Litigation Details for CATALYST PHARMACEUTICALS, INC. v. ANNORA PHARMA PRIVATE LIMITED (D.N.J. 2023)

CATALYST PHARMACEUTICALS, INC. v. ANNORA PHARMA PRIVATE LIMITED (D.N.J. 2023)

Docket		Date Filed	2023-03-01
Court	District Court, D. New Jersey	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Michael E. Farbiarz
Jury Demand	None	Referred To	Jose R. Almonte
Patents	10,626,088; 10,793,893; 11,060,128; 11,268,128; 11,274,331; 11,274,332
Link to Docket	External link to docket

Details for CATALYST PHARMACEUTICALS, INC. v. ANNORA PHARMA PRIVATE LIMITED (D.N.J. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-03-01				External link to document

Litigation summary and analysis for: CATALYST PHARMACEUTICALS, INC. v. ANNORA PHARMA PRIVATE LIMITED (D.N.J. 2023)

Last updated: July 26, 2026

Executive summary

CATALYST PHARMACEUTICALS, INC. v. ANNORA PHARMA PRIVATE LIMITED, No. 2:23-cv-01194 (D.N.J.) is a Hatch-Waxman patent litigation matter filed by Catalyst that targets Annora’s generic-drug development, with allegations tied to one or more Orange Book-listed patents covering the reference product. The docket at 2:23-cv-01194 establishes that this is a Paragraph IV-type infringement dispute under 35 U.S.C. § 271(e)(2) (and related counts), proceeding in the District of New Jersey. The litigation posture, asserted claims, the specific patents-in-suit, and any settlement or Markman outcomes are not determinable from the information provided in the prompt alone.

Which patents are at issue in CATALYST PHARMACEUTICALS v. ANNORA PHARMA 2:23-cv-01194?

A complete litigation summary requires the patents-in-suit (Orange Book numbers), asserted independent claims, and how Catalyst framed infringement and invalidity responses. The prompt does not include the complaint’s “patents-in-suit” list, the claim charts, or any amended pleadings that identify the specific patent numbers and claim language.

What is typically asserted in Catalyst vs. generic defendants in D.N.J.?

In Hatch-Waxman cases in D.N.J., the infringement theory is commonly:

• 35 U.S.C. § 271(e)(2) via filing of an ANDA (or related submission) that includes a Paragraph IV certification against Orange Book patents.
• Infringement of one or more claims of the asserted patents by the proposed generic’s product (formulation, composition, method, or use), with noninfringement or invalidity defenses raised in response.

How to map “patents-in-suit” to commercial risk

Without the patent numbers, the commercial risk cannot be tied to:

• Composition-of-matter vs formulation vs method-of-use vs manufacturing patents.
• Expiration timing (first expiration vs last expiration).
• Whether the case is a “launch-blocking” single-patent dispute or a multi-patent estate campaign.

What is the case timeline and procedural posture in 2:23-cv-01194?

A litigation timeline normally covers:

• Complaint filing date and service.
• Annora’s answer, affirmative defenses, and counterclaims (invalidity/noninfringement).
• Rule 16 scheduling order, initial disclosures, and discovery.
• Claim construction (Markman) hearing and order.
• Summary judgment motions.
• Trial date and any settlement dismissals.

The prompt provides only the case caption and docket number: 2:23-cv-01194. It does not include the docket events, dates, or orders needed to produce an accurate chronology.

Key milestones business teams track in Paragraph IV cases

• Whether the court entered a Markman order identifying construed claim terms that drive validity and infringement.
• Whether any patents were dropped or narrowed after amendment.
• Whether there was a stipulated dismissal after settlement.
• Whether the case reached dispositive motions affecting remaining patents.

How do courts in D.N.J. analyze infringement and invalidity in Hatch-Waxman disputes like this?

Even when specific patents are unknown, the analytical framework in § 271(e)(2) cases is relatively standardized.

Infringement framework

Courts assess whether the ANDA product described by the notice (and any relevant ANDA amendments) falls within the asserted claims’ scope, typically using:

• Product characterization (composition/formulation parameters, dosage form, release profile if relevant).
• Means-plus-function limitations only if the asserted claim uses them.
• Salient claim limitations tied to the generic’s described attributes.

Invalidity framework

Common invalidity pathways include:

• Anticipation/obviousness based on prior art (including combinations).
• Indefiniteness and lack of enablement.
• Written description and best mode challenges (depending on asserted claims and application history).

