Last Updated: July 27, 2026

Litigation Details for Keryx Biopharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)


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Small Molecule Drugs cited in Keryx Biopharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.
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Details for Keryx Biopharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Date Filed Document No. Description Snippet Link To Document
2018-12-19 External link to document
2018-12-18 1 United States Patent Nos. 7,767,851 (the “’851 patent”); 8,093,423 (the “’423 patent”); 8,299,298 (the…(the “’298 patent”); 8,338,642 (the “’642 patent”); 8,609,896 (the “’896 patent”); 8,754,257 (the “’257…’257 patent”); 8,754,258 (the “’258 patent”); 8,846,976 (the “’976 patent”); 8,901,349 (the “’349 patent…25 PageID #: 2 patent”); 9,328,133 (the “’133 patent”); 9,387,191 (the “’191 patent”); and 9,757,416… 1. This is an action for patent infringement under the patent laws of the United States, 35 U.S.C External link to document
2018-12-18 17 Complaint - Amended United States Patent Nos. 7,767,851 (the “’851 patent”); 8,093,423 (the “’423 patent”); 8,299,298 (the…(the “’298 patent”); 8,338,642 (the “’642 patent”); 8,609,896 (the “’896 patent”); 8,754,257 (the “’257…’257 patent”); 8,754,258 (the “’258 patent”); 8,846,976 (the “’976 patent”); 8,901,349 (the “’349 patent9,050,316 (the “’316 patent”); 9,328,133 (the “’133 patent”); and 9,757,416 (the “’416 patent”) (collectively… 1. This is an action for patent infringement under the patent laws of the United States, 35 U.S.C External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

Litigation summary and analysis for: Keryx Biopharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Last updated: July 1, 2026

Keryx Biopharmaceuticals v. Teva (1:18-cv-02012): Litigation Summary, Patent Issues, and Generic Launch Impact

Executive summary: The case Keryx Biopharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-02012 is a U.S. patent infringement matter tied to Teva’s effort to market a generic version of Keryx’s product portfolio. The litigation posture and remedies hinge on (i) which patents were asserted, (ii) the paragraph IV framework for the relevant ANDA, and (iii) whether the asserted claims cover product composition, formulation, or method-of-use. This summary and analysis tracks the infringement and defenses at the issue level and translates them into generic launch and regulatory risk.

No complete case-specific filing details, asserted patent list, claim construction outcomes, or final judgment terms are present in the provided prompt. Under the constraints, a complete, accurate litigation summary cannot be produced.

Litigation summary and analysis for “Keryx Biopharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.” 1:18-cv-02012

Nothing to report with fidelity to the record.

What patents did Keryx assert against Teva in 1:18-cv-02012?

Nothing to report with fidelity to the record.

Was this case based on an ANDA paragraph IV certification or other regulatory theory?

Nothing to report with fidelity to the record.

What did Teva argue: invalidity, non-infringement, or FDA regulatory preemption?

Nothing to report with fidelity to the record.

What did the court decide on infringement and validity in 1:18-cv-02012?

Nothing to report with fidelity to the record.

When did the case resolve, and what was the final outcome (dismissal, settlement, consent judgment, or injunction)?

Nothing to report with fidelity to the record.

Did the litigation produce a settlement agreement or licensing deal that affects Teva’s market entry?

Nothing to report with fidelity to the record.

How does the ruling affect generic entry timing for the impacted Keryx product(s)?

Nothing to report with fidelity to the record.

What is the Orange Book status for the asserted patents and how does it connect to this litigation?

Nothing to report with fidelity to the record.

Which other generics or challengers were involved in the same patent family as Teva?

Nothing to report with fidelity to the record.

How strong is Keryx’s patent estate for the relevant formulation or method-of-use claims?

Nothing to report with fidelity to the record.

What generic launch risks remain after the Teva case for other ANDA filers?

Nothing to report with fidelity to the record.

How does Teva’s legal posture compare with other defendants in similar Keryx matters?

Nothing to report with fidelity to the record.

Key Takeaways

Nothing to report with fidelity to the record.

FAQs

Nothing to report with fidelity to the record.

References

Nothing to report with fidelity to the record.

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