United States Drug Patent 9,107,900: Dronedarone Claims, Expiration, Orange Book Status and Generic Risk
US Patent 9,107,900 protects selected use of dronedarone, marketed as Multaq, to reduce cardiovascular hospitalization in patients with non-permanent atrial fibrillation or flutter. The patent is a patient-selection and treatment-regimen patent, not a compound patent. Its core limitations include twice-daily administration with morning and evening meals, defined atrial-fibrillation status, cardiovascular-risk criteria, exclusions for severe heart failure, and, in dependent claims, treatment for at least 12 months.
The patent was issued to Sanofi and is expected to expire in 2028 based on its reported 2007 priority date, subject to any terminal disclaimer, patent-term adjustment, or patent-term extension recorded in the official patent file. The commercial risk is concentrated in method-of-use claims that may overlap with an ANDA label for dronedarone.
What does US Patent 9,107,900 cover?
US Patent 9,107,900 covers methods of administering dronedarone to defined atrial-fibrillation populations to reduce cardiovascular hospitalization. The patent does not broadly claim all uses of dronedarone or the chemical compound itself.
The principal protected elements are:
| Claim element |
Scope |
| Active ingredient |
Dronedarone or a pharmaceutically acceptable salt |
| Dosing frequency |
Twice daily |
| Administration condition |
With a morning meal and an evening meal |
| Disease population |
Paroxysmal or persistent non-permanent atrial fibrillation or flutter |
| Primary outcome |
Reduced risk of cardiovascular hospitalization |
| Structural heart disease |
Coronary heart disease in claims 1 and 9 |
| Age and risk profile |
Age at least 75, or age at least 70 with at least one listed cardiovascular risk factor |
| Heart-failure exclusion |
No NYHA Class IV heart failure and no heart-failure hospitalization within the prior month |
| Duration |
At least 12 months under claims 7, 8 and 14 |
The patent contains three principal independent method claims:
- Claim 1 addresses cardiovascular hospitalization reduction in a high-risk population with coronary heart disease.
- Claim 6 addresses patients with NYHA Class III congestive heart failure who were not hospitalized for heart failure within the prior month.
- Claim 9 addresses cardiovascular hospitalization reduction for atrial fibrillation in a population substantially similar to claim 1, but focuses on atrial fibrillation rather than atrial fibrillation or flutter.
How are the independent claims different?
Claim 1: high-risk coronary-heart-disease population
Claim 1 requires all of the following:
- Dronedarone administration twice daily.
- Administration with morning and evening meals.
- A history of, or current, paroxysmal or persistent non-permanent atrial fibrillation or flutter.
- Structural heart disease defined as coronary heart disease.
- No severe heart failure.
- No NYHA Class IV heart failure.
- No hospitalization for heart failure within the preceding month.
- Either:
- age 75 or older; or
- age 70 or older plus at least one specified cardiovascular risk factor.
The listed risk factors are hypertension, diabetes, prior cerebral stroke or systemic embolism, left atrial diameter of at least 50 mm, and left ventricular ejection fraction below 40%.
Claim 6: NYHA Class III heart failure population
Claim 6 is materially different. It requires:
- A history of, or current, paroxysmal or persistent non-permanent atrial fibrillation or flutter.
- NYHA Class III congestive heart failure.
- No heart-failure hospitalization within the preceding month.
- Twice-daily dronedarone with morning and evening meals.
Claim 6 does not expressly require coronary heart disease, an age threshold, or one of the five cardiovascular risk factors listed in claim 1.
Claim 9: atrial-fibrillation-only formulation
Claim 9 largely tracks claim 1 but replaces the broader atrial-fibrillation-or-flutter language with paroxysmal or persistent non-permanent atrial fibrillation. It also expressly frames the objective as reducing cardiovascular hospitalization for atrial fibrillation.
What do the dependent claims add?
Claims 2 through 5 narrow claim 1 by selecting a specific cardiovascular risk factor:
- Claim 2: diabetes.
- Claim 3: previous cerebral stroke or systemic embolism.
- Claim 4: left atrial diameter of at least 50 mm.
- Claim 5: left ventricular ejection fraction below 40%.
Claims 10 through 13 impose the same four risk-factor limitations on claim 9.
Claims 7, 8 and 14 add a treatment-duration requirement of at least 12 months. A potentially infringing treatment course must therefore continue for the claimed period. A short prescription or early discontinuation may not satisfy these dependent claims, although the independent claims remain relevant.
When does US Patent 9,107,900 expire?
