US Patent 11,139,056: Scope, Claims, Expiration and Patent Landscape for Contrave

US Patent No. 11,139,056 protects the use of sustained-release naltrexone/bupropion, the active combination in Contrave, for overweight or obese patients with established cardiovascular disease and defined risk factors for major adverse cardiovascular events. The patent is directed primarily to patient selection, cardiovascular-risk outcomes, treatment duration, weight-loss response and the 8 mg/90 mg tablet dosage form.

The patent does not claim naltrexone/bupropion broadly. Its commercial relevance depends on whether a competing product or label includes the claimed cardiovascular-risk population, dose, treatment duration and outcome-related limitations.

What does US Patent 11,139,056 protect?

The patent protects methods of treating overweight or obesity with sustained-release naltrexone and sustained-release bupropion in patients who have cardiovascular disease plus at least one specified cardiovascular-risk characteristic.

The principal limitations are:

Claim element	Scope
Disease treated	Overweight or obesity
Active ingredients	Sustained-release naltrexone and sustained-release bupropion
Naltrexone dose	About 4 mg to about 50 mg per day
Bupropion dose	About 30 mg to about 500 mg per day
Patient population	Overweight or obese subject at increased risk of a major adverse cardiovascular event
Cardiovascular qualification	Established cardiovascular disease plus at least one listed risk factor
Treatment duration	At least 16 weeks in claim 1
Commercial dosage form	Tablet containing 8 mg sustained-release naltrexone and 90 mg sustained-release bupropion
Clinical outcome	At least 5% weight loss in dependent claims
Cardiovascular outcome	Cardiovascular death, nonfatal myocardial infarction or nonfatal stroke

The claims are method-of-treatment claims. They do not claim a new chemical entity, a new salt, a new molecular structure or a general composition of matter.

How is the increased-cardiovascular-risk patient defined?

The patent defines the target population through a closed list of cardiovascular disease criteria and risk factors. The listed characteristics include:

A documented myocardial infarction more than three months before identification.
Prior coronary revascularization, including:
- Coronary artery bypass graft surgery;
- Stent placement;
- Percutaneous transluminal coronary angioplasty; or
- Laser atherectomy.
Angina with ischemic changes, ECG changes on a graded exercise test or a positive cardiac imaging study.
An ankle-brachial index below 0.9 assessed by simple palpation within the prior two years.
At least 50% stenosis of a coronary, carotid or lower-extremity artery within the prior two years.

The distinction between the wording in claims 1 and 7 is material. Claim 1 recites greater than 50% stenosis, while claim 7 and claim 12 recite at least 50% stenosis. Claim 7 therefore reaches patients with exactly 50% stenosis, while claim 1 may be argued to exclude that boundary case.

The risk definition is narrower than a general population with obesity, hypertension or elevated cardiovascular risk. A patient with obesity and conventional risk factors but no qualifying cardiovascular disease may fall outside the independent claims.

What are the independent claims?

Claim 1: broadest treatment method with a 16-week requirement

Claim 1 covers administration of the two sustained-release active ingredients within broad dose ranges to a qualifying cardiovascular-risk patient for at least 16 weeks.

The claim does not require the patient to achieve 5% weight loss. That requirement appears in dependent claim 3. It also does not require the marketed 8 mg/90 mg tablet. That limitation appears in claim 6.

Claim 1 is therefore broader than the commercial tablet-specific claims in one respect, but narrower than a general obesity-treatment claim because it requires the defined cardiovascular disease population and at least 16 weeks of treatment.

Claim 7: tablet-specific method

Claim 7 requires:

The same cardiovascular-risk patient population;
The same broad daily dose ranges; and
A tablet containing 8 mg sustained-release naltrexone and 90 mg sustained-release bupropion.

Unlike claim 1, claim 7 does not expressly state a 16-week treatment period. It is directed more closely to the Contrave dosage form.

Claim 12: cardiovascular-outcome method

Claim 12 covers treatment of an overweight or obese patient at increased risk of a major adverse cardiovascular event where the major adverse cardiovascular event is cardiovascular death, nonfatal myocardial infarction or nonfatal stroke.

Claim 12 does not expressly include the 16-week limitation or the 8 mg/90 mg tablet limitation. It is therefore structurally different from both claims 1 and 7.

What do the dependent claims add?

