News & Analysis as of

Patent Applications Generic Drugs FDA Approval

Robins Kaplan LLP

ANDA Approvals - Fall 2024

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Smart & Biggar

Rx IP Update - February 2019

Smart & Biggar on

Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Hogan Lovells

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents,...

Hogan Lovells on

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the...more

Foley & Lardner LLP

The Hobson's Choice Of The Hatch-Waxman Integrity Act

Foley & Lardner LLP on

As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more

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