Drug Delivery, Drug Delivery Systems and Generic Drugs

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Drug Delivery

Drug Delivery Systems

Generic Drugs

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

Drugs

Drugs Branding Drug Delivery Systems Generic Drugs

Conducting a Biopharmaceutical Freedom-to-Operate (FTO) Analysis: Key Considerations for Generic Drug Stability Testing

Drug Patent Watch

MARCH 11, 2025

Unlocking the Path to Generic Drug Development: A Freedom to Operate Analysis As a generic drug manufacturer, navigating the complex landscape of biopharmaceutical development can be daunting. But what exactly is an FTO analysis, and why is it essential for your generic drug stability testing?

Generic Drugs

Generic Drugs Drug Delivery Systems Drugs Drug Delivery

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

Conducting a Biopharmaceutical Freedom-to-Operate (FTO) Analysis: Key Considerations for Generic Drug Stability Testing

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