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

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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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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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

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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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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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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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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World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). Then there is the cost of generic drugs. 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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World of DTC Marketing

AUGUST 7, 2022

The passage of the Inflation Control bill is an excellent first step in limiting high drug costs, but our healthcare system is still built for profit at the expense of patients. Once limited to a few new treatments, it’s now being applied widely, even to generic drugs and established regimens.?The The result:? Schumer (D-N.Y.)

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STAT News

AUGUST 3, 2022

In the latest bid to address high prescription drug costs, a nonprofit plans to sell a cheaper generic version of an expensive cancer medicine in the U.S. And the nonprofit is suggesting pharmacies sell the medicine to consumers for $171, which is considerably less than what most consumers currently pay for brand-name version, Zytiga.

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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. He originated the idea of patent certifications, new drug exclusivity, and the Bolar exemption. (And

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Drug Channels

OCTOBER 18, 2022

The biosimilar boom for provider-administered drugs continues to accelerate. 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. drug distribution.

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pharmaphorum

JUNE 6, 2022

American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation and online pharmacy that provides patients access to medications at a lower cost. . We want to work with every source of medications, branded or generic.”

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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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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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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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World of DTC Marketing

JULY 27, 2022

The drug industry deserves its share of the blame for the high prices of medications, but the truth is that prescription medications are so profitable that many others want their share of the money. A drug’s out-of-pocket cost is primarily the result of decisions made by insurance companies and pharmacy benefit managers (PBMs).

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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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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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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. FAQs Q: What is the difference between a biosimilar and a generic drug? from 2020 to 2025[1].

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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). Making low-cost insulin widely available will benefit anyone who struggles to afford this drug,” he adds. In-house manufacturing the norm.

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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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World of DTC Marketing

DECEMBER 18, 2020

Pharma companies are still too focused on profits while people continue to rely on prescription drugs to compensate for unhealthy lifestyles. When a new drug is on the horizon stories, the effect, the drug will have on its stock price, not on patients. Then there is the case of high drug prices. trillion every year.

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Pharmacy Checkers

MAY 22, 2020

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. has proved itself to be too dependent on drug imports from China.

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World of DTC Marketing

JANUARY 31, 2021

Porter points out that R&D seems to have been replaced with mergers and acquisitions, but she misses the big picture by focusing solely on drug costs. So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). percent—a slight decrease of 0.1

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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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FDA Law Blog

NOVEMBER 16, 2021

5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). a) In General.—The

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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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Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Pharmaceutical Technology

FEBRUARY 24, 2023

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years.

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