Last updated: July 23, 2026
Impax Laboratories, Inc. sued Actavis Laboratories FL, Inc. in the U.S. District Court for the District of New Jersey under the Hatch-Waxman framework (Paragraph IV-type patent dispute tied to an FDA generic approval path). The case number is 2:16-cv-09416. The specific asserted patents, the ANDA number, the drug product at issue, the procedural posture (dismissal, stipulation, settlement, trial, or judgment), and the claim construction or infringement findings are not provided in the prompt, so a complete, accurate litigation summary and legal analysis cannot be produced.
What happened in Impax v. Actavis (2:16-cv-09416)?
Answer: The prompt provides only the case caption and docket number, not the operative complaint, list of asserted patents, dates of filings, claims asserted, or the final outcome. A litigation summary requires those specifics to be accurate.
What patents were asserted?
The asserted patent(s), including patent numbers and expiration dates, are not included.
What regulatory trigger drove the lawsuit?
The FDA approval and Orange Book listing(s) tied to the dispute (ANDA, applicant, listed patents, and Paragraph IV notice date) are not included.
What court filings matter most?
A real summary must cite the relevant filings, including the complaint, answer, motions to dismiss, claim construction, preliminary injunction briefing (if any), infringement contentions, and any final order. None of these are provided.
What was the outcome?
The disposition type (dismissal with or without prejudice, settlement with stipulated dismissal, summary judgment, trial verdict) is not provided.
How does the court typically handle Actavis-style Hatch-Waxman patent cases?
Answer: District courts in Hatch-Waxman litigations commonly resolve infringement based on claim construction plus the ANDA product’s accused features, often with early dispositive motions on jurisdiction, patent venue, and statutory standing. Injunctions require a showing tied to likelihood of success and irreparable harm.
This is procedural context only and does not substitute for the case-specific record.
Which patents protect the underlying IMPAX drug in this case?
Answer: Not determinable from the provided information.
How to map Orange Book listings to asserted patents
A correct mapping requires:
- the NDA/listed drug name
- Orange Book listed patents
- the listed patent type (drug substance, drug product, method-of-use)
- the Paragraph IV notice and which patents were challenged
None of that is in the prompt.
When did this case reach key milestones?
Answer: Key milestones (complaint date, service, claim construction schedule, summary judgment dates, settlement or dismissal date) are not provided.
What settlement or injunction terms affected generic entry risk?
Answer: Settlement/injunction terms are not provided, and without them the risk profile for generic entry cannot be stated with legal accuracy.
What generic entry risks existed for Actavis after filing?
Answer: Generic entry risks depend on:
- whether the case resulted in a stay or injunction,
- whether a final judgment issued,
- whether a covenant not to sue or stipulated dismissal allowed launch on a specific date.
Those details are not provided.
How strong was Impax’s patent case, legally?
Answer: Patent strength depends on the asserted claims and the court’s substantive rulings (construction and infringement/validity). No ruling text or list of asserted claims is provided.
What defenses did Actavis likely raise?
Answer: Common defenses in Hatch-Waxman cases include non-infringement, invalidity (anticipation/obviousness, lack of enablement, written description, indefiniteness), prosecution-history estoppel, and jurisdiction/standing issues. Case-specific defenses are not provided, so no accurate analysis can be given for this docket.
What is the litigation posture at conclusion?
Answer: Not provided.
Outcome categories (what to look for in a docket)
- Final judgment for plaintiff
- Final judgment for defendant
- Stipulated dismissal with prejudice
- Settlement with covenant not to sue
- Voluntary dismissal
- Dismissal on procedural grounds (lack of standing, improper service, jurisdiction)
No docket outcome is included in the prompt.
Key takeaways
Answer: The prompt does not contain the case record details required to produce a complete and accurate litigation summary and legal analysis for Impax Laboratories, Inc. v. Actavis Laboratories FL, Inc., 2:16-cv-09416.
No litigation-specific conclusions can be stated without the operative complaint, asserted patent list, ANDA/drug identity, and the final docket disposition.
FAQs
1) What patents did Impax assert in 2:16-cv-09416?
Not provided.
2) Did the court issue a preliminary injunction in Impax v. Actavis (2:16-cv-09416)?
Not provided.
3) What ANDA product and drug were accused of infringement?
Not provided.
4) Was the case resolved by settlement, dismissal, or judgment?
Not provided.
5) Did Actavis launch at-risk, and on what timeline?
Not provided.
References
- U.S. District Court, District of New Jersey. Impax Laboratories, Inc. v. Actavis Laboratories FL, Inc., No. 2:16-cv-09416. (Case docket and filings not included in prompt.)
