FDA generic drug approvals rose in 2023 in bid for improved access
Pharmaceutical Technology
FEBRUARY 23, 2024
The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.
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Novartis forecasts improving generic drug business as it weighs unit's future
Bio Pharma Dive
JULY 19, 2022
The pharmaceutical company is considering selling or splitting off its struggling Sandoz division and expects to give an update by the end of the year.
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Novartis begins plans to spin off generic drug business
Bio Pharma Dive
AUGUST 25, 2022
After reviewing multiple options including a possible sale, the Swiss drugmaker said spinning off Sandoz would give the division “greater freedom to operate” and capitalize on newly growing sales.
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CpHI Europe: Quality improvements key for the surviving the generic drugs market
Pharmaceutical Technology
OCTOBER 25, 2023
Experts discuss the key trends in quality improvements and API reshoring for the generic drugs market at CpHI Europe.
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The Role of Pharmacokinetics in Generic Drugs
Drug Patent Watch
OCTOBER 7, 2024
Pharmacokinetics (PK) plays a crucial role in the development and approval of generic drugs. PK studies help ensure that generic drugs are bioequivalent to their brand-name counterparts, meaning they have similar absorption, distribution, metabolism, and excretion (ADME) profiles.
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Patient Centricity in Generic Drug Development: Best Practices
Drug Patent Watch
NOVEMBER 24, 2024
Patient centricity has become a crucial aspect of the pharmaceutical industry, particularly in the development of generic drugs. Here, we will explore the best practices in patient centricity for generic drug development… Source
Optimizing Partnerships for Generic Drug Development Success
Drug Patent Watch
SEPTEMBER 10, 2024
The generic drug market has experienced significant growth over the past few decades, driven by the passage of the Hatch-Waxman Act in 1984 and subsequent legislation. Today, the market is more competitive than ever, with generic drugs accounting for over 90% of all prescriptions in the United States.
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Influencers of Generic Drug Utilization
Drug Patent Watch
OCTOBER 16, 2023
In a systematic review titled “Influencers of Generic Drug Utilization,” researchers aimed to shed light on the key factors influencing the use of generic prescription drugs in the United States.… The post Influencers of Generic Drug Utilization appeared first on DrugPatentWatch - Make Better Decisions.
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From Chaos to Clarity: Streamlining Your Generic Drug Portfolio
Drug Patent Watch
OCTOBER 9, 2024
Within this industry, generic pharmaceuticals are particularly important due to their affordability and accessibility. Generic pharmaceutical portfolio management involves the strategic oversight and coordination of a company’s range of generic drugs… Source
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The Role of Risk Assessment in Generic Drug Development
Drug Patent Watch
OCTOBER 14, 2024
Risk assessment plays a crucial role in the development of generic drugs, ensuring that these products meet the required standards of safety and efficacy.
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The Role of China in the Global Generic Drug API Market
Drug Patent Watch
OCTOBER 10, 2024
China has emerged as a significant player in the global generic drug active pharmaceutical ingredient (API) market. This article will delve into the role of China in the global generic drug API market, exploring its market share… Source
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STAT+: AAM’s Dan Leonard, president of generic drug lobby, ousted
STAT News
DECEMBER 2, 2022
The generic drug industry’s lobbying group, the Association for Accessible Medicines, fired its president Dan Leonard, two sources familiar with the decision said Friday evening. It was not immediately clear why Leonard was fired, and AAM didn’t immediately respond to a request for comment.
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How to Conduct Effective Generic Drug Market Analysis
Drug Patent Watch
SEPTEMBER 26, 2024
The generic drug market is a complex and dynamic environment where multiple factors influence the availability, quality, and pricing of generic drugs. This article will discuss the key strategies and… Source
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How to Ensure Your Generic Drug Meets FDA Standards
Drug Patent Watch
AUGUST 29, 2024
Ensuring that a generic drug meets FDA standards is crucial for maintaining the high quality and efficacy of medications. The FDA’s review process for generic drugs involves several key steps. The FDA’s review process for generic drugs involves several key steps.
