Last updated: July 18, 2026
Executive summary:
Corcept Therapeutics’ suit against Teva in the U.S. District Court for the District of New Jersey (case no. 2:19-cv-05066) centers on Hatch-Waxman patent enforcement tied to Teva’s ANDA and generic entry risk for Corcept’s indicated mifepristone product (Korlym). The case fits the standard Paragraph IV framework: Corcept asserts Orange Book-listed patents are infringed by Teva’s proposed ANDA product, while Teva contests infringement and/or invalidity and seeks FDA approval-to-commercialize timing relief through the 30-month stay and related procedural outcomes. The litigation also functions as a blocking lever against near-term generic launch and as a licensing/settlement catalyst, depending on claim construction, final judgments, and any entered consent judgments.
What is the docket history for Corcept Therapeutics v. Teva (2:19-cv-05066)?
Core case identifiers
- Court: U.S. District Court, District of New Jersey
- Case number: 2:19-cv-05066
- Parties: Corcept Therapeutics, Inc. (plaintiff) v. Teva Pharmaceuticals USA, Inc. (defendant)
Procedural posture (what the case does, practically)
In Hatch-Waxman patent infringement cases of this type, the docket typically tracks:
- Complaint filing after service of Teva’s Paragraph IV notice
- Case-specific discovery on the ANDA formulation/process and infringement contentions
- Claim construction briefing and Markman proceedings
- Summary judgment motions on infringement and invalidity
- Trial or dispositive motion outcomes leading to a final judgment
- Post-judgment motions and any appeal activity
Litigation drivers
- Trigger: Teva’s ANDA filing for the applicable Korlym (mifepristone) strength/form and Corcept’s Orange Book patent notice
- Objective: prohibit Teva’s commercially effective launch until patent expiry or resolution of invalidity/noninfringement
Why the docket matters for business decisions
The business implication is not the mere existence of the suit, but the timeline of key events: claim construction outcomes, whether the court invalidated any asserted patents, and whether the court entered an injunction or declaratory judgment that permitted launch.
What patents were asserted by Corcept against Teva in 2:19-cv-05066?
Answered outcome requirement
Litigation analyses depend on the exact asserted patent list, claim numbers, and allegations. Without the asserted-patent text from the complaint and the docket entries (including the infringement contentions and asserted-claims chart), the patent estate cannot be accurately enumerated.
What can be stated from the case type
- The asserted patents would have been Orange Book-listed for Korlym at the time of Teva’s notice.
- Claims would typically target at least one of: composition/formulation, method-of-use, and/or manufacturing process claims relevant to the ANDA product.
Business impact framing
- If the asserted patents are formulation-only, Teva may focus on design-around changes that avoid the specific claimed excipients/process parameters.
- If method-of-use is asserted (for indicated dosing in Cushing’s syndrome), Teva may rely on carve-outs in labeling or argue non-infringement based on intended use or protocol differences.
How does Paragraph IV litigation in 2:19-cv-05066 work for ANDA timing and 30-month stay?
Featured snippet answer: The case likely tracks the standard Paragraph IV mechanism: Corcept’s suit blocks an immediate commercial launch while the FDA 30-month stay runs, subject to court outcomes and statutory triggers.
Key Hatch-Waxman mechanics (what they mean here)
- Teva files an ANDA with a Paragraph IV certification to one or more Orange Book patents.
- Corcept sues within the statutory window (typically 45 days after receiving the Paragraph IV notice).
- The FDA imposes a 30-month stay of approval from the date of the patent notice or triggering event, unless lifted for statutory reasons (e.g., failure to maintain jurisdiction, final court decision on validity/infringement).
- If the court enters judgment of noninfringement or invalidity, the stay can lift and Teva’s approved product can launch.
- If the court finds infringement and validity, Teva may be enjoined and launch delayed until expiration or a settlement.
Why this drives licensing and investment decisions
For generics, the economic model is time-to-market minus probability-weighted infringement/validity risk. For innovators, it is the probability that the court enforces one or more claims strongly enough to deter launch and preserve market exclusivity.
What is the claim-construction and infringement/invalidity posture in this case?
Answered outcome requirement
A real litigation analysis must address:
- the court’s claim construction holdings (key terms, function/structure scope, doctrine of equivalents treatment)
- infringement findings (literal infringement, infringement under DOE)
- invalidity findings (anticipation/obviousness, written description/enablement, indefiniteness)
Those details require docket- and court-order content that is not present in the information provided.
Business-professional interpretation without speculation
- In patent cases, claim construction often determines whether Teva’s ANDA product design and manufacturing route fall within the asserted scope.
- Invalidity rulings determine whether Corcept’s asserted patents can survive an approach based on prior art.
When did Corcept and Teva litigate milestones (Markman, summary judgment, trial), and what was the result?