Claim	Added limitation	Commercial or legal effect
2	Excludes certain patients with type 2 diabetes and at least two listed risk factors	Narrows the eligible population
3	Patient achieves at least 5% weight loss	Adds an outcome limitation
4	Administration does not increase risk of an adverse cardiovascular outcome	Adds a safety-result limitation
5	Adverse outcome is cardiovascular death, nonfatal MI or nonfatal stroke	Defines the cardiovascular endpoint
6	8 mg naltrexone/90 mg bupropion tablet	Tracks the marketed dosage form
8	Same diabetes-related exclusion as claim 2	Applies to claim 7
9	At least 5% weight loss	Applies to claim 7
10	No increased risk of adverse cardiovascular outcome	Applies to claim 7
11	Cardiovascular death, nonfatal MI or nonfatal stroke	Applies to claim 7
13-15	Repeat limitations concerning diabetes, weight loss and cardiovascular outcome	Drafting and dependency issues arise because these claims refer to claim 7 rather than claim 12

Claims 13 through 15 appear to depend on claim 7 even though they follow claim 12 and correspond substantively to limitations that could have been drafted from claim 12. The issued claim language controls. The dependency may create claim-construction questions, but it does not automatically invalidate the claims.

What is the technical scope of the dosage claims?

Contrave tablets contain 8 mg of naltrexone hydrochloride and 90 mg of bupropion hydrochloride in a sustained-release formulation. The usual maintenance regimen is two tablets twice daily, equivalent to:

32 mg naltrexone hydrochloride per day; and
360 mg bupropion hydrochloride per day.

The claims use wider ranges of approximately 4 mg to 50 mg per day for naltrexone and 30 mg to 500 mg per day for bupropion. The marketed dose falls within those ranges.

Claims 6 and 7 are commercially important because they capture the labeled tablet strength rather than requiring only the broader dose ranges. A generic manufacturer that markets the same 8 mg/90 mg tablet for the claimed cardiovascular-risk population would face a stronger literal-infringement argument if the patent is enforceable and the use is included in the product labeling.

The patent does not appear, from the supplied claims, to require a particular polymer, coating, dissolution profile, particle size, manufacturing process or release-control excipient. Those limitations would need to come from other patents in the Contrave patent family.

When does US Patent 11,139,056 expire?

The patent issued on October 5, 2021. Its expected expiration is based on the earliest effective nonprovisional priority date and the 20-year patent term under 35 U.S.C. § 154.

The relevant expiration analysis is:

Event	Date or status
Patent issuance	October 5, 2021
Statutory term	Generally 20 years from the earliest effective nonprovisional filing date
Expected term	Approximately 2035, subject to the patent record
Patent term adjustment	Must be confirmed from the USPTO patent-front-page data
Patent term extension	No patent-term extension is apparent from the supplied claim information
Terminal disclaimer	Must be checked against the USPTO file and assignment records

The likely statutory term is in the 2035 period if the family claims priority to a 2015 nonprovisional filing. The exact enforceable expiration date should be taken from the USPTO term calculation, including any patent-term adjustment and terminal disclaimer.

Because this is a method patent, an expiration date in 2035 could remain relevant after earlier composition or formulation patents expire if the FDA-approved labeling continues to identify the patented patient population or use.

What is the FDA and Orange Book status of Contrave?

Contrave is an FDA-approved combination product containing naltrexone hydrochloride and bupropion hydrochloride extended release. The FDA approved Contrave under NDA 200063 in 2014 for chronic weight management in adults with obesity or overweight and at least one weight-related comorbidity, together with reduced-calorie diet and increased physical activity.[1]

The FDA-approved indication is broader than the population described in US 11,139,056. The label generally covers adults with:

A body mass index of at least 30 kg/m²; or
A BMI of at least 27 kg/m² with at least one weight-related comorbid condition.

The labeled population is not limited to patients with established cardiovascular disease. The patent therefore does not automatically cover every labeled Contrave prescription.

The Orange Book analysis must distinguish between:

Listed patents covering the active ingredient combination or dosage form;
Method-of-use patents tied to the approved labeling; and
Patents that may be relevant to a generic applicant but are not listed in the Orange Book.

An Orange Book listing does not establish validity or infringement. It can, however, trigger a Paragraph IV notice and a 30-month stay if an ANDA applicant certifies that a listed patent is invalid, unenforceable or will not be infringed.[2]

What Paragraph IV challenges and generic-entry risks exist?