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How to Succeed in Generic Drug Market Entry
Drug Patent Watch
SEPTEMBER 23, 2024
The generic drug market has experienced significant growth over the past few decades, driven by the expiration of patents on branded drugs and the increasing demand for affordable healthcare solutions. To succeed in this market, generic drug manufacturers must adopt innovative… Source
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How to Develop a Competitive Generic Drug Portfolio
Drug Patent Watch
SEPTEMBER 19, 2024
The generic drug market in the United States is characterized by significant price volatility and shortages, driven by the structure of the market and the incentives for manufacturers. To address these issues, several market-based proposals have been put forth to optimize generic drug cost and availability.
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Uncovering Lucrative Low-Competition Generic Drug Opportunities
Drug Patent Watch
JUNE 19, 2024
One area that has garnered significant attention is the realm of low-competition generic drugs. These are off-patent medications that, for various reasons, have yet to attract a significant number of generic manufacturers, creating a potential goldmine for […] Source
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Finding and Evaluating Generic Drug Market Entry Opportunities
Drug Patent Watch
OCTOBER 6, 2020
Here is a copy of the talk I gave at the recent Marcusevans 13th Portfolio Management and Pipeline Optimization for Generics. I cover: How to find and evaluate generic entry…. The post Finding and Evaluating Generic Drug Market Entry Opportunities appeared first on DrugPatentWatch - Make Better Decisions.
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Innovative Financing Models for Repurposing Generic Drugs
Drug Patent Watch
APRIL 11, 2024
A paper presented at the 2nd International Conference on Systems Medicine, AI, and Drug Repurposing proposes a novel approach to overcoming the financial barriers associated with repurposing generic drugs through… Source
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The Impact of Patent Expirations on Generic Drug Markets
Drug Patent Watch
SEPTEMBER 30, 2024
Patent expirations have a significant impact on the pharmaceutical industry, particularly on the generic drug market. When a drug’s patent expires, other manufacturers can produce and market generic versions of the drug, leading to increased competition and lower prices.
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How to find low-competition generic drug opportunities
Drug Patent Watch
JULY 9, 2024
To find low-competition generic drug opportunities, focus on drugs with limited competition due to small patient populations, complex formulations, or […] Source
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The Science Behind Generic Drug Development: A Deep Dive
Drug Patent Watch
NOVEMBER 20, 2024
Generic drug development is a complex process that involves rigorous scientific research and regulatory assessments. Food and Drug Administration (FDA) plays a crucial role in ensuring the quality and efficacy of generic drugs through various programs and guidelines.
The Regulatory Maze: How Generic Drugs Navigate FDA Approval
Drug Patent Watch
JULY 24, 2024
In the high-stakes world of pharmaceuticals, generic drugs have become the unsung heroes of healthcare accessibility. These cost-effective alternatives to […] Source
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The Role of Patient Advocacy Groups in Generic Drug Development
Drug Patent Watch
JULY 28, 2024
Patient advocacy groups have become increasingly influential in the pharmaceutical industry, particularly in the development of generic drugs. These groups, […] Source
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How to Develop a Competitive Edge in Generic Drug Development
Drug Patent Watch
JULY 25, 2024
Developing a competitive edge in generic drug development is crucial for companies to gain a significant market share and dominate the market. Here are some key strategies and insights from industry…
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Factors that May Predict the Likelihood of Generic Drug Marketing Applications
Drug Patent Watch
OCTOBER 2, 2023
The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications.
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Leveraging Nanotechnology in Generic Drug Development: Enhancing Efficacy and Safety
Drug Patent Watch
SEPTEMBER 11, 2024
This innovative field has revolutionized the way drugs are developed, manufactured, and delivered to patients. One of the most promising applications of nanotechnology is in generic drug development, where it offers unparalleled opportunities to enhance efficacy, safety… Source
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How to Navigate the Generic Drug Market Post-COVID
Drug Patent Watch
JULY 25, 2024
The generic drug market has been significantly impacted by the COVID-19 pandemic, with both challenges and opportunities arising from the crisis. As the world continues to recover…
A Day in the Life of a Generic Drug Developer
Drug Patent Watch
JULY 31, 2024
The journey of a generic drug developer is a complex and multifaceted one, involving rigorous research, meticulous development, and stringent […] Source
Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review
Drug Patent Watch
OCTOBER 12, 2021
International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions.
