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Last Updated: December 22, 2024

ARTANE Drug Patent Profile


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

Artane is a drug marketed by Lederle and is included in two NDAs.

The generic ingredient in ARTANE is trihexyphenidyl hydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the trihexyphenidyl hydrochloride profile page.

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Summary for ARTANE
Drug patent expirations by year for ARTANE
Recent Clinical Trials for ARTANE

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

SponsorPhase
Shanghai Mental Health CenterEarly Phase 1
Bachmann Strauss Dystonia & Parkinson Foundation, Inc.
University of Florida

See all ARTANE clinical trials

US Patents and Regulatory Information for ARTANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lederle ARTANE trihexyphenidyl hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 006773-010 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lederle ARTANE trihexyphenidyl hydrochloride TABLET;ORAL 006773-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lederle ARTANE trihexyphenidyl hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 012947-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lederle ARTANE trihexyphenidyl hydrochloride ELIXIR;ORAL 006773-009 Approved Prior to Jan 1, 1982 DISCN No 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

ARTANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ARTANE

Introduction

ARTANE, also known as trihexyphenidyl, is an antispasmodic drug widely used in the treatment of Parkinson's disease and other movement disorders. Understanding its market dynamics and financial trajectory involves examining its usage, pricing, competition, and regulatory environment.

Clinical Uses and Indications

ARTANE is indicated as an adjunct in the treatment of all forms of parkinsonism, including postencephalitic, arteriosclerotic, and idiopathic Parkinson's disease. It is also used to control extrapyramidal disorders caused by central nervous system drugs such as phenothiazines, thioxanthenes, and butyrophenones[1][5].

Market Demand

The demand for ARTANE is driven by the prevalence of Parkinson's disease and other movement disorders. As the global population ages, the incidence of these conditions is expected to increase, thereby sustaining or increasing the demand for treatments like ARTANE.

Pricing and Cost Considerations

ARTANE is a generic drug, which generally means it is priced lower than its branded counterparts. The transition from a branded to a generic drug typically leads to significant price reductions. For instance, generic drug pricing often falls dramatically after patent-related exclusivity ends, with prices sometimes dropping by as much as 28% following privatization of drug benefits[3].

Competitive Landscape

The market for anticholinergic drugs like ARTANE is competitive, with several generic versions available. However, ARTANE remains a preferred option due to its relatively lower side effect profile compared to other anticholinergic agents like belladonna alkaloids[1][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of ARTANE. The FDA's approval process and regulatory oversight can affect the entry of new generic drugs into the market. Delays in regulatory approvals can increase the cost of entry for new competitors, potentially maintaining higher prices for existing drugs. Conversely, faster approvals and lower regulatory costs can lead to increased competition and lower prices[3].

Side Effects and Patient Compliance

While ARTANE is effective, it comes with a range of side effects, including dry mouth, blurred vision, dizziness, and nausea. These side effects can impact patient compliance and may drive the development of newer, more targeted treatments. Recent research has focused on developing novel compounds that retain the beneficial effects of anticholinergic drugs like ARTANE while minimizing side effects[4].

Generic Drug Market Challenges

The generic drug market, including ARTANE, faces challenges such as price-fixing and anticompetitive behavior. Between 2013 and subsequent years, allegations of price-fixing among generic manufacturers led to significant price hikes for many drugs, including those in the same therapeutic class as ARTANE. This highlights the need for robust antitrust enforcement and regulatory oversight to ensure market efficiency[3].

Financial Trajectory

The financial trajectory of ARTANE is influenced by several factors:

Revenue Stability

Given its established use and generic status, ARTANE generates stable revenue. However, the revenue may fluctuate based on market competition and regulatory changes.

Cost Savings

The use of ARTANE and other generic drugs contributes to significant cost savings in healthcare. For example, the greater use of lower-cost generic drugs can reduce healthcare costs substantially, with estimates suggesting that full privatization of drug benefits could reduce prices by up to 28%[3].

Research and Development

Investments in research and development are crucial for maintaining market share. Newer, more targeted treatments could potentially replace ARTANE, but current research aims to improve upon existing anticholinergic drugs rather than replace them entirely[4].

Impact of New Treatments

Emerging treatments for movement disorders, such as those identified in recent preclinical studies, could alter the market dynamics for ARTANE. These new treatments aim to target specific receptors associated with dystonia symptoms, potentially reducing side effects and improving patient outcomes. However, these developments are still in the early stages, and ARTANE is likely to remain a viable treatment option for the foreseeable future[4].

Conclusion

The market dynamics and financial trajectory of ARTANE are shaped by its clinical uses, competitive landscape, regulatory environment, and the ongoing development of new treatments. As a generic drug, ARTANE benefits from lower pricing, which contributes to cost savings in healthcare. However, challenges such as anticompetitive behavior and the emergence of new treatments must be navigated to maintain its market position.

Key Takeaways

  • Stable Demand: ARTANE's demand is driven by the prevalence of Parkinson's disease and other movement disorders.
  • Competitive Pricing: As a generic drug, ARTANE benefits from lower pricing compared to branded alternatives.
  • Regulatory Influence: FDA approvals and regulatory oversight significantly impact the market entry of new competitors.
  • Side Effects and Compliance: Ongoing research aims to develop treatments with fewer side effects, which could influence patient compliance and market share.
  • Financial Stability: ARTANE generates stable revenue, though it may fluctuate based on market and regulatory changes.

FAQs

  1. What is ARTANE used for? ARTANE (trihexyphenidyl) is used as an adjunct in the treatment of all forms of parkinsonism and to control extrapyramidal disorders caused by central nervous system drugs.

  2. What are the common side effects of ARTANE? Common side effects include dryness of the mouth, blurred vision, dizziness, mild nausea, and nervousness. These side effects are generally less severe than those associated with other anticholinergic agents.

  3. How does the generic status of ARTANE affect its pricing? As a generic drug, ARTANE is priced lower than its branded counterparts, contributing to significant cost savings in healthcare.

  4. What regulatory challenges does the generic drug market face? The generic drug market faces challenges such as anticompetitive behavior and price-fixing, which can lead to higher prices despite the presence of generic alternatives.

  5. Are there new treatments being developed to replace ARTANE? Yes, new treatments are being developed to target specific receptors associated with dystonia symptoms, aiming to reduce side effects and improve patient outcomes. However, these are still in the early stages of development.

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