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

MARCH 18, 2025

In emerging markets, the struggle to provide quality healthcare is often hindered by the high cost of branded medications. This is where generic drug development comes in a game-changer for millions of people around the world. Share your thoughts in the comments below! Read the full article here: [link]

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Drug Patent Watch

JANUARY 29, 2025

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. We often assume that generic medications are cheaper because they're, well, generic. Generic drug production involves replicating a brand-name medication's active ingredient, formulation, and dosage.

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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 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

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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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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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

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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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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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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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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Pharmacy Checkers

FEBRUARY 5, 2021

The Rand Corporation has released an impressive study showing that brand name drugs cost far more in the United States than in other countries – on average 344% more. For those of you looking for a methodologically strong analysis of international drug prices and a history of related studies, this is the report for you.

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World of DTC Marketing

JUNE 22, 2022

Then there is the cost of generic drugs. A recent study in the An­nals of In­ter­nal Med­i­cine took a look at al­most 90 gener­ic drugs that the Medicare Part D pro­gram pays for, find­ing that Medicare could’ve saved $3.6 bil­lion in 2020 if it had pur­chased 77 of 89 drugs from Cuban’s firm.

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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

SEPTEMBER 25, 2024

Generic drug manufacturers face significant challenges when attempting to navigate around REMS (Risk Evaluation and Mitigation Strategies) imposed by brand-name drug companies. These strategies, intended to ensure drug safety, are sometimes misused to delay generic competition.

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FDA Law Blog

SEPTEMBER 25, 2024

But forty years ago, Al was the generic drug industry’s patent counsel during the negotiations that led to the Hatch-Waxman Amendments. These days, Al (as we have come to know him) is a Trustee for The Engelberg Foundation, a private foundation that supports the Icahn School of Medicine at Mt.

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STAT News

AUGUST 3, 2022

Civica Rx, which was formed four years ago, is working with a generic manufacturer to supply pharmacies with the abiraterone prostate cancer treatment for $160 for a month’s supply. Continue to STAT+ to read the full story…

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BioTech 365

APRIL 28, 2021

United States Drug Patent Prices Database 2021: Brand vs. Generic Drug Price Gap, find generic entry opportunities – ResearchAndMarkets.com United States Drug Patent Prices Database 2021: Brand vs. Generic Drug Price Gap, find generic entry opportunities – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The … Continue reading (..)

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Pharmacy Checkers

JULY 11, 2019

I’m proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. Our report, based on 40 generic medications that were approved from 2017-2018, clearly shows that generic drug approvals often don’t lead to greater affordability or even access here in the U.S.

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Scienmag

JUNE 15, 2022

MINNEAPOLIS – The cost of brand-name drugs for epilepsy increased by 277% from 2010 to 2018, according to a study published in the June 15, 2022, online issue of Neurology®, the medical journal of the American Academy of Neurology.The cost of generic drugs for epilepsy decreased by 42% over the same period.

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STAT News

JANUARY 24, 2023

users with a new prescription benefit called RxPass, which will allow Prime members to get as many drugs as they need for $5 a month from a list of 50 generic medications used to treat more than 80 common conditions , CNBC tells us. Amazon … Amazon is beefing up its Prime program for U.S.

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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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Pharmaceutical Technology

JULY 25, 2022

Unlike biosimilars, it is simpler for small molecule specialty generics to establish equivalence to their branded forms, explains Vasquez. Watanabe refers to the example of Teva’s immunomodulator drug Copaxone used for the treatment of multiple sclerosis, which the company produced and marketed as its own branded product.

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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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Drug Channels

OCTOBER 18, 2022

Below, we share our estimates for wholesalers’ gross margins for brand-name, generic, and biosimilar drugs. We then explain the channel dynamics behind biosimilar and generic drugs’ profits. We estimate that for 2022, generics and biosimilars accounted for only about 15% of wholesalers’ U.S.

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Pharmaceutical Technology

JULY 15, 2022

CivicaRx is a non-profit generic drug company producing affordable insulin biosimilars in collaboration with the Juvenile Diabetes Research Foundation (JDRF). In-house manufacturing the norm. GlobalData is the parent company of Pharmaceutical Technology. Industry split over the pricing issues.

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Pharmacy Checkers

AUGUST 20, 2020

More than ever, if an American compares drug prices on PharmacyChecker.com, they will learn that most generic drugs are far cheaper domestically than in Canada – or, in some cases, even India. Many of you know that prices on the same brand name drugs sold outside the U.S. are often 90% lower. are often 90% lower.

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Drug Patent Watch

JANUARY 13, 2025

Unlike traditional generic drugs, biosimilars face a more complex regulatory pathway and manufacturing process, which influences their market entry and adoption rates. FAQs Q: What is the difference between a biosimilar and a generic drug?

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Pharmacy Checkers

FEBRUARY 14, 2020

Years ago, they took on the Food and Drug Administration in regards to Budeprion XL distributed by Teva Pharmaceuticals, the supposed generic equivalent to the popular antidepressant, Wellbutrin XL. Many readers complained that it just wasn’t cutting it compared to the brand name version. Just switch back to the brand!”

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BioTech 365

OCTOBER 28, 2020

DUBLIN–(BUSINESS WIRE)–The “Drug Patent Database Subscription: US Drug Prices” database has been added to ResearchAndMarkets.com’s offering. This subscription was created to answer a simple question: When do drug patents expire? Your needs evolve as the industry keeps changing.

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FDA Law Blog

NOVEMBER 16, 2021

While this blogger does not have any particular comments on whether or not the idea of government drug price negotiation is good or bad, the way it has been structured in H.R. 5376 appears to have been without regard to the generic drug an biosimilar biological product industries.

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pharmaphorum

JUNE 6, 2022

MCCPDC bypasses the “middlemen” by working directly with distributors and manufacturers to offer generic drugs at decreased costs. We want to work with every source of medications, branded or generic.” “And, of course, Truepill, who does our prescription fulfilment.”

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Various factors have contributed to the need and growth of API chemical suppliers such as rising healthcare expenditure, increasing disposable incomes, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, increased consumption of generic drugs, and intervention of the new generation APIs.

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XTalks

MARCH 15, 2024

It also introduced a feature that allows users to use coupons at checkout to get manufacturer discounts on brand name medications. Amazon Pharmacy says it is focused on transparent pricing and affordability of both branded and generic drugs.

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Pharmaceutical Technology

DECEMBER 4, 2022

Citing studies comparing such products, there are no important differences between biosimilars and their branded counterpart, says Arnold Vulto, PharmD, professor of hospital pharmacy at Erasmus University, Rotterdam. Watanabe says there are going to be some attempts by an innovator brand to defend its space.

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XTalks

JANUARY 20, 2025

This strategic move transformed Actavis into one of the largest pharma companies globally, with a strong presence across branded, generic and over-the-counter (OTC) medicines. Following the merger, Actavis rebranded itself as Allergan, leveraging the strong recognition of Allergans brand.

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