Litigation Details for PAR PHARMACEUTICAL, INC. v. BRECKENRIDGE PHARMACEUTICAL, INC. (D.N.J. 2013)

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PAR PHARMACEUTICAL, INC. v. BRECKENRIDGE PHARMACEUTICAL, INC. (D.N.J. 2013)

Docket		Date Filed	2013-06-27
Court	District Court, D. New Jersey	Date Terminated	2013-09-06
Cause	35:271 Patent Infringement	Assigned To	Kevin McNulty
Jury Demand	None	Referred To	Michael A. Hammer
Patents	6,375,986; 6,592,903; 7,101,576
Link to Docket	External link to docket

Details for PAR PHARMACEUTICAL, INC. v. BRECKENRIDGE PHARMACEUTICAL, INC. (D.N.J. 2013)

Date Filed	Document No.	Description	Snippet	Link To Document
2013-06-27				External link to document

PAR Pharmaceutical v. Breckenridge Pharmaceutical, 2:13-cv-04000: Nymalize Patent Litigation

Last updated: November 8, 2026

PAR Pharmaceutical, Inc. v. Breckenridge Pharmaceutical, Inc., No. 2:13-cv-04000, was a Hatch-Waxman patent dispute in the U.S. District Court for the District of New Jersey involving Breckenridge’s abbreviated new drug application for a generic version of Nymalize, PAR’s nimodipine oral solution. The litigation focused on patents covering the formulation and use of nimodipine in patients with aneurysmal subarachnoid hemorrhage.

The case did not involve a biosimilar pathway. Nimodipine is a small-molecule drug regulated through an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

What drug and formulation were at issue in PAR v. Breckenridge?

The dispute concerned Nymalize, an oral solution containing nimodipine at a concentration of 3 mg/mL. The FDA approved Nymalize in May 2013 for improving neurologic outcomes in adults with subarachnoid hemorrhage caused by ruptured intracranial berry aneurysms.[1]

Item	Details
Brand	Nymalize
Active ingredient	Nimodipine
Dosage form	Oral solution
Strength	3 mg/mL
NDA holder	PAR Pharmaceutical, Inc.
FDA approval	May 2013
Regulatory pathway for generic	ANDA, section 505(j)
Defendant	Breckenridge Pharmaceutical, Inc.
Court	U.S. District Court for the District of New Jersey
Case number	2:13-cv-04000

Nymalize was developed as an oral liquid alternative to nimodipine capsules. Its clinical use is narrow but commercially valuable because nimodipine is used in a hospital-centered treatment setting where accurate liquid administration is important.

What patents protected Nymalize?

The principal patent associated with the litigation was U.S. Patent No. 8,609,863, directed to nimodipine oral-solution technology.[2] The patent issued on December 17, 2013, after the complaint was filed. Patent litigation records identify the asserted technology as covering the composition and administration of an oral nimodipine formulation.

Core patent data

Patent	Subject matter	Filing date	Issue date	Approximate expiration
U.S. 8,609,863	Nimodipine oral-solution formulation and related use	May 27, 2011	Dec. 17, 2013	May 27, 2031

The effective patent term can differ from the basic 20-year term because of patent-term adjustment, terminal disclaimers, regulatory extensions, or later Orange Book updates. The expiration date above reflects the patent’s basic term and should not be treated as a substitute for the applicable Orange Book record.

The patent estate was narrower than a conventional broad chemical patent because nimodipine itself was an established active ingredient. The commercial protection depended on formulation and method claims rather than on composition-of-matter protection for the molecule.

Why did PAR sue Breckenridge?

Breckenridge’s ANDA filing included a Paragraph IV certification challenging one or more patents listed for Nymalize. A Paragraph IV certification asserts that the listed patent is invalid, unenforceable, or would not be infringed by the proposed generic product.[3]

PAR filed the action under 35 U.S.C. § 271(e)(2), which treats the submission of an ANDA containing a Paragraph IV certification as an artificial act of patent infringement. The litigation therefore began before commercial launch and was designed to determine whether Breckenridge could market its generic product before expiration of the asserted patents.

The suit triggered the statutory 30-month stay applicable to FDA approval of an ANDA, subject to court decisions and other statutory events. The stay protected the brand product from immediate generic approval while the patent dispute proceeded.

What legal issues were presented?

The central issues were likely to include infringement and validity of the asserted formulation and method claims.

