RYTHMOL SR Drug Patent Profile

Which patents cover Rythmol Sr, and when can generic versions of Rythmol Sr launch?

Rythmol Sr is a drug marketed by Glaxosmithkline Llc and is included in one NDA.

The generic ingredient in RYTHMOL SR is propafenone hydrochloride. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rythmol Sr

A generic version of RYTHMOL SR was approved as propafenone hydrochloride by WATSON LABS on October 24^th, 2000.

Summary for RYTHMOL SR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	2
Patent Applications:	1,066
Drug Prices:	Drug price information for RYTHMOL SR
DailyMed Link:	RYTHMOL SR at DailyMed

See drug prices for RYTHMOL SR

Recent Clinical Trials for RYTHMOL SR

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
Mayo Clinic	Phase 3
Medtronic	Phase 3

See all RYTHMOL SR clinical trials

Paragraph IV (Patent) Challenges for RYTHMOL SR

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 RYTHMOL SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-001	Sep 4, 2003		DISCN	Yes	No
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-002	Sep 4, 2003		DISCN	Yes	No
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-003	Sep 4, 2003		DISCN	Yes	No

Expired US Patents for RYTHMOL SR

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	5,681,588
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-002	Sep 4, 2003	5,681,588
Glaxosmithkline Llc	RYTHMOL SR	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021416-003	Sep 4, 2003	5,681,588

International Patents for RYTHMOL SR

See the table below for patents covering RYTHMOL SR around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	9406036
Croatia	P940198	RETARDED-ACTION MICROTABLET MADE OF BETA-PHENYLPROPIOPHENONE DERIVATIVES
Slovenia	9420027	RETARDED-ACTION MICROTABLET MADE OF BETA-PHENYLPROPIOPHENONE DERIVATIVES
South Africa	9402293

Market Dynamics and Financial Trajectory for RYTHMOL SR

Market Overview

The global critical care antiarrhythmic drugs market, which includes drugs like RYTHMOL SR, is experiencing significant growth driven by several key factors.

Increasing Prevalence of Cardiovascular Disorders

The rising prevalence of cardiovascular disorders is a major driver for the market. According to the American Heart Association, cardiac disorders are the leading cause of death globally, with over 17.6 million deaths in 2016 and an expected increase to over 23.6 million by 2030[1].

Market Size and Growth

The global critical care antiarrhythmic drugs market was valued at USD 796.8 million in 2019 and is projected to grow to USD 1,319.7 million by 2027, exhibiting a CAGR of 5.6% during the 2020-2027 period. This growth is partly due to the positive demand shock experienced during the COVID-19 pandemic[1].

Regional Market Dynamics

North America

North America, particularly the U.S., is a significant market for RYTHMOL SR. The region's market size stood at USD 359.2 million in 2019. The increasing number of clinical trials and drug launches in this region are key growth drivers. For instance, the launch of generic versions of antiarrhythmic drugs, such as Mylan N.V.'s Propafenone Hydrochloride Extended-Release Capsules, has contributed to market expansion[1].

Europe

Europe is the second-largest region in terms of market share and revenue. The rapid growth in the geriatric population, increasing cardiac issues, and favorable reimbursement policies are driving the market in this region[1].

Asia Pacific and Other Regions

The Asia Pacific region is expected to grow at a high rate due to government initiatives raising awareness about atrial fibrillation and increasing healthcare spending. Similarly, Latin America and the Middle East & Africa are also experiencing growth due to rising healthcare expenditures and the growing presence of market players[1].

Drug Class and Segment Performance

Beta Blockers and Potassium Channel Blockers

The beta blockers segment is expected to be the leading segment in the market, while the potassium channel blockers segment, which includes drugs like RYTHMOL SR, is anticipated to witness lucrative growth. This is because potassium channel blockers are highly effective in treating atrial fibrillation and related arrhythmias[1].

RYTHMOL SR Specifics

Indications and Usage

RYTHMOL SR (propafenone hydrochloride) is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic AF who do not have structural heart disease. It is not recommended for patients with permanent AF, atrial flutter, or paroxysmal supraventricular tachycardia (PSVT)[2][4].