The reported priority date for the patent family is in May 2007. Under the US patent-term rule applicable to applications filed after June 8, 1995, the basic term is generally 20 years from the earliest effective non-provisional filing date, subject to patent-term adjustment and other statutory modifications.[1]
| Event |
Date or status |
| Earliest reported priority |
May 2007 |
| US patent application family |
Continuation or related US filing |
| Patent issued |
August 18, 2015 |
| Patent number |
US 9,107,900 B2 |
| Expected base expiration |
May 2028, subject to official term calculation |
| Patent type |
Method-of-use patent |
| Active ingredient |
Dronedarone |
The issue date does not determine expiration. The relevant calculation follows the earliest effective US non-provisional filing date, adjusted for any patent-term adjustment, terminal disclaimer, or applicable extension. The USPTO Patent Center record and the FDA Orange Book remain controlling for the final legal term.
What is the Orange Book status of US Patent 9,107,900?
The Orange Book evaluates patents submitted by the sponsor for an approved drug product and lists patent information reported by the application holder. For Multaq, the relevant regulatory protection is principally a method-of-use estate rather than a currently active basic-compound patent.
A listed use patent can affect an ANDA through a Paragraph IV certification. A generic applicant must certify that the patent is not infringed, is invalid, or is unenforceable, or it may seek a section viii statement and omit a patented use where the proposed labeling can lawfully avoid that use.[2]
The commercial importance of US 9,107,900 depends on:
- Whether Sanofi listed the patent for the relevant Multaq indications.
- The exact use code assigned in the Orange Book.
- Whether the proposed generic label includes the protected patient population.
- Whether the applicant makes a Paragraph IV certification or a section viii carve-out.
- Whether another listed patent separately blocks approval or launch.
An Orange Book listing does not establish validity or infringement. It creates a regulatory and litigation pathway for ANDA applicants.
What FDA labeling overlaps with the patent claims?
The FDA-approved Multaq label states that dronedarone is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.[3] The label directs administration as 400 mg twice daily with the morning and evening meals.
The label also contains safety limitations that closely track the patent’s heart-failure exclusions. Multaq is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. The label warns against use in patients with permanent atrial fibrillation and identifies increased risks of death, stroke and heart failure in certain populations.[3]
| FDA label element |
Relationship to patent |
| 400 mg twice daily |
Consistent with claimed twice-daily regimen |
| Morning and evening meals |
Directly recited in claims 1, 6 and 9 |
| Paroxysmal or persistent AF |
Direct overlap with claims 1, 6 and 9 |
| Permanent AF exclusion |
Consistent with “non-permanent” limitation |
| Recent decompensated heart failure exclusion |
Overlaps with claim 1 and claim 9 |
| NYHA Class IV exclusion |
Expressly recited in claims 1 and 9 |
| Cardiovascular hospitalization reduction |
Core claimed therapeutic result |
The label overlap makes a full-label generic strategy commercially difficult if the patent remains listed and enforceable. A successful section viii strategy would need to omit the patented use without removing the FDA-approved indications required for the generic product.
How strong is the patent estate for dronedarone?
The estate is stronger as a regulatory-use barrier than as a compound barrier. The claims are narrow, but they map onto the approved Multaq dosing instructions and the principal FDA indication.
Strengths
- The claims recite a specific patient population rather than an unrestricted treatment.
- The meal-related dosing requirement is concrete and appears in each independent claim.
- The claimed population corresponds closely to the ATHENA clinical-trial treatment concept and the FDA indication.
- The patent covers both a high-risk coronary-heart-disease population and an NYHA Class III population not recently hospitalized.
- The 12-month claims create additional protection for sustained treatment.
Limitations
- Every limitation of an asserted claim must be met.
- Claims 1 and 9 require multiple demographic and clinical facts that may not be present in every patient.
- Claims 2 through 5 and 10 through 13 are narrower and easier to design around.
- The “reducing a risk” language is tied to a therapeutic outcome, which can create proof issues in litigation.
- A generic applicant may pursue a label carve-out for protected uses if FDA regulations permit it.
- Clinical-prescribing instructions and patient behavior may complicate proof of administration with both meals and proof of treatment for at least 12 months.
What generic entry risks exist for Multaq?
The principal generic-entry scenarios are:
| Scenario |
Business effect |
| Paragraph IV certification |
Likely Hatch-Waxman litigation; approval may be delayed by a 30-month stay if statutory conditions are met |
| Section viii carve-out |
Generic may omit a patented use, reducing infringement exposure |
| Paragraph III certification |
Launch waits until patent expiration |
| Patent invalidity challenge |
Could remove the method-of-use barrier before the expected term |
| Label redesign |
Applicant narrows or separates indications to avoid listed use codes |
| Settlement agreement |
Entry date may be earlier than patent expiration but subject to negotiated restrictions |
A Paragraph IV challenge would likely focus on obviousness, written description, enablement, claim construction, and whether the clinical evidence supports the claimed reduction in cardiovascular hospitalization for each recited population.
The strongest infringement theory would involve a generic label that instructs twice-daily administration with meals for the FDA-approved atrial-fibrillation indication, while the strongest design-around theory would omit or narrow the high-risk patient-selection language and rely on an approved use not covered by the asserted patent.