A generic applicant could use several regulatory strategies:

Strategy	Risk to the patent holder
Paragraph III certification	Delays approval until patent expiration
Paragraph IV certification	Creates litigation risk and potentially a 30-month stay
Section viii carve-out	Removes a patented method from the proposed labeling where FDA permits the carve-out
ANDA with restricted indication	Reduces literal infringement exposure
Product launch after patent expiration	Avoids infringement for the expired claims
Different dosage form or strength	May avoid claims 6 and 7 but not necessarily claims 1 or 12

The central generic risk is labeling. If a generic label includes treatment of patients with established cardiovascular disease and the claimed outcomes, the patent holder may argue induced infringement. If the generic label omits the patented cardiovascular-risk use and the product can be prescribed for non-patented obesity indications, the generic may have a stronger Section viii position.

The strength of a carve-out depends on whether the FDA-approved labeling contains the patented use and whether the remaining label still encourages the patented method. Courts examine the totality of the label, promotional conduct and known prescribing behavior.

How strong are the claims under validity scrutiny?

Written description and enablement

The patent claims a defined clinical population, dose range, treatment period and cardiovascular outcome. The specification would need to provide adequate support for treating that population and for the asserted safety and efficacy results.

Claims 4 and 10 are vulnerable to scrutiny because they require that treatment “does not increase” the patient’s risk of an adverse cardiovascular outcome. That language can raise questions about:

The comparator used to measure risk;
The statistical threshold for “does not increase”;
Whether the limitation is an observed clinical result or a treatment step;
Whether the specification enables the full claimed dose and patient range.

Indefiniteness

Potential indefiniteness issues include:

“About” in the dose ranges;
“Increased risk” when tied to a closed list of clinical conditions;
“Does not increase” the risk of an adverse cardiovascular outcome;
The relationship between “major adverse cardiovascular event” and the specific cardiovascular outcomes in claims 5, 11 and 12;
The different use of “greater than 50%” and “at least 50%” stenosis.

The patient-qualification criteria are relatively concrete. The outcome limitations are more likely to generate claim-construction disputes.

Obviousness

The underlying combination of naltrexone and bupropion was known before this patent. An obviousness challenge would likely focus on whether prior art taught:

The use of the combination for obesity;
The 8 mg/90 mg sustained-release tablet;
Treatment in patients with established cardiovascular disease;
At least 16 weeks of treatment;
A 5% weight-loss endpoint; and
Cardiovascular safety or non-inferiority in the claimed population.

The cardiovascular-risk population and clinical-outcome limitations provide the principal distinction from earlier combination patents. Prior clinical-trial disclosures, protocols, publications and regulatory submissions would be central to an obviousness analysis.

What patent landscape surrounds naltrexone/bupropion?

The Contrave patent estate generally falls into four categories.

Core composition and combination patents

Earlier patents cover the combination of naltrexone and bupropion for weight management. These patents may claim the active ingredients, dose ratios, pharmaceutical compositions or general methods of use.

Sustained-release formulation patents

Formulation patents may address:

Extended-release release profiles;
Separate or combined active-ingredient layers;
Tablet architecture;
Release-controlling excipients;
Stability;
Dissolution performance; and
Manufacturing methods.

These patents can create a separate barrier even where a later cardiovascular-use patent is avoided.

Method-of-use patents

US 11,139,056 belongs principally to this category. Its differentiation is the cardiovascular-risk population and the claimed clinical outcomes, not the chemical identity of the active ingredients.

Regulatory and manufacturing barriers

A generic applicant must establish pharmaceutical equivalence, bioequivalence and acceptable release characteristics. Differences in tablet construction can lead to formulation and process patent disputes even when the active ingredients are old.

How does US 11,139,056 compare with earlier Contrave patents?

Issue	Earlier Contrave patents	US 11,139,056
Main subject	Combination, composition or sustained release	Cardiovascular-risk patient selection and treatment
Active ingredients	Naltrexone and bupropion	Same
General obesity use	Often broader	Limited to defined cardiovascular-risk population
Tablet strength	May be claimed directly or indirectly	Expressly claimed in claims 6 and 7
Clinical endpoint	Usually not central	5% weight loss and cardiovascular outcomes
16-week requirement	Not necessarily present	Expressly present in claim 1
Generic carve-out potential	Depends on formulation and indication	Potentially significant because of narrow patient population
Main litigation issue	Equivalence and formulation infringement	Labeling, induced infringement, validity and clinical-result limitations

The patent is best viewed as a late-stage use patent layered on top of earlier Contrave composition and formulation rights.

Which companies could be affected by the patent?

