US Patent 9,636,349: Scope, Claims, Expiration, and Deoxycholic Acid Patent Landscape

US Patent 9,636,349 protects local administration of deoxycholic acid, including sodium deoxycholate, for reducing subcutaneous fat or improving loose skin and wrinkles when the deoxycholic acid has radiocarbon content below 1 part per trillion. The patent is a method-of-use patent with an unusual product-quality limitation directed to synthetic or substantially fossil-derived DCA. Its commercial relevance is linked to Kybella, the FDA-approved deoxycholic acid injection marketed by AbbVie following Allergan's acquisition of Kythera Biopharmaceuticals.

What does US Patent 9,636,349 protect?

The patent protects two principal treatment categories:

Local reduction of a subcutaneous fat deposit.
Local improvement in loose skin or wrinkles through a skin-tightening effect.

The independent claims require the use of a composition containing:

Deoxycholic acid or a DCA salt;
DCA with carbon-14 content below 1 ppt;
A pharmaceutically acceptable excipient; and
Optionally, a lipid.

The patent does not claim every use of deoxycholic acid. It claims methods meeting the combined requirements of local administration, specified therapeutic purpose, composition content, and radiocarbon level.

Claim 1: reduction of subcutaneous fat

Claim 1 covers a method for reducing a subcutaneous fat deposit by administering the DCA composition locally to the deposit.

The claim has five material elements:

Claim element	Scope
Subject	A subject in need of treatment
Treatment objective	Reduction of a subcutaneous fat deposit
Route	Local administration to the fat deposit
Active ingredient	DCA or a DCA salt
Product limitation	DCA with less than 1 ppt carbon-14
Formulation	Pharmaceutical excipient, with lipid optional

The term "optionally a lipid" does not narrow the claim to lipid-containing formulations. A composition without a lipid can still satisfy claim 1.

Claim 2: covered fat-related conditions

Claim 2 expands the treatment scope to specified conditions and anatomical fat presentations, including:

Obesity;
Fat redistribution syndrome;
Eyelid fat herniation;
Lipomas;
Dercum's disease;
Lipodystrophy;
Buffalo hump lipodystrophy;
Dorsocervical fat;
Visceral adiposity;
Breast enlargement;
Hyperadiposity;
Diffuse body fat around the trunk and arms; and
Cellulite-associated fat deposits.

Claim 2 depends on claim 1. A product or treatment must still satisfy the local-administration and sub-1-ppt radiocarbon limitations.

Claim 3: sodium deoxycholate

Claim 3 narrows claim 2 to sodium deoxycholate. This is commercially important because Kybella contains synthetic deoxycholic acid in a sodium deoxycholate formulation. The dependent claim provides a direct coverage position for the principal active form used in the approved product.

Claim 4: loose skin and wrinkles

Claim 4 covers local administration of the same low-radiocarbon DCA composition for reducing the appearance of:

Loose skin; or
Wrinkles.

This claim is materially different from claim 1 because the therapeutic objective is skin tightening or cosmetic improvement rather than fat reduction. It may cover treatment even where the commercial objective is skin tightening and the claim does not require a fat deposit.

Claims 5 through 7: route, location, and salt

Claim 5 specifies subcutaneous or transdermal injection.

Claim 6 identifies treatment areas, including:

Under-eye;
Under-chin;
Under-arm;
Buttock;
Cheek;
Brow;
Calf;
Back;
Thigh;
Ankle; and
Stomach.

Claim 7 narrows claim 4 to sodium deoxycholate.

Why is the less-than-1-ppt carbon-14 limitation important?

The radiocarbon limitation is the patent's principal technical distinction. Carbon-14 testing can differentiate recently biosourced carbon from carbon originating in ancient fossil feedstocks. Synthetic DCA produced from petrochemical starting materials generally has extremely low radiocarbon content, while DCA isolated from animal bile or other contemporary biological sources contains measurable carbon-14.

The limitation creates a hybrid product-and-use claim:

The patent claims a treatment method.
The treatment method requires a composition containing DCA meeting a quantitative chemical-identity or source-related specification.

