Litigation Details for Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC (D. Del. 2018)

Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC (D. Del. 2018)

Docket		Date Filed	2018-12-20
Court	District Court, D. Delaware	Date Terminated	2022-02-09
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To	Christopher J. Burke
Parties	AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
Patents	10,252,010; 12,005,069; 12,151,020; 6,004,973; 6,024,981; 6,197,341; 6,284,770; 6,316,023; 6,335,031; 6,414,016; 6,455,518; 6,592,903; 6,602,911; 6,716,867; 6,720,001; 6,780,889; 7,101,576; 7,262,219; 7,297,703; 7,410,651; 7,431,943; 7,566,462; 7,566,714; 7,601,758; 7,612,073; 7,619,004; 7,659,282; 7,668,730; 7,727,987; 7,741,338; 7,765,106; 7,765,107; 7,795,312; 7,820,681; 7,851,482; 7,851,506; 7,888,342; 7,895,059; 7,906,519; 7,915,269; 7,919,115; 7,932,241; 7,935,731; 7,951,400; 7,964,647; 7,964,648; 7,981,938; 7,994,220; 8,003,126; 8,017,150; 8,026,393; 8,039,009; 8,052,987; 8,062,667; 8,067,416; 8,071,613; 8,093,296; 8,093,297; 8,093,298; 8,097,653; 8,097,655; 8,114,383; 8,168,209; 8,173,708; 8,192,722; 8,227,484; 8,242,131; 8,252,809; 8,263,650; 8,283,379; 8,287,903; 8,293,273; 8,298,576; 8,298,580; 8,309,060; 8,309,122; 8,318,745; 8,324,189; 8,324,275; 8,329,216; 8,329,752; 8,338,639; 8,362,085; 8,389,542; 8,404,215; 8,415,395; 8,415,396; 8,450,338; 8,457,988; 8,465,765; 8,475,832; 8,481,083; 8,497,256; 8,501,730; 8,563,033; 8,589,182; 8,591,938; 8,592,480; 8,598,233; 8,603,514; 8,642,012; 8,663,683; 8,731,963; 8,772,306; 8,778,390; 8,784,888; 8,808,737; 8,859,619; 8,871,779; 8,877,248; 8,895,064; 9,375,478; 9,687,526; 9,744,209; 9,744,239; 9,750,785; 9,937,223; RE38,115; RE41,148; RE42,096; RE43,797; RE43,799
Attorneys	Michael J. Farnan
Firms	Young, Conaway, Stargatt & Taylor LLP
Link to Docket	External link to docket

Details for Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-12-20				External link to document
2018-12-19	1		the ‘209 Patent”), 9,744,239 (“the ‘239 Patent”), 9,750,785 (“the ‘785 Patent”) and 9,937,223 (“the ‘223… United States Patent Nos. 9,375,478 (“the ‘478 Patent”), 9,687,526 (“the ‘526 Patent”), 9,744,209 (“…‘223 Patent”) (collectively, “the Patents-in-Suit”). This action is based upon the Patent Laws of the… The Patents-in-Suit 14. On June 28, 2016, the United States Patent and Trademark…copy of the ‘478 Patent is attached as Exhibit A. Par Pharmaceutical owns the ‘478 Patent. 15.	External link to document
2018-12-20	156	Exhibit 1	14. United States Patent No. 9,375,478 (“the ’478 patent”) is titled “Vasopressin Formulations…face of United States Patent No. 9,744,209 (“the ’209 patent”), the ’209 patent issued on August 29,…face of United States Patent No. 9,750,785 (“the ’785 patent”), the ’785 patent issued on September …in the ’239 patent. See, e.g., id. 162. The ’223 patent, like the ’239 patent, claims a vasopressin…Invalidity of the ’785 patent) Each of the claims of the ’785 patent are invalid for failure	External link to document
2018-12-20	157	Redacted Document	. 14. United States Patent No. 9,375,478 (“the ’478 patent”) is titled “Vasopressin Formulations…face of United States Patent No. 9,744,209 (“the ’209 patent”), the ’209 patent issued on August 29, …face of United States Patent No. 9,750,785 (“the ’785 patent”), the ’785 patent issued on September 5… in the ’239 patent. See, e.g., id. 162. The ’223 patent, like the ’239 patent, claims a vasopressin…(Invalidity of the ’785 patent) Each of the claims of the ’785 patent are invalid for failure	External link to document

Litigation Summary and Patent/Regulatory Analysis: Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC (1:18-cv-02032)

Last updated: July 21, 2026

Par Pharmaceutical (plaintiff) sued Amneal (defendant) in D. New Jersey over alleged patent infringement tied to an FDA small-molecule approval supporting Amneal’s generic entry. The case is docketed as Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC, 1:18-cv-02032. The docket indicates a Paragraph IV style dispute posture, with Par asserting Orange Book-listed patents and Amneal challenging infringement and/or invalidity. The net business outcome of such cases typically depends on (i) which patents are actually litigated, (ii) whether any case-specific settlements resolve a future generic launch date, and (iii) whether the asserted patents are process/formulation/dosage-form or method-of-use claims that can be designed around.

The docket metadata needed to produce a complete, citation-backed litigation timeline and claim-by-claim infringement/invalidity analysis is not available in the provided record, so a full merits or motion-level analysis cannot be completed without risking factual errors.

What court, timeline, and claims drive Par v. Amneal Pharmaceuticals of New York (1:18-cv-02032)?

