Litigation Details for ULTRAGENYX PHARMACEUTICAL INC. v. NAVINTA LLC (D.N.J. 2024)

ULTRAGENYX PHARMACEUTICAL INC. v. NAVINTA LLC (D.N.J. 2024)

Docket		Date Filed	2024-09-26
Court	District Court, D. New Jersey	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Esther Salas
Jury Demand	None	Referred To	Michael A. Hammer
Parties	NAVINTA LLC
Patents	12,551,461; 8,697,748
Link to Docket	External link to docket

Details for ULTRAGENYX PHARMACEUTICAL INC. v. NAVINTA LLC (D.N.J. 2024)

Date Filed	Document No.	Description	Snippet	Link To Document
2024-09-26				External link to document

UltraGenyx Pharmaceutical Inc. v. Navinta LLC (2:24-cv-09483): Litigation Summary, Patent Scope, and Commercial Impact

Last updated: July 16, 2026

UltraGenyx Pharmaceutical Inc. sued Navinta LLC in the U.S. District Court for the District of New Jersey under case number 2:24-cv-09483. The available information provided here does not include the asserted patents, claims, allegations, procedural posture, or any publicly reported FDA/Orange Book linkage tied to the complaint. Without those record-specific details, a complete, accurate litigation analysis cannot be produced.

What is the litigation posture in UltraGenyx Pharmaceutical Inc. v. Navinta LLC, 2:24-cv-09483?

Answer: Not enough case-record detail is provided to determine posture (e.g., complaint filed only vs. motion to dismiss, claim construction, preliminary injunction briefing, or settlement/consent order).

What typically determines posture in Hatch-Waxman or biologics cases?

• Whether the case is a patent infringement action tied to an ANDA or BLA (and which one)
• Whether the filing includes Paragraph IV allegations
• Whether UltraGenyx seeks injunctive relief tied to FDA approval timing
• Whether parties have exchanged infringement/invalidity contentions and marked the case for claim construction

What docket artifacts drive next-step analysis?

• Summons and complaint (asserted patents and theory of infringement)
• Motions to dismiss (standing, venue, infringement sufficiency)
• Motion practice (claim construction, discovery disputes)
• Status conference orders (deadlines and whether a trial date is set)

Which patents protect UltraGenyx products at issue in 2:24-cv-09483?

Answer: The asserted patent numbers and patent holders are not included in the information available here.

What the patent list must include for a real estate-style analysis

• Patent numbers and publication equivalents
• Priority and earliest effective filing date
• Ownership chain (UltraGenyx entities vs. assignees)
• Expiration and any PTA/PTE adjustments
• Terminal disclaimer status
• Whether the asserted claims are composition, method-of-use, formulation, or manufacturing

What is the litigation’s patent scope likely to track?

Without the complaint, the only defensible statement is that patent scope in this matter depends on:

• The specific asserted claims
• Whether infringement is alleged for drug product or manufacturing process
• Whether the case targets formulation/form-factor changes or method-of-use endpoints

How does Navinta LLC’s alleged infringement theory affect potential damages?

Answer: No details are provided on the alleged product, proposed label, therapeutic indication, dosage form, or manufacturing method, so damages exposure cannot be analyzed.

Key drivers of damages exposure in these cases

• Whether the defendant seeks to enter via an abbreviated pathway
• Whether the FDA approval is expected before patent expiry
• Whether the infringement theory is narrow (single formulation) or broad (multiple claim groupings)
• Whether the asserted patents cover the “core” active ingredient vs. downstream IP

What is the exclusivity and Orange Book status at issue in 2:24-cv-09483?

Answer: Orange Book listings, FDA exclusivity periods, and any linkage to the asserted patents are not provided.

What must be checked for a litigation-informed exclusivity map

• Drug product NDA number(s)
• Listed patents (regimen, method-of-use, composition of matter)
• Patent expiry dates and exclusivity end dates (NCE, pediatric exclusivity)
• Any granted PTA/PTE and corresponding Orange Book expiration entries

Has Navinta filed a Paragraph IV challenge, and when would generic or biosimilar entry be triggered?

Answer: No Paragraph IV (or other certification) details are provided.

What timeline analysis depends on

• The FDA submission type (ANDA vs. BLA)
• The certification type (Paragraph I, II, III, IV)
• Whether the case is subject to statutory 30-month stay or longer settlement timing
• Whether there is a court-ordered injunction or stay of approval

What does the litigation complaint allege about infringement and invalidity?

Answer: Allegations and invalidity grounds are not included in the information available here.

What usually appears in a full complaint-based analysis

• Infringement: mapping of accused product/label to specific claim elements
• Validity: anticipation, obviousness, indefiniteness, written description, enablement
• Procedural defenses: improper venue, failure to state claim, lack of standing, prosecution history estoppel

What is the status of any claim construction, motions to dismiss, or preliminary injunction efforts?

Answer: The case record details required to determine motion dates, rulings, and deadlines are not included.

What outcomes typically change the commercial risk curve

• Early dismissal of asserted patents or parties
• Claim construction narrowing (or broadening) the infringement case
• Denial of preliminary injunction (allowing FDA approval risk to rise)
• Settlement that locks in a launch date or licensing fee structure

How much competitive and revenue exposure does this case create for UltraGenyx?

Answer: No UltraGenyx product, revenue concentration, or launch/approval target is identified in the available information, so exposure cannot be quantified.

What data points are required for revenue exposure modeling

• Which UltraGenyx product(s) are involved
• Current net sales by geography and payer mix
• Patent and exclusivity “blocking” status for those products
• Defendant’s development progress (FDA readiness and manufacturing timelines)

Which companies are challenging UltraGenyx’s IP in this docket and related actions?

Answer: Only the caption party identifiers “UltraGenyx Pharmaceutical Inc.” and “Navinta LLC” are provided. No list of other defendants, related cases, or co-litigants is included.

What a true competitive landscape requires

• Consolidated dockets or coordinated filings
• Prior or subsequent Paragraph IV actions against the same NDA/BLA
• Any stipulations of dismissal or settlements in companion cases

Key Takeaways

• Case identified: UltraGenyx Pharmaceutical Inc. v. Navinta LLC, 2:24-cv-09483.
• Limitation: The provided information does not include asserted patents, accused product details, FDA linkage, or docket events, so a litigation summary and patent scope analysis cannot be completed to a business-grade standard.
• Next analytical requirement for accuracy: litigation-specific record details (asserted patent numbers and procedural milestones) must be present to produce a defensible infringement/validity and exclusivity impact assessment.

FAQs

1. What documents matter most in 2:24-cv-09483 for assessing patent scope?
2. Does UltraGenyx’s complaint in 2:24-cv-09483 target method-of-use claims or composition claims?
3. Is any statutory stay of FDA approval implicated by UltraGenyx v. Navinta LLC?
4. What typical settlement terms appear in Hatch-Waxman cases involving UltraGenyx products?
5. How do claim construction outcomes usually affect licensing leverage in disputes like 2:24-cv-09483?

References

1. Docket and case caption information for UltraGenyx Pharmaceutical Inc. v. Navinta LLC, 2:24-cv-09483.