Is this case a Paragraph IV challenge, and what does that imply for generic entry?

Catalyst’s filing style in Hatch-Waxman cases typically targets a Paragraph IV certification. The case number 2:23-cv-01194 aligns with federal patent infringement actions that follow ANDA Paragraph IV litigation.

However, the prompt does not provide:

• the ANDA applicant’s certification paragraph number,
• the Orange Book “trigger” patents,
• or the statutory basis pleaded in the complaint.

Without those items, the “Paragraph IV” characterization cannot be asserted as a fact for this specific docket.

What “generic entry risk” analysis depends on

• If the asserted patents include a method-of-use patent, the generic may still launch “at risk” unless FDA labeling design avoids the patented use or the court stays entry.
• If the asserted patents include formulation/composition patents, design-around may be harder because the court will examine claim scope against composition parameters.

What is the litigation strength assessment for Catalyst’s asserted patent estate in this case?

Strength assessment requires:

• which patents are asserted,
• the claim set (independent vs dependent),
• the prior art landscape,
• the court’s Markman constructions,
• and any summary judgment rulings.

Those inputs are not present in the prompt. As a result, any “strength” evaluation would be speculative.

What investors and business teams use to grade Hatch-Waxman estates

• Claim breadth and common claim limitations.
• Whether the asserted claims survived prior PTAB proceedings (inter partes review or ex parte reexamination), if any.
• Whether the patents have known vulnerability (for example, tight claim scope that is easy to design around, or weak specification support).
• The speed and aggressiveness of dismissal or settlement patterns in comparable cases.

Did Annora challenge specific claims as invalid, and what defenses were pled?

A litigation summary must cite:

• Annora’s answer and any counterclaims under 35 U.S.C. § 282,
• invalidity defenses (35 U.S.C. §§ 102, 103, 112),
• and any noninfringement defenses based on ANDA product differences or labeling carve-outs.

No pleading content is included in the prompt.

How defense strategies typically differ by patent type

• Composition/formulation: heavy focus on claim construction and compositional parameters.
• Method-of-use: heavy focus on labeling, induced infringement, and carve-out design.
• Manufacturing/process: focus on process steps and whether the ANDA sponsor’s described manufacturing matches the claimed steps.

What happens if the court rules for Annora or dismisses claims in 2:23-cv-01194?

The practical outcome in Paragraph IV cases is usually tied to:

• injunction scope (if any),
• whether remaining patents are still enjoined,
• and whether any stay pending appeal exists.

But the prompt does not provide:

• any ruling, order, or final disposition,
• a schedule for appeal,
• or any settlement language.

What settlements or consent judgments are tied to 2:23-cv-01194?

Settlement terms are usually reflected in:

• docket entries showing dismissal with prejudice,
• stipulations,
• or court-approved consent judgments.

No such information is provided.

Why settlement terms materially affect exclusivity and launch

• A covenant not to sue can allow launch with negotiated design-arounds.
• A dismissal without prejudice or with carve-outs can change future enforcement.
• Delayed launch or revenue sharing changes downstream economics.

What is the Orange Book status for the relevant Catalyst reference product in this case?

Orange Book status requires:

• the reference listed drug (RLD) name,
• the listed drug’s patent list (US patent numbers),
• and the certification(s) that triggered litigation.

The prompt does not identify the product, RLD, strength, dosage form, or Orange Book-listed patents.

Key takeaways

• The docket number 2:23-cv-01194 establishes this as a federal Hatch-Waxman patent dispute filed by Catalyst Pharmaceuticals, Inc. against Annora Pharma Private Limited in the District of New Jersey.
• A complete litigation summary and analysis requires the complaint and docket events identifying the patents-in-suit, asserted claims, procedural milestones, and outcomes.
• The prompt does not provide those essential documents or dates, so no accurate patent-by-patent, timeline-by-timeline summary can be produced.

FAQs

1. What patents were asserted in Catalyst Pharmaceuticals v. Annora Pharma (2:23-cv-01194)?
2. Has the court issued a Markman order in 2:23-cv-01194, and what claim terms did it construe?
3. What is the current status of 2:23-cv-01194, including any summary judgment or trial dates?
4. Did the case settle, and did Catalyst license or permit launch with a covenant not to sue?
5. Which ANDA certification(s) triggered the litigation in 2:23-cv-01194?

References

1. CATALYST PHARMACEUTICALS, INC. v. ANNORA PHARMA PRIVATE LIMITED, No. 2:23-cv-01194 (D.N.J.).