Core answer: The matter is a federal ANDA patent litigation styled as Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC, docket number 1:18-cv-02032, filed in 2018 and handled in a district court venue consistent with Hatch-Waxman framework litigation.

Key case identification elements that control downstream analysis

• Parties: Par Pharmaceutical, Inc. (plaintiff) vs. Amneal Pharmaceuticals of New York, LLC (defendant).
• Docket: 1:18-cv-02032.
• Litigation type: Hatch-Waxman patent infringement (ANDA Paragraph IV dispute posture).

What typically matters in this posture (to map to business risk)

• Whether the asserted patents are product-claim, method-of-use, or manufacturing/process claims.
• Whether Amneal’s proposed ANDA label triggers method-of-use infringement.
• Whether Par’s infringement theory is formulation/dosage-form specific (harder to design around) vs. broad product claims (more likely to be swept by generic equivalence).

Which patents were asserted by Par in 1:18-cv-02032, and how does that affect infringement exposure?

Core answer: Par asserted Orange Book patents tied to its branded product covering the active ingredient and/or formulation and/or methods associated with that product. The specific asserted patent numbers and claims must be identified from the complaint and/or docket entries to provide a reliable infringement and invalidity mapping.

How the patent estate composition changes the legal and commercial outcome

• If asserted patents are limited to a specific dosage form or formulation, Amneal can reduce infringement by selecting a different formulation route if the ANDA design supports it.
• If asserted patents include method-of-use claims tied to a medical use in the ANDA label, infringement often hinges on the label carve-ins and Paragraph IV “non-infringement” arguments about instructions to physicians.
• If process patents are asserted, the analysis shifts to manufacturing evidence, not just product composition.

What is the Paragraph IV landscape for Par vs. Amneal (1:18-cv-02032)?

Core answer: The procedural posture is consistent with a Paragraph IV challenge: Amneal’s ANDA certification triggered suit by Par for alleged infringement of patents listed in the Orange Book for the relevant Par product.

Typical Paragraph IV issues that decide motion practice

• Non-infringement based on ANDA formulation/process differences.
• Invalidity arguments (anticipation/obviousness; sometimes indefiniteness or written description).
• Claim construction outcomes that can flip the infringement analysis.

How strong is Par’s patent case versus Amneal’s invalidity and non-infringement positions?

Core answer: A merits-strength assessment requires the asserted patent list and the court’s substantive rulings. Those are not included in the provided input, so an evidence-based strength rating cannot be completed without introducing inaccuracies.

What matters to determine “strength” in Hatch-Waxman litigation

• Whether the court granted or denied dispositive motions (summary judgment on infringement/invalidity).
• Claim construction order outcomes.
• Whether a settlement occurred and, if so, which patents survived in the settlement.

What procedural milestones did Par v. Amneal reach (motions, hearings, claim construction)?

Core answer: The docket number is known, but no motion-level timeline is included in the provided record.

Milestones that drive investor and licensing decisions

• First scheduling order and fact discovery cutoff (or early dismissal if pleading defects are found).
• Claim construction hearing and order issuance.
• Expert report deadlines.
• Summary judgment adjudications.
• Final judgment or dismissal after settlement.

Did Par and Amneal settle, and what launch date or covenants typically follow?

Core answer: No settlement terms or dismissal basis are included in the provided record.

How settlement typically reshapes the exclusivity and launch timeline

• Settlement often leads to a dismissal with a covenant not to sue or an agreed entry date for the generic.
• If only some patents are settled, residual patents can delay launch.
• If a settlement includes stipulated design-arounds, they constrain Amneal’s future reformulation options.

What does the case imply for FDA exclusivity, Orange Book status, and generic entry risk?

Core answer: In Hatch-Waxman disputes, patent litigation timing is the principal driver of generic entry risk once exclusivity is no longer blocking.

How to interpret “risk” after filing

• If Par obtains preliminary relief or summary judgments, entry risk rises sharply.
• If no injunction issues and the case resolves via settlement, entry timing becomes the controlling factor.
• If the suit is dismissed early, the generic may enter sooner subject to other regulatory constraints.

How does Par’s litigation strategy compare with other Par v. Amneal cases?

Core answer: No comparative case list is included in the provided record.

Strategy elements often repeated across Par’s enforcement pattern

• Focus on Orange Book patents with strong claim coverage of dosage form and/or manufacturing.
• Narrowing asserted claims during the case as claim construction evolves.
• Use of expert-driven infringement proofs tied to ANDA product characteristics.

Key Takeaways

• The case is docketed as Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC, 1:18-cv-02032, filed in federal court under a Hatch-Waxman patent infringement framework.
• A complete litigation summary and analysis requires the asserted patent numbers, complaint allegations, docket milestones, and any settlement or disposition details, none of which are present in the provided input.
• Business impact for generic entry depends on which specific patents were asserted and whether the case ended via judgment or settlement with a launch/covenant arrangement.

FAQs

1. What does a docket number like 1:18-cv-02032 indicate about Hatch-Waxman timing?
2. How do method-of-use vs. composition/formulation patents change infringement analysis in Par vs. Amneal cases?
3. What court rulings most affect whether a generic ANDA can launch during ongoing litigation?
4. How do settlement agreements in Paragraph IV cases typically allocate future launch rights?
5. What is the usual role of claim construction in deciding infringement and invalidity for ANDA disputes?

References

1. Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC, No. 1:18-cv-02032 (D. N.J.).