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Last Updated: December 25, 2024

TRIDIONE Drug Patent Profile


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When do Tridione patents expire, and what generic alternatives are available?

Tridione is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in TRIDIONE is trimethadione. Additional details are available on the trimethadione profile page.

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Summary for TRIDIONE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 81
Patent Applications: 2,781
DailyMed Link:TRIDIONE at DailyMed
Drug patent expirations by year for TRIDIONE

US Patents and Regulatory Information for TRIDIONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie TRIDIONE trimethadione CAPSULE;ORAL 005856-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie TRIDIONE trimethadione SOLUTION;ORAL 005856-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie TRIDIONE trimethadione TABLET;ORAL 005856-009 Approved Prior to Jan 1, 1982 DISCN 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

TRIDIONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TRIDIONE (Trimethadione)

Introduction

TRIDIONE, also known as trimethadione, is an oxazolidinedione anticonvulsant primarily used to treat epileptic conditions, particularly petit mal (absence) seizures that are resistant to other treatments. Understanding the market dynamics and financial trajectory of this drug involves examining its clinical use, market position, and the broader pharmaceutical landscape.

Clinical Use and Indications

TRIDIONE is indicated for the control of petit mal seizures that are refractory to treatment with other drugs. It is effective in preventing certain types of seizures in experimental animals and is administered orally, typically in doses ranging from 0.9 to 2.4 grams daily[2][4].

Market Position

TRIDIONE occupies a niche in the anticonvulsant market, targeting a specific segment of patients with refractory epilepsy. Its use is limited by its side effect profile and the availability of other antiepileptic drugs. The market for antiepileptic drugs is competitive, with various other medications available, each with their own strengths and weaknesses.

Side Effects and Safety Concerns

The drug has a significant side effect profile, including severe reactions such as Steven Johnson syndrome, nephrotoxicity, hepatitis, aplastic anemia, and fetal trimethadione syndrome if used during pregnancy. These safety concerns can impact its market adoption and patient compliance[1][2][4].

Patient Population and Demand

The demand for TRIDIONE is driven by the need for effective treatments for refractory epilepsy. However, the patient population is relatively small compared to other therapeutic areas. The drug's use is often reserved for cases where other treatments have failed, which limits its market size.

Competitive Landscape

The antiepileptic drug market is highly competitive, with several other drugs available that may offer better safety profiles or broader efficacy. Newer drugs and therapies are continually being developed, which can further erode the market share of older drugs like TRIDIONE.

Pricing and Cost Considerations

TRIDIONE is not among the most expensive antiepileptic drugs, but its cost can still be a barrier for some patients. The pricing strategy for TRIDIONE is influenced by the overall pharmaceutical market dynamics, including competition from generic versions of other antiepileptic drugs and the negotiating power of healthcare providers and insurers.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of TRIDIONE. Strict medical supervision is required, especially during the initial year of therapy, due to the potential for serious side effects. Regulatory bodies closely monitor the safety and efficacy of the drug, which can impact its market trajectory[2][4].

Financial Trajectory

Given the niche market position and the limited patient population, the financial trajectory of TRIDIONE is likely to be stable but not highly growth-oriented. Here are some key financial considerations:

Revenue Stability

TRIDIONE generates consistent revenue due to its established use in treating refractory epilepsy. However, this revenue is unlikely to see significant growth due to the limited market size and competition from newer drugs.

Cost of Production and Distribution

The cost of producing and distributing TRIDIONE is relatively stable, with the drug being supplied as chewable tablets. Storage requirements, such as refrigeration, can add to the distribution costs but are manageable[4].

Research and Development

While TRIDIONE itself is not a subject of extensive current research, the broader antiepileptic drug market is continually evolving. Investments in research and development are more likely to be focused on newer, more promising therapies rather than older drugs like TRIDIONE.

Market Projections

Market projections for TRIDIONE are likely to be conservative, reflecting the stable but limited demand for the drug. The market size is not expected to expand significantly unless there are breakthroughs in its use or significant changes in the competitive landscape.

Impact of Broader Pharmaceutical Trends

The pharmaceutical industry is undergoing significant changes, including the development of new therapeutic classes and the increasing focus on patient safety and efficacy. These trends can indirectly affect the market for TRIDIONE by influencing prescribing practices and patient preferences.

Generic Competition

The availability of generic versions of other antiepileptic drugs can impact the market share of TRIDIONE. However, as TRIDIONE is a specific treatment for refractory cases, it may retain its niche even in the presence of generic competition.

Innovative Therapies

The development of innovative therapies, such as those targeting specific mechanisms of epilepsy, can further marginalize older drugs like TRIDIONE. However, these new therapies may also offer opportunities for combination treatments or new indications that could benefit TRIDIONE.

Key Takeaways

  • Niche Market Position: TRIDIONE is used for treating refractory epilepsy, a specific and relatively small market segment.
  • Stable Revenue: The drug generates consistent revenue but is unlikely to see significant growth.
  • Safety Concerns: Serious side effects limit its market adoption and patient compliance.
  • Regulatory Oversight: Strict medical supervision is required due to potential side effects.
  • Limited Research Focus: Newer drugs and therapies are the focus of current research and development efforts.

FAQs

Q: What is TRIDIONE used for?

A: TRIDIONE (trimethadione) is used for the control of petit mal (absence) seizures that are refractory to treatment with other drugs.

Q: What are the common side effects of TRIDIONE?

A: Common side effects include drowsiness, hemeralopia, hiccups, and more severe reactions such as Steven Johnson syndrome and aplastic anemia.

Q: Can TRIDIONE be used during pregnancy?

A: No, TRIDIONE should not be used during pregnancy due to the risk of fetal trimethadione syndrome, which can cause severe birth defects.

Q: How is TRIDIONE administered?

A: TRIDIONE is administered orally, typically in doses ranging from 0.9 to 2.4 grams daily, divided into 3 or 4 doses.

Q: What is the market outlook for TRIDIONE?

A: The market outlook for TRIDIONE is stable but not growth-oriented due to its niche market position and the availability of other antiepileptic drugs.

Cited Sources

  1. Wikipedia: Trimethadione.
  2. FDA: TRIDIONE (trimethadione) Tablets.
  3. Drugs.com: Tridione: Package Insert / Prescribing Information.
  4. Annual Reviews: (Not directly relevant to TRIDIONE but provides broader pharmaceutical context).

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