Upadhye Shashank pic

Shashank Upadhye

Shashank Upadhye is one of the most recognized leader in the US pharmaceutical and FDA space. He is a partner at Upadhye Cwik LLP. For 20+ years, he has focused on pharmaceutical law, with an emphasis on IP and FDA issues. He also spent many years as the chief of legal/IP/FDA counsel at Apotex, Sandoz, and Eon Labs, so he brings key business savvy to clients. Because of that in-house experience, he creates innovative strategies on product development, litigation strategy, and verdicts/settlements. He is a prolific speaker and recognized leader in the Hatch Waxman/Para. IV field. Shashank writes the key legal book on pharmaceutical and FDA law, called Generic Pharmaceutical Patent and FDA Law, available here: https://store.legal.thomsonreuters.com/law-products/Treatises/Generic-Pharmaceutical – Patent-and-FDA-Law-2018-2019-ed/p/106153803 He counsels both brand companies [505(b)(2) applicants] seeking to strategically patent and launch their brand name products in the long term. He helps pharmaceutical clients with the 505(b)(2) NDA process, with an emphasis on creating savvy business and legal strategies around intellectual property, FDA, and supply chain. He can assist 505(b)(2) applicants to interpret the “innovative change” and “conditions of approval” standards and whether a 505(b)(2) will be blocked by an exclusivity. And he provides legal support to generic companies seeking to challenge patents (opinions and litigation) and maximize 180-day exclusivity. He provides input at every stage of the product lifecycle from product selection, R&D, regulatory affairs, product launch, and ongoing marketing/sales. Our Hatch-Waxman team has deep experience in leading the largest and smallest generic drug companies in Abbreviated New Drug Application (ANDA) cases. Our attorneys have represented clients in the largest blockbuster products and smallest products in the space. We are routinely called upon to represent clients in sole first-to-file cases. Shashank also works with or against FDA to move product approvals along. We help to overcome changes in approval standards, Guidance & USP changes, exclusivity fights, and product launches. GMP compliance is also a practice focus for Shashank. He advises client on FDA compliance relating to Form 483’s, Warning Letter responses, and enforcement. He helps clients with resolving import alerts and with compliance training.