Drug Patent Watch

JANUARY 14, 2025

Case Study 1: Overcoming Formulation Challenges Let’s kick things off with a look at how generic drug manufacturers are tackling formulation challenges head-on. Generic drug manufacturers are taking a similar approach by developing multiple drugs simultaneously[1]. The bone of contention?

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FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

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Drug Patent Watch

JANUARY 22, 2025

The Unseen Journey of Generic Drugs: A Look into the Regulatory Pathway Have you ever wondered how generic drugs make it to the market? Once approved, the patent holder enjoys a period of exclusivity, during which generic manufacturers cannot enter the market. This is where generic manufacturers come into play.

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Drug Patent Watch

DECEMBER 10, 2024

These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. Regulatory agencies also conduct inspections and audits to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines.

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FDA Law Blog

JULY 23, 2024

Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance.

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Pharma in Brief

FEBRUARY 8, 2024

The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an alternate CRP, which could include another generic drug, when filing an Abbreviated New Drug Submission ( ANDS ). b) of the Regulations. b) of the Regulations.

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Pharmacy Checkers

FEBRUARY 14, 2020

Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market. Compare Wellbutrin Prices.

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Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Pharmaceutical Technology

FEBRUARY 23, 2023

The sooner challenging and unfixable compounds are identified and killed in development, the less R&D expenditure will be incurred, allowing you to focus on compounds that have the legs to make to it market. However, if drug Y has a high F abs (90%) but low F (e.g. Please check your email to download the Whitepaper.

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pharmaphorum

OCTOBER 21, 2020

Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.

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The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. billion, three biosimilar products in development targeting products with a market size of approximately $13.0

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The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches.

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The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. J Neurol Sci. 2003;206(2):165–71.

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XTalks

NOVEMBER 6, 2024

per share, the offering included 1,300,000 ordinary shares, which began trading on the Nasdaq Global Market under the ticker symbol GELS on October 29, 2024. To address growing demand, Gelteq is expanding production capacity with a Good Manufacturing Practice (GMP)-certified facility, aiming for scalable, reliable output by 2025.

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Druggist

MARCH 25, 2021

Although the active ingredient is the same, there are differences in non-active components (the core of the tablet and coating), which reflect both pills’ manufacturing process. As with other drugs, once a patent expires, other manufactures start to produce generic or new brands of the same pill (desogestrel). References: .

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XTalks

FEBRUARY 8, 2021

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

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World of DTC Marketing

FEBRUARY 21, 2022

Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). Reportedly, the cost of production for molnupiravir stands at about $17.74. Experts across the board are predicting demand for antiviral drugs will rapidly outpace supply.

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Drug Patent Watch

DECEMBER 11, 2024

One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). They offer guidance on formulation development and manufacturing considerations. They provide recommendations on the design of in vitro and in vivo studies.

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Drug Patent Watch

FEBRUARY 17, 2025

But have you ever wondered what it takes for a generic drug to hit the market? Once the patent expires, other companies can apply to manufacture and market generic versions of the drug. The ANDA must also demonstrate that the generic drug is bioequivalent to the brand-name drug.

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The Pharma Data

MAY 3, 2021

India’s vaccine shortage will last months, biggest manufacturer warns ( FT ). Alnylam provides long-term look at Oxlumo, aiming to further carve out stake in PH1 market ( Endpoints ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Medtech.

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