You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 18, 2025

RYTHMOL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Rythmol, and what generic alternatives are available?

Rythmol is a drug marketed by Glaxosmithkline Llc and is included in two NDAs.

The generic ingredient in RYTHMOL 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.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for RYTHMOL?
  • What are the global sales for RYTHMOL?
  • What is Average Wholesale Price for RYTHMOL?
Summary for RYTHMOL
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 181
Clinical Trials: 2
Patent Applications: 4,807
Drug Prices: Drug price information for RYTHMOL
What excipients (inactive ingredients) are in RYTHMOL?RYTHMOL excipients list
DailyMed Link:RYTHMOL at DailyMed
Drug patent expirations by year for RYTHMOL
Drug Prices for RYTHMOL

See drug prices for RYTHMOL

Recent Clinical Trials for RYTHMOL

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

SponsorPhase
GlaxoSmithKlinePhase 1
Mayo ClinicPhase 3
MedtronicPhase 3

See all RYTHMOL clinical trials

US Patents and Regulatory Information for RYTHMOL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Glaxosmithkline Llc RYTHMOL propafenone hydrochloride TABLET;ORAL 019151-001 Nov 27, 1989 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Glaxosmithkline Llc RYTHMOL propafenone hydrochloride TABLET;ORAL 019151-002 Nov 27, 1989 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Glaxosmithkline Llc RYTHMOL propafenone hydrochloride TABLET;ORAL 019151-003 Nov 20, 1992 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-001 Sep 4, 2003 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-002 Sep 4, 2003 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Glaxosmithkline Llc RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021416-003 Sep 4, 2003 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Market Dynamics and Financial Trajectory for RYTHMOL

Overview of RYTHMOL

RYTHMOL, specifically RYTHMOL SR, is an antiarrhythmic medication used to treat various heart rhythm disorders, including atrial fibrillation and supraventricular tachycardia. It is a propafenone-based drug, which works by prolonging the time for the recurrence of symptomatic atrial fibrillation in patients without structural heart disease.

Market Size and Growth

The global critical care antiarrhythmic drugs market, which includes RYTHMOL, has been experiencing significant growth. In 2019, the market size was USD 796.8 million, and it is projected to grow to USD 1,319.7 million by 2027, exhibiting a Compound Annual Growth Rate (CAGR) of 5.6% during the 2020-2027 period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the market for antiarrhythmic drugs like RYTHMOL:

Increasing Prevalence of Cardiovascular Disorders

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

Clinical Trials and Drug Launches

The increasing number of clinical trials, especially in regions like North America, and the launch of new drugs are significant growth propellers. For instance, the U.S. launch of Propafenone Hydrochloride Extended-Release Capsules by Mylan N.V. in 2016 contributed to market expansion[1].

Geriatric Population and Healthcare Spending

The rapidly rising geriatric population, particularly in Europe, along with increasing healthcare spending and favorable reimbursement policies, are also key drivers[1].

Regional Market Performance

North America

North America holds a significant market share, with the U.S. being a major contributor due to the high number of clinical trials and drug launches. In 2019, the market size in North America stood at USD 359.2 million[1].

Europe

Europe is the second-largest region in terms of market share and revenue, driven by the growing geriatric population and increasing cardiac issues[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. Latin America and the Middle East & Africa are also experiencing growth driven by increasing market penetration and pilot studies[1].

Competitive Landscape

RYTHMOL SR operates in a competitive market with several key players:

Major Players

Companies like Sanofi, Pfizer, and Mylan N.V. are among the top players in the critical care antiarrhythmic drugs market[1].

Generic Competition

The entry of generic versions of antiarrhythmic drugs can impact the sales of branded drugs like RYTHMOL SR. For example, Mylan N.V.'s launch of a generic version of GlaxoSmithKline's Rythmol SR affected the market dynamics[1][4].

Financial Performance and Projections

Sales Forecasts

Global sales forecasts for RYTHMOL SR indicate continued growth, though the entry of generics can affect sales. According to GlobalData's report, understanding the competitive landscape and sales performance is crucial for making informed business decisions[4].

Revenue Impact

The revenue from RYTHMOL SR is influenced by its efficacy, safety profile, and dosing regimen. The drug's unique profile, including its ability to prolong the time for the recurrence of symptomatic atrial fibrillation, contributes to its sales potential[4].

Medicare Coverage

In the U.S., RYTHMOL is covered by 100% of Medicare prescription drug plans, which helps in maintaining a stable revenue stream[5].

Challenges and Risks

Proarrhythmic Effects

RYTHMOL SR, like other antiarrhythmic agents, carries the risk of proarrhythmic effects, particularly in patients with heart failure or severe myocardial ischemia. This can impact its long-term use and sales[2].

Regulatory Hurdles

The pharmaceutical industry, including the market for antiarrhythmic drugs, faces increasing regulatory hurdles and shorter exclusivity periods, which can affect the financial trajectory of drugs like RYTHMOL SR[3].

Declining ROI in Pharmaceutical R&D

The overall return on investment (ROI) for pharmaceutical research and development has been declining, raising concerns about the sustainability of the current R&D model. This trend can influence the investment strategies for developing new antiarrhythmic drugs[3].

Conclusion

The market for RYTHMOL SR is driven by the increasing prevalence of cardiovascular disorders, clinical trials, and favorable healthcare spending trends. However, it faces challenges such as generic competition, proarrhythmic effects, and declining ROI in pharmaceutical R&D. Understanding these dynamics is crucial for pharmaceutical companies to navigate the market effectively.

Key Takeaways

  • The global critical care antiarrhythmic drugs market, including RYTHMOL SR, is projected to grow significantly by 2027.
  • The increasing prevalence of cardiovascular disorders and clinical trials are key drivers of market growth.
  • Regional markets like North America and Europe are significant contributors due to their large patient populations and favorable healthcare policies.
  • Generic competition and proarrhythmic effects are major challenges.
  • Medicare coverage in the U.S. supports the drug's revenue stability.

FAQs

What is RYTHMOL SR used for?

RYTHMOL SR is used to treat various heart rhythm disorders, including atrial fibrillation and supraventricular tachycardia.

What are the key drivers of the market growth for RYTHMOL SR?

The key drivers include the increasing prevalence of cardiovascular disorders, clinical trials, and favorable healthcare spending trends.

Which regions are significant for the market of RYTHMOL SR?

North America and Europe are the most significant regions, with Asia Pacific and other regions also showing growth potential.

What are the challenges faced by RYTHMOL SR in the market?

Challenges include generic competition, proarrhythmic effects, and declining ROI in pharmaceutical R&D.

Is RYTHMOL SR covered by Medicare?

Yes, RYTHMOL is covered by 100% of Medicare prescription drug plans in the U.S.

What is the projected market size for critical care antiarrhythmic drugs by 2027?

The market is projected to grow to USD 1,319.7 million by 2027.

Sources

  1. Fortune Business Insights: Critical Care Antiarrhythmic Drugs Market Size, Share & Report, 2027.
  2. GSK Pro: RYTHMOL SR Extended Release Capsules.
  3. DrugBank Blog: Investment Trends in Pharmaceutical Research.
  4. PR Newswire: Rythmol SR (Atrial Fibrillation) – Analysis and Forecasts to 2022.
  5. GoodRx: Rythmol Medicare Coverage and Co-Pay Details.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.