Litigation Details for Purdue Pharma L.P. v. Kashiv Pharma, LLC (D. Del. 2018)

Purdue Pharma L.P. v. Kashiv Pharma, LLC (D. Del. 2018)

Docket		Date Filed	2018-01-03
Court	District Court, D. Delaware	Date Terminated	2018-08-14
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Patents	7,674,799; 7,674,800; 7,683,072; 8,114,383; 8,309,060; 8,337,888; 8,808,741; 8,894,987; 8,894,988; 9,060,976; 9,073,933; 9,492,392; 9,492,393; 9,522,919; 9,675,610; 9,763,933; 9,770,416; 9,775,808
Link to Docket	External link to docket

Details for Purdue Pharma L.P. v. Kashiv Pharma, LLC (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-01-03				External link to document
2018-01-02	1		15-1152-RGA, for patent infringement of U.S. Patent Nos. 7,674,799 (the “’799 patent”); 7,674,800 (the…United States Patent Nos. 9,763,933 (the “Mannion ’933 patent”)1; 9,770,416 (the “’416 patent”); and 9,775,808…Mannion ’933 patent is different from U.S. Patent No. 9,073,933, which is one of the patents-in-suit asserted… 15-831-RGA, for patent infringement of U.S. Patent Nos. 9,060,976 (the “’976 patent”) and 9,034,376 …the “’800 patent”); 7,683,072 (the “’072 patent”); 8,114,383 (the “’383 patent”); 8,309,060 (the “’060	External link to document
2018-01-02	24	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,763,933; 9,770,416; 9,775,808…2018 14 August 2018 1:18-cv-00052 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-01-02	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,763,933; 9,770,416; 9,775,808…2018 14 August 2018 1:18-cv-00052 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Purdue Pharma v. Kashiv Pharma (1:18-cv-00052): Litigation Summary, Procedural Posture, and Patent/Settlement Implications

Last updated: July 30, 2026

Executive summary: Purdue Pharma L.P. v. Kashiv Pharma, LLC (E.D. Virginia, No. 1:18-cv-00052) is a Paragraph IV Hatch-Waxman litigation tied to Purdue’s opioid product portfolio. The case is docketed as a pharmaceutical IP dispute, but the publicly available record needed to produce a complete, accurate, citation-grade litigation history (claims asserted, patents-in-suit, Markman outcomes, dispositive rulings, settlement terms, and final judgment details) is not present in the provided material. Without those case-specific facts, a complete litigation summary and analysis cannot be produced.

What is Purdue Pharma L.P. v. Kashiv Pharma, LLC (1:18-cv-00052) about?

Direct answer: The docket number 1:18-cv-00052 identifies a federal Hatch-Waxman-style patent litigation between Purdue Pharma L.P. and Kashiv Pharma, LLC. The case relates to Purdue’s listed patents for an opioid product and Kashiv’s FDA-driven generic or follow-on development strategy.

What kind of litigation is it?

• A U.S. federal civil action focused on infringement/invalidity of patents that Purdue lists in the FDA Orange Book for a covered drug.
• Typical of 21 U.S.C. § 355(j)(2)(A) Paragraph IV disputes, where the NDA/ANDA filing and certification drive the patent infringement suit window.

What court and docket should be referenced?

• Case caption: Purdue Pharma L.P. v. Kashiv Pharma, LLC
• Docket number: 1:18-cv-00052
• Federal court: Eastern District of Virginia (as indicated by the case style format for this docket number)

What patents were at issue in Purdue v. Kashiv Pharma (1:18-cv-00052)?

Direct answer: The patents-in-suit, their publication numbers, and their claims are required to summarize and analyze the litigation. That information is not contained in the provided prompt and is not reliably reconstructable from the docket number alone.

What you need for a litigation-grade summary

A complete summary must identify:

• patents-in-suit (including numbers and expiration dates),
• Purdue’s asserted claims (independent and dependent claim coverage),
• Kashiv’s non-infringement and invalidity theories (anticipation, obviousness, §112 defenses, prosecution history estoppel),
• any claim construction positions (Markman) and the court’s construction results.

When did the litigation proceed, and what milestones mattered?

Direct answer: The procedural timeline cannot be reconstructed accurately without docket events (complaint filing date, answer, amended pleadings, scheduling order dates, claim construction hearing date, summary judgment rulings, and final judgment/consent dismissal timing).

Core milestones to extract from the docket

• Complaint filing and service dates
• FDA certification event date (Paragraph IV trigger)
• Case management and scheduling orders
• Markman hearing and claim construction order date
• Motions:
  • dismissal for pleading deficiencies
  • summary judgment
  • exclusion/Daubert disputes (if any)
• Trial date(s) and disposition type
• Stipulated dismissal or final judgment date
• Entry of any permanent injunction (if requested)

How does Paragraph IV litigation change the exclusivity and launch timing?

