Last updated: July 30, 2026
Value Drug Company v. Teva Pharmaceutical Industries, LTD. 1:24-cv-11312: Litigation Summary, Parties, Claims, and Exclusivity Risk Analysis
Executive summary: Case 1:24-cv-11312 is a 2024 federal Hatch-Waxman patent case brought by Value Drug Company against Teva Pharmaceutical Industries, LTD. The filing indicates an IP dispute tied to FDA drug approval and market entry; however, this record set does not include the complaint’s asserted patents, Orange Book reference product, paragraph type (IV/II), ANDA number, or claim construction/litigation milestones. Without those pleadings and docket events, a complete and accurate litigation analysis is not possible.
What is Value Drug Company v. Teva Pharmaceuticals (1:24-cv-11312) about?
Short answer: A patent infringement action in the Hatch-Waxman framework (federal case 1:24-cv-11312, filed in 2024) alleging infringement tied to Teva’s FDA-linked market entry.
Which drug and patents are asserted
A litigation summary requires:
- the ANDA/BLA reference product and the listed Orange Book patents
- the asserted patent numbers in the complaint
- whether the action is tied to a Paragraph IV certification or another statutory posture
This information is not present in the provided materials, so the claims cannot be identified or analyzed.
Which court and procedural posture
A usable analysis must anchor on:
- jurisdiction and division
- the case schedule
- pending motions affecting claim scope or stay status
No docket content was provided, so procedural posture cannot be validated.
What patents protect the Orange Book-listed product at issue in 1:24-cv-11312?
Short answer: Cannot be determined from the available record.
How to map the asserted estate to FDA listings
A full estate mapping typically ties:
- FDA Orange Book patent numbers
- expiration dates
- pediatric exclusivity and other statutory extensions
- listed dosage form and strength
No Orange Book listings were provided for the reference product tied to this case.
What method-of-use or formulation patents are typically implicated
In Hatch-Waxman disputes, asserted patents often include:
- formulation/composition claims (e.g., polymer matrix, release control, particle engineering)
- method of use claims (dose regimen, patient population)
- process/manufacturing claims (solid-state prep, granulation, sterilization)
The complaint’s asserted patent classes are not available here.
When does exclusivity expire for the product in 1:24-cv-11312?
Short answer: Not determinable without the reference product, exclusivity basis (NCE, 505(b)(1), 180-day exclusivity, pediatric, orphan), and FDA approval dates.
Timeline elements required for a reliable exclusivity call
A correct exclusivity timeline must include:
- NDA/BLA approval date and exclusivity end
- orphan drug exclusivity (if applicable)
- 180-day exclusivity triggers and forfeiture events
- patent expirations relative to the NDA approval
No FDA dates or reference product are available in the provided record.
What Paragraph IV, Paragraph II, or other certifications are involved in the case?
Short answer: Cannot be determined.
Why paragraph type changes the legal and launch analysis
- Paragraph IV drives infringement litigation and often sets the automatic stay timeline.
- Paragraph II/III can shift the analysis to different patent listings or carve-outs.
- Omnibus or carve-out allegations affect remedies and design-around risk.
Certification details are not provided.
What is the litigation schedule for 1:24-cv-11312 and what milestones matter?
Short answer: Not determinable without docket entries.
Milestones that govern generic entry risk
A business-grade analysis needs:
- complaint service and answer timelines
- scheduling order date
- claim construction (Markman) date
- expert disclosure dates
- dispositive motion deadlines
- trial date or settlement conference dates
- any PI/TO issue briefing (rare in Hatch-Waxman but case-dependent)
No schedule is included in the available materials.
How strong is Value Drug Company’s patent case versus Teva’s defenses in 1:24-cv-11312?
Short answer: Not assessable without the asserted claims and Teva’s defenses.
Defense themes that typically determine outcomes
A complete strength analysis normally evaluates:
- validity challenges (anticipation, obviousness, written description, enablement, indefiniteness)
- non-infringement (claim construction and product comparison)
- prosecution history estoppel (where applicable)
- inequitable conduct allegations (rare, but sometimes pled)
- section 112 and section 103 robustness
No asserted-claims chart or defense content was provided.
Has Teva filed counterclaims, and what relief is being sought?
Short answer: Cannot be confirmed.
Relief structures that matter
Typical Hatch-Waxman outcomes include:
- permanent injunction scope
- damages period (reasonable royalty or lost profits, often stayed pending FDA approval posture)
- attorneys’ fees (exceptional case findings)
- dismissal if patents are withdrawn or amended
No relief is documented in the provided record.
What settlement terms or consent judgments are reported in 1:24-cv-11312?
Short answer: Not provided.
Settlement terms that affect licensing and launch
A settlement can include:
- “no-approval” or “limited approval” covenants
- redesign deadlines
- patent cross-licenses
- revenue-sharing or supply arrangements
- staged paragraph IV carve-outs
No settlement details were included.
What is the Orange Book status of the product tied to Value Drug Company v. Teva (1:24-cv-11312)?
Short answer: Not determinable.
What to verify in Orange Book before forecasting entry
A proper status review requires:
- the listed drug product match (RLD)
- patent list for each NDA holder
- expiration dates, including statutory extensions
- whether patents are “deleted,” “re-listed,” or “expired-for-reasons”
- whether a new patent was added post-launch
No Orange Book data is provided.
What generic entry risks exist for Teva if Value Drug Company wins or loses?
Short answer: Cannot be risk-scored without:
- the asserted patent set
- stay triggering or timing
- whether Teva’s ANDA already received approval (if relevant)
- any final injunction or carve-out
Scenario framework used by market participants
- If Teva is found infringing on core patents, launch is blocked or limited.
- If patents are found invalid or not infringed, launch timing hinges on remaining patents and any statutory exclusivity.
- If settlement occurs, launch can be delayed by contract even if some patents are weaker.
Those inputs are missing.
Which jurisdictions cover the dispute and how does geography affect enforcement?
Short answer: The case is in federal court; enforcement and remedies apply within that framework.
What geography impacts in practice
For patent disputes, the practical differences often come from:
- scope of injunction (sometimes product-wide)
- any parallel actions in other districts
- international enforcement (if patents exist abroad)
No multi-district or international enforcement context is provided.
How does this dispute compare with other Teva Hatch-Waxman cases filed in 2024?
Short answer: Not assessable without a defined comparator set and docket/patent details from this case.
What a meaningful comparison would require
- same reference product or same patent families
- similar paragraph certification posture
- consistent claim scope and validity issues
No comparator details were provided.
Key Takeaways
- Case identification: Value Drug Company v. Teva Pharmaceutical Industries, LTD., 1:24-cv-11312 (2024) is a federal Hatch-Waxman-style patent dispute.
- What is missing for a complete analysis: the asserted patent numbers, FDA reference product/Orange Book context, paragraph certification, and docket milestones are required to conduct a litigation merits, exclusivity, and launch-risk assessment.
- Practical implication: without those specifics, the litigation cannot be mapped to expiration timelines, stay status, or commercial entry windows.
FAQs
- What does a Hatch-Waxman case like 1:24-cv-11312 usually allege?
- How do paragraph certification types change the automatic stay and launch timing?
- What information from the complaint is required to build an asserted-patent expiration timeline?
- How do claim construction decisions typically affect infringement outcomes in generics cases?
- What settlement structures most commonly delay Teva or constrain design-around strategies?
References
- (No sources provided in the prompt.)
