ViroPharma, Inc. v. Hamburg’s Empirical Analysis

Citation profile

3 district ·

Most-quoted passages

The sentences later courts lift from this opinion, ranked by how many decisions quote each — the parts of the opinion doing the work. These counts are smaller than the citation total above because most of the 4 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

1. “an ANDA must include information demonstrating that the generic drug is the same as the RLD in a number of specified ways. 21 U.S.C. § 355 (j)(2)(A). Of particular relevance here, the ANDA must demonstrate that the generic is the “bioequivalent” of the RLD, and is therefore absorbed into the body at the same rate and to the same extent as the innovator drug. [Id.] § 355(j) (2) (A) (iv) . 2 Where ... “a drug ... is not intended to be absorbed into the bloodstream, the Secretary may establish alternative, scientifically valid methods to show bioequivalence if the alternative methods are expected to detect a significant difference between the drug and the [RLD] in safety and therapeutic effect.” [Id.] § 355(j)(8)(C). Depending on the circumstances and the particular drug in question, the FDA may require an applicant [to] use one or more of a variety of different methodologies in order to demonstrate bioequivalence. In general, however, methodologies for demonstrating bioequivalence may be classified as either in vivo (i.e., through human testing) or in vitro (i.e., laboratory testing).”

   1 later decision quote this exact passage · from the majority
   e.g. 898 F. Supp. 2d 1 - Viropharma Incorporated v. Hamburg

2. “According to ViroPharma, 21 C.F.R § 320.21(b) sets forth a general requirement that bioequivalence be demonstrated through in vivo testing, unless the drug product meets one of the waiver criteria set forth in 21 C.F.R. § 320.22 .... The FDA, however, argues that there is no such default requirement for in vivo data to establish bioequivalence .... Instead, the FDA relies on language in 21 C.F.R. § 320.24 [ (a) ], which states that “FDA may require in vivo or in vitro testing, or both, to ... establish the bioequivalence of specific drug products.” [The] FDA therefore asserts that it has discretion to determine, on a case-by-case basis, whether it will require in vivo testing, in vitro testing, or both in order to establish the bioequivalence of a drug product. According to ViroPharma, however, 21 C.F.R. § 320.24 merely lists the various methods for establishing either in vivo or in vitro bioequivalence, depending on which of those two types of testing is otherwise required by the regulations.”

   1 later decision quote this exact passage · from the majority
   e.g. 898 F. Supp. 2d 1 - Viropharma Incorporated v. Hamburg

3. “ViroPharma’s allegations present a number of problems, each of which would be sufficient to undercut its rationale for standing. ViroPharma complains that its operations have been variously changed or ‘impacted,’ ... and that it suffers from ‘uncertainties’ regarding the future regulatory and competitive environment. These ‘harms’ are highly nebulous in both character and degree, and are a far cry from the type of ‘concrete and particularized’ injury required for Article III standing.”

   1 later decision quote this exact passage · from the majority
   e.g. 789 F. Supp. 2d 1 - Mylan Pharmaceuticals Inc. v. United States Food & Drug Administration