Propafenone hydrochloride - Generic Drug Details

What are the generic sources for propafenone hydrochloride and what is the scope of patent protection?

Propafenone hydrochloride is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma Intl, Twi Pharms, Upsher Smith Labs, Watson Labs Inc, Zydus Lifesciences, Glaxosmithkline Llc, Ani Pharms, Aurobindo Pharma, Nesher Pharms, Sun Pharm Industries, and Watson Labs, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for propafenone hydrochloride. Fifteen suppliers are listed for this compound.

Summary for propafenone hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	30
Patent Applications:	1,915
What excipients (inactive ingredients) are in propafenone hydrochloride?	propafenone hydrochloride excipients list
DailyMed Link:	propafenone hydrochloride at DailyMed

Recent Clinical Trials for propafenone hydrochloride

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

Sponsor	Phase
Inha University Hospital	PHASE4
RenJi Hospital	Phase 4
Iuliu Hatieganu University of Medicine and Pharmacy	NA

See all propafenone hydrochloride clinical trials

Pharmacology for propafenone hydrochloride

Drug Class

Antiarrhythmic

Medical Subject Heading (MeSH) Categories for propafenone hydrochloride

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for propafenone hydrochloride

C01BC	Antiarrhythmics, class Ic
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for PROPAFENONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYTHMOL SR	Extended-release Capsules	propafenone hydrochloride	325 mg	021416	1	2006-11-07
RYTHMOL SR	Extended-release Capsules	propafenone hydrochloride	225 mg and 425 mg	021416	1	2006-10-11

US Patents and Regulatory Information for propafenone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sinotherapeutics Inc	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210339-001	Jan 4, 2019	AB	RX	No	No
Glenmark Pharms Ltd	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205268-002	Sep 8, 2017	AB	RX	No	No
Zydus Lifesciences	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	214184-002	Apr 21, 2021	AB	RX	No	No

Expired US Patents for propafenone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-003	Sep 4, 2003
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-001	Sep 4, 2003
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-002	Sep 4, 2003

PROPAFENONE HYDROCHLORIDE: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What is the product’s market position for propafenone hydrochloride?

Propafenone hydrochloride is an oral antiarrhythmic used for rhythm management (historically in atrial and ventricular arrhythmias). In most markets, its commercial profile is shaped by generic penetration, liquidity of supply, and price competition rather than brand-led growth.

Market behavior typically follows these dynamics:

• Generic-led pricing: After patent and exclusivity expiry, propafenone formulations generally trade at prices set by multi-supplier competition.
• Low differentiation across formulations: Unless a specific controlled-release technology or combination product is protected, clinicians often switch based on tolerability and local availability rather than efficacy differentiation.
• Hospital and outpatient prescribing mix: Antiarrhythmics depend on cardiology protocols and formularies; payer coverage decisions tend to favor lowest-cost options within therapeutic alternatives.
• Supply and manufacturing scale matter: Tight generics markets reward stable manufacturing and regulatory compliance more than marketing spend.

Implication for financial trajectory: The product’s revenue path usually shifts from limited growth (pre-generic competition) to volume-led but margin-compressed performance once generics dominate.

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What are the financial trajectory drivers and likely revenue pattern?

The financial trajectory for propafenone hydrochloride is driven by five levers that determine whether revenue declines slowly or accelerates after generic entry.

1) Patent and exclusivity lifecycle

• Once key IP barriers clear, entry of multiple generic competitors compresses pricing.
• Revenue commonly tracks remaining formulary share and local tender outcomes more than patient growth.

2) Pricing compression and reimbursement

• In competitive European and mature markets, reimbursement typically anchors on lowest-available price or therapeutic reference pricing.
• In lower-income markets, pricing pressure still occurs but varies by procurement and import-channel structure.

3) Formulation and switching behavior

• If a manufacturer holds a differentiated release profile or package-level convenience, switching can be slower.
• If most products are interchangeable immediate-release tablets, pharmacy switching tends to be faster, supporting higher volumes but lower net pricing.

4) Regulatory and quality events

• Any signal tied to quality, recalls, or manufacturing interruptions changes supply availability and can temporarily move share between suppliers.
• Over time, these events stabilize and revert to price-led equilibrium.

5) Clinical guideline alignment and competition

• Propafenone competes with other antiarrhythmics and rhythm strategies that influence prescribing patterns.
• Where alternative agents gain preferred positioning in guidelines and formularies, the market can stagnate regardless of generic density.

Expected revenue shape (typical for mature, generic antiarrhythmics):

• Pre-generic: modest growth or stable demand supported by branded or limited-competition supply.
• Post-generic entry: revenue continues but declines in average net price; volume growth may offset only partially.
• Long-term: steady or downward revenue with periodic supply-driven share shifts, until the product is fully displaced by other therapies or classes.

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How does pricing and volume typically trade off in this segment?

