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Last Updated: December 22, 2024

NAVANE Drug Patent Profile


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Which patents cover Navane, and what generic alternatives are available?

Navane is a drug marketed by Pfizer and is included in three NDAs.

The generic ingredient in NAVANE is thiothixene hydrochloride. There are six drug master file entries for this compound. Additional details are available on the thiothixene hydrochloride profile page.

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Summary for NAVANE
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 55
Patent Applications: 6,453
DailyMed Link:NAVANE at DailyMed
Drug patent expirations by year for NAVANE

US Patents and Regulatory Information for NAVANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer NAVANE thiothixene CAPSULE;ORAL 016584-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer NAVANE thiothixene hydrochloride INJECTABLE;INJECTION 016904-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer NAVANE thiothixene CAPSULE;ORAL 016584-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer NAVANE thiothixene hydrochloride INJECTABLE;INJECTION 016904-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer NAVANE thiothixene CAPSULE;ORAL 016584-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer NAVANE thiothixene CAPSULE;ORAL 016584-003 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

NAVANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Navane

Overview of Navane

Navane, also known as thiothixene, is a first-generation (typical) antipsychotic drug used primarily to treat schizophrenia and other psychotic disorders. Here’s a detailed look at the market dynamics and financial trajectory of Navane.

Market Size and Growth

Global Antipsychotic Drugs Market

The global antipsychotic drugs market, which includes Navane, was valued at USD 16.88 billion in 2023 and is projected to grow at a CAGR of 6.1% from 2024 to 2030[1].

Segmental Analysis

Navane falls under the first-generation antipsychotic drugs category. While this segment is not expected to grow as rapidly as the second and third generations, it still maintains a significant market presence due to its long-standing use and established patient base.

Revenue Share and Market Position

First-Generation Antipsychotics

The first-generation antipsychotic drugs, including Navane, accounted for a smaller but still substantial share of the market. However, this segment is expected to decline in market share as newer, more advanced antipsychotics gain prominence. In 2023, the second-generation therapeutic class held the largest market revenue share of 62.9%, while the first-generation drugs, such as Navane, saw a declining trend[1].

Regional Performance

North America

North America, particularly the United States, has been a significant market for antipsychotic drugs, including Navane. This region dominated the market with a revenue share of 37.67% in 2023, driven by the high prevalence of psychiatric illnesses and the presence of prominent biopharmaceutical companies[1].

Financial Trajectory

Historical Spending

Historically, spending on retail prescription drugs, including antipsychotics like Navane, has increased rapidly over the past few decades. However, the growth in spending on first-generation antipsychotics is expected to be slower compared to newer generations. For instance, between 1960 and 2021, retail prescription drug spending per capita in the U.S. increased from $101 to $1,147, but this growth is anticipated to moderate in the next decade[2].

Future Projections

The financial trajectory for Navane is likely to be influenced by several factors:

  • Declining Market Share: As second and third-generation antipsychotics gain more market share due to their enhanced efficiency and safety, the revenue from Navane is expected to decline.
  • Regulatory Impact: The Inflation Reduction Act, which includes provisions to cap out-of-pocket prescription drug spending and negotiate prices for certain high-spend drugs, may impact the overall financial dynamics of the antipsychotic drug market. However, these provisions are more directly applicable to Medicare and may not significantly affect Navane's market position immediately[2].

Challenges and Opportunities

Safety Concerns

Navane, like other first-generation antipsychotics, is associated with several side effects and safety concerns, such as increased mortality in elderly patients with dementia-related psychosis. These risks can affect its prescription rates and overall market performance[5].

Competition from Newer Drugs

The emergence of second and third-generation antipsychotics, such as brexpiprazole and aripiprazole, which offer better safety profiles and efficacy, poses a significant competitive threat to Navane. These newer drugs are expected to register faster CAGRs, further eroding the market share of first-generation antipsychotics[1].

Key Takeaways

  • Market Size: The global antipsychotic drugs market, including Navane, is growing but with a declining share for first-generation drugs.
  • Regional Performance: North America remains a significant market, but the overall revenue share of Navane is expected to decrease.
  • Financial Trajectory: Moderate spending growth and declining market share are anticipated for Navane.
  • Challenges: Safety concerns and competition from newer drugs are major challenges.

FAQs

What is the current market size of the global antipsychotic drugs market?

The global antipsychotic drugs market was valued at USD 16.88 billion in 2023[1].

Which region dominates the antipsychotic drugs market?

North America, particularly the United States, dominates the market with a revenue share of 37.67% in 2023[1].

What are the main challenges facing Navane in the market?

Navane faces challenges from safety concerns, such as increased mortality in elderly patients, and competition from newer, more advanced antipsychotic drugs[1][5].

How is the Inflation Reduction Act expected to impact the antipsychotic drugs market?

The Inflation Reduction Act is expected to cap out-of-pocket prescription drug spending and negotiate prices for certain high-spend drugs, which may moderate the growth in prescription drug spending but has a more direct impact on Medicare-covered drugs[2].

What is the projected growth rate for the global antipsychotic drugs market?

The global antipsychotic drugs market is projected to grow at a CAGR of 6.1% from 2024 to 2030[1].

Sources

  1. Grand View Research: Antipsychotic Drugs Market Size And Share Report, 2030
  2. Health System Tracker: Recent and Forecasted Trends in Prescription Drug Spending
  3. Morgan Stanley: Scaling Up the Impact of Obesity Drugs
  4. IndustryARC: Antipsychotic Drugs Market - Forecast(2024 - 2030)
  5. FDA: NAVANE® - Thiothixene Capsules Thiothixene Hydrochloride Concentrate Label

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