George A. O'Brien

George A. O'Brien

Senior Associate, Washington, D.C.

Email george.obrien@​

Phone +1 202 637 5497

Fax +1 202 637 5910


Practice groupRegulatory

George O'Brien works with innovative pharmaceutical and biotech companies on lifecycle management issues. He's probably best known for his substantial experience with orphan drug designation and exclusivity matters.

In particular, George helps clients avoid the pitfalls that can delay an orphan designation or award of orphan exclusivity, such as issues related to prevalence, orphan subsets, and clinical superiority. When clients must resolve a dispute with an agency over orphan issues, George's comprehensive knowledge of relevant precedent is a valuable tool.

George assists companies at all stages of product development to maximize their FDA regulatory exclusivities, including Hatch-Waxman, orphan drug, and pediatric exclusivities. Drafting citizen petitions is a key part of his practice, and he's collaborated with other organizations to create drafts on a wide range of issues, including bioequivalence and approval requirements for generic products, the operation of 180-day exclusivity, therapeutic equivalence issues, and new chemical entity exclusivity.

George recently served on the Drugs & Biologics Committee of the Food and Drug Law Institute. He also has spoken on orphan drug issues at FDLI conferences and elsewhere.

Awards and recognitions


Rising Stars, Food & Drugs
Washington, D.C. Super Lawyers

Education and admissions


J.D., University of Maryland School of Law, magna cum laude, Order of the Coif, 2008

A.B., Dartmouth College, cum laude, 1995

Bar admissions and qualifications

District of Columbia


Representative experience

Submitted citizen petition convincing FDA to recognize five-year "new chemical entity" exclusivity for certain fixed-dose combination products.

Represented Depomed, Inc. in regulatory proceedings and federal litigation regarding orphan drug designation and exclusivity.

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