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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Pharmaceutical Technology

JULY 25, 2022

Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market. The only way forward for generics producers. More specifically, Frank says drug-device combinations share some of these characteristics.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing.

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Camargo

NOVEMBER 11, 2020

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. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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World of DTC Marketing

AUGUST 7, 2022

Once limited to a few new treatments, it’s now being applied widely, even to generic drugs and established regimens.?The 87% of doctors say patients’ conditions have worsened because of red-tape regulations, and 83% worry the patients will suffer prolonged pain. Prior authorization is out of control. The result:?

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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. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

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World of DTC Marketing

JUNE 22, 2022

The company has hired former senior health regulators to help it navigate America’s healthcare bureaucracy. . Then there is the cost of generic drugs. bil­lion in 2020 if it had pur­chased 77 of 89 drugs from Cuban’s firm. Generic drugs versus branded is also a considerable expense.

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Drug Patent Watch

JANUARY 13, 2025

As we delve into the intricate world of biosimilar market dynamics, we’ll explore how these complex molecules are reshaping treatment paradigms across diverse patient populations. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 from 2020 to 2025[1].

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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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Camargo

SEPTEMBER 8, 2021

devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. The drugs approved via PANDAs are often used as the reference listed drug (RLD) for ANDAs under 505(j), and they can also be used as the listed drug for 505(b)(2) applications.

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FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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pharmaphorum

JULY 29, 2021

The UK has levied another big fine for anticompetitive activity in the pharma market in a fortnight, with Advanz Pharma and former owners on the hook for more than £100 million ($140 million) after increasing the price of a thyroid disease drug by 1,110% over an eight-year period. ” Advanz itself was directly fined £40.9

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pharmaphorum

JUNE 8, 2021

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”.

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Pharmaceutical Technology

NOVEMBER 29, 2022

The drug is also known for its illegal recreational use. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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BioPharma Reporter

DECEMBER 22, 2022

Expanding generic drug competition and a decline in the demand for COVID-19 vaccines and therapies have brought down the aggregate market capitalization of the global top 20 biopharmaceutical companies by 9.1%.

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Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.

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pharmaphorum

JULY 28, 2022

Logistical challenges of getting the right materials in the right place remain two years after the pandemic began, causing significant drug shortages to end-users. Many of the medicines most badly affected by these shortages are generic drugs to treat common conditions such as diabetes and heart disease.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Even so, current figures show firms’ biggest portion of spend is still on marketing and administration at 33.1%,

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Outsourcing Pharma

OCTOBER 5, 2021

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations.

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Pharma Marketing Network

FEBRUARY 27, 2025

Introduction Pharma marketing is changing, and pay-per-click advertising (PPC) is leading the charge. But how can pharma marketers maximize their PPC campaigns while staying compliant with strict regulations? Why PPC is Essential for Pharma Marketing The pharma industry operates in a highly regulated and competitive space.

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pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. It has however been contraindicated in people taking opioids.

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FDA Law Blog

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. His presentation will focus on “MoCRA is Here – Now What?

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XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company. Cassiopea spun out of Ireland-domiciled Cosmo Pharma in 2015.

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FDA Law Blog

JUNE 28, 2023

1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023. The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food.

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FDA Law Blog

JUNE 2, 2022

Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.

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The Pharma Data

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilars marketed in the U.S.

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The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. But it is not always clear which types of patents are eligible for listing in the Orange Book. The FDA Commissioner is quoted as saying that “[t]he FDA stands ready to assist the FTC.

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FDA Law Blog

SEPTEMBER 6, 2021

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information. The catch is, as we have learned from the GSK v.

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Pharmacy Checkers

JANUARY 10, 2020

That word “same” is hard to answer when it comes to prescription drugs. For example, when I’m asked if an FDA-approved generic is the exact same as the FDA-approved brand, my answer is often “no.” The drug company responsible for marketing both Livalo and Alipza is called Kowa Pharmaceuticals, a Japanese company.

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FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.”

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FDA Law Blog

AUGUST 16, 2021

While generic drugs as we know them are a creation of the 1984 Hatch-Waxman Amendments, the Federal Register Notice explains that FDA first introduced the concept of an ANDA in 1968 to facilitate approval of Drug Efficacy Study Implementation (DESI) drugs.

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FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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The Pharma Data

JANUARY 17, 2021

The Company will continue to leverage its scientific expertise and operations in Europe and North America for product development and optimization while it plans to add significant commercial experience in the fields of manufacturing, distribution, marketing and sales. Drug Formulations and Delivery.

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Druggist

MARCH 8, 2021

In pharmaceuticals, it is possible to market enantiomers as separate drugs. Common prescription drugs which exist as mirror images of each other are for example esomeprazole and omeprazole (see Esomeprazole vs Omeprazole post). . Atomoxetine availability in the UK. Is atomoxetine a cognitive enhancer?

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