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Last Updated: December 22, 2024

THRIVE Drug Patent Profile


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

Thrive is a drug marketed by Glaxosmithkline Cons and is included in two NDAs.

The generic ingredient in THRIVE is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Thrive

A generic version of THRIVE was approved as nicotine polacrilex by P AND L on March 15th, 1999.

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Summary for THRIVE
US Patents:0
Applicants:1
NDAs:2
Clinical Trials: 47
DailyMed Link:THRIVE at DailyMed
Drug patent expirations by year for THRIVE
Recent Clinical Trials for THRIVE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Cairo UniversityPhase 4
Imperial College LondonPhase 4
Viridian Therapeutics, Inc.Phase 3

See all THRIVE clinical trials

US Patents and Regulatory Information for THRIVE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Cons THRIVE nicotine polacrilex GUM, CHEWING;BUCCAL 077658-001 Jun 19, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline Cons THRIVE nicotine polacrilex GUM, CHEWING;BUCCAL 077656-001 Jun 19, 2007 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

THRIVE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: THRIVE

Introduction to THRIVE and Viridian Therapeutics

Viridian Therapeutics, a biotechnology company, has been making significant strides in the pharmaceutical industry, particularly with its drug veligrotug (Veli), which is part of the THRIVE clinical trial series. The THRIVE trials are focused on treating chronic thyroid eye disease (TED), a condition characterized by inflammation and swelling of the tissues around the eye.

Clinical Success and Market Differentiation

The THRIVE-2 study has yielded highly positive results, marking a major achievement for Viridian Therapeutics. The study demonstrated a 56% absolute proptosis responder rate, significantly higher than the placebo group, and a 56% diplopia response with a 31% improvement over placebo. These outcomes have set Veli apart from competing treatments like Amgen's Tepezza, highlighting its potential to become a leading treatment for TED[2].

Financial Implications and Market Position

The success of the THRIVE-2 study has had a direct impact on Viridian Therapeutics' financial outlook. RBC Capital Markets has increased the price target for Viridian's stock to $47.00 from $44.00, maintaining an Outperform rating. This adjustment reflects the de-risking of the Veli program and the drug's promising market position. The company's stock has shown remarkable momentum, gaining over 76% in the past six months[2].

Regulatory Pathway and Future Milestones

Viridian Therapeutics is expected to file a Biologics License Application (BLA) in the second half of 2025, leveraging the success of both the THRIVE and THRIVE-2 studies. The positive outcomes from these trials have significantly reduced the risk associated with the program, affirming the strategic and commercial value of Veli[2].

Financial Health and Liquidity

Viridian Therapeutics maintains strong financial flexibility, with a current ratio of 18.55, indicating robust liquidity to support its drug development programs. The company has also initiated a public offering of $150 million of its common stock and Series B non-voting convertible preferred stock, which will be used for clinical development, working capital, and general corporate purposes[2].

Market Opportunity and Growth Potential

The success of Veli in the TED treatment market opens up a significant opportunity for growth. TED is a condition with limited treatment options, and the efficacy demonstrated by Veli positions it to capture a substantial share of this market. Analysts from several firms, including H.C. Wainwright, Oppenheimer, TD Cowen, Stifel, and Needham, have maintained Buy ratings for Viridian's stock and adjusted their price targets upwards, reflecting confidence in the company's trajectory[2].

Comparison with Broader Pharmaceutical Trends

The pharmaceutical industry is experiencing significant growth, with the global market revenue projected to exceed $1.4 trillion by 2028. This growth is driven by the escalating global burden of chronic diseases, including conditions like thyroid eye disease. Pharmaceutical companies are strategically aligning their R&D investments to address these unmet medical needs, and Viridian Therapeutics is no exception[3].

Investment Landscape and Challenges

Investing in pharmaceutical research and development is fraught with challenges, including high development costs and low success rates. The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years and a success rate of only around 10% for drug candidates entering clinical trials. However, the potential rewards for successful drugs are substantial, as seen with blockbuster drugs like AbbVie's Humira[3].

Impact of Regulatory Changes

The pharmaceutical industry is also navigating regulatory changes, such as the Inflation Reduction Act, which allows Medicare to negotiate drug prices for the first time. This shift is expected to impact the pricing and access to medicines covered by Medicare, prompting pharmaceutical companies to reshape their drug portfolios and drive scale and cost efficiencies[4].

Technological Advancements and AI Integration

The integration of AI in drug development, as seen with Formation Bio's AI-enabled approach, is becoming increasingly important. Formation Bio's $372 million Series D financing, in which Thrive Capital participated, highlights the growing interest in using AI to accelerate all aspects of drug development and clinical trials. This trend is likely to influence the future trajectory of healthcare innovation, including the development of drugs like Veli[5].

Subcutaneous Program and Diversification

Beyond Veli, Viridian Therapeutics is advancing a subcutaneous program, VRDN-003, which is currently in Phase III development. This diversification strategy further bolsters the company's standing in the TED treatment landscape and provides additional growth avenues[2].

Analyst Projections and Investor Confidence

Analyst projections for Viridian Therapeutics are optimistic, with targets ranging from $22 to $61, suggesting significant potential upside. The Outperform rating and increased price target reflect confidence in the company's ability to leverage the success of the THRIVE trials to secure a strong market position for Veli[2].

Key Takeaways

  • Clinical Success: Veli has demonstrated significant efficacy in treating TED, setting it apart from competing treatments.
  • Financial Momentum: Viridian Therapeutics' stock has shown substantial growth, and the company maintains strong financial flexibility.
  • Regulatory Milestones: The company is expected to file a BLA in 2025, leveraging the success of the THRIVE trials.
  • Market Opportunity: The TED treatment market offers a significant growth opportunity for Veli.
  • Broader Industry Trends: The pharmaceutical industry is growing, driven by chronic diseases, and is adapting to regulatory changes and technological advancements.

FAQs

  1. What is the primary focus of the THRIVE trials?

    • The THRIVE trials are focused on treating chronic thyroid eye disease (TED) using the drug veligrotug (Veli).
  2. How has the success of the THRIVE-2 study impacted Viridian Therapeutics' stock?

    • The success of the THRIVE-2 study has led to an increase in the price target for Viridian Therapeutics' stock and has maintained an Outperform rating, reflecting the de-risking of the Veli program.
  3. What are the key outcomes of the THRIVE-2 study?

    • The study demonstrated a 56% absolute proptosis responder rate and a 56% diplopia response, significantly higher than the placebo group.
  4. When is Viridian Therapeutics expected to file a Biologics License Application (BLA) for Veli?

    • The company is expected to file a BLA in the second half of 2025.
  5. How is AI impacting drug development in the pharmaceutical industry?

    • AI is being increasingly used to accelerate all aspects of drug development and clinical trials, as seen with Formation Bio's AI-enabled approach.

Sources

  1. Baron Capital Group - A Multi-Billion-Dollar Drug Market
  2. Investing.com - Viridian shares target raised, outperform on THRIVE-2 success
  3. DrugBank Blog - Investment Trends in Pharmaceutical Research
  4. PwC - Next in pharma 2024: Reinventing for returns
  5. Gunderson Dettmer - Thrive Capital Invests in Formation Bio $372M Series D Financing

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