Litigation Details for Azurity Pharmaceuticals, Inc. v. Appco Pharma LLC (D. Del. 2026)

Azurity Pharmaceuticals, Inc. v. Appco Pharma LLC (D. Del. 2026)

Docket		Date Filed	2026-04-08
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Gregory B. Williams
Jury Demand	None	Referred To
Parties	APPCO PHARMA LLC
Patents	11,478,456; 11,529,333; 12,491,179
Link to Docket	External link to docket

Details for Azurity Pharmaceuticals, Inc. v. Appco Pharma LLC (D. Del. 2026)

Date Filed	Document No.	Description	Snippet	Link To Document
2026-04-08				External link to document

Litigation summary and analysis for: Azurity Pharmaceuticals, Inc. v. Appco Pharma LLC (D. Del. 2026)

Last updated: July 14, 2026

Azurity Pharmaceuticals v. Appco Pharma LLC (1:26-cv-00402): Litigation Summary, Patent Claims, and Commercial Exposure

What is the Azurity v. Appco Pharma LLC case (1:26-cv-00402) about?

Azurity Pharmaceuticals, Inc. v. Appco Pharma LLC is docketed as 1:26-cv-00402 in the U.S. District Court for the District of Delaware (with Azurity as plaintiff). The case is a patent infringement dispute framed under the Hatch-Waxman model, indicating the core issues typically include:

• infringement of Orange Book-listed patents tied to Azurity’s reference product(s),
• a Paragraph IV (or related) FDA certification dispute, and
• an asserted sales/ANDA entry threat tied to a generic or other FDA-eligible competitor’s application.

Case number: 1:26-cv-00402
Parties: Azurity Pharmaceuticals, Inc. (Plaintiff) vs. Appco Pharma LLC (Defendant)
Court: U.S. District Court (Delaware)
Filing year: 2026

What litigation claims and causes of action are at issue?

In Hatch-Waxman-style pharmaceutical patent litigation, claims almost always target:

• one or more U.S. patents listed in the Orange Book for the relevant drug product;
• alleged infringement by the defendant’s proposed drug manufacturing, use, sale, offer for sale, or importation based on ANDA/filing disclosures; and
• associated declaratory relief tied to the defendant’s FDA pathway.

Likely claim types for this docket format (standard structure):

• Infringement of one or more composition, formulation, method-of-use, or manufacturing/process patents
• A case-specific claim for injunctive relief to prevent FDA approval and launch during the patent term (or until specific patent/regulatory milestones are reached)

What patents are asserted in 1:26-cv-00402?

No patent numbers or asserted claims are provided in the available input. Without the complaint text (or a docket entry that lists asserted patent estates), a complete, accurate summary of asserted patents, claims, and legal theories cannot be produced.

What is the litigation posture and timeline for Azurity v. Appco (1:26-cv-00402)?

The available input includes only the case caption and docket number. It does not include:

• complaint filing date,
• answer or responsive pleadings,
• amended complaints,
• Markman schedule,
• claim construction filings,
• summary judgment briefing,
• trial scheduling,
• settlement or consent judgment docket entries.

A precise litigation timeline cannot be produced from the provided information.

Has Appco Pharma filed a Paragraph IV certification in this dispute?

The case number format and typical Hatch-Waxman litigation pattern indicate a likelihood of FDA ANDA litigation context (Orange Book patent infringement allegations paired with a certification challenge). However, the input does not state the FDA ANDA number, the Paragraph IV status, or the specific certification type, so the exact certification posture cannot be stated.

Who are the likely patent holders and what is the strength of the estate?

The question of patent holders, assignees, and estate strength depends on the exact asserted patent set (and their prosecution history, remaining term, and litigation history). That requires:

• the asserted patent list from the complaint or docketed exhibits,
• the expiration dates and maintenance status,
• whether the patents are composition vs. formulation vs. method-of-use vs. process,
• and whether there are prior invalidity or noninfringement findings.

No such data is present in the available input, so an estate-strength assessment cannot be completed.

What remedies are Azurity seeking in 1:26-cv-00402?

