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Last Updated: December 26, 2024

REZENOPY Drug Patent Profile


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Which patents cover Rezenopy, and when can generic versions of Rezenopy launch?

Rezenopy is a drug marketed by Summit Biosci and is included in one NDA.

The generic ingredient in REZENOPY is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rezenopy

A generic version of REZENOPY was approved as naloxone hydrochloride by HOSPIRA on September 24th, 1986.

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Summary for REZENOPY
US Patents:0
Applicants:1
NDAs:1
Patent Applications: 1,772
DailyMed Link:REZENOPY at DailyMed
Drug patent expirations by year for REZENOPY

US Patents and Regulatory Information for REZENOPY

REZENOPY is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Summit Biosci REZENOPY naloxone hydrochloride SPRAY;NASAL 215487-001 Apr 19, 2024 RX Yes Yes ⤷  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

REZENOPY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory in the Pharmaceutical Industry: Insights Relevant to REZENOPY

U.S. Pharmaceutical Market Overview

The U.S. pharmaceutical market is poised for significant growth, projected to reach USD 1,093.79 billion by 2033, growing at a CAGR of 6.15% from 2024 to 2033[1].

Segmentation and Growth Drivers

By Molecule Type

The market is dominated by conventional drugs (small molecules), holding a 56.21% revenue share in 2023. However, the biologics and biosimilars segment is expected to witness the fastest CAGR from 2024 to 2033, indicating a shift towards more complex and innovative therapies[1].

By Disease

The cancer segment dominated the market with a 16.79% share in 2023, while the neurological disorders segment is expected to grow at the fastest CAGR from 2024 to 2033. This trend highlights the increasing focus on treating chronic and complex diseases[1].

By Route of Administration

Oral routes dominated the market with a 59.9% revenue share in 2023, but the parenteral route is expected to expand at the fastest CAGR over the forecast period. This shift could be driven by the need for more targeted and efficient drug delivery systems[1].

Financial Trajectory of Pharmaceutical Companies

Research and Development Costs

The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline of 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, making the investment highly risky[3].

Return on Investment (ROI)

The ROI for pharmaceutical R&D has been declining, with Deloitte's 2022 analysis showing a forecasted ROI of just 1.2% for the 20 largest pharmaceutical companies. This decline is attributed to stricter regulatory hurdles and shorter exclusivity periods due to patent challenges and the introduction of generics or biosimilars[3].

Market Dynamics and Company Performance

Oncology's Dominance

Cancer treatments are a significant driver of revenue in the pharmaceutical industry. Drugs like Merck's Keytruda, projected to generate over $27 billion in sales in 2024, exemplify this trend. The global oncology spending has more than doubled in six years, reaching $218 billion in 2023[4].

Competitive Landscape

The success of drugs like Keytruda has reshaped the industry's competitive landscape. Companies like Merck & Co., Johnson & Johnson, and AstraZeneca are expected to lead the oncology market by 2030. The constant need for innovation is highlighted by the decline of blockbuster drugs like AbbVie's Humira after patent expiration[4].

Impact of Regulatory Changes

FDA Initiatives

The FDA's proposed rule "Nonprescription Drug Product with an Additional Condition for Nonprescription Use" aims to increase the development and marketing of safe and effective nonprescription drug products. This initiative could enhance public health by broadening the range of nonprescription drugs available, potentially impacting the prescription segment's dominance[1].

End Market and Distribution

Hospitals and Clinics

Hospitals dominated the pharmaceutical market with a 51.66% revenue share in 2023, but clinics are estimated to expand at the fastest CAGR from 2024 to 2033. This shift indicates a growing demand for outpatient care and more accessible healthcare services[1].

Consumer Trends and Preferences

Shift to OTC Alternatives

The high cost of prescription pharmaceuticals is driving a shift towards over-the-counter (OTC) alternatives. The OTC segment is anticipated to experience the fastest growth, supported by the increasing approval of OTC drugs and their greater accessibility to cost-conscious consumers[1].

Pediatric and Adult Markets

Pediatric Segment Growth

The children and adolescent segment is expected to witness steady growth from 2024 to 2033, driven by the rising number of medication approvals for the pediatric population. For example, Pfizer Inc.'s NGENLA, approved for treating pediatric patients, is expected to contribute to this growth[1].

Adult Segment Dominance

The adult segment held the largest share of 60.00% in the pharmaceuticals market in 2023 and is expected to advance at the fastest growth rate over the forecast period. This dominance reflects the ongoing need for treatments targeting chronic diseases prevalent in the adult population[1].

Key Takeaways

  • The U.S. pharmaceutical market is projected to reach USD 1,093.79 billion by 2033, driven by a robust pipeline of specialty drugs and increasing brand name pharmaceutical manufacturers.
  • Biologics and biosimilars are expected to grow at the fastest CAGR, while the oncology and neurological disorders segments will see significant growth.
  • The shift towards OTC alternatives is driven by high prescription costs and increasing FDA approvals.
  • Regulatory changes, such as the FDA's initiatives on nonprescription drugs, will impact market dynamics.
  • The adult segment will continue to dominate, but the pediatric segment will see steady growth due to new medication approvals.

FAQs

1. What is the projected size of the U.S. pharmaceutical market by 2033? The U.S. pharmaceutical market is expected to reach around USD 1,093.79 billion by 2033[1].

2. Which segment is expected to grow the fastest in the pharmaceutical market from 2024 to 2033? The biologics and biosimilars segment is expected to witness the fastest CAGR from 2024 to 2033[1].

3. What is driving the growth in the oncology segment of the pharmaceutical market? The growing incidence of cancer worldwide and significant investments in cancer treatments are driving the growth in the oncology segment[4].

4. How are regulatory changes impacting the pharmaceutical market? Regulatory changes, such as the FDA's proposed rule on nonprescription drugs, are expected to enhance public health by broadening the range of nonprescription drug products available[1].

5. What is the trend in the return on investment (ROI) for pharmaceutical R&D? The ROI for pharmaceutical R&D has been declining, with a forecasted ROI of just 1.2% for the 20 largest pharmaceutical companies in 2022, due to stricter regulatory hurdles and shorter exclusivity periods[3].

Cited Sources:

  1. U.S. Pharmaceutical Market Size to Reach USD 1,093.79 Billion By 2033 - Biospace
  2. Earnings Season is Starting Better Than Expected - YouTube
  3. Investment Trends in Pharmaceutical Research - DrugBank Blog
  4. Top pharmaceutical drugs by projected 2024 global sales - Statista
  5. Roadzen Reports Fiscal Second Quarter and First Half FY2025 Financial Results - Benzinga

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