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Last Updated: December 22, 2024

MYSOLINE Drug Patent Profile


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When do Mysoline patents expire, and when can generic versions of Mysoline launch?

Mysoline is a drug marketed by Fhta and Valeant and is included in two NDAs.

The generic ingredient in MYSOLINE is primidone. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the primidone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mysoline

A generic version of MYSOLINE was approved as primidone by WATSON LABS on December 31st, 1969.

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Summary for MYSOLINE
Drug patent expirations by year for MYSOLINE
Drug Prices for MYSOLINE

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Drug Sales Revenue Trends for MYSOLINE

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Recent Clinical Trials for MYSOLINE

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

SponsorPhase
Shanghai Jiao Tong University School of MedicinePhase 2
Dr. Reddy's Laboratories LimitedPhase 1
Mutual Pharmaceutical Company, Inc.Phase 1

See all MYSOLINE clinical trials

Pharmacology for MYSOLINE

US Patents and Regulatory Information for MYSOLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fhta MYSOLINE primidone SUSPENSION;ORAL 010401-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant MYSOLINE primidone TABLET;ORAL 009170-003 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant MYSOLINE primidone TABLET;ORAL 009170-002 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MYSOLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MYSOLINE

Overview of MYSOLINE

MYSOLINE, also known as primidone, is an antiepileptic drug used in the treatment of various types of seizures. It belongs to the first generation of antiepileptic drugs and has been a staple in epilepsy management for decades.

Market Segmentation

By Drug Type

The antiepileptic drugs market, which includes MYSOLINE, is segmented into first, second, and third generations of drugs. MYSOLINE falls under the first generation category, which includes other drugs like Zarontin, Carbatrol, and Topamax. Although the second-generation drugs currently hold the largest market share due to their higher effectiveness, the first-generation drugs still maintain a significant presence due to their established use and patient familiarity[1].

Financial Performance

Revenue Trends

Bausch Health, the company that manufactures MYSOLINE, has reported varying revenue figures for this drug over the years. For instance, in the third quarter of 2021, MYSOLINE generated $6 million in revenue, which is consistent with previous quarters. This stability indicates a steady demand for the drug despite the emergence of newer generations of antiepileptic medications[2].

Market Drivers and Challenges

Drivers

  • Established Use: MYSOLINE has been in use for a long time, making it a trusted option for many healthcare providers and patients. This established use contributes to its steady revenue.
  • Global Demand: The increasing prevalence of epilepsy and neurological disorders globally drives the demand for antiepileptic drugs, including MYSOLINE.
  • Healthcare Infrastructure: In regions with robust healthcare infrastructure, such as North America, the diagnosis and treatment rates are higher, which benefits the sales of MYSOLINE[1].

Challenges

  • Side Effects: Antiepileptic drugs, including MYSOLINE, can have significant side effects, which may reduce patient compliance and market growth.
  • Competition from Newer Drugs: The emergence of second and third-generation antiepileptic drugs, which are often more effective and have fewer side effects, poses a significant challenge to the market share of MYSOLINE[1].

Distribution Channels

Offline vs. Online

The distribution of MYSOLINE is primarily through offline channels such as hospital pharmacies, retail pharmacies, and drug stores. However, the trend is shifting towards online platforms due to the convenience and time-saving aspects they offer. This shift could impact the sales dynamics of MYSOLINE, as more patients opt for online purchases[1].

Geographical Performance

Regional Market Share

North America, particularly the U.S. and Canada, has been a significant market for MYSOLINE due to the advanced healthcare infrastructure and high living standards. However, the Asia-Pacific region is expected to offer lucrative growth opportunities in the future due to the increasing prevalence of neurological disorders and improving healthcare infrastructure in countries like India and China[1].

Research and Development

While MYSOLINE itself is not a subject of current R&D efforts due to its established status, Bausch Health's overall R&D focus on new and innovative treatments can indirectly impact the market dynamics of older drugs. The company's investments in new products and technologies can sometimes divert resources away from older drugs, but they also contribute to the company's overall financial health and innovation pipeline[3].

Financial Health of Bausch Health

Bausch Health, the parent company of MYSOLINE, has shown significant financial stability and growth. In 2023, the company reported revenue of $4.61 billion, with an organic growth rate of 6%. The company has also made substantial progress in reducing its debt and improving its liquidity, which positions it well for future investments and market expansion[3].

Key Takeaways

  • Stable Revenue: MYSOLINE maintains a stable revenue stream due to its established use and patient trust.
  • Market Competition: The drug faces competition from newer, more effective antiepileptic medications.
  • Geographical Growth: The Asia-Pacific region offers potential growth opportunities for MYSOLINE.
  • Distribution Trends: The shift towards online pharmacies could impact the sales dynamics of MYSOLINE.
  • Parent Company Performance: Bausch Health's financial health and R&D investments support the overall market presence of its products, including MYSOLINE.

FAQs

Q: What is MYSOLINE used for? A: MYSOLINE, also known as primidone, is used in the treatment of various types of seizures and epilepsy.

Q: Which generation of antiepileptic drugs does MYSOLINE belong to? A: MYSOLINE belongs to the first generation of antiepileptic drugs.

Q: What are the main challenges facing MYSOLINE in the market? A: The main challenges include side effects associated with the drug and competition from newer, more effective antiepileptic medications.

Q: How is the distribution of MYSOLINE changing? A: The distribution is shifting from offline channels to online platforms due to convenience and time-saving benefits.

Q: Which region is expected to offer significant growth opportunities for MYSOLINE? A: The Asia-Pacific region is expected to offer lucrative growth opportunities due to the increasing prevalence of neurological disorders and improving healthcare infrastructure.

Sources

  1. IndustryARC: Antiepileptic Drugs Market Size Report, 2024-2030.
  2. Bausch Health: Financial Results - Bausch Health Companies Inc.
  3. Bausch Health: Annual Report 2023.

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