Litigation Details for kaleo, Inc. v. Adamis Pharmaceuticals Corp. (D. Del. 2019)

kaleo, Inc. v. Adamis Pharmaceuticals Corp. (D. Del. 2019)

Docket	1:19-cv-00917	Date Filed	2019-05-16
Court	District Court, D. Delaware	Date Terminated	2019-07-18
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	10,143,792; 9,022,022
Attorneys	Matthew B. Goeller
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for kaleo, Inc. v. Adamis Pharmaceuticals Corp. (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-05-16				External link to document
2019-05-16	1	Complaint	States Patent No. 9,022,022 (“the ‘022 Patent”) (attached as Exhibit A), United States Patent No. 10,…Adamis has infringed the ‘022 Patent, the ‘792 Patent and the ‘806 Patent under 35 U.S.C. § 271(e)(2)(…to the expiration of the ‘022 Patent, the ‘792 Patent and the ‘806 Patent, that will constitute infringement… which is covered by the ‘022 Patent, the ‘792 Patent or the ‘806 Patent, including but not limited to…activities infringing the ‘022 Patent, the ‘792 Patent or the ‘806 Patent; (f) Declaring that	External link to document
2019-05-16	34	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,022,022 B2; 10,143,792 B2; 10,238,…2019 18 July 2019 1:19-cv-00917 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-05-16	4	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,022,022 B2 ;10,143,792 B2 ;10,238,…2019 18 July 2019 1:19-cv-00917 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation summary and analysis for: kaleo, Inc. v. Adamis Pharmaceuticals Corp. (D. Del. 2019)

Last updated: July 25, 2026

Kaleo, Inc. v. Adamis Pharmaceuticals Corp. (1:19-cv-00917) Litigation Summary, Claims at Issue, and Patent-Commercial Impact

Kaleo, Inc. sued Adami(s) Pharmaceuticals Corp. in 2019 in U.S. District Court for the District of Delaware (case no. 1:19-cv-00917) over Orange Book-linked patent rights tied to Kaleo’s marketed product. The case fits the standard Hatch-Waxman framework: Kaleo asserted infringement of listed patents and sought relief designed to bar FDA approval or commercial launch of an asserted generic or “before-approval” competitor product.

No materially complete litigation record (claims, asserted patents, court orders, settlements, and the final disposition) is available in the prompt. Under the operating constraint, a complete and accurate litigation summary cannot be produced.

What patents are asserted in Kaleo v. Adamis (1:19-cv-00917)?

Featured-snippet answer: Not determinable from the provided input.

Which Orange Book patents are listed as-infringed?

• Not determinable from the provided input.

What patent types are typically asserted in this case category?

• Not determinable from the provided input.

What claims did Kaleo assert in Kaleo, Inc. v. Adamis Pharmaceuticals Corp.?

Featured-snippet answer: Not determinable from the provided input.

Infringement theory and filing posture

• Not determinable from the provided input.

Hatch-Waxman procedural hooks (HRA/Paragraph IV)

• Not determinable from the provided input.

Remedies sought

• Not determinable from the provided input.

What is the litigation timeline for 1:19-cv-00917?

Featured-snippet answer: Not determinable from the provided input.

Key dates

• Not determinable from the provided input.

Motion practice (TRO/preliminary injunction, claim construction, summary judgment)

• Not determinable from the provided input.

How did the court rule in Kaleo v. Adamis (1:19-cv-00917)?

Featured-snippet answer: Not determinable from the provided input.

Final disposition

• Not determinable from the provided input.

Findings that affect generics launch risk

• Not determinable from the provided input.

What settlement or consent decree terms were reached, if any?

Featured-snippet answer: Not determinable from the provided input.

Scope of any settlement

• Not determinable from the provided input.

Launch dates and design-around outcomes

• Not determinable from the provided input.

What generic entry risks existed for Kaleo’s product during the Adami(s) litigation?

Featured-snippet answer: Not determinable from the provided input.

Paragraph IV timing and exclusivity windows

• Not determinable from the provided input.

Design-around and noninfringement pathways

• Not determinable from the provided input.

How does Kaleo v. Adami(s) compare with other Hatch-Waxman patent cases from 2019–2021 in the District of Delaware?

Featured-snippet answer: Not determinable from the provided input.

Typical patterns (stay duration, litigation pace, claim construction)

• Not determinable from the provided input.

Regulatory status impact: did FDA approval depend on the litigation in 1:19-cv-00917?

Featured-snippet answer: Not determinable from the provided input.

Orange Book listing and FDA approval linkage

• Not determinable from the provided input.

Possible effect on approval/launch sequencing

• Not determinable from the provided input.

Commercial exposure: what revenue impact would a ruling against Kaleo or Adami(s) create?

Featured-snippet answer: Not determinable from the provided input.

Loss of exclusivity vs. forced delay

• Not determinable from the provided input.

At-risk launch economics and market share assumptions

• Not determinable from the provided input.

Key Takeaways

Not provided because the prompt does not include sufficient case record details to produce a complete, accurate litigation summary.

FAQs

1. What Orange Book patents did Kaleo list in support of its complaint in 1:19-cv-00917?
2. Which claims and patent counts were asserted versus dismissed in Kaleo v. Adami(s)?
3. Did the court issue a preliminary injunction or stay relief in the case?
4. Did the parties reach a settlement, and did it include a launch-date commitment?
5. What FDA pathway and approval status were at issue in the Kaleo v. Adami(s) dispute?

References

Not provided.