Legal Opinion
Otsuka Pharm. Co. v. Burwell
Court of Appeals for the D.C. Circuit
Decided July 28, 2016No. Civil Action No. 15–cv–1688 (KBJ)PublishedCited by 10 opinions
1Opinion of the Court
KETANJI BROWN JACKSON, United States District Judge *381To incentivize the development and marketing of safe, effective, and affordable drug products, the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 321 et seq. , provides a variety of benefits for drug manufacturers, including prescribed periods of "exclusivity" in the marketplace. Drug manufacturers that develop and get approval for drug products containing entirely new chemical entities-i.e., drugs in which "no active ingredient" has ever before been approved for marketing-receive a five-year period of exclusivity for marketing…
2Cases cited65 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Auer v. RobbinsSupreme Court of the United States · 1997
- Christensen v. Harris CountySupreme Court of the United States · 2000
- Food & Drug Administration v. Brown & Williamson Tobacco Corp.Supreme Court of the United States · 2000
- National Cable & Telecommunications Assn. v. Brand X Internet ServicesSupreme Court of the United States · 2005
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3Cited by10 opinions
- Braeburn Inc. v. U.S. Food & Drug Admin.Court of Appeals for the D.C. Circuit · 2019
- Healthalliance Hosps., Inc. v. AzarCourt of Appeals for the D.C. Circuit · 2018
- Otay Mesa Prop., L.P. v. U.S. Dep't of the InteriorCourt of Appeals for the D.C. Circuit · 2018
- (SS) Mansfield v. Commissioner of Social SecurityDistrict Court, E.D. California · 2022
- Braeburn Inc. v. United States Food and Drug AdministrationDistrict Court, District of Columbia · 2019
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