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Capabilities / Generic Drug / ANDA Litigation

Generic Drug / ANDA Litigation

Innovative strategies in ANDA patent litigation.

Our law firm helps manufacturers of generic pharmaceuticals navigate the regulatory thicket of the Food and Drug Administration (FDA) and bring products to market quickly. To advance clients’ business goals, our team develops innovative strategies that include District Court litigation, inter partes reviews (IPR) and work-arounds. Our record of success with Abbreviated New Drug Application (ANDA) and generic drug cases includes advising clients on bringing to market generic competitors for brand-name drugs such as Ambien CR®, Clarinex®, Cymbalta®, Lidoderm®, Trintellix® and Wellbutrin XL®.

Husch Blackwell has one of the premier ANDA and generic drug patent litigation practices in the country. Our ANDA litigation and pharmaceutical patent attorneys have extensive experience at the trial and appellate levels litigating Hatch-Waxman statutory patent infringement and other actions involving prescription drugs. We are recognized leaders in using IPR to challenge the validity of existing patents more quickly and economically. In addition, Husch Blackwell is the only law firm that is a member of the Association for Accessible Medicines (AAM), the leading trade association for the generic drug industry.

News Releases | October 15, 2021
Husch Blackwell Scores Victory for Sigmapharm in Hatch-Waxman Litigation

Husch Blackwell successfully defended Sigmapharm Laboratories, LLC in connection with its application for approval of a generic version of the antidepressant vortioxetine.

News Releases | February 28, 2019
Seth Mailhot Joins Husch Blackwell's Washington, DC and Sacramento, CA Offices

Seth Mailhot, who has over 20 years of experience with all aspects of FDA regulation, brings to Husch Blackwell a practice that is broad in scope.

Testimonial Tina Guilder, CEO, Virtus Pharmaceuticals

“The Husch Blackwell attorneys were fierce and tireless advocates for Virtus. In the face of aggressive actions by our competitors and FDA regulators, they developed and executed a legal plan that protected an important market for us. They have my gratitude and highest recommendation.”

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