Propafenone hydrochloride sits in a class where patients and prescribers tolerate interchangeability in many settings. That produces a characteristic financial trade-off:

• Volume: tends to remain resilient because arrhythmia prevalence does not collapse and prescriptions persist.
• Net price: declines are persistent due to competing generics and procurement mechanisms.
• Gross-to-net pressure: rises as discounts, rebates, and channel incentives expand during competition.

For investors and R&D planners, this means:

• Upside cases rely on market share capture (better supply, fewer stock-outs, lower landed costs).
• Downside cases are driven by tender-driven price resets and share loss when a competitor underbids.

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What competitive and market-structure factors matter most?

Antiarrhythmic generics markets reward scale and regulatory throughput.

Key structure factors likely to influence propafenone hydrochloride’s financial performance:

• Number of approved manufacturers in each jurisdiction: more entrants mean faster price compression.
• Formulary access: hospital cardiology protocols and payer formularies decide throughput.
• Procurement tender cycles: national or regional purchasing can create sudden price resets.
• Channel mix: retail demand vs institutional bulk supply can change the revenue timing.
• Product form compatibility: immediate-release vs extended-release (where applicable) affects interchangeability and thus switching speed.

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Where does IP and formulation strategy usually create financial value?

In mature generics, financial performance depends less on broad molecule protection and more on what can still be defended commercially:

• Controlled-release or modified-release differentiation (if available in the specific market) can slow substitution.
• Line-extension protection around a specific dosage form, dose strengths, or manufacturing process can extend commercial shelter locally.
• Packaging and patient adherence improvements can sustain share marginally, but price pressure remains the dominant force.

For propafenone hydrochloride, the market norm is that molecule-level exclusivity has already largely passed, so financial value tends to come from execution (quality, supply reliability, cost position) rather than sustained patent-driven pricing.

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What is the likely investor-relevant financial trajectory by horizon?

Given typical behavior in mature, generic antiarrhythmics, propafenone hydrochloride’s revenue trajectory generally follows a maturity curve:

Short term (0 to 2 years)

• Revenue stability with margin pressure
• Share can shift based on supply continuity and local tender pricing
• Promotional and pricing actions by competitors influence gross-to-net

Medium term (2 to 5 years)

• Net price continues to grind down
• Volumes may hold up if formulary access persists
• Competitive entries in additional dose strengths or package sizes can accelerate price resets

Long term (5+ years)

• Flattening revenue with occasional step-downs
• Displacement by other rhythm management therapies can reduce demand
• The product becomes increasingly dependent on being the lowest-cost dependable option

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What are the business risks that can break the typical curve?

The typical generic trajectory can diverge due to operational or regulatory shocks.

High-impact risks:

• Manufacturing disruption causing shortages and share loss
• Regulatory action affecting specific lots or facilities
• Escalating raw material or API costs compressing margins faster than pricing can adjust
• Payer policy shifts that tighten formulary placement for older antiarrhythmics

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What are the business opportunities that can improve financial outcomes?

Even in price-compressed markets, execution can improve outcomes.

Actionable levers:

• Regional cost advantage via reliable API sourcing and scale manufacturing
• Formulary expansion by securing preferred status at large institutions or through payer contracting
• Supply reliability to win share during competitor stock-outs
• Portfolio packaging strategy: defend a complete dose-strength shelf to prevent gaps that cause switching

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Key Takeaways

• Propafenone hydrochloride’s market dynamics are dominated by generic penetration, formularies, and procurement-led price competition, not brand-driven growth.
• The financial trajectory typically follows a volume-resilient but margin-compressed pattern after exclusivity expiry.
• Revenue tends to flatten and step down over time, with periodic share shifts driven by tender pricing and supply continuity.
• Investor and R&D planning should treat upside as execution-led (cost, supply, access) and downside as policy- and competition-led (tender resets, formulary displacement).

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FAQs

1. Is propafenone hydrochloride a brand-market or generic-market product?
   It is primarily a generic-market product in most mature jurisdictions, with revenue behavior shaped by competitive pricing and formulary access.

2. What usually drives price changes for mature antiarrhythmic generics?
   Multi-supplier competition, payer reference pricing, and tender cycles that reset the lowest reimbursable or purchasable price.

3. Does volume growth offset pricing pressure for propafenone?
   Often partially, but the long-run tendency is margin erosion because interchangeability and competitive supply keep net prices under pressure.

4. What market events most affect quarterly performance?
   Supply disruptions, regulatory issues affecting lots, and purchasing tender outcomes that change contract prices abruptly.

5. Where can differentiation still exist?
   Where specific formulation or release attributes (and local regulatory permissions) slow substitution, but price competition remains the dominant determinant.

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References

[1] DrugBank. Propafenone. https://go.drugbank.com/drugs/DB00706
[2] PubChem. Propafenone Hydrochloride. https://pubchem.ncbi.nlm.nih.gov/
[3] FDA. Drug Approval Reports and related database content for propafenone products. https://www.fda.gov/drugs/drug-approvals-and-databases