The primary commercial parties are:

The Contrave product sponsor and current rights holder;
ANDA applicants seeking approval for naltrexone/bupropion extended-release tablets;
Contract manufacturers producing equivalent extended-release tablets;
Companies developing obesity products that rely on the same active combination; and
Licensees or distributors with rights to market the product in specific territories.

The patent creates limited risk for competing obesity drugs with different active ingredients, including GLP-1 receptor agonists and other incretin-based therapies. It does not claim semaglutide, tirzepatide, liraglutide or other unrelated anti-obesity agents.

What is the geographic coverage?

US 11,139,056 provides protection only in the United States. Foreign protection would require corresponding national or regional family members, such as European, Canadian, Australian or other national patents.

Foreign claims may differ materially because of:

National restrictions on medical-treatment claims;
Different patentability standards;
Added subject-matter rules;
Claim amendments during prosecution; and
Different patent-term and regulatory-extension rules.

A US freedom-to-operate conclusion cannot be extended to Canada, Europe or other markets without reviewing the corresponding family members.

What litigation and settlement issues matter?

A Paragraph IV dispute could involve:

Whether the patent is listed for the relevant FDA-approved method;
Whether a proposed generic label includes the claimed cardiovascular-risk population;
Whether the generic’s 8 mg/90 mg tablet satisfies the sustained-release limitations;
Whether the claims are anticipated or obvious;
Whether claims 4 and 10 are indefinite or lack enablement;
Whether the patent is enforceable; and
Whether a settlement permits an agreed generic-entry date before expiration.

No settlement term should be inferred from the existence of the patent or from the approval of a generic product. Settlement agreements must be reviewed for entry dates, authorized-generic rights, supply provisions, acceleration clauses and scope of the release.

Key Takeaways

US 11,139,056 is a method-of-treatment patent focused on Contrave use in patients with established cardiovascular disease and specified risk factors.
Claims 1, 7 and 12 are the principal independent claims.
Claim 7 is the most directly aligned with the commercial 8 mg/90 mg tablet.
Claim 1 requires at least 16 weeks of treatment.
Dependent claims add 5% weight loss, cardiovascular-event definitions and safety-outcome limitations.
The likely term extends into approximately 2035, subject to USPTO patent-term adjustment and terminal-disclaimer records.
The patent does not cover all obesity treatment with naltrexone/bupropion.
A generic’s principal avoidance strategy would be a Section viii labeling carve-out, provided the remaining label does not encourage the patented use.
The most significant validity issues concern obviousness, the “does not increase risk” limitations, “about” dose language and differences between “greater than 50%” and “at least 50%” stenosis.
Earlier Contrave composition and formulation patents must be analyzed separately because they may create independent infringement risk.

FAQs

Does US 11,139,056 cover all Contrave prescriptions?

No. The claims require a defined cardiovascular disease population with at least one listed risk factor. Prescriptions for obesity patients without that qualifying cardiovascular history may fall outside the claims.

Is the 8 mg/90 mg Contrave tablet specifically protected?

Yes. Claims 6 and 7 expressly recite a tablet containing 8 mg sustained-release naltrexone and 90 mg sustained-release bupropion. Other claims rely on broader dose ranges and do not require that exact tablet strength.

Can a generic sell naltrexone/bupropion for obesity after carving out cardiovascular-risk patients?

Potentially. A Section viii carve-out may reduce infringement exposure if the generic label omits the patented method and does not otherwise encourage the carved-out use. The result depends on the final label and litigation facts.

Does the patent claim cardiovascular safety as a product property?

No. The patent claims methods in which administration does not increase the risk of an adverse cardiovascular outcome. That language is a method limitation and may create separate enablement, indefiniteness and proof-of-infringement issues.

Are biosimilar rules relevant to Contrave?

No. Contrave is a small-molecule combination product, not a biologic. Generic competition proceeds through the ANDA pathway rather than the biosimilar pathway under the Public Health Service Act.

References

U.S. Food and Drug Administration. (2014). Contrave prescribing information, NDA 200063.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
United States Patent and Trademark Office. (2021). U.S. Patent No. 11,139,056, methods of treating overweight or obesity.
35 U.S.C. § 154. Patent term.
21 U.S.C. § 355(j). Abbreviated new drug applications and patent certifications.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	093694	⤷ Start Trial
Argentina	125234	⤷ Start Trial
Australia	2013271622	⤷ Start Trial
Australia	2018203271	⤷ Start Trial
Brazil	112014030282	⤷ Start Trial
Canada	2875056	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,139,056

Which drugs does patent 11,139,056 protect, and when does it expire?

Summary for Patent: 11,139,056