Upadhye Cwik LLP – The “Go-To” US Law Firm for Pharma IP & FDA
Upadhye Cwik LLP’s pharmaceutical practice has a prime focus on strategy and execution. UC counsels both brand pharma companies to strategically patent and launch their brand name products for the long term; and to generic companies that challenge patents to bring drugs to the market. We provide input at every stage of the product lifecycle from product selection, R&D, regulatory affairs, product launch, and ongoing marketing/sales. We help pharma clients succeed in patents & trademarks (applications, licensing, and enforcement), trade secrets, and FDA regulatory law.  We have particular success in patent litigation, Patent Office (PTAB) invalidation & cancelations (IPR’s and PGR’s), and applications.
Shashank Upadhye is the group leader as he is a trusted advisor and widely recognized as one of the leading Hatch-Waxman Paragraph IV attorneys. For 20+ years, he has focused on pharma 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 help clients. He is a prolific speaker and recognized leader in the Hatch Waxman/Para. IV field.
505(b)(2) Practice. UC counsels brand companies [505(b)(2) applicants] seeking to strategically patent and launch their brand name products in the long term. We help 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. We 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.
Generic Drug Practice. 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.
FDA GMP Compliance Practice. 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.
He can be reached at: shashank@ipfdalaw.com and his bio is here: https://ipfdalaw.com/shashank-upadhye/