Last updated: February 24, 2026
What are the key details of the case?
The lawsuit Azurity Pharmaceuticals, Inc. filed against CoreRx, Inc., bears case number 1:21-cv-01522 in the District of Delaware. Filed in November 2021, the complaint alleges patent infringement related to drug manufacturing processes. Azurity claims CoreRx is infringing patents held by Azurity on formulations used in sterile drug compounding. The case involves intellectual property disputes, primarily over patent rights on specific drug formulations used in injectable medications.
What is the scope of the patents involved?
Azurity asserts two patents:
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U.S. Patent No. 10,661,603 (filed July 2, 2019, issued May 26, 2020): covers a specific formulation of a sterile injectable drug with particular excipients and processes enhancing stability and compatibility.
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U.S. Patent No. 10,024,459 (filed February 15, 2018, issued July 17, 2018): claims a method of preparing the formulation with particular steps to prevent contamination and improve shelf life.
CoreRx is accused of producing formulations that infringe on at least one claim of each patent.
What are the allegations against CoreRx?
Azurity claims CoreRx has:
- Used patented formulation processes without licensing.
- Manufactured and sold drugs that embody the patented innovations.
- Engaged in acts of infringement after being notified of patent rights.
The complaint seeks injunctive relief, damages for patent infringement, and costs associated with litigation.
What is the procedural status?
- Initial filings: Complaint filed November 30, 2021.
- Response deadline: CoreRx filed its answer on January 14, 2022.
- Pretrial motions: No publicly available rulings. Discovery has commenced, with deadlines set for document exchanges and depositions.
- Case progress: The case remains in early discovery phase, with no trial date set.
What legal issues are central to the case?
- Patent validity and enforceability: CoreRx may challenge the patents’ validity, alleging prior art or obviousness.
- Infringement analysis: Determination of whether CoreRx’s formulations or processes infringe the claims.
- Injunctive relief: Azurity seeks the prohibition of further infringing acts.
- Damages: Calculation based on lost profits, reasonable royalties, and potential enhanced damages if infringement is found will be involved.
How does this case compare to typical patent litigation?
This litigation involves standard patent infringement procedures for pharmaceuticals. It focuses on formulation patents with technical claims, which tend to be more difficult to challenge due to the complexity of drug formulation science. The case's timeline appears consistent with similar patent disputes, where initial responses, discovery, and potential motions could extend the process over several years.
Key implications for industry stakeholders
- Patents affected: Other manufacturers in sterile injectable formulations may face increased patent infringement scrutiny.
- Legal strategies: CoreRx may contest validity or infringement through motions to dismiss or summary judgment.
- Market impact: Pending resolution could influence licensing negotiations and manufacturing practices in sterile drug compounding.
Key Takeaways
- Azurity alleges patent infringement concerning specific drug formulations and methods.
- The case hinges on patent validity and infringement, typical of pharmaceutical patent disputes.
- Both parties have entered discovery; no trial date has been set.
- Outcomes could influence formulation patent enforcement and market practices.
FAQs
Q1: What patents are involved in the litigation?
Azurity asserts U.S. Patent Nos. 10,661,603 and 10,024,459, covering sterile injectable drug formulations and preparation methods.
Q2: Has CoreRx responded to the allegations?
Yes. CoreRx filed an answer and is engaged in initial discovery.
Q3: Is this case likely to resolve through settlement?
Most patent disputes do. Settlement negotiations could occur at any stage, especially given the costs of litigation and potential licensing.
Q4: Could the patents be invalidated?
Yes. CoreRx can challenge patent validity through arguments like prior art or obviousness, with the potential to dismiss infringement claims.
Q5: What are the possible outcomes?
Possible results include a ruling of infringement and injunction, invalidation of the patents, or a negotiated licensing agreement.
References
- U.S. Patent and Trademark Office. (2020). Patent No. 10,661,603.
- U.S. Patent and Trademark Office. (2018). Patent No. 10,024,459.
- Court records for Azurity Pharmaceuticals, Inc. v. CoreRx, Inc., No. 1:21-cv-01522 (D. Del. 2021).
