Astellas Pharma Inc. et al. v. Various ANDA Filers
Active- Docket:
- 2:24-cv-09403
Patents:11839689
This case is part of the broader litigation surrounding generic versions of the drug Xtandi® (enzalutamide), involving US Patent 11,839,689.
Defendant
Various ANDA Filers
1 case as defendant.
Company profile
Profile: Various ANDA Filers
"Various ANDA Filers" is not a single corporate entity but a legal term of art used in U.S. patent litigation dockets. It refers to one or more pharmaceutical companies that have filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA). Companies that file ANDAs, known as "ANDA filers," are typically manufacturers seeking approval to market a generic version of a brand-name drug. As this is a placeholder designation for multiple, distinct corporate litigants, details such as headquarters, founding date, employee count, or revenue are not applicable.
The core activity of an ANDA filer is to demonstrate to the FDA that its proposed generic drug is bioequivalent to a previously approved brand-name drug, thereby avoiding the need to conduct new, extensive clinical trials for safety and efficacy. This process is governed by the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. The Act established the ANDA pathway to expedite the availability of lower-cost generic medications.
The patent litigation posture of ANDA filers is unique and statutorily defined. Under the Hatch-Waxman Act, the act of filing an ANDA that includes a "Paragraph IV certification"—asserting that a patent on the brand-name drug is invalid, unenforceable, or will not be infringed—is legally considered an act of patent infringement. This provision allows the brand-name drug company to sue the generic applicant before the generic product enters the market. Consequently, ANDA filers appear in litigation almost exclusively as defendants, as reflected in the case data showing one defendant case and zero plaintiff cases. This litigation frequently occurs in jurisdictions with a high concentration of pharmaceutical companies, such as the District of New Jersey.
The tracked case, Astellas Pharma Inc. et al. v. Various ANDA Filers, is a typical example of this legal framework in action. In such cases, a brand-name pharmaceutical company like Astellas sues generic manufacturers that have filed ANDAs for one of its patented drugs. These lawsuits are a central feature of the pharmaceutical industry, allowing patent holders to defend their market exclusivity while generic companies challenge those patents to bring more affordable alternatives to market.