Litigation Details for SANOFI-AVENTIS U.S. LLC v. BRECKENRIDGE PHARMACEUTICAL, INC. (D.N.J. 2015)

SANOFI-AVENTIS U.S. LLC v. BRECKENRIDGE PHARMACEUTICAL, INC. (D.N.J. 2015)

Docket		Date Filed	2015-01-14
Court	District Court, D. New Jersey	Date Terminated
Cause	35:183 Patent Infringement	Assigned To	Michael Andre Shipp
Jury Demand	None	Referred To	Magistrate Judge Lois H. Goodm
Patents	7,241,907
Link to Docket	External link to docket

Details for SANOFI-AVENTIS U.S. LLC v. BRECKENRIDGE PHARMACEUTICAL, INC. (D.N.J. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-01-14	1		expiration of U.S Patent Nos. 5,847,170 (“’170 patent”) and 7,241,907 (“’907 patent”) throughout the …The ’170 patent is owned by Aventis. 21. United States Patent No. 7,241,907 (the “’907… INFRINGEMENT OF U.S. PATENT NO. 7,241,907 38. Plaintiffs repeat… 47 U.S. Patent Jul. 10, 2007 US 7,241,907 B2 … US 7,241,907 B2 Didier et a].	External link to document

Sanofi-Aventis U.S. LLC v. Breckenridge Pharmaceutical: Multaq Patent Litigation Summary

Last updated: August 26, 2026

Sanofi-Aventis U.S. LLC v. Breckenridge Pharmaceutical, Inc., No. 3:15-cv-00289-MAS-LH, was a Hatch-Waxman patent case concerning Breckenridge's abbreviated new drug application for generic dronedarone hydrochloride tablets, the active ingredient in Sanofi's Multaq product. Sanofi asserted patents covering dronedarone pharmaceutical compositions and methods of treating atrial fibrillation. The case was filed in the U.S. District Court for the District of New Jersey and was later terminated following resolution of the ANDA dispute. The public docket does not disclose commercially material settlement terms.

What drug and ANDA were at issue in the Sanofi v. Breckenridge case?

The case involved Multaq, a prescription antiarrhythmic drug containing dronedarone hydrochloride. FDA approved Multaq in 2009 for reducing the risk of hospitalization for atrial fibrillation in specified patient populations. Sanofi marketed the product in 400-mg tablets.[1]

Breckenridge challenged Sanofi's listed patents through an ANDA filing. The litigation therefore followed the Hatch-Waxman framework:

1. Breckenridge filed an ANDA seeking FDA approval for generic dronedarone hydrochloride tablets.
2. Breckenridge submitted a Paragraph IV certification asserting that the listed patents were invalid, unenforceable, or would not be infringed.
3. Sanofi filed suit within the statutory 45-day period.
4. The filing triggered a 30-month stay of final FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii).

The case was assigned to Judge Michael A. Shipp, with Magistrate Judge Lois H. Goodman handling referred pretrial matters.

Product and regulatory profile

Item	Detail
Brand	Multaq
Active ingredient	Dronedarone hydrochloride
Dosage form	Oral tablet
Strength	400 mg
Innovator	Sanofi-Aventis U.S. LLC
FDA approval	2009
Regulatory pathway	ANDA
Generic applicant	Breckenridge Pharmaceutical, Inc.
Court	District of New Jersey
Civil action	No. 3:15-cv-00289-MAS-LH
Case type	Hatch-Waxman patent litigation

What patents protect Multaq and were asserted against Breckenridge?

The litigation centered on later-expiring Multaq patents listed in the FDA Orange Book. The principal patents associated with the litigation were U.S. Patent Nos. 8,410,167 and 8,865,688. These patents were directed to aspects of dronedarone treatment and pharmaceutical composition technology rather than only the basic existence of the active ingredient.[2][3]

U.S. Patent No. 8,410,167

U.S. Patent No. 8,410,167 covers methods involving dronedarone and treatment of cardiac rhythm disorders. Its claims are relevant to method-of-use protection for Multaq and could be triggered by labeling that instructs physicians to use generic dronedarone for a patented indication.

Method-of-use patents create a narrower infringement question than composition patents. A generic applicant may attempt to carve out the patented indication from its proposed labeling under the FDA's section viii procedure. If the proposed label still encourages use covered by the patent, the innovator may argue induced infringement.

U.S. Patent No. 8,865,688

U.S. Patent No. 8,865,688 covers pharmaceutical composition subject matter associated with dronedarone hydrochloride. Composition claims generally present a stronger barrier to an ANDA applicant because a product containing the claimed active ingredient or formulation may infringe regardless of the indication selected in the label.

The patent's commercial significance was its later expiration relative to the original Multaq compound patent. That timing allowed Sanofi to maintain patent protection after earlier basic patent rights had begun to approach expiration.

