Last updated: July 25, 2026
- Plaintiff: Corcept Therapeutics, Inc.
- Defendant: Sun Pharma Global FZE
- Court: U.S. District Court for the District of New Jersey
- Case No.: 2:19-cv-15678
- Year filed: 2019
What product and patent family is implicated?
This matter is evaluated in the context of Corcept’s major IP holdings in Cushing’s disease therapy. The likely asserted asset set typically includes:
- Drug substance and composition claims (formulation, solid state, particle properties, salt/solvate)
- Method-of-use claims (patient population, dosing regimen, disease monitoring)
- Regulatory-linked exclusivity triggers (Orange Book listing-driven infringement theories)
Because the docket is referenced at a high level only, the precise asserted patent numbers and claim charts cannot be reconstructed from the prompt.
Which patents were asserted in Corcept v. Sun Pharma Global FZE (2:19-cv-15678)?
Short answer: The prompt does not include the complaint or the asserted-patent list, so an accurate enumeration of patent numbers, USPTO publication numbers, and claim categories cannot be produced from available information in this session.
How to interpret “asserted patents” in Hatch-Waxman litigation
When Corcept sues a generic filer, the asserted set typically comes from:
- Orange Book-listed patents tied to the reference drug
- A Paragraph IV theory that the generic does not infringe and/or asserted claims are invalid
- Alternative theories of infringement tied to manufacture, use, or sale as described in FDA labeling
What procedural milestones occurred in 2:19-cv-15678?
Short answer: The docket timing aligns with the standard 2019 Hatch-Waxman schedule: complaint filing, motions practice (joinder, claim construction, venue or jurisdictional issues), discovery limited to infringement/validity, then resolution by settlement or final judgment.
Typical D. N.J. schedule in this posture
- Filing of complaint after the ANDA notice (Paragraph IV)
- Markman claim construction briefing and limited discovery
- Injunction posture (automatic stay under 35 U.S.C. § 271(e)(4) if applicable)
- Settlement or dispositive rulings
- Judgment entries and dismissal with or without prejudice depending on settlement terms
When did the litigation move toward settlement, and how did that affect generic launch timing?
Short answer: The case is consistent with a branded-generic settlement structure that controls launch timing. Without the specific docket events (settlement date, entry of consent judgment, and any reverse-payment style constraints if present), the exact “clock” for launch is not attributable to this prompt.
What to measure for exclusivity and launch control
For this case, the decision factors normally include:
- Whether a 30-month stay was triggered and when it expired
- Whether the parties agreed to a license/settlement that fixes a launch date or restricts design-around
- Whether there were ongoing post-settlement stipulations related to additional patents or continuations
How strong was Corcept’s patent case versus Sun Pharma’s invalidity and non-infringement arguments?
Short answer: A strength assessment requires the asserted claims, claim construction outcomes, and validity rulings (or settlement posture with admitted issues). Those specifics are not provided in the prompt.
What arguments typically decide these cases
- Non-infringement: differences in dosage form, composition, or labeling induced by FDA requirements
- Invalidity: obviousness, anticipation, lack of written description/enablement, indefiniteness
- Claim construction leverage: narrowing of method-of-use triggers (patient selection, monitoring, dosing thresholds)
Did Corcept obtain an injunction or win at trial in 2:19-cv-15678?
Short answer: The prompt does not state trial outcomes. The litigation in this posture usually ends in one of these ways:
- Consent judgment / settlement dismissal
- At least one dispositive ruling (summary judgment on infringement or invalidity)
- Final judgment after claim construction and trial
None can be confirmed from the prompt alone.
What is the Orange Book status of the implicated Corcept product for this litigation?
Short answer: Orange Book status depends on the specific reference listed drug and the exact Orange Book patents tied to the ANDA. The prompt does not include the reference product name (e.g., Korlym) or the listed patents, so an accurate Orange Book mapping cannot be produced.
What “Orange Book status” should include in a litigation analysis
A complete litigation map typically covers:
- Patent numbers and expiration dates for each Orange Book entry
- Whether patents are drug substance, drug product, or method-of-use
- Whether any patents are withdrawn, amended, or subject to prior litigation
Which companies are competing on the same IP estate around relugolix/mifepristone Cushing’s disease?
Short answer: Competitive landscape mapping requires the generic filer identity, the ANDA list, and current challengers. The prompt only identifies Sun Pharma Global FZE, not the other Paragraph IV filers or the ANDA applicant(s).
How to benchmark competitive risk
The benchmark should be built from:
- ANDA applicants for the same reference listed drug
- Their litigation history with Corcept
- Whether any other players were allowed to launch via a settlement or court ruling
What generic entry risks exist for Sun Pharma after 2:19-cv-15678?
Short answer: Post-judgment or post-settlement risk depends on:
- Remaining unasserted patents still in the Orange Book
- Whether the settlement permits launch subject to design-around constraints
- Whether there are continuing litigation obligations, covenants not to sue, or field-of-use restrictions
These details are not included in the prompt.
How does this case compare with other Corcept vs. generic litigations?
Short answer: Without the asserted-patent list, outcome, and settlement terms, comparative strength and timeline comparisons cannot be made from the prompt alone.
Comparison axes that matter
- Overlap of asserted patents across cases
- Claim construction consistency across jurisdictions
- Speed to settlement and whether settlements cluster around identical “core” patents
Regulatory timeline interaction: how FDA review affected the infringement dispute
Short answer: Hatch-Waxman timing is driven by ANDA/notice timing. The prompt does not provide ANDA number, FDA approval dates, or whether the 30-month stay was triggered and lifted.
Key takeaways
- Case identity: Corcept Therapeutics, Inc. v. Sun Pharma Global FZE (D.N.J., 2:19-cv-15678) is a Hatch-Waxman-style IP dispute positioned to control generic entry in a Corcept Cushing’s disease IP cluster.
- Actionable litigation levers: The business impact typically turns on (1) Orange Book patent mapping, (2) claim construction outcomes, and (3) settlement terms controlling launch.
- Current state cannot be quantified from the prompt: asserted patents, outcome, settlement date, and launch timing are not provided, so no defensible patent-by-patent or timeline-by-timeline conclusions can be stated.
FAQs
- What type of claims are usually asserted by Corcept in Cushing’s disease generic challenges?
- How do Paragraph IV filings change the 30-month stay in D. N.J. Hatch-Waxman cases?
- What post-settlement covenants typically govern future launches in Corcept generic settlements?
- How do method-of-use claim constructions affect design-around strategies for generics?
- What Orange Book patent categories (drug substance, drug product, method-of-use) most often drive settlement in Corcept disputes?
References
- (No sources were provided in the prompt to cite.)
