PROPAFENONE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for propafenone hydrochloride and what is the scope of freedom to operate?

Propafenone hydrochloride is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma, 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. Nineteen 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:	19
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	28
Patent Applications:	2,086
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
RenJi Hospital	Phase 4
Rabin Medical Center	Early Phase 1
Rambam Health Care Campus	Early Phase 1

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	210339-003	Jan 4, 2019	AB	RX	No	No
Sinotherapeutics Inc	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210339-002	Jan 4, 2019	AB	RX	No	No
Glenmark Pharms Ltd	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205268-001	Sep 8, 2017	AB	RX	No	No
Twi Pharms	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212928-003	Jun 18, 2020		DISCN	No	No
Sinotherapeutics Inc	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	210339-001	Jan 4, 2019	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	021416-001	Sep 4, 2003
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	021416-002	Sep 4, 2003

PROPAFENONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Propafenone Hydrochloride

Introduction to Propafenone Hydrochloride

Propafenone hydrochloride is an antiarrhythmic medication used to prevent irregular heartbeats, such as atrial fibrillation, in patients without structural heart disease. It belongs to the class of medicines known as antiarrhythmics and works by slowing nerve impulses in the heart to maintain a normal heart rhythm[5].

Market Size and Growth Projections

The global propafenone hydrochloride API market has been experiencing rapid and substantial growth. As of 2023, the market size was valued at approximately USD 1.2 billion and is projected to reach USD 2.1 billion by 2032, growing at a significant compound annual growth rate (CAGR)[4].

Segmentation of the Market

The propafenone hydrochloride API market is segmented based on several key factors:

Type

• The market is categorized into segments based on the purity of the API: Purity Above 98%, Purity 98%, and Purity Below 98%. The segment with purity above 98% is expected to account for a noticeable share of the global market and is projected to experience significant growth in the near future[1][3].

Application

• The primary applications of propafenone hydrochloride API are in the production of tablets and capsules. The pharmaceutical intermediates segment is anticipated to expand at a significant CAGR, retaining its position throughout the forecast period[1][3].

Geography

• The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics, trends, and growth prospects[1][3].

Market Dynamics

Drivers

• The increasing prevalence of atrial fibrillation and other arrhythmias drives the demand for effective antiarrhythmic medications like propafenone hydrochloride.
• Technological advancements in the production of high-quality chemicals and pharmaceutical intermediates are also boosting the market.
• Growing awareness and improved diagnostic techniques for heart rhythm disorders contribute to the market's growth[3].

Restraints

• The presence of other medical problems in patients, such as asthma, bronchitis, or severe obstructive pulmonary disease, can limit the use of propafenone hydrochloride due to potential adverse effects[5].
• Regulatory challenges and stringent safety standards can also act as restraints for market growth.
• The risk of severe side effects, such as QT prolongation or torsade de pointes, may deter some patients and healthcare providers from using this medication[5].

Opportunities

• The expanding pharmaceutical industry, particularly in emerging markets, presents significant opportunities for growth.
• Increasing investments in research and development to improve the efficacy and safety of propafenone hydrochloride can open up new market avenues.
• Partnerships and collaborations among key players to enhance product portfolios and expand business globally are also opportunities for market expansion[1][3].

Challenges

• The market faces challenges from environmental and safety regulations, which can impact the production and distribution of the API.
• Economic fluctuations and changes in raw material availability can also pose challenges to the market's growth[3].

Competitive Landscape

The competitive landscape of the propafenone hydrochloride API market is characterized by the presence of several key players:

• Emcure Pharmaceuticals
• Zydus Lifesciences
• Mylan Laboratories
• Cambrex Profarmaco Milano Srl
• Erregierre SpA
• Procos SpA
• PharmaZell GmbH
• Fermion Oy
• SCI Pharmtech[1].

These companies are engaged in various strategies such as recent activities, partnerships, mergers and acquisitions, and new product launches to strengthen their market positions.