A competitor cannot necessarily avoid the patent by using the same therapeutic method with the same DCA salt. It may need to establish that its DCA has carbon-14 content at or above 1 ppt, or that the product does not satisfy another claim element.

Potential claim-construction issues

The principal technical issues are likely to include:

Meaning of "14C content." The claim does not, on its face, specify the analytical protocol, sample preparation, reporting convention, or whether the measurement is normalized to total carbon.
Proof in an infringement case. The patent owner would need reliable analytical evidence that the accused DCA contains less than 1 ppt carbon-14.
Source versus measured property. A product made synthetically may still require testing. Manufacturing origin alone does not necessarily establish the claimed numerical limitation.
Batch variation. A generic applicant would need to control the radiocarbon specification across commercial batches.
Method-of-use enforcement. The patent does not claim the vial or active ingredient in isolation. Infringement depends on the use of the composition in a claimed manner.

What is the FDA status of the related deoxycholic acid product?

Kybella is the relevant FDA-approved product. The FDA approved Kybella on April 29, 2015, under NDA 206333 for improvement in the appearance and profile of moderate to severe convexity or fullness associated with submental fat in adults. The product contains synthetic deoxycholic acid and is administered by subcutaneous injection into preplatysmal submental fat.[2]

The approved label is narrower than the patent claims. The patent lists numerous body areas and conditions, while the FDA approval is limited to submental fat in adults.

Regulatory item	Status
Product	Kybella
Active ingredient	Deoxycholic acid
Sponsor at approval	Kythera Biopharmaceuticals
Current commercial owner	AbbVie, through Allergan
NDA	206333
FDA approval	April 29, 2015
Approved indication	Moderate to severe submental convexity or fullness associated with submental fat
Administration	Subcutaneous injection
Strength	10 mg/mL
Biosimilar pathway	Not applicable
Generic pathway	ANDA under the Hatch-Waxman Act

Kybella's FDA label does not establish approval for obesity, lipomas, cellulite, wrinkles, loose skin, or the other broader conditions listed in patent claim 2.

When does US Patent 9,636,349 lose exclusivity?

US Patent 9,636,349 was issued on May 2, 2017. Its expected patent-term expiration is in November 2033, based on the priority and filing record associated with the patent family. The precise enforceable expiration date depends on the USPTO patent-term calculation, including any patent-term adjustment and terminal-disclaimer effects.[1]

Milestone	Date
Patent issued	May 2, 2017
Expected expiration	November 2033
FDA NCE exclusivity for Kybella	April 29, 2020
Practical patent protection period after FDA approval	Approximately 18 years, subject to final term calculation

FDA regulatory exclusivity and patent exclusivity are separate. Kybella's five-year new chemical entity exclusivity expired in 2020. That expiration permitted ANDA applicants to submit Paragraph IV certifications, but it did not remove the patent barriers.

Any applicable pediatric exclusivity, patent-term extension, or approved-product-listing effect must be evaluated against the current USPTO and FDA records. The patent's commercial significance is primarily its remaining patent term, not the expired NCE period.

What is the Orange Book status of US Patent 9,636,349?

US Patent 9,636,349 has been associated with the Kybella patent estate and is relevant to the Orange Book analysis for deoxycholic acid injection. Orange Book relevance depends on whether the patent is listed against the approved NDA and whether its claims cover the approved product or an approved method of use.[3]

The patent is not a conventional composition-of-matter patent for DCA. Its claims are directed to treatment methods. That distinction matters because:

A method-of-use listing generally requires a corresponding use code.
The approved indication is submental fat, not the full range of conditions in claims 2 and 6.
An ANDA applicant may challenge the listed method patent through a Paragraph IV certification.
A non-infringement or section viii carve-out strategy may depend on the exact use code and proposed labeling.

The Orange Book listing does not automatically make every claim in the patent enforceable against every generic product. The relevant question is whether the generic's proposed labeling and intended use practice the listed claim.

How strong is the patent estate for Kybella?

The patent estate has meaningful strengths but also identifiable limits.

Strengths

The carbon-14 limitation is difficult to design around accidentally. A competitor using synthetic DCA may satisfy the limitation even if its formulation, supplier, or manufacturing process differs.

The claims cover sodium deoxycholate. This is the most commercially relevant DCA salt for Kybella-type products.

