Tag Archives: Generic

FDA Grants Approval for Generic Narcan (naloxone HCL) Nasal Spray

Recently, the FDA approved the first generic Narcan nasal spray to treat opioid overdose.  Narcan temporarily reverses the effects of opioid analgesics and is essentially an antidote for opioid overdose.  While generics of the injectable version of this medication, Evzio, … Continue reading

Posted in Health Law | Tagged , , , | Leave a comment

Accelerating Generic Entry: A Proven Solution to the Problem of Prescription Drug Pricing

High prescription drug prices and their impact on costs borne by the government in Medicaid, Medicare Part D and other federal programs, is a front burner topic in Washington. The President has committed to reducing the price of prescription drugs, … Continue reading

Posted in Intellectual Property | Tagged , , , , , , , , | Leave a comment

Generic Kivexa®: Supreme Court confirms interim injunctive relief

×Reading time: 4 minutes Case No. 4A_575/2018 (Supreme Court) | Decision of 12 March 2019 on appeal against S2018_004 (FPC) | Decision of 22 October 2018 | ‘Abacavir / Lamivudine’ Please see this Blog here for a detailed review of … Continue reading

Posted in Intellectual Property | Tagged , , , , , , , | Leave a comment

Don’t Test Me! FDA Applies “Deemed Triggered” Regulation to 180-Day Generic Drug Exclusivity

By Kurt R. Karst — “Don’t test me!”— that’s a warning that I, along with my younger brother, Erik, heard more than once from our parents while growing up.  The warning would come up from time to time—but particularly during … Continue reading

Posted in Products Liability | Tagged , , , , , , , , , | Leave a comment

Patent-Eligibility Not Supported by an Ordered Combination of Generic Technology Elements

Patent claims reciting “buying and selling an item relating to unique subjects” unsurprisingly could not meet the patent-eligibility bar of 35 U.S.C. § 101 and the Alice/Mayo test when the patent owner appealed a lower court’s Rule 12(b)(6) dismissal. VOIT Technologies, … Continue reading

Posted in Copyright Law | Tagged , , , , , , | Leave a comment