Dosage and Administration

The dosage of RYTHMOL SR is initiated at 225 mg every 12 hours and can be increased to 325 mg and then 425 mg every 12 hours, based on patient response and tolerance. Dose adjustments are necessary for patients with hepatic impairment, significant widening of the QRS complex, or second- or third-degree AV block[2][5].

Safety and Contraindications

RYTHMOL SR has several contraindications, including heart failure, cardiogenic shock, and severe myocardial ischemia. It can also cause proarrhythmic effects, particularly in patients with pre-existing heart failure or coronary artery disease. The drug may worsen premature ventricular contractions, ventricular tachycardia, or ventricular fibrillation[2][4][5].

Financial Trajectory

Revenue Growth

The financial trajectory for RYTHMOL SR is closely tied to the overall growth of the critical care antiarrhythmic drugs market. With the market projected to grow from USD 899.8 million in 2020 to USD 1,319.7 million by 2027, drugs like RYTHMOL SR are expected to contribute significantly to this revenue increase[1].

Market Players

Top players in the market, including Sanofi, Pfizer, and Mylan N.V., are driving innovation and growth through increased investments in research and development. The launch of generic versions and new formulations also contributes to the financial growth of these companies[1].

Key Drivers and Challenges

Key Drivers

• Increasing Prevalence of Cardiac Disorders: The rising number of cardiovascular disorders globally is a significant driver.
• Clinical Trials and Drug Launches: The increasing number of clinical trials and drug launches, especially in North America, is propelling market growth.
• Government Initiatives and Awareness: Government initiatives in regions like Asia Pacific are raising awareness and driving demand for antiarrhythmic drugs.
• Favorable Reimbursement Policies: Policies in regions like Europe are supporting market growth[1].

Challenges

• Proarrhythmic Effects: Drugs like RYTHMOL SR can cause proarrhythmic effects, which can be a significant challenge.
• Contraindications: The drug has several contraindications, limiting its use in certain patient populations.
• Competition: The market is competitive, with multiple players and generic versions available, which can impact the financial trajectory of specific drugs[2][4][5].

Conclusion

The market dynamics for RYTHMOL SR are favorable, driven by the increasing prevalence of cardiovascular disorders, ongoing clinical trials, and favorable reimbursement policies. However, the drug's use is also subject to several challenges, including proarrhythmic effects and contraindications. As the global critical care antiarrhythmic drugs market continues to grow, RYTHMOL SR is expected to play a significant role in treating atrial fibrillation and related arrhythmias.

Key Takeaways

• The global critical care antiarrhythmic drugs market is projected to grow to USD 1,319.7 million by 2027.
• RYTHMOL SR is indicated for treating symptomatic atrial fibrillation in patients without structural heart disease.
• The drug has several contraindications and can cause proarrhythmic effects.
• North America and Europe are significant markets for RYTHMOL SR.
• Government initiatives and favorable reimbursement policies are driving market growth.

FAQs

What is RYTHMOL SR used for?

RYTHMOL SR is used to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic AF who do not have structural heart disease[2][4].

What are the common side effects of RYTHMOL SR?

Common side effects include proarrhythmic effects such as increased premature ventricular contractions (PVCs), ventricular tachycardia (VT), and ventricular fibrillation (VF). It can also worsen heart failure in certain patients[2][4][5].

Can RYTHMOL SR be used in patients with heart failure?

RYTHMOL SR should be avoided in patients with heart failure (NYHA III and IV) or severe myocardial ischemia due to the risk of proarrhythmic effects and worsening heart failure[2][4][5].

What is the dosage of RYTHMOL SR?

The dosage is initiated at 225 mg every 12 hours and can be increased to 325 mg and then 425 mg every 12 hours, based on patient response and tolerance[2][5].

Which regions are driving the growth of the critical care antiarrhythmic drugs market?

North America, Europe, and the Asia Pacific are the key regions driving the growth of the market, with North America being the largest market and the Asia Pacific showing significant growth potential[1].