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

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

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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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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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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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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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

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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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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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 Medicare drug insurance is a product of compromise after decades of debate in Congress. In effect, the Part D system slices the market into as many groups of consumers as there are plans. The result:?

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Pharmaceutical Technology

OCTOBER 5, 2008

In addition, one very notable deal with India hints that Asia’s emerging market is also having a growing influence on what is happening in Japan. ’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi.

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XTalks

JANUARY 20, 2025

Among these, mergers and acquisitions (M&As) have played a pivotal role in reshaping the industry landscape, enabling companies to bolster their portfolios, enhance R&D capabilities and expand their global market reach. Following the merger, Actavis rebranded itself as Allergan, leveraging the strong recognition of Allergans brand.

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World of DTC Marketing

JULY 27, 2022

A drug’s out-of-pocket cost is primarily the result of decisions made by insurance companies and pharmacy benefit managers (PBMs). In 2021 pharma provided a staggering $204 billion in price concessions for brand-name medicines to PBMs. Insurers and PBMs have even devised schemes to overcharge patients for generic drugs.

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World of DTC Marketing

JANUARY 31, 2021

So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). PBM’s and insurers required that patients with high cholesterol first use generic versions of Lipitor and Crestor to save money. In pharma R&D returns have declined to 1.8

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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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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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World of DTC Marketing

DECEMBER 18, 2020

were dispensed using generic drugs. When both brand and generic versions of the prescribed medication were available, the generic was chosen 97 percent of the time, resulting in significant patient savings. healthcare system saved almost $2 trillion from 2009 to 2019 in healthcare costs due to generic drugs.

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FDA Law Blog

NOVEMBER 16, 2021

Qualifying single-source drugs are those that were approved at least 7 years ago (for drugs) or licensed 11 years ago (for biologics) for which no generic or biosimilar product has been approved/licensed and marketed. 5376 appears to have been without regard to the generic drug an biosimilar biological product industries.

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pharmaphorum

JUNE 6, 2022

The “middlemen” The individuals or companies within that complicated supply chain are what MCCPDC calls “the middlemen,” namely pharmacy benefit managers (PBM) or group purchasing organisations (GPOs), who can be the source of prescription prices that are substantially higher than market value.

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Pharmaceutical Technology

NOVEMBER 29, 2022

The treatment, sold under the brand name Spravato by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson , is also indicated for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal thoughts. Moreover, securing funding is a significant challenge, says Schwenk.

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pharmaphorum

JULY 29, 2021

Now, interchangeable status means that is considered to have no clinically meaningful difference to Lantus in safety, purity or potency, so can be substituted for the reference drug without any prescriber intervention – just like a regular generic drug can in many US states.

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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. With digital engagement becoming the primary way to reach healthcare professionals (HCPs) and patients , pharma brands can no longer rely solely on traditional advertising. best migraine treatment or new diabetes medication).

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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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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. There are many thousands of drugs approved for the U.S.

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Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. There are 19,000 approved prescription drugs for marketing in the U.S. Of course, the faster a safe and effective medicine can come to market, the better.

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pharmaphorum

NOVEMBER 2, 2020

Mylan’s $12 billion takeover of Pfizer’s Upjohn unit has been cleared by the US authorities, but on the condition that the two companies divest various generic drug products. Once formed, Viatris will be a generics behemoth with annual sales of around $19 to $20 billion and operations in 165 markets around the word.

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FDA Law Blog

MAY 25, 2022

That effort, which has most recently emerged in the forms of the “ Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 ” ( H.R. 2853 , or “BLOCKING Act”), the “ Expanding Access to Low-Cost Generics Act of 2021 ” ( S. And now there’s a report and analysis to back up that claim!

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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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Drug Channels

MARCH 7, 2023

WHAT YOU WILL LEARN The rapid expansion of patient-paid prescriptions—via cash-pay pharmacies and discount card vendors—is transforming the prescription market. Organizations that purchased corporate access for The Drug Channels 2023 Video Webinar Series will receive a custom, branded signup link so employees can easily register.

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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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pharmaphorum

MARCH 16, 2022

Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery and called Breyna – has been cleared for the same indications as the brand, namely maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD).

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Pharmacy Checkers

JANUARY 10, 2020

A friend of mine, who has very difficult to control cholesterol, was prescribed Livalo, an FDA-approved brand of the drug pitavastatin. He went to our site to discover that brand-name Livalo ( pitavastatin ). He went to our site to discover that brand-name Livalo ( pitavastatin ). Is the drug safe?

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FDA Law Blog

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

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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

MAY 11, 2023

Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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Delveinsight

SEPTEMBER 15, 2021

Similarly, the rise in various government and non-government initiatives to curb the occurrence of cancer diseases and the availability of cancer therapies has also contributed immensely to market growth. It covers the in-depth analysis of epidemiology as well as the emerging therapies in the market.

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FDA Law Blog

MARCH 30, 2022

1463 ) and the “ Simplifying the Generic Drug Application Process Act ” ( S. We intended to quickly follow up that post with another post addressing a couple of bills that we thought fit the role of Lee Van Cleef as “the Bad,” and Eli Wallach as “the Ugly”: the “ Prompt Approval of Safe Generic Drugs Act ” ( H.R.

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