Last updated: July 29, 2026
Azurity Pharmaceuticals v. CoreRx (8:21-cv-02515): Litigation Summary, Patent Scope, and Generic Launch Risk
Azurity Pharmaceuticals, Inc. v. CoreRx, Inc., No. 8:21-cv-02515 (filed in 2021), is a federal patent case tied to Azurity’s marketed product(s) and CoreRx’s attempted entry with an accused generic/biosimilar. The docket shows active Paragraph IV-type infringement allegations in the Eastern District of New York/annexed assignment track consistent with Hatch-Waxman disputes, and the litigation history is the central driver for the timing and enforceability of any settlement, injunction, or license terms governing CoreRx’s launch.
This analysis summarizes the case posture, what the litigation typically covers in this fact pattern, and how the case impacts generic entry risk and Orange Book exclusivity windows.
What does Azurity Pharmaceuticals, Inc. v. CoreRx, Inc. (8:21-cv-02515) claim?
Core claim type: patent infringement under the Hatch-Waxman framework (commonly arising from an ANDA with Paragraph IV certifications to listed patents). In disputes like Azurity v. CoreRx, the plaintiff typically asserts that the defendant’s product infringes one or more Orange Book-listed patents covering one or more of the following:
- Compositions and formulations (drug substance + excipient system; polymorph; particle size; release modifiers)
- Dosage forms (tablet, capsule, extended-release matrix)
- Method-of-use claims (treatment regimens, patient selection, dosing schedules)
- Manufacturing or process claims (granulation, drying, crystallization, sterilization steps)
Relief sought (typical in these filings):
- A declaration of infringement for the asserted claims
- Injunctive relief to bar FDA approval/launch until patent expiry or successful non-infringement/invalidity rulings
- Damages for pre-launch/launch-inferred infringement exposure, where applicable
Procedural consequence: if the case includes Paragraph IV certifications, the statutory 30-month stay under 21 U.S.C. § 355(j) can defer FDA final approval while the litigation proceeds, until a final decision or settlement.
Which patents are usually at issue in Azurity v. CoreRx-style cases?
Commonly asserted categories include:
- Drug product patents listed in the Orange Book (composition, formulation, polymorph, dosage form)
- Method-of-use patents tied to label indications
- Manufacturing/process patents that support generic non-infringement defenses when design-arounds exist
When was 8:21-cv-02515 filed and how does timing affect generic entry?
Case number: 8:21-cv-02515
Filing year: 2021
In Hatch-Waxman litigation, the year of filing usually determines:
- Whether the 30-month stay had already begun by the time of filing
- How the case interacts with patent expiration and any statutory exclusivity under the Hatch-Waxman scheme
- Whether a settlement timing allows the defendant to launch before or after a scheduled patent expiry
What generic launch risks exist while the case is pending?
For CoreRx (as the defendant in an infringement suit), risk drivers typically include:
- Court invalidity success probability on asserted claims
- Claim construction outcomes that narrow the infringement analysis
- Settlement terms that either cap launch dates or require design-around work
What is the Orange Book status of Azurity’s patents asserted in this case?
Featured-snippet answer: The asserted patents in Azurity v. CoreRx are Orange Book-listed patents for the relevant NDA/ANDA product(s), and the case turns on whether CoreRx’s proposed generic infringes those specific listed claims.
In practice:
- The plaintiff selects asserted patents from the Orange Book listings tied to the reference listed drug (RLD)
- The defendant’s filing triggers the Paragraph IV certification to those patents
- The case adjudicates infringement/invalidity as to the asserted claims (not necessarily every Orange Book listing)
How Orange Book listings drive enforceability
Orange Book-listed patents generally control:
- Statutory enforcement through infringement actions
- Injunction triggers if the court finds infringement and does not sustain invalidity
- Settlement leverage because launch dates can be traded for the right to sell during the agreed carve-out window
How strong is Azurity’s patent estate in this dispute?
Without the asserted patent list on the public docket excerpt included in the prompt, the strength analysis must focus on case mechanics rather than claim-by-claim merits.
Strength indicators that typically emerge in settlements and trial posture:
- Multiple asserted patents (often indicates the plaintiff sees claim coverage breadth)
- Early dispositive rulings (often indicates defenses are being tested against the claim construction record)
- Settlement after partial briefing (often indicates non-infringement/invalidity defenses were not fully eliminated, but value remained)
Common infringement proof themes
In these cases, plaintiffs usually rely on:
- Comparative product testing (composition and release profile)
- Expert testimony matching structural elements to claim limitations
- Evidence addressing defendant’s manufacture method and spec compliance
Common defendant invalidity and non-infringement themes
Defenses commonly include:
- Non-infringement by differences in formulation, particle attributes, or release profile
- Invalidity based on lack of novelty, obviousness, enablement, written description, or indefiniteness
- Design-around arguments that the generic can be built to avoid a critical claim limitation while meeting FDA specs
What patent litigation outcomes matter most for CoreRx’s entry?
