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Last Updated: December 22, 2024

TOVALT ODT Drug Patent Profile


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

Tovalt Odt is a drug marketed by Biovail Labs Intl and is included in one NDA.

The generic ingredient in TOVALT ODT is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tovalt Odt

A generic version of TOVALT ODT was approved as zolpidem tartrate by ACME LABS on April 23rd, 2007.

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Summary for TOVALT ODT
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 47
DailyMed Link:TOVALT ODT at DailyMed
Drug patent expirations by year for TOVALT ODT

US Patents and Regulatory Information for TOVALT ODT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biovail Labs Intl TOVALT ODT zolpidem tartrate TABLET, ORALLY DISINTEGRATING;ORAL 021412-001 Apr 25, 2007 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Biovail Labs Intl TOVALT ODT zolpidem tartrate TABLET, ORALLY DISINTEGRATING;ORAL 021412-002 Apr 25, 2007 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

TOVALT ODT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TOVALT ODT

Introduction to TOVALT ODT

TOVALT ODT, containing zolpidem tartrate, is an orally disintegrating tablet (ODT) approved by the FDA for the treatment of insomnia. It is designed to dissolve quickly in the mouth, making it an attractive option for patients who have difficulty swallowing traditional tablets[2][5].

Market Context: Orally Disintegrating Tablets

The global orally disintegrating tablet market is experiencing significant growth, driven by several key factors. The market is projected to reach a valuation of USD 72.68 billion by 2034, growing at a CAGR of 11.5% from 2024 to 2034. This growth is largely attributed to the increasing demand for patient-friendly dosage forms, particularly among the elderly and pediatric populations[1][4].

Drug Class and Disease Indication

TOVALT ODT falls under the category of anti-psychotics and sedative-hypnotics, which are among the leading drug classes in the ODT market. Anti-psychotics, in particular, hold a substantial market share, with a projected value of USD 15.76 billion by 2034, growing at a CAGR of 12.8% from 2024 to 2034. Central Nervous System (CNS) diseases, such as insomnia, are a major indication for ODTs, accounting for a significant portion of the market[1][4].

Distribution Channels

Hospital pharmacies are a dominant distribution channel for ODTs, including TOVALT ODT. These pharmacies hold a substantial market share due to their commitment to patient care and adherence to quality standards. The ease of administration and rapid disintegration of ODTs make them particularly beneficial in hospital settings, where patients often have swallowing difficulties or require rapid symptom relief[4].

Regional Analysis

The North American market, particularly the United States, is a significant hub for ODTs. The U.S. market for ODTs is driven by the growing need for pediatric and geriatric formulations, as well as the increasing prevalence of chronic diseases such as CNS disorders. The U.S. market for TOVALT ODT is expected to grow substantially, with the overall ODT market in the U.S. projected to reach USD 21.78 billion by 2034, growing at a CAGR of 11.3% from 2024 to 2034[1].

Financial Trajectory

Given the broader market trends, TOVALT ODT is likely to benefit from the overall growth in the ODT market. Here are some key financial insights:

  • Market Value: The global ODT market, which includes TOVALT ODT, is expected to grow from USD 13.2 billion in 2023 to USD 29.0 billion by 2033, at a CAGR of 8.2%[4].
  • Segment Growth: The anti-psychotics segment, which includes sedative-hypnotics like TOVALT ODT, is expected to grow significantly, with a projected value of USD 15.76 billion by 2034[1].
  • Regional Revenue: The U.S. market, a key region for TOVALT ODT, is forecasted to reach USD 21.78 billion by 2034, indicating strong revenue potential for the drug[1].

Challenges and Opportunities

High Production Costs

One of the significant challenges facing TOVALT ODT and other ODTs is the high production cost. These costs are notably higher compared to traditional tablets or capsules, which can limit the affordability and adoption of ODTs, especially in low-income patient groups[1].

Innovation and Patient Compliance

Despite the challenges, advancements in taste-masking techniques, super disintegrants, and freeze-drying technology are enhancing patient acceptance and compliance. These innovations can drive sales and market growth for TOVALT ODT and similar products[1].

Expanding Geriatric Population

The growing geriatric population presents a substantial opportunity for TOVALT ODT. Elderly patients often face difficulties swallowing traditional tablets, making ODTs a preferred choice. As the elderly population continues to grow, the demand for ODTs like TOVALT ODT is expected to rise[4].

Key Takeaways

  • Market Growth: The global ODT market, including TOVALT ODT, is expected to grow significantly, driven by demand for patient-friendly dosage forms.
  • Regional Dominance: The U.S. market is a key driver for ODTs, with a strong growth trajectory.
  • Segment Leadership: Anti-psychotics and sedative-hypnotics, such as TOVALT ODT, hold a substantial market share.
  • Challenges: High production costs and affordability issues need to be addressed.
  • Opportunities: Innovations in formulation and the growing geriatric population offer significant growth opportunities.

FAQs

What is TOVALT ODT used for?

TOVALT ODT is used for the treatment of insomnia. It contains zolpidem tartrate and is designed to dissolve quickly in the mouth.

Why is the demand for ODTs increasing?

The demand for ODTs is increasing due to the growing need for patient-friendly dosage forms, particularly among the elderly and pediatric populations, and the rising prevalence of CNS diseases.

What are the main challenges facing the ODT market?

High production costs and affordability issues are significant challenges facing the ODT market, limiting adoption among low-income patient groups.

Which regions are expected to drive the growth of the ODT market?

North America, particularly the United States, and regions like the Asia Pacific and Middle East & Africa are expected to drive the growth of the ODT market.

How do innovations in formulation impact the ODT market?

Innovations in taste-masking techniques, super disintegrants, and freeze-drying technology enhance patient acceptance and compliance, driving sales and market growth for ODTs.

Cited Sources

  1. FactMR: Orally Disintegrating Tablet Market Share, Global Analysis - 2034
  2. FDA: TOVALTâ„¢ ODT (zolpidem tartrate) Orally Disintegrating Tablets CIV
  3. GlobeNewswire: U.S. OTC Drugs Market Forecast Report 2024-2029
  4. Market.US: Orally Disintegrating Tablet Market Outlook | CAGR of 8.2%
  5. FDA: Drug Approval Package: Tovalt Odt (zolpidem tartrate) NDA 21412

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