Answered outcome requirement
Accurate milestone dates and outcomes must cite:
- the Markman schedule and order(s)
- summary judgment order(s)
- any bench or jury trial (if any)
- final judgment and any injunction/consent judgment entries
- appeals and appellate dispositions
No milestone date or outcome can be produced from the current input without risking factual error.
What settlements or consent judgments affected the FDA launch timeline in 2:19-cv-05066?
Answered outcome requirement
Whether the case ended via settlement, dismissal with prejudice, consent judgment, or final adjudication changes the practical launch risk profile. That requires docket and settlement order content.
Business meaning (framework)
- Settlement with an agreed launch date converts litigation into a predictable exclusivity-to-competition window.
- Consent judgments can include “triggering” events (FDA approval timing, labeling changes) that later control whether Teva can launch.
- Dismissal without substantive relief can still leave open appeal or future litigation risk.
How strong is Corcept’s patent estate for Korlym against Teva’s ANDA in this litigation?
Answered outcome requirement
“Strength” must be tied to which patents were asserted and the court’s rulings, including which claims survived.
General strength framework (not case-specific factual assertions)
- Strongest posture is usually when the court construes claims narrowly but still finds infringement on at least one claim and declines to invalidate that claim.
- Weakest posture is when construction narrows Corcept’s claim scope to a point that Teva’s product falls outside, or when key claims are invalidated by prior art.
Business translation
If the asserted set includes a mix of formulation and method-of-use claims, Corcept typically benefits when at least one claim category survives. If only method-of-use survives, generic launch may be labeled-restricted rather than fully blocked.
How does the case affect generic entry risk and biosimilar risk for mifepristone?
Featured snippet answer: The matter affects ANDA generic entry risk for oral mifepristone tablets; biosimilar pathways are not directly implicated because this is a small-molecule drug product.
Generic entry mechanics
- Teva’s commercial launch is controlled by FDA approval status and the presence of any enforceable injunction/consent judgment.
- Even if the FDA approves, litigation outcomes can delay market entry through court orders or settlement terms.
Biosimilar scope
- Biosimilars apply to biologics, not mifepristone. The risk here is ANDA-based generic competition.
What is the Orange Book status of the relevant Korlym patents implicated by this suit?
Answered outcome requirement
Orange Book status requires enumerating the specific patent numbers listed for the drug product, their expiration dates, and whether they are listed for particular strengths or dosage forms.
Practical consequence
Orange Book listing is the link between Teva’s Paragraph IV certification and Corcept’s ability to enforce those patents via 35 U.S.C. § 271(e)(2).
Which companies are in the competitive set for Korlym generics, and how does this case fit?
Answered outcome requirement
A competitive landscape analysis must list other ANDA filers and other Hatch-Waxman cases around Korlym, then compare asserted patent sets and outcomes. That requires external case and Orange Book data.
Framework only
- Korlym’s competitive risk usually concentrates among early ANDA filers with strong Paragraph IV positions.
- Case outcomes often set benchmarks for subsequent filers regarding claim construction and validity.
What does Teva’s litigation strategy typically involve in this drug category?
Answered outcome requirement
Strategy must be tied to record content: Teva’s defenses, expert positions, and the court’s rulings on disputed claim terms.
General defense patterns in ANDA Paragraph IV cases
- Noninfringement based on ANDA composition, dosage form, or process differences
- Invalidity on obviousness/anticipation based on prior art
- Procedural defenses (jurisdiction, claim sufficiency)
Timeline: How 2:19-cv-05066 likely maps onto Hatch-Waxman steps
Note: Without docket dates, a precise litigation timeline cannot be reliably reconstructed.
Expected step sequence
- Paragraph IV notice receipt by Corcept
- ANDA approval stay trigger in the FDA system
- Complaint filed and served (within statutory window)
- Case scheduling: early disclosures, infringement contentions, validity contentions
- Markman
- Dispositive motions or trial
- Final judgment
- Appeal (if any)
- Launch permission or launch delay, depending on enforceability
Key Takeaways
- 2:19-cv-05066 is a Hatch-Waxman Paragraph IV patent infringement action in the District of New Jersey between Corcept Therapeutics and Teva involving Korlym (mifepristone).
- The economic impact is determined by the asserted Orange Book patents, claim construction outcomes, and any injunction or settlement/consent judgment affecting Teva’s ability to launch after FDA approval.
- A complete litigation and patent-estate strength analysis requires asserted patent identification and the court’s substantive rulings; those specifics are not provided in the input.
FAQs
- What is the 30-month stay trigger for Paragraph IV ANDAs in the District of New Jersey?
- How do claim construction rulings typically change infringement outcomes in ANDA Paragraph IV cases?
- What happens if Corcept dismisses a case without prejudice or with prejudice in Hatch-Waxman litigation?
- How do consent judgments affect the launch date and labeling design-around for generic entry?
- Does a final judgment of noninfringement automatically enable generic launch upon FDA approval?
References
- (No citable sources were provided in the input.)
