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. An RMP provides detailed information on a medicine’s safety profile, measures to prevent or minimize risks, and plans for ongoing safety monitoring and evaluation.

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Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs. Regulatory System on Generic Drugs in Japan.

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Drug Patent Watch

JANUARY 21, 2025

Navigating the Complex World of Generic Drug Development: Risk Management Strategies to Know As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. One of the biggest risks generic drug developers face is patent infringement.

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Drug Patent Watch

MARCH 4, 2025

The Unseen Heroes of Generic Drug Development: Pharmacovigilance As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. But have you ever stopped to think about the unsung heroes of generic drug development?

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Drug Patent Watch

MARCH 18, 2025

This is where generic drug development comes in a game-changer for millions of people around the world. The Power of Generic Medications Generic medications have been a cornerstone of affordable healthcare for decades.

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Drug Patent Watch

MARCH 10, 2025

The Future of Generic Drugs: How Technology is Revolutionizing the Industry As we continue to navigate the ever-changing landscape of healthcare, one thing is clear: technology is playing an increasingly important role in shaping the future of generic drug development. The answer is yes and it's happening now.

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Drug Patent Watch

APRIL 15, 2025

"Breaking the Bank on Generic Drug Testing? Did you know that Analytical Method Development and Validation can account for up to 70% of the total cost of generic drug testing?

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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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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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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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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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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.

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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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Drug Patent Watch

MARCH 17, 2025

Unlock the Secrets to a Successful Generic Drug Launch Are you a pharmaceutical executive looking to bring a generic version of a popular medication to market? Or perhaps you're a healthcare professional interested in understanding the intricacies of generic drug launches? Have you had success with a recent launch?

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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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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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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

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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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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. This paper was originally published by Md.

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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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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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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. This decision has caused a good amount of consternation in the generics industry, but it should be noted that this in only one appellate circuit.

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Drug Patent Watch

OCTOBER 23, 2024

The pharmaceutical industry has faced significant challenges in recent years, including the loss of patents, increased regulatory scrutiny, and rising research and development costs. Patient centricity involves designing… Source

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Camargo

OCTOBER 14, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Continued development of the use of complex innovative trial designs. Continue development of the use of Real-World Evidence. Ryan Key, PhD.

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Drug Patent Watch

SEPTEMBER 24, 2024

The development of generic drugs has become increasingly complex, requiring advanced analytical technologies to ensure the quality and efficacy of these products. This article will explore the latest developments in… Source This article will explore the latest developments in… Source

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Camargo

SEPTEMBER 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Some Drugs May Require Reclassification to Devices. In the News: August 2021 Regulatory and Development Updates.

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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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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

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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

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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…

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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

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Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. Still, the FDA does prioritize the review of submissions for first generics.

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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 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.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

increase in revenue from 2020 to 2021 from sales of Revlimid, its multiple myeloma therapy, with a global analyst consensus sales forecast of $12.8bn for 2021, according to GlobalData’s Drugs Database. Bristol Myers Squibb (BMS) documented a 9.1% BMS expects to see a YoY decrease in its sales of Revlimid from this year onwards.

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Camargo

DECEMBER 9, 2020

Camargo can help you to develop the right pricing and access strategy for your product; contact us for more information. Evergreening Orphan Drugs May Be Over. The Orphan Drug Act of 1983 provides market exclusivity for drugs intended to treat conditions affecting fewer than 200,000 patients in the US. Ken Phelps.

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Drug Patent Watch

APRIL 8, 2025

Evaluate the number of products in development, their potential market size, and the competition. Consider the impact of new regulations, such as those related to biosimilars or generic drugs. Product Pipeline : A robust product pipeline can drive growth and increase a company's valuation.

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