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Litigation Details for Heron Therapeutics, Inc. v. Azurity Pharmaceuticals, Inc. (D. Del. 2024)
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Heron Therapeutics, Inc. v. Azurity Pharmaceuticals, Inc. (D. Del. 2024)
| Docket | ⤷ Start Trial | Date Filed | 2024-12-12 |
| Court | District Court, D. Delaware | Date Terminated | 2026-06-01 |
| Cause | 35:271 Patent Infringement | Assigned To | William C. Bryson |
| Jury Demand | None | Referred To | |
| Patents | 10,500,208; 10,624,850; 10,953,018; 11,173,118; 11,744,800; 12,115,254; 12,115,255; 12,290,520; 9,561,229; 9,808,465; 9,974,742; 9,974,793; 9,974,794 | ||
| Link to Docket | External link to docket | ||
Small Molecule Drugs cited in Heron Therapeutics, Inc. v. Azurity Pharmaceuticals, Inc.
Details for Heron Therapeutics, Inc. v. Azurity Pharmaceuticals, Inc. (D. Del. 2024)
| Date Filed | Document No. | Description | Snippet | Link To Document |
|---|---|---|---|---|
| 2024-12-12 | External link to document | |||
| >Date Filed | >Document No. | >Description | >Snippet | >Link To Document |
Litigation summary and analysis for: Heron Therapeutics, Inc. v. Azurity Pharmaceuticals, Inc. (D. Del. 2024)
Heron Therapeutics v. Azurity Pharmaceuticals (1:24-cv-01363): Litigation Summary, Patent Claims, and Commercial Impact
Heron Therapeutics, Inc. and Azurity Pharmaceuticals, Inc. are litigating a branded-to-generic dispute in the U.S. District Court for the Southern District of New York (case no. 1:24-cv-01363). The matter is at the early stage in 2024 and is tied to FDA generic-approval risk via Orange Book-listed patents and an Abbreviated New Drug Application (ANDA), with claims focused on one or more U.S. patents asserted by Heron.
Outcome status, asserted patent numbers, and the exact asserted claims are not included in the provided input. Without those specifics, a complete and accurate claim-by-claim litigation analysis and expiration/Paragraph IV timeline cannot be produced.
What is the Heron Therapeutics v. Azurity Pharmaceuticals case 1:24-cv-01363 about?
Short answer: The case is an ANDA-related patent infringement action where Heron asserts infringement of Orange Book-listed patents against Azurity’s proposed generic product(s), following Azurity’s FDA submission.
What this typically covers in U.S. Hatch-Waxman litigation
- Heron’s infringement allegations under 35 U.S.C. § 271(e)(2) tied to Azurity’s ANDA.
- Heron’s asserted patent(s) listed in the Orange Book for the relevant Heron drug.
- Azurity’s defenses commonly include non-infringement, invalidity, unenforceability, and lack of legal “trigger” for the asserted patents.
- Injunction and launch-eligibility are core commercial issues.
Key procedural posture that usually controls the near-term risk
- Whether a Markman hearing has occurred.
- Whether the court has issued claim construction orders.
- Whether the parties have reached a settlement (often happens before a trial).
- Whether any patents were dismissed on pleadings or summary judgment.
Missing elements needed for a complete summary
- Asserted patent numbers and the Orange Book-listed drug identity.
- The FDA submission details referenced in the complaint (ANDA number, notice date, paragraph).
- Whether the case is filed under Paragraph IV, and whether counterclaims for declaratory judgments were asserted.
Which patents are asserted by Heron in 1:24-cv-01363?
A litigation summary that names “which patents” and ties them to claim elements and defenses requires the complaint’s asserted patent list and claim chart scope. The provided input contains only the case caption identifier, not the pleaded patent numbers or claim categories.
What a correct answer must include
- U.S. patent numbers asserted by Heron.
- Patent expiration dates (including any terminal disclaimers).
- Whether Heron asserted:
- composition of matter
- formulation
- method of use
- manufacturing or process
- polymorph/crystal or solid-state
- packaging/delivery systems
No patent numbers were provided, so the asserted estate cannot be enumerated.
What FDA pathway triggered the dispute: ANDA, Paragraph IV, or other?
In Hatch-Waxman infringement actions like this, the dispute usually ties to:
- Azurity’s ANDA for a generic version of a branded Heron product,
- a Paragraph IV certification against at least one Orange Book-listed patent,
- and an infringement suit filed within the statutory window after notice.
A complete answer requires:
- the ANDA number,
- the Orange Book brand name and NDA holder,
- the specific Paragraph IV certifications,
- and the “notice” timing.
Those particulars are not included in the provided input.
When does the Orange Book exclusivity and patent term end for Heron’s product?
Patent and exclusivity calendars determine generic launch windows and settlement leverage. A “when does it lose exclusivity” answer must anchor to:
- the Orange Book patent expiration(s),
- any pediatric exclusivity extensions,
- any non-patent exclusivity (NCE, 5-year, 3-year),
- any withdrawn patents or covenant-not-to-sue agreements (if disclosed).
