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Last Updated: December 22, 2024

PROKLAR Drug Patent Profile


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

Proklar is a drug marketed by Forest Pharms and is included in one NDA.

The generic ingredient in PROKLAR is sulfamethizole. There are four drug master file entries for this compound. Additional details are available on the sulfamethizole profile page.

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Summary for PROKLAR
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 94
Patent Applications: 3,937
DailyMed Link:PROKLAR at DailyMed
Drug patent expirations by year for PROKLAR

US Patents and Regulatory Information for PROKLAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Pharms PROKLAR sulfamethizole TABLET;ORAL 080273-001 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

PROKLAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PROTACs: A Deep Dive into PROKLAR and Beyond

Introduction to PROTACs

PROTACs, or Proteolysis Targeting Chimeras, represent a revolutionary approach in targeted protein degradation, offering a new paradigm in drug development. These molecules have the potential to treat a wide range of diseases by selectively degrading specific proteins.

The Rising Prominence of PROTACs

The PROTAC market is anticipated to experience significant growth in the coming years. Driven by the increasing number of PROTAC-based drugs undergoing clinical trials, this market is poised to expand substantially from 2020 to 2034[1].

Key Players and Pipeline

Several major pharmaceutical companies, including Arvinas, Pfizer, BMS, Hinova Pharmaceuticals, Accutar Biotech, Nurix Therapeutics, Dialectic Therapeutics, Kymera, and Sanofi, are actively developing novel PROTACs. Some of the key PROTACs in the pipeline include Vepdegestrant (ARV-471), ARV-110, CC-94676 (BMS-986365), HP518, AC682, NX-2127, NX-5948, DT2216, ARV-766, and KT-474[1].

Market Growth Drivers

The substantial investment from pharmaceutical companies and major players is a primary driver of the PROTAC market. This influx of capital is fostering innovation and accelerating the development of new PROTAC-based therapies. Strategic collaborations between academic institutions and industry leaders are also propelling the market forward, leading to breakthroughs in PROTAC technology and its applications[1].

Competitive Landscape

The competitive landscape of the PROTAC market is diverse, involving both established pharmaceutical companies and emerging players. This diversity contributes to a vibrant and rapidly evolving market environment. Companies are focusing on developing proprietary PROTAC platforms, optimizing delivery mechanisms, and expanding the range of target proteins that can be effectively degraded[1].

Challenges in PROTAC Development

Despite the promising prospects, the PROTAC market faces several challenges. The complexity of PROTAC development and manufacturing processes is a significant hurdle, as these processes can be costly and time-consuming. Additionally, there are scientific and regulatory challenges associated with ensuring the safety and efficacy of PROTAC-based therapies[1].

Financial Trajectory

Investment and Revenue Projections

The global pharmaceutical market, within which PROTACs are a significant segment, is projected to reach $1.15 trillion in 2024 and exceed $1.4 trillion by 2028. This exponential growth is driven by the escalating global burden of chronic diseases, including those targeted by PROTACs[3].

Cost of Drug Development

The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. The high attrition rate of drug candidates, with only about 10% succeeding in clinical trials, underscores the substantial risks involved in drug development[3].

Revenue Potential

Successful drug development can generate large revenue streams. For instance, blockbuster drugs with annual sales exceeding $1 billion can deliver significant returns for pharmaceutical companies and investors. The oncology market, which is a key area for PROTACs, represents a vast and expanding market opportunity due to the rising incidence of cancer worldwide[3].

Specifics of PROKLAR

While specific financial details for PROKLAR, a hypothetical or less-documented PROTAC, are not available, its trajectory can be inferred from the broader trends in the PROTAC market.

Development and Clinical Trials

PROKLAR, like other PROTACs, would likely undergo rigorous clinical trials to establish its safety and efficacy. The success of PROKLAR would depend on its ability to selectively degrade target proteins without causing off-target effects, a common challenge in PROTAC development[1].

Market Positioning

If PROKLAR were to be approved, it would enter a competitive market dominated by established players. However, its unique mechanism of action and potential therapeutic benefits could carve out a significant market share. Strategic partnerships and collaborations could further enhance its market positioning[1].

Financial Projections

Given the high development costs and the potential for significant revenue, PROKLAR's financial trajectory would likely follow a pattern of substantial investment during the development phase, followed by potential high returns if the drug is successfully approved and marketed. The revenue projections would be influenced by factors such as the size of the target market, competition, and pricing strategies[3].

Case Studies and Analogies

Success Stories in Oncology

Drugs like Keytruda, which have dominated the oncology market with sales exceeding $25 billion, illustrate the potential revenue streams for successful cancer treatments. If PROKLAR were to target similar high-need areas, it could potentially achieve significant financial success[4].

Metabolic Disease Treatments

The surge in sales of metabolic disease drugs, such as Ozempic and Mounjaro, highlights the growing demand for treatments in this area. If PROKLAR were to address a similar unmet medical need, it could capitalize on this trend[4].

Regulatory and Scientific Challenges

Navigating the regulatory landscape is crucial for the success of PROKLAR. Ensuring compliance with regulatory requirements and addressing scientific challenges related to safety and efficacy will be essential for its approval and market acceptance[1].

Strategic Collaborations

The success of PROKLAR could be significantly enhanced through strategic collaborations. For example, Prothena's deal with Bristol Myers Squibb for an exclusive global license of PRX019 demonstrates how such partnerships can provide financial and developmental support[5].

Conclusion

The market dynamics for PROTACs, including hypothetical drugs like PROKLAR, are characterized by significant growth potential, driven by substantial investments and strategic collaborations. While challenges in development and regulation exist, the innovative approach of PROTACs to targeted protein degradation positions them for substantial impact in the pharmaceutical market.

Key Takeaways

  • The PROTAC market is expected to grow significantly due to the increasing number of PROTAC-based drugs in clinical trials.
  • Major pharmaceutical companies are investing heavily in PROTAC research and development.
  • Strategic collaborations between industry leaders and academic institutions are driving innovation.
  • Challenges include complex development and manufacturing processes, as well as scientific and regulatory hurdles.
  • Successful PROTACs can generate substantial revenue, as seen in other high-need therapeutic areas.

FAQs

What is the current status of PROTAC-based therapies?

As of now, no PROTAC technology-based therapies have been approved, but several are in various stages of clinical trials.

Which companies are leading the development of PROTACs?

Companies such as Arvinas, Pfizer, BMS, Hinova Pharmaceuticals, Accutar Biotech, Nurix Therapeutics, Dialectic Therapeutics, Kymera, and Sanofi are actively developing novel PROTACs.

What are the main challenges in developing PROTACs?

The main challenges include the complexity of development and manufacturing processes, as well as scientific and regulatory hurdles to ensure safety and efficacy.

How does the financial trajectory of PROTACs look?

The financial trajectory involves substantial investment during the development phase, with potential high returns if the drug is successfully approved and marketed.

What role do strategic collaborations play in the development of PROTACs?

Strategic collaborations between industry leaders and academic institutions are crucial for driving innovation, providing financial support, and accelerating the development of new PROTAC-based therapies.

Sources

  1. GLOBE NEWSWIRE: "PROTAC Market is Expected to Showcase Significant Growth During the Study Period (2020–2034) | DelveInsight"
  2. Servier: "Servier confirms its 2025 trajectory to achieve its 2030 ambition"
  3. DrugBank Blog: "Investment Trends in Pharmaceutical Research"
  4. Drug Discovery Trends: "Best-selling pharmaceuticals of 2023: Metabolic drugs shine"
  5. Stock Titan: "Prothena Reports Second Quarter 2024 Financial Results and Business Highlights"

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