Drug Patent Watch

APRIL 8, 2025

Patient Safety in the Era of Generic Drugs: A Call to Action As the pharmaceutical industry continues to evolve, one thing remains constant: the need for patient safety. With the rise of generic drugs, it's more important than ever to ensure that these alternatives meet the same high standards as their brand-name counterparts.

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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. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.

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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

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? But why is pharmacovigilance so important?

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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

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

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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Drug Patent Watch

OCTOBER 10, 2024

China has emerged as a significant player in the global generic drug active pharmaceutical ingredient (API) market. The country’s vast production capacity, low costs, and strategic location have made it an attractive destination for pharmaceutical companies seeking to source APIs.

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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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Pharmaceutical Technology

JULY 25, 2022

Specialty generics is a term used to refer to generic versions of drugs that are often expensive, complex, or “high touch”—requiring significant involvement of service to manage. Specialty drugs are most used to treat different cancers, rheumatoid arthritis, and multiple sclerosis. But there are some exceptions.

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Drug Patent Watch

DECEMBER 9, 2024

This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents? This approach has led to the discovery of numerous potential drug candidates. What is a Drug Patent?

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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.

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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.

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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

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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NY Times

SEPTEMBER 18, 2021

Competition for market share at rock-bottom prices has led to shortages, price-spikes, allegations of price-fixing, and substandard and even dangerous practices.

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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

APRIL 8, 2025

Product Pipeline : A robust product pipeline can drive growth and increase a company's valuation. 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.

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Pharmaceutical Technology

JULY 15, 2022

California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form. This CMO will be responsible for product roll-out and distribution. In-house manufacturing the norm.

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Pharmaceutical Technology

DECEMBER 15, 2022

Inflation at its current levels poses a major threat to generics production and usage. Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable. Inflation can damage production viability of European drugs.

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Fierce Pharma

AUGUST 31, 2023

recently made comments about the untenable nature of generic drug production in the U.S., recently made comments about the untenable nature of generic drug production in the U.S., After FDA Commissioner Robert Califf, M.D., a clutch of governors has raised its own set of concerns about shortages.

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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. Most of these, or 918 (59%) were for non-complex formulations while 640 (41%) were for complex products, Zhang said. © 2021 Regulatory Affairs Professionals Society.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

These companies often have limited in-house resources for product development or scale-up, and so depend on CDMO partnerships to achieve development milestones. Narrower Product Focus Emphasis on Development End-to-End Support and Manufacturing Flexibility Manufactured in the USA Continuous Reinvestment. Narrower product focus.

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Drug Channels

OCTOBER 18, 2022

The biosimilar boom for provider-administered drugs continues to accelerate. Some major biological reference products have now lost a majority of their unit sales to their biosimilars. Below, we share our estimates for wholesalers’ gross margins for brand-name, generic, and biosimilar drugs. drug distribution.

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Drug Patent Watch

JANUARY 13, 2025

The Rise of Biosimilars: A Healthcare Revolution Biosimilars, often referred to as the “generic equivalents” of biologic drugs, have been making waves in the pharmaceutical industry for over a decade. Misconceptions about the efficacy and safety of biosimilars can lead to hesitancy in prescribing or using these products.

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Drug Patent Watch

JUNE 18, 2024

Branded generics are generic drugs that are marketed under a brand name by the manufacturer. These products contain the same active ingredients as their brand-name counterparts but are typically sold at a lower price point.

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Pharmaceutical Technology

AUGUST 12, 2022

And while the gloomiest predictions around medicine shortages do not appear to have come to pass, shortfalls in drugs like HRT products have been partially attributed to Brexit. Because the products would already have been tested within the exporting country, the testing would be duplicative and (to many people’s minds) unnecessary.

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Camargo

SEPTEMBER 8, 2021

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. This is in response to the decision from the U.S.

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Camargo

OCTOBER 14, 2021

The expanded use of the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting : INTERACT meetings are intended to facilitate IND-enabling efforts where a sponsor is facing a novel, challenging issue that might delay the progress of the product towards entry into the clinic in the absence of this early FDA input.

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Pharmaceutical Technology

OCTOBER 5, 2008

’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi. ” The move, which came in June, also gives Japanese drugs maker Daiichi Sankyo a foothold in the Indian market through Ranbaxy’s location. .”

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XTalks

MARCH 15, 2024

LillyDirect Pharmacy Solutions, Eli Lilly’s direct-to-consumer (DTC) drugs website, is teaming up with Amazon Pharmacy to deliver select medications to people’s homes. The drugs include Lilly’s newly approved GLP-1 obesity drug Zepbound (tirzepatide), around a dozen of the company’s insulins and migraine drug Emgality (galcanezumab).

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Camargo

DECEMBER 9, 2020

Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product.

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FDA Law Blog

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.

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pharmaphorum

JULY 29, 2021

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus.

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STAT News

MARCH 16, 2023

regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products.

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