health Organization.