Legal Opinion
Sigma-Tau Pharmaceuticals, Inc. v. Schwetz
Court of Appeals for the Fourth Circuit
Decided May 2, 2002No. 01-2206PublishedCited by 10 opinions
1Opinion of the Court
Affirmed by published opinion. Chief Judge WILKINSON wrote the opinion, in which Judge WIDENER and Senior Judge STAPLETON joined.
OPINION
WILKINSON, Chief Judge.
Sigma-Tau Pharmaceuticals, Inc. claims that the Food and Drug Administration acted contrary to law in approving generic versions of its levocarnitine drug because the generics infringed on the seven-year period of orphan exclusivity that its drug currently enjoys under the Orphan Drug Act, 21 U.S.C. §§ 360aa-ee. The district court disagreed, concluding that the FDA did not act unlawfully in approving the generics for an indication that…
2Cases cited16 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- United States v. Mead Corp.Supreme Court of the United States · 2001
- Auer v. RobbinsSupreme Court of the United States · 1997
- Caminetti v. United StatesSupreme Court of the United States · 1917
- Food & Drug Administration v. Brown & Williamson Tobacco Corp.Supreme Court of the United States · 2000
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3Cited by10 opinions
- Nightingale Home Healthcare, Inc. v. Anodyne Therapy, LLCCourt of Appeals for the Seventh Circuit · 2009
- Crutchfield v. County of HanoverCourt of Appeals for the Fourth Circuit · 2003
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- Catalyst Pharmaceuticals, Inc. v. Xavier BecerraCourt of Appeals for the Eleventh Circuit · 2021
- Spectrum Pharmaceuticals, Inc v. Sylvia BurwellCourt of Appeals for the D.C. Circuit · 2016
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