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Last Updated: December 22, 2024

TRIHEXYPHENIDYL HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for trihexyphenidyl hydrochloride and what is the scope of freedom to operate?

Trihexyphenidyl hydrochloride is the generic ingredient in three branded drugs marketed by Lederle, Mikart, Pharm Assoc, Pharm Ventures, Schering, Hikma, Natco Pharma Ltd, Novitium Pharma, Nylos, Vangard, and Watson Labs, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for trihexyphenidyl hydrochloride. Nine suppliers are listed for this compound.

Summary for TRIHEXYPHENIDYL HYDROCHLORIDE
US Patents:0
Tradenames:3
Applicants:11
NDAs:16
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 9
Raw Ingredient (Bulk) Api Vendors: 105
Clinical Trials: 4
Patent Applications: 3,138
What excipients (inactive ingredients) are in TRIHEXYPHENIDYL HYDROCHLORIDE?TRIHEXYPHENIDYL HYDROCHLORIDE excipients list
DailyMed Link:TRIHEXYPHENIDYL HYDROCHLORIDE at DailyMed
Recent Clinical Trials for TRIHEXYPHENIDYL HYDROCHLORIDE

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

SponsorPhase
National Taiwan University HospitalPhase 4
University of Florida
Bachmann Strauss Dystonia & Parkinson Foundation, Inc.

See all TRIHEXYPHENIDYL HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for TRIHEXYPHENIDYL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for TRIHEXYPHENIDYL HYDROCHLORIDE

US Patents and Regulatory Information for TRIHEXYPHENIDYL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novitium Pharma TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride TABLET;ORAL 040254-001 Dec 24, 1998 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco Pharma Ltd TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride TABLET;ORAL 091630-002 Nov 17, 2010 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mikart TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride ELIXIR;ORAL 040251-001 Sep 27, 1999 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride TABLET;ORAL 085117-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco Pharma Ltd TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride TABLET;ORAL 091630-001 Nov 17, 2010 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Vangard TRIHEXYPHENIDYL HYDROCHLORIDE trihexyphenidyl hydrochloride TABLET;ORAL 088035-001 Jul 30, 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

TRIHEXYPHENIDYL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Trihexyphenidyl Hydrochloride

Introduction

Trihexyphenidyl hydrochloride, a small molecule drug targeting muscarinic acetylcholine receptors (mAChRs), has been a staple in the treatment of various nervous system and endocrinology-related conditions since its approval in 1949. Here, we delve into the market dynamics and financial trajectory of this drug.

Historical Context and Approval

Trihexyphenidyl hydrochloride was first approved in the United States in May 1949, marking the beginning of its long and successful presence in the pharmaceutical market. Over the years, it has gained global approval and is widely used for treating conditions such as Parkinson's disease, akathisia, and drug-induced dyskinesias[1][3][4].

Therapeutic Uses and Indications

The drug's versatility is evident in its multiple therapeutic uses. It is primarily used for the symptomatic treatment of Parkinson's disease, both in mono and combination therapy. It also treats extrapyramidal side effects caused by antipsychotic medications, essential tremor, and akathisia. Additionally, it has applications in pediatrics for conditions like dystonia due to cerebral palsy and in controlling drooling[3][4].

Mechanism of Action and Efficacy

Trihexyphenidyl hydrochloride works by blocking the action of acetylcholine, a neurotransmitter in the brain, thereby alleviating symptoms associated with its approved indications. This mechanism helps restore the balance of neurotransmitters, improving motor function in patients with Parkinson's disease. Studies indicate that 50-75% of people with Parkinson's disease experience a 20-30% symptomatic improvement with this drug[1][3].

Market Competition

The market for mAChRs antagonists, like trihexyphenidyl hydrochloride, is competitive. Other drugs in this class include benztropine and diphenhydramine. While these alternatives have similar indications, they differ in side effect profiles and usage contexts. For instance, benztropine is also used to treat Parkinson's disease and extrapyramidal side effects, but it has a different side effect profile compared to trihexyphenidyl hydrochloride[2].

Global Development and Approval Status

Trihexyphenidyl hydrochloride has reached the highest phase of development and is approved globally. This widespread approval underscores its reliability and effectiveness. Companies like Pfizer Inc. and C.H. Boehringer Sohn AG & Co. KG are among the leaders in developing mAChRs antagonists, with Pfizer having the highest number of approved drugs in this category[1].