The method claims address local injection. This aligns with the approved subcutaneous route and reduces the gap between the patented use and the commercial product.

The patent reaches beyond the approved indication. Claims covering multiple body regions and cosmetic conditions may create licensing value for future DCA products, although enforcement would require applicable labeling, use, and evidence.

Limitations

The patent is not a broad molecule patent. It does not prevent all manufacture, sale, or use of DCA.

The numerical limitation creates proof issues. The patent owner must show that the accused DCA satisfies the sub-1-ppt threshold.

The FDA label is narrower than the claims. The commercial product's approved use is limited to submental fat.

Many claims are method-dependent. Infringement may be difficult to establish where a generic omits patented indications, uses a different label, or relies on physician-directed off-label use without promoting the patented method.

The patent does not necessarily block non-DCA fat-reduction technologies. Liposuction, cryolipolysis, phosphatidylcholine-based products, energy devices, and other injectable agents fall outside the claims unless they also use the claimed DCA composition.

Which companies are challenging the Kybella patent estate?

No publicly reported final Paragraph IV judgment or settlement involving US Patent 9,636,349 is identified in the cited FDA, Orange Book, and patent records. The absence of a reported case does not establish that no ANDA applicant has filed a certification. ANDA filings and Paragraph IV notices can remain commercially confidential until litigation is initiated or publicly disclosed.

The most likely generic challenge would target:

Whether the proposed DCA contains less than 1 ppt carbon-14;
Whether the proposed labeling induces local treatment of subcutaneous fat;
Whether the formulation is covered by the relevant Orange Book use code;
Whether the claims are enabled across the full range of listed conditions;
Whether the claims are definite concerning the carbon-14 measurement; and
Whether prior art discloses local DCA administration for fat reduction.

A generic manufacturer could also seek a label carve-out for non-covered uses, although the approved submental-fat indication may remain difficult to avoid if the listed patent use code maps directly to that indication.

What formulation and manufacturing barriers exist?

The patent does not require a particular excipient or lipid. That provides broad formulation coverage, but it leaves room for formulation differentiation outside the claim language.

The main manufacturing barrier is control of the DCA starting material and radiocarbon profile. A competing product would need to manage:

DCA source and synthetic route;
Residual carbon-containing process materials;
Batch-to-batch radiocarbon variability;
Analytical testing at the sub-1-ppt level;
Salt formation, especially sodium deoxycholate;
Sterility and injectable-product controls; and
FDA comparability and pharmaceutical-quality requirements.

A supplier using animal-derived DCA may avoid the carbon-14 limitation, but it would face separate regulatory, consistency, impurity, transmissible-agent, and supply-chain issues. Synthetic DCA is commercially more compatible with the Kybella product profile but may increase patent exposure.

How does US Patent 9,636,349 compare with competing DCA patents?

Patent category	Coverage focus	Commercial relevance
US 9,636,349	Local treatment using low-radiocarbon DCA; fat reduction and skin tightening	Directly relevant to Kybella-type synthetic DCA use
Earlier DCA formulation patents	Injectable formulation, concentration, excipients, stability, or composition	May create separate formulation infringement risks
Method-of-use patents	Submental fat, body contouring, cellulite, or cosmetic skin applications	Relevant to product labeling and physician-use evidence
Process patents	Synthetic production or purification of DCA	Relevant to suppliers and API manufacturers
Device patents	Injection patterns, delivery devices, or treatment systems	Potentially relevant to administration protocols

The key distinction is that US 9,636,349 combines a broad therapeutic objective with a narrow chemical-quality limitation. A competitor that avoids a formulation patent may still face this method patent if it uses low-radiocarbon DCA for local fat reduction.

What generic launch scenarios exist?

Scenario 1: Paragraph IV challenge and launch after litigation

A generic applicant certifies that the patent is invalid, unenforceable, or not infringed. The patent owner files suit within the statutory period, triggering a 30-month stay of final FDA approval under applicable Hatch-Waxman rules.[4]

Scenario 2: Section viii carve-out

The applicant removes patented uses from its labeling. This approach is strongest where the approved label can be separated from the patent's listed use code. It is less effective if the Orange Book use code covers the core submental-fat indication.