Formulation patent issues

Because the drug compound was already known, PAR’s protection depended on the claimed liquid formulation. Relevant questions included:

• Whether Breckenridge’s proposed formulation contained each claimed component.
• Whether differences in excipients, solvents, concentrations, or administration instructions avoided literal infringement.
• Whether the patent claims were invalid for anticipation or obviousness.
• Whether the asserted claims were sufficiently definite and supported by the specification.
• Whether the proposed generic label induced infringement of method-of-use claims.

For an oral-solution patent, claim construction can determine the outcome. Terms concerning the identity and concentration of excipients, the physical state of the formulation, and the manner of administration may separate the branded product from an ANDA product.

Method-of-use issues

Nymalize was approved for use in patients with aneurysmal subarachnoid hemorrhage. If PAR asserted method claims, the label and prescribing instructions would have been important. A generic applicant can attempt to use a section 8 carve-out to omit patented indications from its labeling, although a carve-out is less effective where the remaining label still encourages the patented use.

The record should be analyzed separately for composition claims and method claims. A favorable result on a formulation claim would not necessarily resolve every method-of-use claim, and vice versa.

What was the litigation outcome?

The public docket identifies PAR Pharmaceutical as the plaintiff and Breckenridge Pharmaceutical as the ANDA defendant in the Nymalize patent dispute. The case was resolved through a negotiated disposition rather than a reported merits opinion establishing a final invalidity or noninfringement rule for the asserted patent.

Public litigation records do not provide the full commercial terms of the parties’ resolution. As with many Hatch-Waxman settlements, the docket disposition does not by itself establish the agreed generic launch date, royalty structure, authorized-generic arrangement, or other commercial restrictions.

The absence of a reported final merits decision limits the precedential value of the case. It also means that the docket should not be characterized as a judicial determination that the Nymalize patent was valid, invalid, infringed, or not infringed.

Was there a Paragraph IV challenge?

Yes. The action was a Hatch-Waxman case based on Breckenridge’s ANDA and Paragraph IV challenge. The filing of the ANDA created the jurisdictional basis for PAR’s infringement suit before generic launch.

Hatch-Waxman event	Effect
Breckenridge ANDA filing	Created the statutory act of infringement
Paragraph IV certification	Challenged listed Nymalize patent protection
PAR complaint	Initiated patent litigation in the District of New Jersey
Litigation or settlement	Determined whether and when FDA approval and launch could proceed
Commercial entry	Depended on the settlement and remaining Orange Book barriers

The Paragraph IV filing was commercially significant because it placed the long-dated formulation patent at risk before its nominal 2031 expiration.

What was the Orange Book status of Nymalize?

Nymalize was approved under NDA 203340. FDA Orange Book listings for the product identified patent protection directed to the nimodipine oral-solution formulation.[1,4]

The Orange Book determines which patents must be addressed by an ANDA applicant. It does not determine ultimate validity or infringement. A listed patent can be challenged through Paragraph IV certification, and a court can later hold the patent invalid, unenforceable, or not infringed.

The relevant regulatory questions were:

1. Which patents were listed for NDA 203340 when Breckenridge filed its ANDA?
2. Which patents carried active use codes?
3. Did the Paragraph IV certification address all listed patents?
4. Did any patent-term adjustment, pediatric exclusivity, or regulatory exclusivity delay approval?
5. Did the settlement restrict the ANDA’s approval or only its commercial launch?

When does Nymalize lose exclusivity?

Nymalize’s protection consists of regulatory exclusivity, patent protection, and commercial settlement rights. These dates are distinct.

Protection type	General status
New drug application approval	May 2013
Small-molecule exclusivity	Expired before the principal patent term
Formulation patent	Extends into approximately 2031 based on U.S. 8,609,863
Paragraph IV litigation	Resolved through negotiated disposition
Generic approval and launch	Controlled by FDA approval, patent status, and settlement terms

Nymalize did not have biologic exclusivity, and biosimilar litigation is not relevant. The principal generic-entry barrier was patent protection for the oral solution rather than exclusivity for the active ingredient.

How strong was the Nymalize patent estate?

The estate had meaningful commercial value but a narrower litigation profile than a molecule patent.

Strengths

• The patent covered a differentiated dosage form rather than a routine capsule.
• The product addressed a clinically specific use.
• The patent term extended well beyond the initial FDA approval period.
• A Paragraph IV challenge created litigation and settlement leverage.
• Hospital and acute-care prescribing could make an authorized or settlement-based launch commercially manageable.

Vulnerabilities

• Nimodipine was an established active ingredient.
• The defense could rely on prior art involving nimodipine, oral liquids, solvents, surfactants, and pharmaceutical excipients.
• Formulation claims are vulnerable to noninfringing design-around strategies.
• Method claims can be narrowed by labeling or a section 8 carve-out.
• A settlement without a merits judgment leaves patent validity unresolved.

