Germain v. Teva Pharmaceuticals’s Empirical Analysis

Citation profile

2 federal appellate · 2 district · 6 state decisions

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 35 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

1. “does not create a plausible inference that it is true.”

   2 later decisions quote this exact passage · from the majority
   e.g. Red Hed Oil, Inc. v. H.T. Hackney Co. · Evans v. Armenta

2. “First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: it must have the same “active ingredient” or “active ingredients,” “route of administration,” “dosage form,” and “strength” as its brand-name counterpart. 21 U.S.C. §§ 355 (j)(2)(A)(ii) and (iii). Second, a proposed generic must be “bioequiva-lent” to an approved brand-name drug. § 355(j)(2)(A)(iv). That is, it must have the same “rate and extent of absorption” as the brand-name drug. § 355(j)(8)(B). Third, the generic drug manufacturer must show that “the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.” § 355(j)(2)(A)(v).”

   1 later decision quote this exact passage · from the majority
   e.g. Helen Franzman v. Wyeth Inc.

3. “Under existing FDA regulations, ANDA holders cannot make labeling changes through the formal supplement process under. 21 CFR 314.70 in all circumstances in which NDA holders can because an ANDA’s labeling must be the same as the NDA RLD’s labeling (with some exceptions, as described in 21 CFR 314.94(a)(8)(iv)). Accordingly the [CBE] supplement process under 21 CFR 314.70(c) is not expressly available to ANDA holders except to match the RLD labeling or' to respond to FDA’s specific request to submit a labeling change under this provision.”

   1 later decision quote this exact passage · from the majority
   e.g. In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings