Litigation Details for AXSOME MALTA LTD. v. ALKEM LABORATORIES LTD. (D.N.J. 2023)

AXSOME MALTA LTD. v. ALKEM LABORATORIES LTD. (D.N.J. 2023)

Docket		Date Filed	2023-09-13
Court	District Court, D. New Jersey	Date Terminated	2026-06-04
Cause	35:271 Patent Infringement	Assigned To	Stanley R. Chesler
Jury Demand	None	Referred To	Leda Dunn Wettre
Parties	HETERO LABS LIMITED UNIT-V; HIKMA PHARMACEUTICALS USA INC.
Patents	10,195,151; 10,351,517; 10,512,609; 10,912,754; 10,940,133; 10,959,976; 11,160,779; 11,439,597; 11,560,354; 11,648,232; 8,440,715; 8,877,806; 9,604,917
Attorneys	ALEXANDER LEE CALLO; REBEKAH R. CONROY
Firms	Counsel Not Admitted to Usdc Nj Bar, Quinn Emanuel Urquhart & Sullivan, LLP; Midlige Richter LLC
Link to Docket	External link to docket

Details for AXSOME MALTA LTD. v. ALKEM LABORATORIES LTD. (D.N.J. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-09-13				External link to document
2023-09-13	1	Complaint	(“the ’917 patent”), 10,351,517 (“the ’517 patent”), 10,195,151 (“the ’151 patent”), 10,512,609 (“the…715 patent, the ’151 patent, the ’609 patent, the ’597 patent, the ’754 patent, the ’976 patent, the…715 patent, the ’151 patent, the ’609 patent, the ’597 patent, the ’976 patent, the ’779 patent, the…715 patent, the ’151 patent, the ’609 patent, the ’597 patent, the ’754 patent, the ’976 patent, the…715 patent, the ’151 patent, the ’609 patent, the ’597 patent, the ’754 patent, the ’976 patent, the	External link to document
2023-09-13	32	Answer to Complaint AND Counterclaim	(“the ’917 patent”), 10,351,517 (“the ’517 patent”), 10,195,151 (“the ’151 patent”), 10,512,609…infringed U.S. Patent Nos. 8,440,715 (‘the ’715 patent”), 10,195,151 (“the ’151 patent”), 10,512,609 (… to list U.S. Patent Nos. 8,440,715 (‘the ’715 patent”), 10,195,151 (“the ’151 patent”), 10,512,609…Declaratory Judgment of Noninfringement of U.S. Patent No. 10,195,151) 35. Hetero incorporates …Declaratory Judgment of Invalidity of U.S. Patent No. 10,195,151) 39. Hetero incorporates	External link to document
2023-09-13	62	Answer to Counterclaim	United States Patent Nos. 8,440,715 (‘the ’715 patent”), 10,195,151 (“the ’151 patent”), 10,512,609 …) to list U.S. Patent Nos. 8,440,715 (‘the ’715 patent”), 10,195,151 (“the ’151 patent”), 10,512,609 …’715 patent, the ’151 patent, the ’609 patent, the ’597 patent, the ’754 patent, the ’976 patent, the…the ’779 patent, the ’133 patent, the ’354 patent, and the ’232 patent. ANSWER: Axsome admits …10,512,609 (“the ’609 patent”), 11,439,597 (“the ’597 patent”), 10,912,754 (“the ’754 patent”), 10,959,976 (“	External link to document

Litigation summary and analysis for: AXSOME MALTA LTD. v. ALKEM LABORATORIES LTD. (D.N.J. 2023)

Last updated: July 18, 2026

Litigation summary for Axsome Malta Ltd. v. Alkem Laboratories Ltd., 2:23-cv-20354 (D.N.J.)

Axsome Malta Ltd. sued Alkem Laboratories Ltd. in the District of New Jersey (case no. 2:23-cv-20354), seeking to block FDA-approved generic entry tied to asserted intellectual property covering a branded pharmaceutical product. The docket reflects an IP enforcement action structured as Hatch-Waxman litigation. The litigation’s posture, deadlines, and event history are not provided in the prompt, so a complete, accuracy-guaranteed summary cannot be produced from the available information.

What patents protect Axsome Malta’s drug vs. Alkem’s generic at 2:23-cv-20354?

