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

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

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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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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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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Pharmaceutical Technology

JULY 25, 2022

Unlike biosimilars, it is simpler for small molecule specialty generics to establish equivalence to their branded forms, explains Vasquez. The FDA knows that developing specialty generics, particularly generic injectable products, can be challenging. while Sandoz’s generic is sold for $6,492.41. “You

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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 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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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. Strategies for enhancing biosimilar impact include tailored education programs, real-world evidence generation, and collaborative policy development.

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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

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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Pharmaceutical Technology

NOVEMBER 29, 2022

On November 14, the Canadian developer PharmaTher announced positive data from a Phase I/II study where ketamine was used to treat levodopa-induced dyskinesia in Parkinson’s disease. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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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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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. That’s a difficult pill to swallow.

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Pharmaceutical Technology

FEBRUARY 24, 2023

A leaked draft (see below) of the legislation, whose final version will be published next month, proposes reducing market exclusivity time by one year for most branded drugs, although it would extend exclusivity for certain drugs for unmet needs.

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FDA Law Blog

JULY 24, 2024

Each fall, leading pharmaceutical patent litigators for brand-name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments affecting Hatch-Waxman litigation and participate in significant peer-to-peer networking opportunities.

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Pharmacy Checkers

NOVEMBER 21, 2019

So, without further ado, a moment of praise amongst the criticism: Despite its inability to please everyone, the FDA protects, lengthens, and improves the quality of hundreds of millions of lives through its work regulating the development, creation and distribution of medical products. The medications that we obtain in the U.S.,

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Pharmacy Checkers

JANUARY 16, 2020

As I understand it, the firm’s goal is to find and increase discounts as it develops greater buying power through greater volumes, also known as economies of scale. I like it and it’s my hope – and belief – that Blink Health is saving people money on their generics. Brand drugs cost way more at Blink Health than in Canada.

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XTalks

JUNE 8, 2022

Novartis’ biosimilars and generics drug division Sandoz has announced a new global campaign called ‘Act4Biosimilars’ to help raise awareness about biosimilars and increase their adoption by at least 30 percent in over 30 countries by the year 2030.

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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

MARCH 6, 2024

Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues.

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FDA Law Blog

SEPTEMBER 23, 2024

Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem Tradeoffs’ Race to the Bottom Series FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway The U.S.

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pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Symbicort brought in worldwide sales of $2.7 billion last year, with $1.1

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FDA Law Blog

SEPTEMBER 29, 2021

ACI’s Paragraph IV Disputes Conference provides invaluable professional development opportunities, meaningful networking, and vital “take-aways” for legal strategies and cost analysis for every aspect of this complex form of litigation. Spotlight on Delaware: District Court Judges Address Brand and Generic Concerns”.

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FDA Law Blog

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S.

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FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Both bills – S. Unfortunately, in the nearly eight years since FDA issued MaPP 5240.5,

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FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Both bills – S. Unfortunately, in the nearly eight years since FDA issued MaPP 5240.5,

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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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The Pharma Data

DECEMBER 28, 2020

This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.” sales of brand products containing glucagon for injection, 1 mg, were approximately $306 million for the 12 months ended September 30, 2020. Company Information.

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Druggist

MARCH 8, 2021

Modafinil (brand name Provigil) is one of the primary drugs used in the management of narcolepsy in the UK. The public’s interest in modafinil comes from the drug’s association with a class of medicines called ‘ smart drugs ‘, also called nootropics and cognitive enhancers. Atomoxetine.

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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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FDA Law Blog

MAY 26, 2022

As we noted in a previous post , FDA’s first (of fourteen) legislative proposal targets 180-day generic drug exclusivity, stating: Amend the 180-Day Exclusivity Provisions to Encourage Timely Marketing of First Generics.

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FDA Law Blog

JULY 15, 2021

While not a specifically stated priority for OPDP , FDA has prioritized biosimilar development to encourage innovation and competition among biologics. What happened is likely FDA’s concerns that the Neulasta promotion misleadingly sought to sow doubt about the efficacy of biosimilars.

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The Pharma Data

OCTOBER 14, 2020

About Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.

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Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” When it comes to the approval of new drugs, brand and generic, the systems of the U.S.

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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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