Generic Drugs - Clinical Research Informer

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.

Generic Drugs

Generic Drugs Drugs Marketing

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.

Generic Drugs

Generic Drugs Drugs Branding

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.

Generic Drugs

Generic Drugs Drugs Development Manufacturing

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

Generic Drugs

Generic Drugs Development Drugs Manufacturing

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

Generic Drugs

Generic Drugs FDA Approval Drugs

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

Generic Drugs

Generic Drugs Drugs

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

Generic Drugs

Generic Drugs Development Drugs

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.

Generic Drugs

Generic Drugs Development Medicine Drugs

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

Generic Drugs

Generic Drugs Drugs Manufacturing Marketing

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…

Generic Drugs

Generic Drugs Development Drugs Marketing

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…

Generic Drugs

Generic Drugs Marketing Drugs

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

Generic Drugs

Generic Drugs Development Drugs Research

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.

Generic Drugs

Generic Drugs Drugs Research

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

Generic Drugs

Generic Drugs Drugs Medicine

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.

Generic Drugs

Generic Drugs Marketing Drugs

Innovative Manufacturing Technologies for Generic Drug Production

Drug Patent Watch

AUGUST 27, 2024

These innovations aim to enhance drug quality, efficiency, and customization. Despite their potential, the adoption of AMTs in generic drug manufacturing has been slow, mainly due to high upfront investment costs and regulatory barriers.

Generic Drugs

Generic Drugs Manufacturing Production Drugs

How to Enhance Generic Drug Development Efficiency

Drug Patent Watch

AUGUST 6, 2024

Enhancing the efficiency of generic drug development is crucial for improving patient access to affordable medications. The Food and Drug […] Source

Generic Drugs

Generic Drugs Development Drugs

Effective Communication Strategies for Generic Drug Teams

Drug Patent Watch

AUGUST 8, 2024

Effective communication is crucial for generic drug teams to ensure timely and accurate submissions to regulatory bodies, such as the […] Source

Generic Drugs

Generic Drugs Drugs

How to Conduct Effective Generic Drug Clinical Studies

Drug Patent Watch

AUGUST 1, 2024

Conducting effective generic drug clinical studies is crucial for ensuring the safety and efficacy of generic medications. The FDA plays […] Source

Generic Drugs

Generic Drugs Drugs

The Role of Academic Research in Generic Drug Development

Drug Patent Watch

AUGUST 14, 2024

The role of academic research in generic drug development is multifaceted and crucial. Academic research plays a vital role in driving pharmaceutical innovation by fueling scientific discoveries…

Generic Drugs

Generic Drugs Development Research Drugs

The Economics of Generic Drug Pricing Strategies: A Comprehensive Analysis

Drug Patent Watch

AUGUST 19, 2024

The pricing of generic drugs is a crucial aspect of the pharmaceutical industry, with significant implications for consumers and healthcare […] Source

Generic Drugs

Generic Drugs Drugs

The Role of Patent Attorneys in Generic Drug Development

Drug Patent Watch

AUGUST 11, 2024

The development of generic drugs is a crucial aspect of the pharmaceutical industry, as it provides affordable alternatives to expensive […] Source

Generic Drugs

Generic Drugs Development Drugs

Overcoming Formulation Challenges in Generic Drug Development: A Case Study

Drug Patent Watch

AUGUST 7, 2024

Introduction Generic drug development is a crucial aspect of the pharmaceutical industry, as it provides access to affordable medications for […] Source

Generic Drugs

Generic Drugs Development Drugs

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.

Generic Drugs

Generic Drugs Marketing Drugs

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.

Generic Drugs

Generic Drugs Drugs Medicine

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.

Generic Drugs

Generic Drugs Drugs Branding Medicine

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.

Generic Drugs

Generic Drugs Sales Drugs

Health Canada disclosing more information on pending generic drug submissions

Pharma in Brief

FEBRUARY 25, 2024

On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. In Canada, the ANDS pathway is used to review and approve generic prescription drugs (but not biosimilars).

Generic Drugs

Generic Drugs Drugs Medicine Life Science

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.

Generic Drugs

Generic Drugs Drugs

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.

Generic Drugs

Generic Drugs Marketing Drugs

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

Generic Drugs

Generic Drugs Drugs Marketing

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.

Generic Drugs

Generic Drugs Production Development Drugs

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.

Generic Drugs

Generic Drugs Drugs Regulation

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.

Generic Drugs

Generic Drugs Development Drugs

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

Generic Drugs

Generic Drugs Drugs Medicine

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.

Generic Drugs

Generic Drugs Drugs Marketing

How PBMs and Discount Cards Impact Generic Drug Prices (video)

Drug Channels

JUNE 22, 2022

In the video below, I discuss how generic drug pricing and the rise of patient-paid, discount card prescriptions pose a risk to pharmacy benefit plans and the PBM business. Recently, I explored the complex web of relationships and conflicts that support today’s discount card economics.