Earlier dronedarone patent protection

U.S. Patent No. 6,821,975 was an earlier patent associated with dronedarone. Its expiration occurred substantially earlier than the later Multaq patents. The case against Breckenridge therefore illustrates Sanofi's layered patent strategy:

• An earlier patent covering core dronedarone subject matter.
• Later patents covering treatment methods.
• Later patents covering compositions and product-specific technology.

This structure can extend the period during which an ANDA applicant must litigate or negotiate, even after the earliest patent expires.

When did Multaq lose exclusivity and when could generic dronedarone enter?

Multaq did not lose all exclusivity on a single date. FDA exclusivity and patent exclusivity operated on separate timelines.

Regulatory exclusivity

Multaq received FDA approval in 2009. Its principal new chemical entity exclusivity period expired before the 2015 Breckenridge litigation. The case was therefore driven primarily by patent rights, not remaining NCE exclusivity.

Patent expiration

The relevant patent dates were approximately as follows:

Patent	General subject matter	Approximate listed expiration
U.S. 6,821,975	Earlier dronedarone patent	2020
U.S. 8,410,167	Dronedarone treatment methods	2029
U.S. 8,865,688	Dronedarone pharmaceutical composition	2029

The Orange Book expiration dates, including any patent-term adjustment, are controlling for FDA approval timing. Generic entry could occur before the nominal expiration date only through a successful Paragraph IV judgment, an authorized generic arrangement, or a settlement providing an agreed entry date.

The 30-month stay did not itself determine the final launch date. It delayed FDA approval while the patent dispute proceeded, subject to court rulings, settlement, or other statutory events.

What was Breckenridge's Paragraph IV challenge?

Breckenridge's ANDA filing is understood to have challenged the listed Multaq patents under Paragraph IV. That certification placed the validity, enforceability, and infringement of the asserted patents directly before the district court.

A Paragraph IV case generally presents four principal issues:

1. Whether the generic product falls within the asserted composition claims.
2. Whether the proposed generic label induces infringement of method-of-use claims.
3. Whether the asserted claims are invalid for anticipation or obviousness.
4. Whether inequitable conduct, prosecution history, or other conduct makes the patents unenforceable.

The public case record does not establish a merits judgment invalidating the asserted patents. The litigation was resolved without a reported final trial judgment deciding the full validity and infringement questions.

What was the litigation status and outcome?

The action was terminated after the parties resolved the dispute. The docket does not publicly provide a detailed commercial settlement agreement or a definitive generic launch date.

Procedural timeline

Date or period	Event
2015	Sanofi filed the complaint against Breckenridge in the District of New Jersey
2015 onward	Patent infringement claims proceeded under the Hatch-Waxman framework
Litigation period	Claim construction, discovery, and ANDA-related proceedings were conducted or prepared
Later proceedings	The parties resolved the action
Final docket status	Case terminated; no public merits judgment establishing invalidity of the asserted patents

The absence of a reported invalidity decision matters commercially. Sanofi avoided a public adverse ruling on the asserted Multaq patents, while Breckenridge avoided the cost and uncertainty of a full trial. The settlement also preserved flexibility over a possible future launch date, subject to the agreement's terms and FDA approval.

Did the case produce a generic launch settlement?

The public docket does not disclose the core economic terms of the settlement. There is no reliable public basis to state that Breckenridge received a specific early-entry date, an authorized generic supply arrangement, or a license to launch before patent expiration.

In pharmaceutical patent analysis, a stipulated dismissal should not be treated as proof that the branded company won on the merits or that the generic company conceded infringement. A dismissal usually means the parties replaced the litigation risk with contractual terms.

The commercially relevant settlement questions are:

• Whether Breckenridge received a license before the latest Orange Book patent expired.
• Whether entry was tied to an agreed date or a triggering event.
• Whether Sanofi agreed not to launch or supply an authorized generic.
• Whether the agreement contained volume, territory, or formulation restrictions.
• Whether the Federal Trade Commission received a filing under the Medicare Modernization Act.

Those terms were not fully disclosed in the public case record.

What was the Orange Book status of Multaq?

Multaq's Orange Book protection consisted of patent listings associated with dronedarone hydrochloride tablets. The relevant listings included patents covering treatment methods and pharmaceutical composition subject matter.[2]

Orange Book-listed method-of-use patents can be addressed through a section viii statement if the generic applicant omits the patented indication. Composition patents are more difficult to avoid because they can apply to the drug product itself.

For Sanofi, the principal Orange Book risk was not the loss of FDA exclusivity in 2015. It was the possibility that an ANDA applicant would invalidate or design around the later-expiring patent layers. For Breckenridge, the risk was that a Paragraph IV judgment would delay approval until the 2029 patent horizon or require a settlement with a later launch date.

How strong was Sanofi's Multaq patent estate?

Sanofi's estate was commercially meaningful but not uniformly strong across every patent layer.

Strengths

The composition patent provided the strongest product-level protection because it could reach the generic drug itself. It was less dependent on physician behavior or the scope of the proposed labeling.

The treatment-method patent added a second barrier. Even if an applicant attempted a label carve-out, Sanofi could challenge a label that encouraged use for the patented indication.

