Generic Drugs/ANDAs and 505(b)(2) NDAs

Advice and Representation for Approval and Market Entry

For over 20 years, OFW Law’s attorneys have advised clients on how to bring generic drugs to market under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. We aid clients in their approval and market entry strategies — including Abbreviated New Drug Applications (ANDAs), 505(b)(2) NDAs, and ANDA Suitability Petitions — by helping them answer questions related to eligibility for the abbreviated and 505(b)(2) application processes, labeling, patent certifications, 180-day exclusivity provisions, and the scope of various non-patent exclusivity provisions.

For more information about our services, contact OFW Law’s Washington D.C. offices by telephone at (202) 789-1212 or complete our online contact form. We look forward to working with you.