Generic Drugs

Generic Drugs Pharmacy Drugs

Medicare could save up to $3.6 billion by purchasing generic drugs at Mark Cuban prices

Scienmag

JUNE 20, 2022

billion by purchasing generic drugs at Mark Cuban prices Abstract: [link] URL goes live when the embargo lifts A brief research report found that Medicare could have saved up to $3.6 billion by purchasing generic drugs at the same prices as the Mark Cuban Cost Plus Drug […]. Medicare could save up to $3.6

Generic Drugs

Generic Drugs Drugs Research

Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market

Drug Patent Watch

AUGUST 12, 2020

Just because a drug has received FDA approval does not mean that it is available in the marketplace. The post Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market appeared first on DrugPatentWatch - Make Better Decisions.

Generic Drugs

Generic Drugs Marketing Drugs FDA Approval

Leveraging Big Data in Generic Drug Development: A Comprehensive Guide

Drug Patent Watch

AUGUST 21, 2024

The pharmaceutical industry has witnessed a significant surge in the availability of public disease and drug-related data, which has facilitated […] Source

Big Data

Big Data Generic Drugs Drugs Development

The Role of Digital Twins in Generic Drug Manufacturing

Drug Patent Watch

AUGUST 20, 2024

Digital twins are revolutionizing the pharmaceutical and biopharmaceutical industries by integrating physical plants, data collection, data analysis, and system control. […] Source

Generic Drugs

Generic Drugs Manufacturing Drugs

FDA welcomes alternative approaches to generic drug development

The Pharma Data

MAY 5, 2021

FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of Generic Drugs (OGD) has increased steadily since FY 2013. FDA webinar on product specific guidance for generic drugs . In FY 2019, 252 were issued, as were 208 in FY 2018. . Source link.

Generic Drugs

Generic Drugs Development Drugs Production

Using Blockchain to Minimize Consumers’ Risk Aversion Toward Generic Drugs

Pharmaceutical Commerce

JANUARY 23, 2024

Study describes how a game theoretic model can successfully analyze how adoption of blockchain technology can reveal quality information.

Generic Drugs

Generic Drugs Drugs

Amazon expands drug subscription program to Medicare members

Bio Pharma Dive

JUNE 20, 2024

RxPass, which fills prescriptions for generic drugs, is now available to more than 50 million Medicare members after Amazon brought it into compliance with the insurance program’s regulatory standards.

Generic Drugs

Generic Drugs Compliance Drugs

FDA generic drug approvals rose in 2023 in bid for improved access

How to Ensure Your Generic Drug Meets FDA Standards

Trending Sources

Optimizing Partnerships for Generic Drug Development Success

Leveraging Nanotechnology in Generic Drug Development: Enhancing Efficacy and Safety

The Regulatory Maze: How Generic Drugs Navigate FDA Approval

How to find low-competition generic drug opportunities

The Role of Patient Advocacy Groups in Generic Drug Development

The Role of Green Chemistry in Generic Drug Development: A Sustainable Approach to Medicine

Uncovering Lucrative Low-Competition Generic Drug Opportunities

How to Develop a Competitive Edge in Generic Drug Development

How to Navigate the Generic Drug Market Post-COVID

A Day in the Life of a Generic Drug Developer

Influencers of Generic Drug Utilization

Innovative Financing Models for Repurposing Generic Drugs

CpHI Europe: Quality improvements key for the surviving the generic drugs market

Innovative Manufacturing Technologies for Generic Drug Production

How to Enhance Generic Drug Development Efficiency

Effective Communication Strategies for Generic Drug Teams

How to Conduct Effective Generic Drug Clinical Studies

The Role of Academic Research in Generic Drug Development

The Economics of Generic Drug Pricing Strategies: A Comprehensive Analysis

The Role of Patent Attorneys in Generic Drug Development

Overcoming Formulation Challenges in Generic Drug Development: A Case Study

Factors that May Predict the Likelihood of Generic Drug Marketing Applications

STAT+: AAM’s Dan Leonard, president of generic drug lobby, ousted

STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

Novartis begins plans to spin off generic drug business

Health Canada disclosing more information on pending generic drug submissions

Novartis forecasts improving generic drug business as it weighs unit's future

Finding and Evaluating Generic Drug Market Entry Opportunities

13 Proven Tactics to Outmaneuver Generic Drug Rivals

Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

Strategies for Pricing Generic Drugs

FDA and EMA team up to expedite complex generic drug development

FTC targets middlemen in generic drug shortages probe

Shark Tank's Mark Cuban Dives into Generic Drug Market

How PBMs and Discount Cards Impact Generic Drug Prices (video)

Medicare could save up to $3.6 billion by purchasing generic drugs at Mark Cuban prices

Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market

Leveraging Big Data in Generic Drug Development: A Comprehensive Guide

The Role of Digital Twins in Generic Drug Manufacturing

FDA welcomes alternative approaches to generic drug development

Using Blockchain to Minimize Consumers’ Risk Aversion Toward Generic Drugs

Amazon expands drug subscription program to Medicare members

Stay Connected