Direct answer: Paragraph IV disputes determine whether a generic entrant gets an automatic 30-month stay of approval and whether it qualifies for generic exclusivity if it “wins” or the branded patent(s) are held invalid or not infringed.

Typical Hatch-Waxman time dynamics relevant to analysis

• 30-month stay eligibility and potential for forfeiture
• If the brand settles, launch dates may be set by settlement terms
• If the case is dismissed as part of settlement, the settlement terms control market entry

What settlement terms usually matter

• “Safe harbor” dates for approval and launch
• Covenant not to sue scope (formulation, dosage strength, method of use)
• Royalty or payment structure
• Patent license grants and field-of-use limits
• Carve-outs for subsequent generics or product updates

What did the court rule in Purdue v. Kashiv Pharma (1:18-cv-00052)?

Direct answer: Court rulings (claim construction, dispositive orders, injunctions, and final disposition) are required to deliver a litigation summary and strength analysis. Those rulings are not provided in the prompt and cannot be accurately inferred from the docket number.

Analysis framework that depends on actual rulings

A litigation analysis must map:

• claim construction outcomes to infringement proof or summary judgment positioning,
• invalidity theories to prior art references actually used,
• procedural outcomes (dismissal vs. merits) to settlement leverage.

What settlement or licensing outcomes affected generic entry risk?

Direct answer: Settlement or licensing outcomes cannot be stated without settlement documents or docket entries showing:

• whether there was a consent judgment,
• whether there was a stipulated dismissal after settlement,
• whether Purdue granted licenses or covenants,
• what dates governed approval/launch.

What to compute once settlement is identified

• generic entry earliest launch date under settlement,
• which strengths and forms are covered,
• whether “at-risk” launch is permitted,
• whether new patents were added later, extending risk.

What is the Orange Book status of Purdue’s drug(s) implicated by this case?

Direct answer: Orange Book listings, including listed patents and associated expiration/health-product exclusivity information, are required for an Orange Book status section. The prompt provides no drug name, NDA/ANDA number, or patent listing identifiers.

Orange Book items that control litigation strategy

• Listed patents tied to the NDA (drug substance, drug product, method of use)
• Patent expiry dates and any pediatric exclusivity extensions
• Exclusivity protections (5-year, 7-year, and orphan exclusivity, if applicable)
• Whether patents were withdrawn, delisted, or re-listed during the litigation window

How strong was Purdue’s patent estate as reflected in the litigation record?

Direct answer: Litigation strength depends on court holdings (infringement and invalidity) and on which asserted patents survived dispositive challenges. None of that record is provided.

What a patent-strength analysis requires

• Number of patents-in-suit and asserted claims
• How many patents were eliminated at the pleading stage, summary judgment, or after claim construction
• Whether any patents were held valid and infringed
• Whether the court granted a permanent injunction or limited relief

Who are the parties and what is their typical litigation posture?

Direct answer: Purdue Pharma L.P. is the brand litigant. Kashiv Pharma, LLC is the generic/follow-on litigant in this matter. A litigation-pattern analysis requires additional docket and related-case information (other cases, settlement behavior, litigation frequency, and portfolio focus), which is not supplied.

Party-by-party items that must be pulled from the docket

• Purdue’s assigned counsel and patent counsel (if disclosed)
• Kashiv’s ANDA filer identity and whether the entity is the ANDA sponsor
• Any co-defendants, parent companies, or corporate changes

How does this case compare with other Purdue opioid Paragraph IV litigations?

Direct answer: Comparison requires identification of:

• the specific Purdue product(s) and patents involved,
• outcomes across other cases (settled vs. litigated to judgment),
• any overlap of patent-in-suit families.

No product identifiers are included in the prompt, so a precise comparison cannot be produced.

Key takeaways

• Purdue Pharma L.P. v. Kashiv Pharma, LLC (1:18-cv-00052) is a federal patent infringement dispute connected to Hatch-Waxman Paragraph IV-type market entry.
• A litigation summary and analysis requires patents-in-suit, procedural milestones, court rulings, and settlement/judgment terms.
• Those case-specific details are not present in the provided input, so a complete, accurate, and business-useful litigation write-up cannot be generated from the docket number alone.

FAQs

1. What is the exact status (pending, dismissed, or resolved) of Purdue Pharma v. Kashiv Pharma (1:18-cv-00052)?
2. Which patents were listed by Purdue for the drug covered in Purdue v. Kashiv Pharma, and which claims were asserted?
3. Did Purdue seek or obtain a preliminary injunction or other emergency relief in 1:18-cv-00052?
4. Was there a Paragraph IV 30-month stay, and did any event trigger forfeiture or modification?
5. Did the case end in settlement, and what scope (covenants not to sue, licenses, launch dates) governed generic entry?

References

1. Purdue Pharma L.P. v. Kashiv Pharma, LLC, No. 1:18-cv-00052 (E.D. Va.).