In Hatch-Waxman cases, plaintiffs typically seek:

• injunction preventing the defendant from commercially manufacturing/using/selling/importing the infringing product until patent expiry or legal resolution,
• damages for past infringement (if relevant to the claims),
• costs and fees where authorized, and
• declaratory relief that the defendant’s proposed launch is not permitted during the patent term.

Specific requested remedies and counts cannot be confirmed without the complaint.

What defenses are likely raised by Appco in a Delaware ANDA patent case?

Common defenses in Hatch-Waxman patent infringement suits include:

• noninfringement (no practicing of each claim element),
• invalidity (anticipation/obviousness, lack of written description/enablement, indefiniteness, etc.),
• unenforceability (inequitable conduct, prosecution history estoppel), and
• lack of standing or improper venue (less common post-transfer into Delaware for Hatch-Waxman).

But the actual defenses for this docket cannot be stated from the provided input.

How does this case affect generic entry risk for Azurity’s product(s)?

Commercial entry risk hinges on:

• whether the asserted patents include early-expiring composition-formulation claims or later-expiring method/process claims,
• the ability to design around the claim scope,
• whether any settlement triggers a “first applicant” or non-launch carve-out,
• and the current stage of litigation relative to FDA approval windows.

No product identity, drug strength/dosage form, or patent expiration dates are provided, so a quantified generic entry-risk assessment cannot be produced.

What is the Orange Book status of the relevant Azurity product in this dispute?

Orange Book status requires:

• the specific listed drug name (RLD),
• NDC(s),
• patent numbers,
• and listing codes (drug substance, drug product, method of use).

None of these details are present, so Orange Book listing analysis cannot be completed.

Could this become a biosimilar or 505(b)(2) style dispute instead of an ANDA?

A biosimilar case would center on BPCI Act provisions and would not map to the standard Orange Book Hatch-Waxman framework. A 505(b)(2) case is also distinct.
The input does not include product type, FDA application number, or regulatory pathway.

A pathway classification cannot be stated without docket or complaint details.

What settlement terms are possible in this kind of Azurity v. Appco litigation?

Where Hatch-Waxman cases settle, common terms include:

• a launch date agreement,
• a “carve-out” that may allow earlier launch for non-infringing strengths/forms,
• mutual covenants not to sue,
• dismissal with or without stipulated final judgment,
• and sometimes licensing fees or royalties.

No settlement docket entries or press releases are provided.

Which court filings typically drive outcomes (and where the case likely stands)

For early-stage patent litigation, the most outcome-determinative milestones include:

• claim construction (Markman),
• preliminary injunction briefing (if sought),
• dispositive motions (12(b)(6), 35 U.S.C. challenges for invalidity contentions),
• Daubert challenges (if technical experts),
• and summary judgment on infringement/invalidity.

No filings or hearing dates are included in the input, so the current posture cannot be mapped.

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Key Takeaways

• Case identified: Azurity Pharmaceuticals, Inc. v. Appco Pharma LLC, 1:26-cv-00402 in Delaware.
• Dispute type: Most consistent with Hatch-Waxman-style patent infringement litigation against a prospective generic entry, but specific FDA, Orange Book, and asserted patent details are not provided.
• Cannot be completed from current input: asserted patent numbers, claim scope, infringement/invalidity arguments, remaining term and expiration dates, Markman or motion schedule, and settlement status.

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FAQs

1. What court and district is Azurity v. Appco Pharma LLC filed in (1:26-cv-00402)?
2. Is 1:26-cv-00402 an ANDA Paragraph IV dispute or another FDA pathway challenge?
3. Which Azurity product and NDC(s) are at issue in 1:26-cv-00402?
4. What patents (Orange Book-listed) does Azurity assert against Appco in this case?
5. Has this case reached claim construction, summary judgment, or settlement as of today?

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References

1. U.S. District Court for the District of Delaware. Azurity Pharmaceuticals, Inc. v. Appco Pharma LLC, Case No. 1:26-cv-00402. (Case docket information provided in prompt).