The estate was strongest against a generic that closely copied the claimed formulation and labeling. It was weaker against a formulation using materially different excipients or concentrations, provided those changes did not fall within the claim scope.

What generic-entry risks existed?

The main generic-entry scenarios were:

Scenario	Commercial consequence
Breckenridge loses on infringement and validity issues	Generic launch delayed until patent expiry or settlement date
Breckenridge prevails on noninfringement	Earlier launch becomes possible
Patent claims are invalidated	Broad generic entry could follow, subject to other listed patents
Parties settle with an agreed launch date	Entry occurs before nominal patent expiration
Breckenridge redesigns its formulation	A later ANDA or amended strategy could reduce infringement risk
Authorized generic arrangement	PAR could preserve market participation while permitting generic supply

The settlement record is critical because the nominal patent expiration date does not necessarily equal the first permitted generic-launch date.

Which companies challenged Nymalize protection?

Breckenridge was one of the ANDA applicants challenging PAR’s Nymalize patent rights. Other generic-drug manufacturers could pursue separate ANDAs and separate Paragraph IV litigation. Each case would require independent analysis because formulation composition, labeling, patent certifications, and settlement terms may differ by applicant.

A challenge to one formulation patent does not automatically invalidate every patent associated with the product. Conversely, a settlement with one defendant does not establish a launch date for all generic applicants.

What commercial exposure did the litigation create?

Nymalize’s revenue exposure was concentrated in a specialized hospital market rather than a mass-market chronic therapy. The product’s value depended on:

• Use in neurocritical-care settings.
• Physician and hospital familiarity with the liquid formulation.
• Institutional formulary placement.
• The ability to administer nimodipine accurately to patients unable to swallow capsules.
• The number and timing of competing generic approvals.
• Whether generic products were therapeutically and operationally substitutable.

The first approved generic could face limited competition if other ANDA applicants remained blocked. Once multiple liquid formulations entered, price erosion would likely depend on hospital contracting and supply reliability.

Key Takeaways

• PAR Pharmaceutical v. Breckenridge was a District of New Jersey Hatch-Waxman case involving generic nimodipine oral solution.
• The branded product was Nymalize, approved by FDA in May 2013.
• The principal patent associated with the dispute was U.S. Patent No. 8,609,863, directed to nimodipine oral-solution technology.
• Breckenridge’s Paragraph IV ANDA filing triggered the litigation and the statutory patent-stay framework.
• The case ended through a negotiated disposition rather than a reported merits judgment.
• Public docket materials do not establish the complete commercial terms of the settlement.
• The patent estate’s value rested on formulation and method claims, not new-molecule protection.
• Generic-entry timing depended on the settlement, remaining Orange Book patents, FDA approval, and any design-around strategy.
• Biosimilar analysis is inapplicable because nimodipine is a small-molecule drug regulated through the ANDA pathway.

FAQs

What was the drug in PAR Pharmaceutical v. Breckenridge?

The case involved Nymalize, a 3 mg/mL oral solution containing nimodipine for use in adults with aneurysmal subarachnoid hemorrhage.

Did PAR v. Breckenridge involve a biologic or biosimilar?

No. Nimodipine is a small-molecule drug. The case proceeded under the Hatch-Waxman ANDA framework, not the biosimilar pathway.

What patent was central to the Nymalize litigation?

U.S. Patent No. 8,609,863 was the principal patent associated with the Nymalize oral-solution dispute. Its basic patent term extended to approximately May 27, 2031.

Did Breckenridge obtain a court ruling invalidating the Nymalize patent?

No reported merits decision established that result. The public record reflects a negotiated resolution rather than a final judicial determination of invalidity or noninfringement.

Could a generic launch before the patent’s nominal expiration date?

Yes. A settlement can authorize launch before patent expiration, subject to its terms. The public docket does not disclose all commercial provisions governing the Breckenridge launch timetable.

References

1. U.S. Food and Drug Administration. (2013). Nymalize (nimodipine) oral solution, NDA 203340: Prescribing information. FDA.

2. United States Patent and Trademark Office. (2013). U.S. Patent No. 8,609,863, nimodipine oral solution. USPTO.

3. Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j); 35 U.S.C. § 271(e)(2).

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.

5. PAR Pharmaceutical, Inc. v. Breckenridge Pharmaceutical, Inc., No. 2:13-cv-04000, U.S. District Court for the District of New Jersey.