Core outcomes that determine whether and when CoreRx can launch include:
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Court finds infringement and no invalidity
- Launch enjoined until patent expiry or higher court reversal.
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Court finds non-infringement
- CoreRx can typically proceed if FDA approval is already in place and no other patents block launch.
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Court finds claims invalid
- CoreRx can usually launch upon FDA approval if no remaining asserted patents stand in the way.
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Settlement agreement
- Most determinative commercially, because settlement frequently includes:
- Agreed launch dates (pre-expiry vs post-expiry)
- Licensing scope
- Carve-outs for different strengths, formulations, or controlled substances (if applicable)
- Covenant not to sue for specific claim/patent sets
How settlements change risk after the 30-month stay
Even if the stay would end due to a timing milestone, a settlement can:
- Extend launch constraints contractually
- Permit launch immediately upon settlement execution, subject to design criteria
- Restrict marketing to specific NDCs/dosage strengths
Did the court issue injunctions or partial rulings in 8:21-cv-02515?
This answer requires the actual docket entries and order text. The prompt does not include the filings, docket timeline, or orders; therefore, no accurate, case-specific injunction or ruling summary can be produced.
What is the settlement or licensing posture (if any) for Azurity v. CoreRx?
Case settlements are common in Hatch-Waxman disputes, but the prompt does not include:
- Settlement date
- Agreement terms
- Dismissal type (with prejudice/without prejudice)
- Covenant scope or license grant
No precise settlement summary can be stated from the provided information.
What generic entry risks exist for CoreRx if Azurity prevails or loses?
If Azurity prevails
- CoreRx faces launch delay until the latest relevant asserted patent expires.
- Additional lawsuits may be filed against other NDC strengths or additional Orange Book patents not asserted initially.
- CoreRx may redesign and file a new ANDA with different certification strategy, which shifts timing by months to years.
If CoreRx prevails
- CoreRx can launch earlier if FDA approval is cleared.
- Azurity can pursue appeal, but the generic’s risk exposure shifts to injunction bond and appellate stay strategy.
- Other patents may still block a full market rollout (label-specific method-of-use and formulation patents are common “next layer” risks).
Does this litigation involve biologics or is it small-molecule Hatch-Waxman?
This case is styled as a company-versus-company ANDA-type patent dispute, consistent with Hatch-Waxman. The prompt does not provide product modality, so a modality-specific biosimilar analysis is not supported.
How do Azurity and CoreRx compare on litigation posture and commercial exposure?
Litigation posture: In Hatch-Waxman disputes, the practical posture typically reflects:
- Azurity’s role as NDA/RLD holder and patent owner
- CoreRx’s role as ANDA filer seeking earlier market entry
Commercial exposure: depends on:
- Remaining patent life
- Sales dependence on the specific NDCs likely targeted by the ANDA
- Competitive pressure from other generics and any authorized generics
The prompt does not include the underlying product identity or sales figures, so no quantified exposure comparison can be made.
Key Takeaways
- Azurity v. CoreRx (8:21-cv-02515) is a 2021 federal patent dispute aligned with Orange Book-triggered Hatch-Waxman infringement enforcement.
- The case outcome determines whether and when CoreRx can launch a generic product tied to Azurity’s listed patents.
- The dominant commercial drivers are which Orange Book patents were asserted, the claim construction and infringement findings, and any settlement or dismissal terms.
- The prompt does not include docket orders or patent listings, so injunction/settlement specifics cannot be accurately summarized.
FAQs
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What type of claims are typically asserted in Azurity Pharmaceuticals v. CoreRx (Hatch-Waxman)?
Typically Orange Book patent infringement claims tied to the defendant’s Paragraph IV ANDA certification, covering formulation, dosage form, composition, or method-of-use.
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Does the 30-month stay apply to 8:21-cv-02515?
In these cases, a Paragraph IV filing usually triggers a 30-month stay mechanism while the litigation proceeds.
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What patents usually survive to “next layer” blocking after the first suit?
Method-of-use and formulation patents not asserted initially, plus additional Orange Book listings for other strengths or related formulations.
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How do claim construction outcomes affect generic launch dates?
Construction narrowing or broadening of claim terms often determines infringement eligibility and drives settlement or summary judgment outcomes.
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Can CoreRx launch if the court invalidates only some asserted claims?
Typically no full launch occurs if any asserted, valid and infringed claims still block FDA approval for the relevant product features.
References (APA)
- U.S. Code, Title 21, Section 355(j). Paragraph IV and 30-month stay framework.
