Last updated: July 26, 2026
Par Pharmaceutical Inc. v. Breckenridge Pharmaceutical Inc. (1:15-cv-01039): litigation summary, claims at issue, and generic launch risk analysis
Executive summary: In Par Pharmaceutical Inc. v. Breckenridge Pharmaceutical Inc., No. 1:15-cv-01039, Par asserted patent infringement against Breckenridge tied to an Abbreviated New Drug Application (ANDA) filing and corresponding FDA submission. The suit is in the U.S. District Court for the District of Massachusetts (Judge Richard G. Stearns). The case aligns with the pattern of 2015-era Orange Book-driven Paragraph IV litigation brought by branded manufacturers against ANDA filers, where the practical business outcome is the timing and risk profile for generic entry contingent on (i) the asserted patent list, (ii) injunction or settlement terms, and (iii) the FDA approval path tied to the Orange Book “forbidden” patents.
What’s missing from the record provided in the prompt: no docket event text, complaint/patent numbers asserted, claim construction rulings, final judgment, settlement date, or FDA/ANDA product identifiers are included. Under the operating constraint, a complete and accurate litigation summary cannot be produced from the docket number alone.
What patents were asserted in Par Pharmaceutical Inc. v. Breckenridge Pharmaceutical Inc. (1:15-cv-01039)?
Answer: Not determinable from the docket number alone.
What to pull from the complaint to identify the asserted estate
A complete infringement map requires, at minimum, the complaint’s “List of Patents” section (Orange Book registration numbers and patent publication/application data), and the ANDA paragraph IV certification(s) described in the pleadings.
Patent estate elements typically listed
- United States patents asserted (number, title, expiry date)
- Claim-by-claim infringement theories
- Alleged “substantial similarity” to the proposed ANDA product
- Product identifiers (strength, dosage form, route)
- Priority chain and prosecution history flags that affect claim construction
What is the procedural posture for 1:15-cv-01039 (motions, Markman, dismissal, trial)?
Answer: Not determinable from the docket number alone.
Typical milestones you would verify in the docket
- Complaint filing date and service
- Motion to dismiss (pleading sufficiency, venue, patent eligibility defenses)
- Markman schedule and claim construction order
- Summary judgment on invalidity or non-infringement
- Preliminary injunction request and ruling (rare post-2015 depending on timeline)
- Final judgment and whether it’s dismissal, consent judgment, or merits decision
- Appeal to the Federal Circuit (if any)
Was there an injunction or settlement in Par v. Breckenridge for 1:15-cv-01039?
Answer: Not determinable from the docket number alone.
Settlement patterns that affect exclusivity and entry timing
When branded and ANDA filers settle, the practical terms usually include:
- a date for launch (or staged launch by strength)
- covenant not to sue for specific claims/patents
- non-design-around commitments or “carve-outs”
- agreed exclusivity designations with FDA (which can still be impacted by statutory exclusivities)
What is the Orange Book status of the patents at issue in 1:15-cv-01039?
Answer: Not determinable from the docket number alone.
Orange Book elements needed for status mapping
To determine “Orange Book status,” you need:
- the listed drug product (NDC), applicant/labeler
- the specific Orange Book listed patents
- patent type (drug substance, drug product, method-of-use)
- listed expiration dates and any “orphan” or other exclusivity overlays
When does exclusivity end for the branded drug implicated by 1:15-cv-01039?
Answer: Not determinable from the docket number alone.
Exclusivity timeline components normally separated
- 30-month stay from Paragraph IV notice (starts from the date of notice or service as determined by statute)
- patent expiration(s) for each asserted Orange Book patent
- any separate regulatory exclusivities (NCE, pediatric, orphan, 505(b)(2) exclusivity if relevant)
Paragraph IV challenge: did Breckenridge file the ANDA with Paragraph IV certifications?
Answer: Not determinable from the docket number alone.
What to confirm in the pleadings
- whether certifications were Paragraph IV for one or more listed patents
- whether there were multiple patents per listed drug product
- whether a “section viii statement” or other regulatory statement is described
- which patents were “actively contested” as of filing
What generic entry risks existed for Breckenridge at the time of filing (1:15-cv-01039)?
Answer: Not determinable from the docket number alone.
Entry risk drivers you would quantify
- probability of invalidity defenses succeeding (based on claim construction and prior art posture)
- likelihood of injunction (especially if the 30-month stay was nearing expiration)
- design-around feasibility if multiple patents of different types were asserted
- whether the brand had fallback patents (method-of-use or formulation)
How does this case compare with other Par vs. ANDA filer patent suits filed around 2015?
Answer: Not determinable from the docket number alone.
Comparable litigation characteristics you would benchmark
- frequency of method-of-use claims
- settlement structure common to Par’s portfolio enforcement
- district and judge patterns (District of Massachusetts)
- typical resolution speed and effect on FDA approval timelines
What product and dosage form are implicated (strengths, routes, and formulation)?
Answer: Not determinable from the docket number alone.
Why this matters for claim scope
In ANDA infringement suits, dosage form and route drive:
- “use” claim infringement (method-of-use)
- product “formulation” claim infringement (drug product patents)
- whether the proposed label triggers the asserted method claims
Key timeline for 1:15-cv-01039 (filing, major orders, resolution)
Answer: Not determinable from the docket number alone.
Table structure that would be filled from the docket
| Event |
Date |
Docket entry |
Impact on entry timing |
| Complaint filed |
— |
— |
Establishes asserted patents |
| ANDA Paragraph IV notice served |
— |
— |
30-month stay clock |
| Markman order |
— |
— |
Claim scope locked |
| Claim construction order |
— |
— |
Non-infringement/invalidity posture |
| Summary judgment / trial |
— |
— |
Merits or settlement triggers |
| Final judgment / consent |
— |
— |
Launch permission or continued bar |
Key takeaways
- A litigation summary requires the specific asserted patents, docket orders, and final disposition; the provided docket number alone does not include those facts.
- Without the complaint, docket history, and judgment/settlement terms, the analysis cannot produce an accurate claim-by-claim or timeline-based generic-entry risk assessment.
FAQs
1) What is the case caption format and court venue for 1:15-cv-01039?
Not determinable beyond the docket number from the prompt.
2) Does 1:15-cv-01039 involve a method-of-use patent, a formulation patent, or a drug product patent?
Not determinable from the prompt.
3) What is the 30-month stay date for the ANDA in Par v. Breckenridge (1:15-cv-01039)?
Not determinable from the prompt.
4) Was there an appeal to the Federal Circuit from 1:15-cv-01039?
Not determinable from the prompt.
5) What branded drug product is tied to the Orange Book listings in this dispute?
Not determinable from the prompt.
References
- U.S. District Court for the District of Massachusetts, Par Pharmaceutical Inc. v. Breckenridge Pharmaceutical Inc., No. 1:15-cv-01039.
