Last updated: July 8, 2026
Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC (1:10-cv-01100): Litigation Summary, Patent Issues, and Case Outcome
Somaxon Pharmaceuticals Inc. sued Actavis Elizabeth LLC in 1:10-cv-01100 alleging infringement of Somaxon patents tied to Chlorpromazine hydrochloride (oral product line marketed by Somaxon). The docket reflects an IP dispute in the Hatch-Waxman context with paragraph IV-type arguments and standard infringement/non-infringement and invalidity defenses. The case resolves without a continuing merits trial in the record described here.
What is the docket and procedural posture of Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC 1:10-cv-01100?
Case: Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC
Court: U.S. District Court, District of New Jersey
Docket No.: 1:10-cv-01100
Type: Hatch-Waxman patent infringement action (generic entry vs. Orange Book-listed drug and FDA marketing application)
Procedural characteristics typical of this docket type (as reflected in the case record structure):
- Complaint filed by the NDA holder/patent owner (Somaxon).
- Actavis response includes non-infringement and invalidity positions and challenges tied to the asserted claims.
- Case proceeds through scheduling and claim construction stages or their functional equivalents.
- Disposition occurs without a later publicly visible trial record in the cited docket snapshot.
Which patents and Orange Book listings were at issue in 1:10-cv-01100?
This matter is described as an asserted-patent Hatch-Waxman infringement dispute between Somaxon and Actavis regarding a chlorpromazine HCl oral product. The specific asserted patent numbers, claim sets, and Orange Book identifiers are not provided in the input record, so an exact claim-by-claim mapping cannot be produced from the available information.
What infringement theories did Somaxon allege against Actavis in 1:10-cv-01100?
Somaxon’s complaint is consistent with standard Hatch-Waxman infringement pleading in which the NDA holder/patent owner alleges that Actavis’s proposed generic product would infringe one or more Orange Book-listed patents (typically composition, formulation, method-of-use, and/or manufacturing-related patents depending on the asserted estate). The record snapshot available here does not list the specific asserted claims or the precise infringement theory (literal infringement vs. equivalents; direct vs. induced vs. contributory).
How did Actavis Elizabeth LLC defend in 1:10-cv-01100 (invalidity and non-infringement)?
Actavis’s defenses in this docket are consistent with Hatch-Waxman patent litigation practice:
- Non-infringement: dispute that the generic formulation or use falls within Somaxon’s asserted claim scope.
- Invalidity: challenge novelty, obviousness, and/or statutory subject matter, depending on the asserted patent types.
- Procedural defenses: typical defenses related to claim construction, timeliness, and the scope of the asserted Orange Book patents.
The input record does not include claim-specific invalidity grounds or the particular invalidity references asserted.
What was the litigation outcome in 1:10-cv-01100?
The available docket-level description indicates a resolved dispute without a continuing merits trial record in the provided material. A complete statement of the judgment type (dismissal with prejudice, summary judgment, consent judgment, settlement, or other) and the date requires docket entry data that is not included in the supplied input.
Did the case result in a settlement or a consent judgment?
No settlement agreement details, settlement terms, or consent judgment terms are present in the provided input record. As a result, the litigation impact on launch timing, potential “carve-out” design, or licensing terms cannot be quantified here.
How does this case affect freedom-to-operate for generic chlorpromazine products?
For Hatch-Waxman disputes, outcome drives immediate generic entry risk. Without the specific disposition type and asserted patent list, the impact cannot be translated into:
- which patents are effectively cleared,
- which patents remain barriers, or
- whether design-around or invalidity rulings control.
What does the case imply for Paragraph IV strategy and generic launch risk?
Generic paragraph IV risk assessment depends on:
- which patents were asserted,
- which claims were found infringed or invalidated,
- the effective stay/termination mechanics, and
- whether a settlement created a timed entry arrangement.
The input record does not provide those determinations, so a quantified risk view cannot be generated.
Key Litigation Facts Table (from provided docket-only context)
| Item |
Value |
| Case name |
Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC |
| Docket |
1:10-cv-01100 |
| Court |
U.S. District Court, District of New Jersey |
| Litigation type |
Hatch-Waxman patent infringement action (generic vs. NDA holder/patent owner) |
| Asserted product context |
Chlorpromazine hydrochloride oral product line |
| Outcome |
Resolved (no full trial merits record described in provided input) |
| Settlement terms |
Not provided in input |
| Patents asserted |
Not provided in input |
| Claims/infringement analysis |
Not provided in input |
Key Takeaways
- The case is a Hatch-Waxman patent litigation between Somaxon and Actavis (D.N.J. 1:10-cv-01100) involving a chlorpromazine HCl product context.
- The provided information supports a litigation existence and general Hatch-Waxman framing, but it does not contain the asserted patent numbers, specific claims, claim constructions, invalidity references, or the precise disposition type.
- A business-grade freedom-to-operate or settlement-impact analysis requires the docket’s specific entries and the asserted patent list, which are not included in the provided input.
FAQs
- What is the procedural timeline for Somaxon v. Actavis 1:10-cv-01100?
- Which Somaxon patents were listed as Orange Book patents for the chlorpromazine HCl product at issue in 1:10-cv-01100?
- Did Actavis’s paragraph IV certification trigger a 30-month stay, and when did it terminate in 1:10-cv-01100?
- What claim types (composition, formulation, method-of-use, or manufacturing) were asserted in Somaxon v. Actavis?
- What settlement or design-around outcomes resulted from the litigation in 1:10-cv-01100?
References
- Court docket: Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC, No. 1:10-cv-01100 (D.N.J.).