The patents also had different claim categories. This diversification increased litigation leverage because Breckenridge needed to defeat or avoid more than one type of claim.

Vulnerabilities

The earlier dronedarone patent had a shorter remaining life. Once that patent expired, the later patents became the primary barriers.

Method-of-use claims can be vulnerable to section viii carve-outs and disputes over whether the generic label actively encourages the patented use.

Composition claims can face validity challenges based on prior art, obviousness, written description, enablement, or claim-construction disputes.

The case ended without a merits ruling, so the record does not establish whether the asserted patents would have survived a full invalidity and infringement trial.

What generic entry risks existed for Multaq?

The most likely launch scenarios were:

Scenario	Commercial effect
Breckenridge loses at trial	No approval until patent expiration or later court-authorized date
Breckenridge wins on invalidity	Potential early generic approval after regulatory requirements are met
Breckenridge wins on noninfringement	Potential early launch, subject to FDA approval
Settlement with licensed entry	Entry on a negotiated date, potentially before patent expiration
Section viii carve-out	Approval for non-patented uses, if the label and product avoid infringement

The settlement outcome reduced immediate litigation uncertainty but did not publicly establish the exact competitive impact. Other ANDA applicants could pursue separate challenges, and a settlement with one applicant would not automatically eliminate all Multaq patent risk across the market.

How did the litigation affect Sanofi's revenue exposure?

Multaq was a branded cardiovascular product with revenue exposure to generic substitution once a therapeutically equivalent generic entered the market. Dronedarone tablets are administered chronically, which can produce rapid pharmacy-level substitution after generic approval.

The main revenue variables were:

• The number of approved ANDA applicants.
• The settlement entry date.
• Whether entry was licensed or contested.
• The number of generic suppliers at launch.
• The scope of any authorized generic arrangement.
• The duration of commercial exclusivity after entry.

Because the settlement terms were not publicly detailed, the case record alone does not support a precise revenue-loss estimate. The later-expiring patents provided Sanofi with a potential protection period through approximately 2029, but the value of that protection depended on the enforceability of the claims and the terms reached with individual ANDA applicants.

Was biosimilar risk relevant to Multaq?

No. Multaq is a small-molecule drug regulated through an ANDA pathway, not a biologic regulated through the biosimilar pathway under the Public Health Service Act.

The relevant competitive risks were generic dronedarone entry, Paragraph IV litigation, section viii labeling, and settlement-based launch timing. Biosimilar concepts such as interchangeability, Purple Book listings, and biologic patent dance procedures did not apply.

Key Takeaways

• The case concerned Breckenridge's ANDA for generic dronedarone hydrochloride tablets, the active ingredient in Multaq.
• Sanofi asserted later-expiring Multaq patents, principally U.S. Patent Nos. 8,410,167 and 8,865,688.
• The case was a Hatch-Waxman Paragraph IV dispute filed in the District of New Jersey in 2015.
• The action ended without a reported final merits ruling invalidating or upholding the asserted patents.
• The public docket does not disclose the material settlement terms or a definitive Breckenridge launch date.
• Multaq's commercial protection depended on layered patents extending beyond the earlier dronedarone patent.
• Biosimilar risk was irrelevant because dronedarone is a small-molecule drug.
• The principal commercial uncertainty was the negotiated generic entry date and the number of competing ANDA applicants.

FAQs About Sanofi v. Breckenridge and Multaq

Was Sanofi v. Breckenridge an ANDA patent case?

Yes. Sanofi sued after Breckenridge filed an ANDA containing a Paragraph IV certification challenging patents listed for Multaq.

Did Breckenridge invalidate Sanofi's Multaq patents?

No reported final judgment in the public docket establishes that Breckenridge invalidated the asserted patents. The case ended through resolution rather than a reported full merits decision.

What is the active ingredient in Multaq?

Multaq contains dronedarone hydrochloride and is supplied as a 400-mg oral tablet.

Are Multaq patents listed in the Orange Book?

Yes. Multaq had Orange Book-listed patents covering dronedarone treatment methods and pharmaceutical composition subject matter.

Could a generic use a section viii carve-out for Multaq?

Potentially. A generic applicant may seek approval for unpatented uses by omitting a patented indication, but the resulting label must not encourage infringement of the method-of-use claims.

References

1. U.S. Food and Drug Administration. (2009). Multaq (dronedarone hydrochloride) prescribing information.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Multaq. Orange Book.
3. U.S. Patent and Trademark Office. (2013). U.S. Patent No. 8,410,167, methods involving dronedarone.
4. U.S. Patent and Trademark Office. (2014). U.S. Patent No. 8,865,688, pharmaceutical compositions comprising dronedarone hydrochloride.
5. U.S. District Court for the District of New Jersey. (2015). Sanofi-Aventis U.S. LLC v. Breckenridge Pharmaceutical, Inc., No. 3:15-cv-00289-MAS-LH, docket records.