Scenario 3: Non-infringing DCA source

The applicant uses DCA with carbon-14 content at or above the claimed threshold. This creates a technical design-around but may require a different API source and additional quality controls.

Scenario 4: Post-expiration launch

A generic launches after the patent's final expiration date, subject to any remaining regulatory or pediatric exclusivity. On the current term estimate, the principal launch window begins in late 2033.

Does US Patent 9,636,349 create biosimilar risk?

No. Kybella is a chemically synthesized small-molecule drug, not a biologic. Biosimilar provisions under the Public Health Service Act do not apply. Competitive entry proceeds through the ANDA pathway, with bioequivalence, pharmaceutical equivalence, labeling, and patent-certification issues evaluated under the Federal Food, Drug, and Cosmetic Act.

What licensing deals affect the patent?

Kythera developed ATX-101, later approved as Kybella. Allergan acquired Kythera in 2015 for approximately $2.1 billion, transferring the relevant product and intellectual-property assets to Allergan. AbbVie acquired Allergan in 2020.[5][6]

The public transaction record is more significant than a separate patent license. It places US Patent 9,636,349 within the Allergan and subsequently AbbVie commercial portfolio. No publicly documented standalone license materially altering ownership of this patent is identified in the cited sources.

Key Takeaways

US Patent 9,636,349 is a method-of-use patent for local DCA treatment of fat deposits, loose skin, and wrinkles.
The central technical limitation is DCA with less than 1 ppt carbon-14.
Sodium deoxycholate is expressly covered.
The patent reaches far beyond Kybella's FDA-approved submental-fat indication.
Kybella's five-year NCE exclusivity expired in 2020, while the patent's expected term extends to approximately November 2033.
The patent is relevant to Orange Book and Paragraph IV analysis but is not a broad DCA composition patent.
Generic risk is highest for synthetic DCA products labeled for local treatment of submental or other subcutaneous fat.
Biosimilar competition is irrelevant because Kybella is a small-molecule drug.
The strongest technical design-around is use of DCA that does not meet the sub-1-ppt carbon-14 limitation, subject to separate formulation and process patents.

FAQs About US Patent 9,636,349

What drug is most closely associated with US Patent 9,636,349?

Kybella, an injectable synthetic deoxycholic acid product approved for submental fat, is the principal commercial product associated with the patent.

Can a generic avoid US Patent 9,636,349 by using a different DCA salt?

Not necessarily. Claim 1 covers DCA or a DCA salt. Claims 3 and 7 expressly identify sodium deoxycholate, but changing the salt would not automatically avoid the independent claims.

Does the patent cover injectable deoxycholic acid for obesity?

Claim 2 expressly lists obesity, but FDA approval does not extend Kybella to obesity. Patent coverage and FDA-approved labeling are separate questions.

Can a non-injectable DCA product avoid the patent?

A product administered by a route other than local, subcutaneous, or transdermal administration may avoid specific claims, depending on how the treatment is performed and whether another claim or patent applies.

What is the principal invalidity risk for US Patent 9,636,349?

Potential challenges may focus on written description, enablement, definiteness of the carbon-14 threshold, prior-art disclosure of DCA fat reduction, and whether the claimed scope is commensurate with the technical disclosure.

References

United States Patent and Trademark Office. (2017). U.S. Patent No. 9,636,349, Methods for reducing subcutaneous fat and improving skin appearance.
U.S. Food and Drug Administration. (2024). Kybella (deoxycholic acid) injection prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355.
Allergan plc. (2015). Allergan to acquire Kythera Biopharmaceuticals.
AbbVie Inc. (2020). AbbVie completes acquisition of Allergan.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	9,636,349	⤷ Start Trial				IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING	⤷ 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	067440	⤷ Start Trial
Argentina	112325	⤷ Start Trial
Australia	2008265721	⤷ Start Trial
Brazil	PI0813140	⤷ Start Trial
Canada	2690841	⤷ Start Trial
Canada	2789109	⤷ Start Trial
Chile	2008001783	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,636,349

Which drugs does patent 9,636,349 protect, and when does it expire?

Summary for Patent: 9,636,349