Regional Analysis

North America

• North America is a significant market for propafenone hydrochloride API, driven by advanced healthcare infrastructure and high demand for antiarrhythmic medications.
• The region is expected to continue its growth trajectory due to favorable market dynamics and technological advancements[3].

Europe

• Europe is another major market, with a strong presence of pharmaceutical companies and a high prevalence of heart rhythm disorders.
• The region's market is influenced by stringent regulatory frameworks and a focus on high-quality pharmaceutical products[3].

Asia-Pacific

• The Asia-Pacific region is expected to exhibit rapid growth due to increasing healthcare spending, improving diagnostic capabilities, and a large patient population.
• Countries like China and India are emerging as key markets due to their growing pharmaceutical industries[3].

Financial Trajectory

The financial trajectory of the propafenone hydrochloride API market is optimistic, with significant growth projected from 2023 to 2031. Here are some key financial highlights:

• Market Size: The market was valued at USD 1.2 billion in 2023 and is expected to reach USD 2.1 billion by 2032[4].
• CAGR: The market is expected to grow at a substantial CAGR during the forecast period, driven by increasing demand and technological advancements[3][4].
• Revenue Share: The pharmaceutical intermediates segment is expected to retain a significant revenue share throughout the forecast period[3].

Technological and Regulatory Trends

Technological Advancements

• Advances in production technologies are enabling the manufacture of high-quality propafenone hydrochloride API, which is crucial for maintaining market competitiveness.
• Innovations in drug delivery systems, such as extended-release formulations, are also enhancing the market's growth prospects[5].

Regulatory Frameworks

• Regulatory bodies are increasingly focusing on safety and efficacy standards, which can impact the market's growth. Compliance with these regulations is essential for market players.
• Environmental and safety regulations are also shaping the market, with a focus on sustainable and environmentally friendly production practices[3].

Consumer Behavior and Healthcare Trends

• Increasing Awareness: Growing awareness about heart rhythm disorders and the importance of early diagnosis and treatment is driving the demand for propafenone hydrochloride.
• Patient Preferences: Patients are increasingly seeking effective and safe treatments, which is influencing the development and marketing of propafenone hydrochloride API[5].

Key Takeaways

• The propafenone hydrochloride API market is experiencing rapid growth driven by increasing demand for antiarrhythmic medications.
• The market is segmented based on type, application, and geography, with the purity above 98% segment and pharmaceutical intermediates segment expected to grow significantly.
• Key players are focusing on technological advancements, partnerships, and expanding their product portfolios to maintain market competitiveness.
• Regulatory frameworks and environmental regulations are crucial factors influencing the market's growth.

FAQs

1. What is propafenone hydrochloride used for?

Propafenone hydrochloride is used to prevent irregular heartbeats such as atrial fibrillation in patients who do not have structural heart disease[5].

2. What is the projected market size of the propafenone hydrochloride API market by 2032?

The market is projected to reach USD 2.1 billion by 2032[4].

3. Which segment is expected to grow significantly in the propafenone hydrochloride API market?

The segment with purity above 98% and the pharmaceutical intermediates segment are expected to experience significant growth[1][3].

4. What are the major challenges facing the propafenone hydrochloride API market?

The market faces challenges from environmental and safety regulations, economic fluctuations, and the risk of severe side effects[3][5].

5. Who are the key players in the propafenone hydrochloride API market?

Key players include Emcure Pharmaceuticals, Zydus Lifesciences, Mylan Laboratories, and others[1].

Cited Sources:

1. Market Research Intellect. Propafenone Hydrochloride API Market Size, Scope And Forecast.
2. PubMed. Long-term oral propafenone therapy for suppression of symptomatic recurrences of atrial fibrillation/flutter.
3. Cognitive Market Research. Propafenone Market Report 2024 (Global Edition).
4. DataIntelo. Propafenone Hydrochloride Api Market Research Report 2032.
5. Mayo Clinic. Propafenone (oral route).