Last updated: June 21, 2026
Executive summary: Teva Pharmaceuticals International GmbH sued Fresenius Kabi USA, LLC in the District Court for a Paragraph IV-related patent dispute tied to a Teva-listed drug in the FDA Orange Book. The litigation’s docket number is 1:18-cv-01586. The available record provided here does not include the case caption details needed to identify the asserted patents, the drug name, FDA application (ANDA/NDA/BLA), the Orange Book listing(s), the filing date of the complaint, any Markman schedule, claim construction outcomes, settlement terms, or the final disposition. Without those docket-linked specifics, no complete, accurate litigation summary can be produced.
1:18-cv-01586: What patents did Teva assert against Fresenius Kabi?
- Answer: Not determinable from the information provided.
- Missing case-specific facts required for a litigation summary: asserted Orange Book patents (publication/patent numbers), asserted claims, Teva’s ANDA/NDA linkage (drug strength/dosage form), and Fresenius Kabi’s corresponding generic application.
Patent estate mapping: which Teva-listed Orange Book patents were at issue?
- Answer: Not determinable from the information provided.
- What the analysis requires:
- Orange Book listing identifiers for the branded/RLD at issue
- patent numbers and expiration dates
- whether Teva alleged non-infringement, invalidity, or both
- whether the case proceeded under 35 U.S.C. § 271(e)(2) as a Paragraph IV dispute
What claims did Teva allege Fresenius Kabi infringed in 1:18-cv-01586?
- Answer: Not determinable from the information provided.
- What a correct answer must contain:
- infringement theory (literal vs. DOE)
- dosage form and formulation parameters (if relevant)
- method-of-use or manufacturing process claim categories (if asserted)
Method-of-use vs. formulation vs. manufacturing method
- Answer: Not determinable from the information provided.
- What to extract from the docket for this section:
- complaint claim chart content
- whether Teva asserted method-of-use claims
- whether Teva asserted formulation composition or manufacturing method claims
When was the complaint filed, and when did the case reach key milestones?
- Answer: Not determinable from the information provided.
- Key milestones that must be cited from docket entries:
- complaint filing date
- first answer/date of responsive pleading
- Rule 16 scheduling order
- initial disclosures and expert deadlines
- Markman/claim construction dates
- summary judgment motions
- trial/bench schedule (if any)
- final judgment date or dismissal date
How did claim construction affect infringement/invalidity arguments?
- Answer: Not determinable from the information provided.
- What a litigation-grade analysis must include:
- claim construction holdings
- which terms were construed
- whether constructions narrowed scope and how that mapped to infringement defenses
What motions were decided in Teva v. Fresenius Kabi (1:18-cv-01586)?
- Answer: Not determinable from the information provided.
- Examples of motion categories that must be docket-cited:
- motion to dismiss (failure to state a claim, improper venue, standing, limitations)
- motion for preliminary injunction
- motion for summary judgment
- Daubert motions (expert admissibility)
- motions related to confidentiality or protective orders
Did the parties settle, and what was the litigation outcome in 1:18-cv-01586?
- Answer: Not determinable from the information provided.
- What determines “outcome” in these cases:
- court judgment on asserted patents (infringement and validity)
- stipulated dismissal
- consent judgment
- settlement agreement terms (launch date, exclusivity carve-outs, covenant not to sue)
If settled: what were the typical settlement levers?
- Answer: Not determinable from the information provided.
- Settlement terms that must be sourced from docket or public filings:
- effective date of settlement
- dates for first commercial marketing
- agreed-at-risk date and/or stipulations of non-infringement/validity
- royalty or payment structure (if disclosed)
- confidentiality scope
What is the Orange Book status of the drug implicated in 1:18-cv-01586?
- Answer: Not determinable from the information provided.
- A correct Orange Book status section must include:
- branded reference listed drug (RLD) name
- all listed patents for that RLD and their expiration dates
- which patents were asserted in this case
- whether any patents were listed as “method-of-use” and their end dates
- whether pediatric exclusivity or other extensions applied
What is the Paragraph IV landscape for Teva vs. Fresenius Kabi in this dispute?
- Answer: Not determinable from the information provided.
- A complete landscape analysis must cite:
- which patent(s) were the basis of the Paragraph IV notice
- the relevant FDA application type (ANDA/NDA/BLA)
- the notice date and FDA “patent certification” details
- statutory 30-month stay timeline tied to the procedural posture
What generic entry risks existed for Fresenius Kabi at the time of filing?
- Answer: Not determinable from the information provided.
- Risk drivers that must be mapped to case posture:
- likelihood of invalidation based on claim breadth and prior art categories
- whether the court entered an injunction preventing launch
- whether a stay applied or expired due to litigation schedule
- whether a settlement removed launch barriers
How does Teva’s patent strength in this case compare with typical Paragraph IV estates?
- Answer: Not determinable from the information provided.
- To compare strength, the analysis needs:
- number of asserted patents
- whether asserted patents share a single specification family
- claim scope (composition breadth vs. narrow process steps)
- whether patents have lapsed or are near expiration
- prior validity challenges in related cases
Which other companies were involved, and are there parallel litigations?
- Answer: Not determinable from the information provided.
- A correct answer requires docket checks for:
- co-defendants or additional defendants
- consolidated cases or transfer history
- related actions in other districts or with the same Orange Book listing
Key Takeaways
- Teva Pharmaceuticals International GmbH filed suit against Fresenius Kabi USA, LLC under docket 1:18-cv-01586.
- The record provided does not include the drug identity, the asserted patent numbers, the Orange Book listings, the complaint and motion outcomes, or the case disposition.
- A litigation-grade summary and analysis cannot be completed from the information available here.
FAQs
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What drug and FDA application are connected to Teva v. Fresenius Kabi (1:18-cv-01586)?
Not determinable from the information provided.
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Which specific Teva Orange Book patents were asserted in 1:18-cv-01586?
Not determinable from the information provided.
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Did the court issue an injunction or enter judgment on infringement/invalidity?
Not determinable from the information provided.
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Was there a settlement, and what launch date did it allow?
Not determinable from the information provided.
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What is the 30-month stay timeline for the FDA application tied to the case?
Not determinable from the information provided.
References (APA)
- No sources cited.
