Legal Opinion
Vanda Pharmaceuticals Inc. v. Food and Drug Administration
District Court, District of Columbia
Decided September 10, 2024No. Civil Action No. 2023-2812Published
1Opinion of the Court
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA VANDA PHARMACEUTICALS INC., Plaintiff, v. Case No. 23-cv-2812 (CRC) FOOD AND DRUG ADMINISTRATION, et al., Defendants. MEMORANDUM OPINION AND ORDER Plaintiff Vanda Pharmaceuticals Inc. (“Vanda”) developed, manufactures, and sells the sleep-disorder drug tasimelteon under the brand name Hetlioz®. Following the lapse of Vanda’s exclusivity period in January 2019, the Food and Drug Administration (“FDA”) authorized multiple generic versions of tasimelteon products. It did so most recently in early 2023, approving MSN Pharmaceuticals,…
2Cases cited51 opinions
- Ashcroft v. IqbalSupreme Court of the United States · 2009
- Bell Atlantic Corp. v. TwomblySupreme Court of the United States · 2007
- Abbott Laboratories v. GardnerSupreme Court of the United States · 1967
- Buckley v. ValeoSupreme Court of the United States · 1976
- Bennett v. SpearSupreme Court of the United States · 1997
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