Which companies are challenging the dronedarone patent estate?
No specific Paragraph IV challenger, district-court complaint, or settlement involving US 9,107,900 is established by the patent and FDA materials cited here. Public confirmation requires matching the patent against FDA Paragraph IV notices, ANDA litigation records and PACER filings.
The relevant competitive group consists of:
- Sanofi, the Multaq sponsor and patent holder.
- Generic-drug companies seeking approval for dronedarone tablets.
- Contract manufacturers and distributors that may enter after ANDA approval.
- Potential licensees or settlement counterparties in Hatch-Waxman litigation.
Dronedarone is a small molecule. Biosimilar pathways do not apply. Any follow-on product would proceed through an ANDA or, depending on the proposed product and clinical differences, another drug-approval pathway. The principal competition risk is therefore generic substitution, not biosimilar substitution.
What formulation and manufacturing patents protect dronedarone?
US 9,107,900 does not claim a tablet composition, crystal form, manufacturing process, particle-size distribution, or pharmaceutical formulation. It claims therapeutic use and patient selection.
Potentially separate protection may exist for:
- Dronedarone chemical composition.
- Salt forms.
- Polymorphs or crystalline forms.
- Tablet compositions.
- Manufacturing and purification methods.
- Stability and packaging systems.
- Other method-of-use indications.
Those rights must be analyzed separately by patent family. A generic applicant can face residual manufacturing or formulation barriers even if it defeats or avoids US 9,107,900. Conversely, expiration of a formulation patent does not eliminate an active method-of-use patent.
Does US 9,107,900 have international coverage?
US 9,107,900 has legal effect only in the United States. Related applications may exist in Europe, Canada, Japan and other jurisdictions, but foreign patents can differ in claim scope, prosecution history, expiration, opposition status and enforceability.
The core international claim strategy would likely divide into:
- Dronedarone treatment for non-permanent atrial fibrillation.
- Prevention or reduction of cardiovascular hospitalization.
- Exclusion of severe or recently decompensated heart failure.
- Meal-linked twice-daily administration.
- High-risk patient selection.
A global launch assessment cannot assume that a US claim outcome applies abroad.
What patent litigation affects Multaq generic entry?
The relevant litigation question is whether an ANDA applicant has made a Paragraph IV certification against the listed patent and whether Sanofi filed a timely infringement action. The patent number alone does not prove that litigation exists.
For transaction and launch planning, the decisive events are:
- Orange Book listing and use code.
- First Paragraph IV notice.
- Sanofi’s complaint and asserted claims.
- FDA’s 30-month-stay determination.
- Claim-construction rulings.
- Summary-judgment or trial outcome.
- Any licensed settlement and agreed entry date.
- Final patent-term calculation.
Key Takeaways
- US 9,107,900 is a dronedarone method-of-use patent.
- Claims 1 and 9 target older or high-risk patients with non-permanent atrial fibrillation and coronary heart disease.
- Claim 6 separately targets NYHA Class III heart-failure patients who were not hospitalized within the prior month.
- Twice-daily dosing with morning and evening meals is required by all independent claims.
- Claims 7, 8 and 14 require treatment for at least 12 months.
- The reported expected expiration is in 2028, subject to the official USPTO term calculation.
- The patent’s commercial strength comes from overlap with the FDA-approved Multaq regimen and indication.
- Generic applicants may consider Paragraph IV litigation or a section viii label carve-out.
- Biosimilar risk does not apply because dronedarone is a small-molecule drug.
- Separate compound, formulation and manufacturing patents must be reviewed for a complete Multaq freedom-to-operate analysis.
FAQs About US Patent 9,107,900
Is US Patent 9,107,900 a compound patent?
No. It is a method-of-use patent covering selected administration of dronedarone for reducing cardiovascular hospitalization.
Does the patent cover every Multaq prescription?
No. The claims require specific clinical, demographic and dosing conditions. A prescription outside those conditions may not meet every limitation of an asserted claim.
Does claim 6 cover NYHA Class IV heart failure?
No. Claim 6 requires NYHA Class III congestive heart failure and no heart-failure hospitalization within the preceding month. Claims 1 and 9 expressly exclude NYHA Class IV heart failure.
Can a generic company launch dronedarone before the patent expires?
Potentially, if it obtains approval through a successful Paragraph IV challenge, a lawful section viii carve-out, a settlement license, or another path that removes the relevant regulatory barrier.
Are patents on dronedarone manufacturing covered by US 9,107,900?
No. The supplied claims do not cover manufacturing, formulation, crystal form, tablet composition or packaging. Those rights would reside in separate patent families.
References
- United States Patent and Trademark Office. (2015). US Patent No. 9,107,900 B2.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- U.S. Food and Drug Administration. (2023). Multaq (dronedarone hydrochloride) prescribing information. Sanofi-aventis U.S. LLC.
