21 U.S.C. § 855
Alternative fine
In lieu of a fine otherwise authorized by this part, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds.
Notes of Decisions
Cited in 7
cases (1 in the last 5 years), 1983–2024 · leading case: Hi-Tech Pharmacal Co. v. United States Food & Drug Administration
Hi-Tech Pharmacal Co. v. United States Food & Drug Administration (2008)
“See 21 U.S.C. § 855 (j)(2)(B). An ANDA-applicant must also give notice of its paragraph IV certification to the NDA-holder and the patent owner, including a description of the legal and factual basis for the assertion that the patent is invalid or not infringed.”
Otsuka Pharmaceutical Co., Lt v. Thomas Price (2017)
“21 U.S.C. § 855 (c)(3)(E)(ii)-(iv), Noting that roman-ette iii’s language, “such drug in the [first-in-time] application,”- refers .”
In Re Ciprofloxacin Hydrochloride Antitrust Litigation (2001)
“See 21 U.S.C. § 855 et seq. Hatch Waxman also minimizes the time it takes for a generic drug to enter the market by permitting a new drug applicant to affirm to the FDA that the drug it seeks to market contains the same active ingredient(s) as a drug already approved and listed…”
United States v. Levino Michelena-Orovio (1983)
“The defendant was convicted of conspiracy to possess marijuana on the high seas with intent to distribute, in violation of 21 U.S.C. § 855 (a), while Michelena-Orovio was convicted of conspiracy to possess with intent to distribute in violation of 21 U.”
In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings (2015)
“An RLD is a previously approved drug ‘identified by FDA as the drug product upon which an applicant relies in seeking approval of ,its [ANDA]/ 21 C.”
Allergan, Inc. v. Barr Laboratories, Inc. (2013)
“” 21 U.S.C. § 855 (b)(2)(A)(iv). Sandoz likewise filed an ANDA for a generic version of Lumi-gan®, also with an accompanying Paragraph IV certification.”
Christopher Michael Callaway (2024)
“18 21 U.S.C. § 855 . 19 Leasing or maintaining, owning, or occupying any space 20 that is used for marijuana business.”
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