Financial Trajectory

The financial trajectory of trihexyphenidyl hydrochloride is influenced by several factors:

Generic Availability

The drug is available in generic form, which has significantly reduced its cost. Generic availability has made it more accessible to a broader patient population, contributing to its sustained market presence[2][4].

Pricing and Market Demand

Despite being a generic drug, trihexyphenidyl hydrochloride maintains a steady market demand due to its efficacy and the chronic nature of the conditions it treats. The pricing, although lower than brand-name drugs, remains stable due to consistent demand and the lack of newer, more effective alternatives for its specific indications[2].

Combination Therapy

Trihexyphenidyl hydrochloride is often used in combination with other medications, such as levodopa, to enhance therapeutic efficacy. This multidimensional approach not only improves patient outcomes but also contributes to the drug's financial stability by ensuring continued prescription and use[3][4].

Side Effects and Safety Profile

While the drug has a favorable safety profile, it does come with side effects such as dry mouth, dizziness, and nervousness. However, these side effects are generally manageable, and the drug's benefits often outweigh the risks. This balance contributes to its continued use and financial stability[3][4].

Regional Market Dynamics

China is a significant player in the development and approval of mAChRs antagonists, including trihexyphenidyl hydrochloride. The region's rapid development in this area indicates a growing market for these drugs, further solidifying the financial trajectory of trihexyphenidyl hydrochloride[1].

Industry Trends and Future Outlook

The pharmaceutical industry is witnessing intense competition in the development of small molecule drugs targeting mAChRs. However, trihexyphenidyl hydrochloride's long history of approval and widespread use ensure its continued relevance. As research continues to uncover new therapeutic applications for mAChRs antagonists, the market for trihexyphenidyl hydrochloride is likely to remain stable or even grow.

Research and Development

Ongoing research and clinical trials in the field of mAChRs antagonists suggest a dynamic market. With 377 drugs targeting mAChRs worldwide, and 2952 clinical trials underway, the potential for new indications and improved formulations of trihexyphenidyl hydrochloride or similar drugs is high[1].

Key Takeaways

  • Long-standing Approval: Trihexyphenidyl hydrochloride has been approved globally since 1949.
  • Therapeutic Versatility: It treats various conditions including Parkinson's disease, akathisia, and drug-induced dyskinesias.
  • Mechanism of Action: Blocks acetylcholine receptors to alleviate symptoms.
  • Market Competition: Faces competition from other mAChRs antagonists like benztropine and diphenhydramine.
  • Financial Stability: Supported by generic availability, consistent market demand, and use in combination therapy.
  • Regional Dynamics: China is a significant player in the development and approval of mAChRs antagonists.

FAQs

Q: What is the primary mechanism of action of trihexyphenidyl hydrochloride?

A: Trihexyphenidyl hydrochloride works by blocking the action of acetylcholine, a neurotransmitter in the brain, thereby alleviating symptoms associated with its approved indications[1][3].

Q: What are the common side effects of trihexyphenidyl hydrochloride?

A: Common side effects include dry mouth, dizziness, mild nausea, and nervousness. More severe side effects can include delusions, skin rash, and fast heart rate[3][4].

Q: Is trihexyphenidyl hydrochloride available in generic form?

A: Yes, trihexyphenidyl hydrochloride is available in generic form, which has reduced its cost and made it more accessible to patients[2][4].

Q: How does trihexyphenidyl hydrochloride compare to other mAChRs antagonists?

A: While it shares similar indications with drugs like benztropine and diphenhydramine, it has a distinct side effect profile and is often used in combination therapy to enhance efficacy[2][3].

Q: What is the future outlook for trihexyphenidyl hydrochloride in the market?

A: The drug is likely to maintain its market presence due to its long history of approval, therapeutic versatility, and ongoing research in the field of mAChRs antagonists[1][3].

Sources

  1. Patsnap Synapse: Decoding trihexyphenidyl hydrochloride: A Comprehensive Study of its R&D Trends.
  2. Drugs.com: Trihexyphenidyl Alternatives Compared.
  3. Wikipedia: Trihexyphenidyl.
  4. Mayo Clinic: Trihexyphenidyl (oral route).

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