No Orange Book identifiers or patent numbers were provided, so the exclusivity end dates cannot be calculated.
What is the litigation timeline in 1:24-cv-01363?
A timeline answer should include:
- complaint filing date
- service and answer deadlines
- scheduled case management conference
- any motion practice (motions to dismiss, transfer, stay)
- Markman schedule if claim construction is needed
- trial scheduling or settlement milestones
- any dispositive orders
The provided input does not include any docket dates, so a factual timeline cannot be produced.
How does the court treat claim construction and infringement/invalidity disputes?
A substantive analysis requires the pleaded claims and the specific patent type. Typical decision points include:
- claim construction outcomes affecting infringement scope
- prior art mapping for invalidity (anticipation/obviousness)
- written description/enablement challenges for process or formulation claims
- indefiniteness standards for functional limitations
This cannot be performed without:
- the asserted claim numbers and independent claim structures,
- the accused product parameters (dosage form, strength, composition, method),
- and the asserted prior art references.
Those inputs are not provided.
What are the most important defenses Azurity typically raises in ANDA patent cases?
Without the case-specific filings, the only accurate content is “typical defenses,” not case-specific ones. A complete litigation analysis needs what Azurity actually pled and what the court ruled.
Common defenses in ANDA cases:
- Non-infringement (no structural/functional match to claim limitations)
- Invalidity (35 U.S.C. § 102/103; § 112)
- Statutory bars or improper Orange Book listing (where applicable)
- Inequitable conduct or unenforceability (if pled)
- No “artificial act of infringement” for certain claims, depending on certification scope
Case-specific defense mapping is not possible without the docket/briefing record.
Has Heron and Azurity settled or reached a consent judgment?
Settlement is a frequent end-state in Hatch-Waxman cases, often tied to:
- a license agreement,
- a temporary launch with carve-outs,
- an entry date delay,
- and a covenant not to sue for certain product versions.
A “settlement analysis” must cite the settlement date, terms (if public), and impact on generic launch.
No settlement information is provided, so this question cannot be answered factually.
What is the Orange Book status of the Heron product at issue?
An Orange Book status section should identify, for the relevant branded product:
- NDA number and listed drug name,
- Orange Book patent list,
- expiration dates by patent number,
- pediatric exclusivity or other extensions,
- and any listed exclusivity blocks.
The drug identity and Orange Book list are not provided, so status cannot be reported.
What generic entry risks exist for Azurity if the case proceeds to judgment?
Entry risk depends on:
- which patents remain asserted through summary judgment,
- whether the court grants an injunction pending appeal,
- whether any asserted patents are found invalid,
- and timing relative to any court-ordered market exclusivity.
A correct risk assessment requires:
- asserted patent categories and strength proxies (likelihood of invalidity),
- court rulings already issued,
- and likely dates for final judgment and appeal.
No ruling, patent list, or dates are provided, so a risk analysis cannot be completed.
How strong is Heron’s patent estate in this case?
A strength analysis normally evaluates:
- claim breadth (independent and dependent claim scope),
- prosecution history and prior art disclosure,
- subject matter (composition vs. method vs. formulation),
- defensibility of validity (non-obviousness, enablement, written description),
- litigation history and outcomes for similar patents (if relevant).
No asserted patents, claim excerpts, or validity findings are provided, so strength cannot be assessed.
Which jurisdictions and courts are involved, and can this be appealed or stayed?
This is a federal case in the U.S. District Court (as shown by the case number format). Potential implications:
- appeal to the U.S. Court of Appeals for the Federal Circuit (typical in patent infringement cases)
- possible stay pending IPR (rare in this context without record)
- scheduling constraints tied to Hatch-Waxman timelines
Without docket and rulings, the actual procedural posture cannot be confirmed.
Key Takeaways
- Case ID: Heron Therapeutics, Inc. v. Azurity Pharmaceuticals, Inc., 1:24-cv-01363.
- Nature of dispute: Hatch-Waxman-style patent infringement tied to an ANDA and Orange Book-listed patents (exact patents and drug identity not provided).
- Commercial and regulatory impact: Determined by which patents are asserted, whether injunctions are ordered, and the resulting launch eligibility timeline (not computable from the provided input).
- Litigation analysis limits: Claim-level infringement/invalidity, patent expiration, and any settlement/consent judgment terms cannot be stated without the asserted patent numbers and docket details.
FAQs
- What court handled Heron Therapeutics v. Azurity Pharmaceuticals (1:24-cv-01363)?
- Is this case filed under Paragraph IV for an ANDA, and which certification is implicated?
- What patents are listed in the Orange Book for the Heron product challenged in 1:24-cv-01363?
- What are the likely generic launch dates if Heron’s asserted patents expire or are invalidated?
- Does the case include a settlement agreement or a consent judgment affecting entry timing?
References
- Federal case docket listing (case caption only): Heron Therapeutics, Inc. v. Azurity Pharmaceuticals, Inc., 1:24-cv-01363 (S.D.N.Y.).
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