FDA Law Blog

JUNE 13, 2024

Though some drug companies have been reluctant to delist certain patents from the Orange Book, the District Court of New Jersey just ordered Teva to delist 5 of its patents that it deemed improperly listed. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable.

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FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. In fact, federal law and regulation appear to require AbbVie to list these patents.”

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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 FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

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XTalks

OCTOBER 27, 2021

Genentech’s ocular implant drug delivery system for treatment of macular degeneration has received approval from the US Food and Drug Administration (FDA). Susvimo delivers ranibizumab via a port delivery system into a surgically placed implant in the eye, allowing for continuous delivery of the drug.

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XTalks

AUGUST 30, 2022

According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. Global sales of over-the-counter and prescription products related to central nervous system (CNS) disease added up to $86 billion in 2019.

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Pharmaceutical Technology

APRIL 24, 2023

Researchers may develop nanodrugs due to their smaller surface area to allows drugs to dissolve faster, or nanoparticles may encapsulate drugs, so they last longer in the body. Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages.

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