A complete patent-by-patent mapping (listed patents, patent numbers, expiration dates, and asserted claims) is not available in the prompt. Without the asserted patent list and the claims asserted in the complaint and any infringement contentions, no complete analysis of the patent estate can be provided.

Which Orange Book patents were asserted in Axsome Malta’s complaint?

Axsome Malta’s complaint typically asserts one or more Orange Book listed patents tied to the NDA/BLA reference product and corresponding generic ANDA. The prompt does not include:

• the reference product name
• the ANDA number(s) at issue
• the Orange Book patent list
• the specific Orange Book patents Axsome Malta asserted under 35 U.S.C. § 271(e)(2)

No featured-snippet-ready answer can be generated.

What is the litigation theory: direct infringement, induced infringement, or both?

Hatch-Waxman cases usually plead infringement under § 271(e)(2) and may also include supplemental theories. The prompt provides no pleading excerpt or summary of alleged infringement theories, so none can be stated as fact.

When does Axsome Malta’s asserted patent(s) expire, and when does exclusivity end?

No patent expiration dates or regulatory exclusivity details are included in the prompt. Without the asserted patent numbers and listed expiration data, any exclusivity timeline would risk inaccuracy.

What is the likely Paragraph IV structure and certification date?

Paragraph IV challenges depend on the ANDA’s certification and filing dates, which are not present in the prompt. A certification-by-certification chronology cannot be produced.

What procedural events and motion rulings occurred in 2:23-cv-20354?

A litigation summary requires the docket’s event list, including: complaint filing date, service date, answer, claim construction schedule (if any), Markman briefing, PI motions, settlement/consent judgment, and trial or dispositive motion rulings. None of these are included in the prompt. A litigation timeline cannot be completed accurately.

Has the case resulted in a settlement or stipulated dismissal?

No settlement outcome, dismissal status, or consent judgment terms are included in the prompt. This cannot be determined.

Were any patents narrowed or dropped during the litigation?

No amendment history or case management orders are provided. A change-log cannot be generated.

What generic entry risks exist for Alkem based on this litigation?

The generic entry risk analysis depends on the outcome of any PI motion, the presence of an injunction, and any settlement terms that affect launch timing. The prompt does not include any of these results, so risk can’t be quantified.

Did the court grant or deny any preliminary injunction?

No PI outcome is provided. Without it, launch risk cannot be assessed.

What settlement terms typically govern launch in Axsome Malta vs. Alkem, and did they occur here?

Settlement analysis requires documented terms such as:

• launch date
• carve-outs (dosage strengths, package sizes, regional markets)
• continued exclusivity at FDA via “skinny label” restrictions
• covenants not to sue
• payment amounts or reverse-payment provisions (if any)

No settlement terms appear in the prompt, so none can be stated.

Which FDA pathway and ANDA status is implicated by the complaint?

No ANDA number, FDA reference product, drug substance, dosage form, strength, or approval status (tentative approval vs. approval) is included in the prompt. Without these, FDA status analysis cannot be accurate.

What is the Orange Book status of the reference product at issue?

Orange Book listings cannot be reproduced without the reference product and NDA number.

How does this litigation compare with other Hatch-Waxman suits against Alkem by brand owners?

A comparative analysis requires either:

• the same brand owner’s other cases against Alkem
• Alkem’s other defendants’ cases
• similar asserted patent estates and outcomes

The prompt only provides the case caption and docket number, which is insufficient to support a comparison as fact.

Key Takeaways

• Axsome Malta Ltd. brought a Hatch-Waxman-style patent infringement action against Alkem Laboratories Ltd. in D.N.J., case no. 2:23-cv-20354.
• The prompt does not include the asserted patent list, FDA/Orange Book context, docket event history, or motion/settlement outcomes.
• A complete, accuracy-guaranteed litigation summary and patent estate analysis cannot be produced from the information provided.

FAQs

1. What is the typical claim set in Hatch-Waxman cases like Axsome Malta v. Alkem?
2. How do Paragraph IV certifications affect when a generic can launch during litigation?
3. What docket events most influence launch timing in D.N.J. patent cases?
4. How can settlement terms alter the FDA approval path (including “skinny label” scope)?
5. What data sources are used to map asserted patents to Orange Book listings in litigation reviews?

References (APA)

1. United States District Court for the District of New Jersey. Axsome Malta Ltd. v. Alkem Laboratories Ltd., No. 2:23-cv-20354. (Docket and filings).