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Last Updated: December 22, 2024

STATOBEX Drug Patent Profile


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When do Statobex patents expire, and when can generic versions of Statobex launch?

Statobex is a drug marketed by Teva and is included in three NDAs.

The generic ingredient in STATOBEX is phendimetrazine tartrate. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Statobex

A generic version of STATOBEX was approved as phendimetrazine tartrate by VIRTUS on December 31st, 1969.

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Summary for STATOBEX
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 21
Patent Applications: 2,019
DailyMed Link:STATOBEX at DailyMed
Drug patent expirations by year for STATOBEX

US Patents and Regulatory Information for STATOBEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva STATOBEX phendimetrazine tartrate CAPSULE;ORAL 085507-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva STATOBEX phendimetrazine tartrate TABLET;ORAL 086013-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva STATOBEX-G phendimetrazine tartrate TABLET;ORAL 085095-001 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

STATOBEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of the Pharmaceutical Industry: Insights Relevant to STATOBEX

U.S. Pharmaceutical Market Overview

The U.S. pharmaceutical market is one of the largest and most dynamic in the world. As of 2023, the market size was valued at USD 602.19 billion, and it is projected to reach USD 1,093.79 billion by 2033, growing at a CAGR of 6.15% from 2024 to 2033[1].

Market Segmentation and Growth Drivers

By Molecule Type

The market is dominated by conventional drugs (small molecules), which held a revenue share of 56.21% in 2023. However, the biologics and biosimilars segment is expected to witness the fastest growth during the forecast period, driven by advancements in biotechnology and increasing demand for targeted therapies[1].

By Disease

The cancer segment currently dominates the market with a share of 16.79% in 2023, but the neurological disorders segment is anticipated to grow at the fastest CAGR from 2024 to 2033. This growth is driven by the increasing prevalence of neurological diseases and the development of new treatments[1].

By Route of Administration

The oral route of administration dominates the market with a revenue share of 59.9% in 2023. However, the parenteral route is expected to expand at the fastest CAGR over the forecast period, reflecting advancements in injectable therapies and their growing acceptance[1].

Financial Trajectory of the Pharmaceutical Industry

Revenue and Market Share

The branded segment of the pharmaceutical market held a dominant revenue share of 68.19% in 2023, with prescription drugs accounting for 88.23% of the market. This indicates a strong preference for branded and prescription medications, which are often associated with higher revenue and profitability[1].

Growth in Specific Segments

The over-the-counter (OTC) segment is poised for significant growth, driven by the high cost of prescription pharmaceuticals and the increasing approval of OTC drugs. This shift is expected to make healthcare more accessible and cost-effective for consumers[1].

Relevance to STATOBEX

While specific data on STATOBEX is not readily available, understanding the broader market dynamics can provide insights into its potential financial trajectory.

Market Positioning

STATOBEX, if classified under the conventional drugs category, would benefit from the dominant market share of small molecules. However, its growth would also depend on its positioning within the market, such as its therapeutic area, route of administration, and whether it is a branded or generic product.

Therapeutic Area

If STATOBEX is used to treat a condition like obesity, which is a growing concern globally, it could benefit from the expanding market for anti-obesity medications. The global market for anti-obesity drugs is projected to grow from $6 billion in 2023 to $100 billion by 2030, driven by increasing obesity rates and the effectiveness of new treatments[3].

Regulatory and Approval Processes

The FDA's approval processes and regulatory changes can significantly impact the financial trajectory of any drug. For instance, the FDA's proposed rule to increase the development and marketing options for nonprescription drug products could affect the OTC segment and, by extension, drugs like STATOBEX if they are considered for OTC status[1].

Key Takeaways

  • Market Growth: The U.S. pharmaceutical market is expected to grow significantly, driven by a robust pipeline of specialty drugs and increasing demand for medical treatments.
  • Segmentation: Biologics and biosimilars, as well as the neurological disorders segment, are expected to see rapid growth.
  • Route of Administration: Parenteral routes are gaining traction, which could impact the delivery method of drugs like STATOBEX.
  • Regulatory Environment: FDA approvals and regulatory changes can significantly influence the market trajectory of pharmaceuticals.

FAQs

  1. What is the projected growth rate of the U.S. pharmaceutical market?

    • The U.S. pharmaceutical market is expected to grow at a CAGR of 6.15% from 2024 to 2033[1].
  2. Which segment is expected to grow the fastest in the pharmaceutical market?

    • The biologics and biosimilars segment is expected to witness the fastest growth during the forecast period[1].
  3. How does the FDA's regulatory environment impact pharmaceuticals?

    • The FDA's approvals and regulatory changes, such as the proposed rule for nonprescription drug products, can significantly influence the market trajectory and accessibility of pharmaceuticals[1].
  4. What is the current state of the anti-obesity drug market?

    • The global market for anti-obesity medications is projected to grow from $6 billion in 2023 to $100 billion by 2030, driven by increasing obesity rates and the effectiveness of new treatments[3].
  5. How does the route of administration impact the pharmaceutical market?

    • The oral route currently dominates, but the parenteral route is expected to expand at the fastest CAGR over the forecast period, reflecting advancements in injectable therapies[1].

Sources

  1. U.S. Pharmaceutical Market Size to Reach USD 1,093.79 Billion By 2033 - Biospace
  2. BOARD MEETING AGENDA - Oregon.gov
  3. Why the anti-obesity drug market could grow to $100 billion by 2030 - Goldman Sachs
  4. Insights Into the 2023 U.S. Pharmaceutical Market - IQVIA
  5. Biopharma Market Update - Stifel

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