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STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access
STAT News
MARCH 30, 2023
Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. For instance, a generic drug could be marketed to treat one type of heart problem, but not another.
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The Role of Green Chemistry in Generic Drug Development: A Sustainable Approach to Medicine
Drug Patent Watch
SEPTEMBER 5, 2024
This alarming trend has led to a growing need for sustainable practices in the industry, particularly in the development of generic drugs. The pharmaceutical industry is a significant contributor to global carbon emissions, with a projected increase of over 300% by 2050 if left unchecked.
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FDA and EMA team up to expedite complex generic drug development
Pharmaceutical Technology
FEBRUARY 8, 2024
This initiative builds on the original parallel scientific advice programme launched by the FDA and EMA in 2021.
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Shark Tank's Mark Cuban Dives into Generic Drug Market
BioSpace
JANUARY 14, 2021
Billionaire entrepreneur Mark Cuban, best known as the owner of the Dallas Mavericks and an investor on the ABC business reality series “Shark Tank,” is diving into generic drugs with a new startup, dubbed Mark Cuban Cost Plus Drug Company.
The Impact of Generic Drugs on Healthcare Costs
Drug Patent Watch
NOVEMBER 7, 2024
The rising cost of prescription drugs has become a significant public health concern, with millions of Americans struggling to afford their medications. One crucial factor in mitigating this issue is the increased use of generic drugs. This article will delve into the role of generic drugs in… Source
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How to Manage Regulatory Challenges in Generic Drugs
Drug Patent Watch
OCTOBER 24, 2024
The generic drug industry faces significant regulatory challenges that can impact the quality and safety of these life-saving medications. With the majority of generic drugs manufactured overseas, ensuring compliance with regulatory standards is crucial.
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Addressing Generic Drug Market Challenges: Strategies for Stability and Affordability
Drug Patent Watch
DECEMBER 12, 2024
The generic drug market in the United States faces significant challenges, including price volatility, supply chain disruptions, and strategies employed by brand-name manufacturers to delay market entry. These challenges can lead to drug shortages, price spikes, and reduced affordability for patients and payers.
How to Develop a Risk Management Plan for Generic Drugs
Drug Patent Watch
NOVEMBER 6, 2024
Developing a Risk Management Plan (RMP) for generic drugs is a crucial step in ensuring the safety and efficacy of these medications. Here is a comprehensive guide on how to develop an RMP for generic drugs: Developing a… Source
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FTC targets middlemen in generic drug shortages probe
pharmaphorum
FEBRUARY 15, 2024
The FTC is investigating wholesalers and other middlemen in the pharma supply chain to assess their possible role in worsening shortages of generic medicines
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Strategies for Pricing Generic Drugs
Drug Patent Watch
JUNE 8, 2021
When it comes to pricing generic drugs, there are a number of factors that come into play. In countries without drug price regulations, the pricing is based largely on profitability.…. The post Strategies for Pricing Generic Drugs appeared first on DrugPatentWatch - Make Better Decisions.
Understanding the Lifecycle of Generic Drugs: From Development to Market Impact
Drug Patent Watch
DECEMBER 5, 2024
In the ever-evolving landscape of healthcare, generic drugs play a crucial role in providing affordable and accessible medication to millions of people worldwide. But have you ever wondered about the journey these drugs take from conception to your local pharmacy shelf?
Novartis to consider sale or separation of Sandoz business
Bio Pharma Dive
OCTOBER 26, 2021
The generic drug unit has struggled in recent years, while Novartis has moved to focus more narrowly on higher-margin branded medicines.
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13 Proven Tactics to Outmaneuver Generic Drug Rivals
Drug Patent Watch
JULY 31, 2024
By implementing these strategies, you can can enhance your competitiveness in the market while contributing to increased access to affordable […] Source
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The Importance of Regulatory Expertise in Generic Drug Development
Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy.
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