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Last Updated: December 22, 2024

STAVZOR Drug Patent Profile


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

Stavzor is a drug marketed by Bionpharma and is included in one NDA.

The generic ingredient in STAVZOR is valproic acid. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the valproic acid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Stavzor

A generic version of STAVZOR was approved as valproic acid by CATALENT on October 29th, 1991.

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

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

SponsorPhase
Barbara Ann Karmanos Cancer InstitutePhase 1
PfizerPhase 2
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhase 2

See all STAVZOR clinical trials

US Patents and Regulatory Information for STAVZOR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bionpharma STAVZOR valproic acid CAPSULE, DELAYED RELEASE;ORAL 022152-001 Jul 29, 2008 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bionpharma STAVZOR valproic acid CAPSULE, DELAYED RELEASE;ORAL 022152-002 Jul 29, 2008 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bionpharma STAVZOR valproic acid CAPSULE, DELAYED RELEASE;ORAL 022152-003 Jul 29, 2008 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

STAVZOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for STAVZOR (Valproic Acid)

Introduction

STAVZOR, a delayed-release formulation of valproic acid, is a versatile medication used in the treatment of various neurological and psychiatric conditions, including bipolar disorder, complex partial seizures, and migraine prophylaxis. Understanding the market dynamics and financial trajectory of STAVZOR involves analyzing its clinical use, market competition, and the financial performance of its manufacturer.

Clinical Indications and Usage

STAVZOR is indicated for the acute treatment of manic or mixed episodes associated with bipolar disorder, monotherapy and adjunctive therapy for complex partial seizures and absence seizures, and the prophylaxis of migraine headaches[1][4].

Market Position

STAVZOR operates in a competitive market dominated by other anticonvulsants and mood stabilizers. Its unique delayed-release formulation provides a distinct advantage in terms of patient compliance and therapeutic efficacy. However, the market is also influenced by generic versions of valproic acid, which can impact pricing and market share.

Competitive Landscape

The neurology and psychiatry drug market is highly competitive, with several major players. For instance, AbbVie's neuroscience portfolio, which includes drugs like Vraylar and Ubrelvy, has shown significant growth, indicating a robust market for neurological treatments[2].

Financial Performance

While specific financial data for STAVZOR alone is not readily available, the overall performance of its manufacturer and similar drugs can provide insights. The neuroscience portfolio of companies like AbbVie has seen significant growth, with Vraylar and Ubrelvy contributing substantially to their revenue[2].

Revenue Streams

STAVZOR generates revenue through its prescription sales. The pricing strategy is crucial, as it must balance profitability with affordability and competition from generic alternatives. The market size for neurological and psychiatric treatments is substantial, with the global market for such drugs expected to grow significantly over the coming years[3].

Pricing and Cost Considerations

The cost of STAVZOR can be a significant factor in its market dynamics. The drug is generally priced higher than its generic counterparts, which can affect its market share. However, its delayed-release formulation and established efficacy can justify the premium pricing for many patients and healthcare providers[4].

Patient and Prescriber Preferences

Patient compliance and prescriber preference play critical roles in the market dynamics of STAVZOR. The convenience of a delayed-release formulation can enhance patient adherence, which is a key factor in the long-term management of chronic conditions like bipolar disorder and epilepsy[1][4].

Regulatory Environment

The regulatory environment is another crucial factor. STAVZOR must comply with FDA regulations, and any changes in regulatory requirements or the approval of new drugs can impact its market position. For instance, the FDA's approval process and post-marketing surveillance can influence the drug's safety profile and usage guidelines[1].

Long-Term Market Outlook

The long-term outlook for STAVZOR is influenced by several factors, including the growth of the neurological and psychiatric drug market, competition from new and generic drugs, and advancements in treatment options. The market for neurological treatments is expected to expand, driven by increasing awareness and diagnosis of neurological disorders[3].

Challenges and Opportunities

One of the challenges facing STAVZOR is the lack of systematic data supporting its long-term use beyond acute treatment phases. This gap in evidence can make it harder for clinicians to recommend the drug for long-term management of conditions like bipolar disorder[1][4].

However, the safety of STAVZOR in long-term use is supported by data from record reviews involving approximately 360 patients treated with valproate for more than 3 months. This provides a basis for continued use and potential growth in the market[1][4].

Key Takeaways

  • Clinical Versatility: STAVZOR is used for various neurological and psychiatric conditions.
  • Market Competition: The drug faces competition from other anticonvulsants and mood stabilizers, including generic versions.
  • Financial Performance: Revenue is influenced by prescription sales and pricing strategies.
  • Regulatory Compliance: Adherence to FDA regulations is crucial.
  • Long-Term Outlook: The market for neurological treatments is expected to grow, but challenges include the need for long-term efficacy data.

FAQs

Q: What are the primary indications for STAVZOR? A: STAVZOR is indicated for the acute treatment of manic or mixed episodes associated with bipolar disorder, monotherapy and adjunctive therapy for complex partial seizures and absence seizures, and the prophylaxis of migraine headaches[1][4].

Q: How is STAVZOR administered? A: STAVZOR is administered orally and must be swallowed whole. The dosage is typically titrated upward to achieve the desired therapeutic effect[1][4].

Q: What are the potential side effects of STAVZOR? A: Common side effects include dizziness, drowsiness, and changes in liver function. Serious side effects can include liver damage and pancreatitis[4].

Q: Can STAVZOR be used for long-term treatment? A: While there is no systematic data supporting long-term use beyond acute treatment phases, the safety of STAVZOR in long-term use is supported by data from record reviews involving approximately 360 patients treated with valproate for more than 3 months[1][4].

Q: How does STAVZOR compare to other anticonvulsants in the market? A: STAVZOR's delayed-release formulation provides a distinct advantage in terms of patient compliance and therapeutic efficacy, but it faces competition from other anticonvulsants and generic versions of valproic acid[1][4].

Cited Sources

  1. FDA Label for STAVZOR: This label provides detailed information on the indications, dosage, and administration of STAVZOR[1].
  2. AbbVie Financial Results: AbbVie's financial reports offer insights into the broader neuroscience market and the performance of similar drugs[2].
  3. Baron Capital Group Article: This article discusses the potential market size and growth opportunities in the neurological and psychiatric drug market[3].
  4. RxList Information on STAVZOR: This source provides comprehensive details on the side effects, uses, and dosage of STAVZOR[4].

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