Shashank Upadhye has one of the most recognizable brands in the world of brand and generic drug development. As the former chief in-house counsel at three leading pharmaceutical companies, he is known for spearheading innovative business and legal strategies to protect existing drug or device patents – or challenge those of a competitor. A prolific writer and frequent speaker, Shashank is the author of numerous articles and the leading treatise on navigating complex U.S. laws of FDA brand/generic drug development: Generic Pharmaceutical Patent & FDA Law, now in its 11th Edition (2018-19).
Hatch Waxman Act Practice Combined With Trusted Business Savvy
Shashank is widely regarded as one of the leading Hatch-Waxman “Paragraph IV” attorneys in the country. His clients range from small pharmaceutical development companies to Fortune 500 companies. Small to mid-market players turn to him to overturn brand patents in Paragraph IV litigations, aimed at bringing generic versions of medicines swiftly and effectively to the marketplace. Brand pharmaceutical companies trust him to protect their brand from such challenges. For all of his clients, Shashank provides strategic guidance from the initial product idea, through product design, R&D, clinical trials, FDA approval, and product launch. He has an unwavering goal to help bring products to the market and help keep them there.
Shashank is a trusted advisor at every step of the drug product lifecycle, including product selection, research and development, product application, product launch, and ongoing marketing and sales. His long track record in-house makes him adept in both the intricacies of drug laws and the demands of corporate and transactional work.
505(b)(2) Specialist – Drug Reformulation and Re-positioning
He also maintains a robust practice with drug re-positioning and life cycle management. 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. We 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.
At The Forefront of Biosimilars
Shashank also helped pioneer the legal framework around biosimilars under the new 351(k) application process. We have experience in stem cells, nucleic acids, antibodies (chimeric and humanized), vaccines, and other biotechnologies. We help companies navigate the BPCIA regime, in counseling to litigation.
FDA Interactions and Approvals – cGMP Compliance
Shashank has a robust counseling and compliance practice where he advises clients on matters relating to drug approval, drug marketing, supply chain management, and marketing and data exclusivity issues. He also assists clients with FDA enforcement defense and counseling, including:
Good Manufacturing Practices (GMP) violations
180-Day marketing exclusivity and forfeiture
label/label carve-outs and advertising review
guidance and compendial reviews for impact on drug marketing
Citizen Petition drafting or responses
He is a USA Hockey® Level 3 certified ice hockey coach and a PADI® certified Master Scuba Diver; someday, he plans to invent (and patent) a way to play underwater hockey. He is also very active as a Scoutmaster for the Boy Scouts of America.
Published by S. Upadhye, “Open Sesame: Criminal Mutual Legal Assistance Treaties Provide The Keys To Unlock Swiss Bank Secrecy Laws”; 1 New Eng. Journal Int’l. & Comp. Law 99 (1994).
A prolific writer and frequent speaker, Shashank is the author of numerous articles and the leading treatise on navigating complex U.S. laws of FDA brand/generic drug development: Generic Pharmaceutical Patent & FDA Law, now in its 11th Edition (2018-19).
The Book has been cited in countless briefings and judicial opinions. The Book is available in hard copy, on Westlaw database, and also as a fully interactive e-book. The book can be purchased on the Thomson Reuters store: