United States Drug Patent 8,367,649: Claim Scope, Kybella Coverage, Expiration and Patent Landscape

U.S. Patent No. 8,367,649 protects a narrow but commercially important deoxycholate formulation: an aqueous product containing approximately 0.5% to 1.5% w/v deoxycholate at a pH of about 8.3. The claims cover injectable and non-injectable formulations, with dependent claims directed to subcutaneous administration and conventional excipients such as water, buffers and preservatives.

The patent is associated with Kythera Biopharmaceuticals' deoxycholic acid development program, later acquired by Allergan and incorporated into AbbVie's Kybella franchise. The claim set is formulation-based rather than indication-specific. A competing product can face infringement risk even if it is marketed for a different indication, provided it falls within the claimed concentration and pH parameters.

What does U.S. Patent 8,367,649 protect?

The patent's independent claim requires four core elements:

Claim element	Required scope
Dosage form	Aqueous pharmaceutical formulation
Active formulation component	Deoxycholate
Concentration	About 0.5% to about 1.5% w/v
pH	About 8.3
Other components	At least one pharmaceutically acceptable excipient and/or carrier

Claim 1 is the controlling claim. Claims 2 through 4 add narrower limitations but do not expand the independent claim.

The patent does not, on the face of the supplied claims, require:

A particular indication;
Deoxycholic acid rather than a specific salt form of deoxycholate;
A specific injection volume;
A specific anatomical treatment site;
A particular buffer system;
A particular preservative;
A particular container or syringe;
A particular manufacturing process;
A particular dosage regimen; or
A specific commercial brand.

That breadth makes the patent relevant to competing injectable deoxycholate products beyond submental-fat treatment.

How broad is claim 1 of patent 8,367,649?

Claim 1 is broad in product type but narrow in concentration and pH.

Concentration limitation

The claimed concentration is approximately 0.5% to 1.5% w/v. For a deoxycholate formulation, this corresponds to approximately 5 to 15 mg/mL, depending on the molecular form and how the concentration is calculated.

Kybella contains 10 mg/mL deoxycholic acid, equivalent to 1.0% w/v, placing the labeled product within the claimed concentration range.[2]

The words "about 0.5%" and "about 1.5%" create potential boundary disputes. Courts generally assess "about" in light of the specification, prosecution history, technical context and evidence regarding measurement tolerances. A formulation at 0.49% or 1.51% is not automatically outside the claim. The commercial significance is that routine manufacturing variation around 0.5%, 1.0% or 1.5% could require technical and legal analysis.

pH limitation

The formulation must have a pH of about 8.3. This is a meaningful limitation. A product at pH 7.4, 8.0 or 9.0 would not automatically satisfy the limitation, although the legal scope of "about 8.3" depends on the patent record and technical evidence.

A competitor could attempt a design-around using a materially different pH. That strategy may affect stability, tolerability, solubility, preservative performance and injection-site reactions. The pH limitation therefore creates a practical formulation barrier, not only a legal limitation.

Aqueous formulation requirement

The claimed product must be aqueous. An anhydrous formulation, solid dosage form, implant, liposomal suspension or nonaqueous injectable would not literally satisfy the aqueous limitation.

The claim does not require a particular amount of water. Water may be the carrier, an excipient, or both.

Closed transition and formulation composition

Claim 1 uses the transition "consisting of." That language generally signals a closed claim. The formulation is therefore defined by deoxycholate plus at least one pharmaceutically acceptable excipient and/or carrier.

The practical effect is important. A product containing an additional active pharmaceutical ingredient, an unlisted functional additive, or another formulation component may argue that it falls outside the literal scope of the claim. The interpretation depends on the claim grammar, specification and prosecution history. The presence of common incidental materials, impurities, pH-adjusting agents or manufacturing residues would not necessarily defeat infringement.

What do claims 2, 3 and 4 add?

What does claim 2 protect?

Claim 2 limits the formulation to one suitable for subcutaneous injection.

This limitation narrows claim 1 by adding intended and functional suitability for subcutaneous delivery. The claim does not specify:

Injection depth;
Needle gauge;
Injection volume;
Number of injection sites;
Dose per site;
Treatment interval; or
An anatomical location.

A formulation that satisfies claim 1 and is suitable for subcutaneous injection can fall within claim 2 even if it is not used to treat submental fullness.

What does claim 3 protect?

Claim 3 limits the excipient or carrier to one or more of:

Water;
A buffer; or
A preservative.

The group is broad and covers formulations using any one of those categories, subject to the other limitations of claim 1.

A formulation containing water and a buffer would remain within the claim. A formulation containing water, buffer and preservative would also remain within the claim if the formulation otherwise satisfies the concentration and pH requirements.

What does claim 4 protect?

Claim 4 combines the subcutaneous-injection limitation of claim 2 with the specified excipient or carrier limitation of claim 3.

It is the narrowest supplied claim. A product must be:

Aqueous;
Within the claimed deoxycholate concentration range;
At about pH 8.3;
Suitable for subcutaneous injection; and
Formulated with water, a buffer or a preservative.

Is Kybella covered by patent 8,367,649?

Kybella is the principal commercial product associated with this patent landscape.

Kybella characteristic	Relevance to patent 8,367,649
Active ingredient	Deoxycholic acid
Concentration	10 mg/mL
Approximate w/v concentration	1.0%
Dosage form	Sterile aqueous injection
Route	Subcutaneous
pH	Approximately 8.3
Excipients	Water, sodium chloride, phosphate components, benzyl alcohol and pH-adjusting agents
FDA indication	Improvement in the appearance of moderate to severe submental convexity or fullness in adults

The labeled concentration and pH place Kybella within the central technical territory of claim 1. Its subcutaneous route aligns with claim 2, and its aqueous vehicle, buffer components and preservative align with claims 3 and 4.[2]

The claim language does not require the product to be approved for submental fat. The commercial indication is therefore narrower than the apparent product claim.

When does U.S. Patent 8,367,649 expire?

The patent has a nominal 20-year term measured from the applicable U.S. nonprovisional priority framework. Public patent records identify an expiration date in August 2029 for the relevant deoxycholate patent family, subject to any applicable patent-term adjustment or other statutory modification.[1]

Event	Date or status
Earliest family priority	August 2009
U.S. patent issuance	February 5, 2013
Nominal patent-family expiration	August 2029
Patent term extension	Must be confirmed against the Orange Book entry and FDA regulatory review record
Patent-term adjustment	Must be confirmed in USPTO Patent Center
Current commercial relevance	High while the patent remains listed and enforceable

Patent expiration is separate from FDA regulatory exclusivity. Kybella received new chemical entity exclusivity after its 2015 approval. That exclusivity period has expired, but patent rights can continue after regulatory exclusivity ends.[2][3]

What is the Orange Book status of patent 8,367,649?

The patent has been associated with the Kybella NDA patent listing. Orange Book listing generally indicates that the NDA holder submitted the patent as covering the approved drug or an approved method of using the drug. Listing does not establish that every claim is valid or infringed by every competing product.

The relevant regulatory distinction is:

Issue	Effect
Orange Book listing	Gives an NDA holder a mechanism to identify the patent to an ANDA applicant
Paragraph IV certification	Applicant asserts that the patent is invalid, unenforceable or not infringed
Paragraph III certification	Applicant accepts delayed approval until patent expiry
30-month stay	May arise if the NDA holder files patent litigation within the statutory period
Patent expiration	Removes the patent-based barrier after the effective expiration date, subject to other listed patents

An ANDA applicant seeking approval for a deoxycholate product that references Kybella would need to evaluate every relevant listed patent, not only patent 8,367,649. A Paragraph IV challenge to this patent could trigger litigation and, if timely filed, a statutory approval stay under the Hatch-Waxman framework.[4]

Which patents compete with 8,367,649 in the Kybella estate?

The commercial estate is broader than the four claims supplied. The Kybella-related patent landscape includes later patents and continuation-family rights that may address methods of treatment, injection protocols, formulations and related use limitations.

Patent category	Typical protected subject matter	Risk to a generic or competitor
Core formulation patents	Deoxycholate concentration, pH and aqueous composition	Direct product infringement
Subcutaneous-use claims	Injectable use and administration	Product-by-use and method-of-use exposure
Treatment-method patents	Reduction of submental or localized adipose tissue	Labeling and induced-infringement risk
Injection-regimen patents	Dose, injection sites, spacing and treatment cycles	Narrower but potentially valuable blocking claims
Manufacturing patents	Purification, formulation, filling or processing	Supply-chain and freedom-to-operate risk
Continuation patents	Modified claim scope from the same disclosure	Extended enforcement complexity

Publicly associated Kybella patent families include U.S. Patent Nos. 8,367,649, 9,095,737 and 9,205,100, with later family members also reported in FDA and patent records. The exact legal effect depends on each patent's claims, continuity data, terminal disclaimers, PTA and Orange Book status.[1][3]

A competitor cannot assume that expiration of 8,367,649 alone creates an unrestricted launch path.

Are there formulation patents beyond patent 8,367,649?

Yes. Formulation risk commonly exists at three levels:

Composition overlap

A rival product using approximately 5 to 15 mg/mL deoxycholate at pH 8.3 is the clearest technical overlap with patent 8,367,649.

Excipient overlap

Claims 3 and 4 reach formulations using water, a buffer or a preservative. A competitor cannot avoid those claims merely by changing from one ordinary buffer to another if the patent's claim interpretation covers the substituted component.

Stability and presentation claims

Separate patents may claim:

Specific buffer concentrations;
Preservative systems;
Container closure systems;
Storage conditions;
Reconstitution or dilution;
Ready-to-use syringes;
Injection devices; or
Stability profiles.

Those rights may create additional barriers even where a competitor designs around the core pH range.

What generic entry risks exist for a deoxycholate injection?

A generic or follow-on entrant faces four principal risks.

Product-specific infringement

A product matching Kybella's 10 mg/mL concentration and pH of approximately 8.3 has a direct risk under claim 1. Subcutaneous use creates additional exposure under claim 2.

Paragraph IV litigation

An ANDA applicant can challenge listed patents through a Paragraph IV certification. The patent owner may sue within 45 days, potentially triggering a 30-month stay of approval.[4]

Labeling constraints

A proposed generic label may omit a patented method of use through a section viii statement. That strategy is more difficult if the approved product's principal commercial use is the patented use or if the label encourages the patented administration.

Formulation redesign

A competitor could pursue:

A pH outside the "about 8.3" range;
A concentration below 0.5% or above 1.5%;
A nonaqueous or alternative delivery system;
A different salt or active form;
A formulation not suitable for subcutaneous injection; or
A product using a different excipient architecture.

Each design-around may introduce development, stability, clinical, manufacturing or regulatory costs.

Which companies are challenging the Kybella patent estate?

There is no publicly established generic entrant with an approved FDA substitute for Kybella based solely on a challenge to patent 8,367,649. Publicly available regulatory records do not identify a marketed generic deoxycholic acid injection that has displaced Kybella.

The competitive field includes aesthetic products and procedures that do not necessarily contain deoxycholate, including liposuction, cryolipolysis, energy-based body contouring and injectable alternatives. These products compete commercially but generally do not create the same patent-infringement profile.

Biosimilar risk is not relevant. Kybella is a chemically defined small-molecule drug, not a biologic subject to the Biologics Price Competition and Innovation Act.

How strong is the patent estate for 8,367,649?

The patent is strongest against a directly substitutable product with the following profile:

Aqueous;
Deoxycholate at approximately 1.0%;
pH approximately 8.3;
Subcutaneous administration;
Conventional water, buffer and preservative system; and
A label directed to localized fat reduction.

Its strength is lower against:

Nonaqueous delivery systems;
Products with materially different pH;
Products outside the concentration range;
Devices delivering a different formulation;
Products using a different active compound; and
Products with no subcutaneous use.

The patent's principal weakness is claim narrowness around pH and concentration. Its principal strength is that those same parameters correspond closely to the approved Kybella formulation.

Patent validity would depend on prior art, written description, enablement, indefiniteness, prosecution history and any terminal-disclaimer or priority issues. The claims are technically specific enough to provide a defined infringement test, but formulation patents remain vulnerable to prior-art references showing the same concentration, pH and excipient architecture.

What licensing deals affect the patent rights?

Kythera developed the deoxycholate program and commercialized Kybella before Allergan acquired Kythera in 2015. AbbVie later acquired Allergan in 2020.[5][6]

The material commercial consequence is ownership consolidation:

Period	Relevant company
Original development	Kythera Biopharmaceuticals
Post-2015 acquisition	Allergan
Post-2020 acquisition	AbbVie
Current commercial franchise	AbbVie

An acquisition does not change patent scope or expiration. It changes enforcement authority, licensing control, settlement authority and commercial strategy.

What is the revenue exposure from patent 8,367,649?

AbbVie does not generally report Kybella revenue as a separately disclosed major operating segment. Revenue exposure must therefore be assessed through the broader aesthetics portfolio rather than a separately reported Kybella line item.[5]

The economic value of the patent is linked to:

The absence or presence of an FDA-approved generic;
Kybella's share of noninvasive fat-reduction procedures;
Physician adoption;
Reimbursement limitations;
Cash-pay consumer demand;
Competing aesthetic technologies; and
The remaining life of other Kybella-related patents.

The patent has greater strategic value as part of the combined estate than as an isolated asset. A generic entrant must clear the full Orange Book and freedom-to-operate landscape, while AbbVie can rely on formulation, method-of-use and continuation rights in combination.

Key Takeaways

Patent 8,367,649 claims an aqueous deoxycholate formulation at approximately 0.5% to 1.5% w/v and pH about 8.3.
Kybella's 10 mg/mL aqueous, subcutaneous formulation falls within the core technical profile.
Claim 1 is product-focused and not limited to submental-fat treatment.
Claim 2 adds subcutaneous-injection suitability.
Claims 3 and 4 cover formulations using water, buffers or preservatives.
The patent family has a nominal expiration in August 2029, subject to the official USPTO and Orange Book term records.
FDA exclusivity and patent exclusivity are separate. Kybella's regulatory exclusivity has expired, while patent rights can continue.
No biosimilar pathway applies because Kybella is a small-molecule drug.
A generic entrant would need to evaluate Paragraph IV exposure, method-of-use patents, continuation patents and any later-listed Kybella patents.
The strongest design-around options involve changing pH, concentration, dosage form, route or active compound.
The commercial value lies in the combined Kybella patent estate, not in patent 8,367,649 alone.

FAQs About U.S. Patent 8,367,649 and Deoxycholate Injections

Does patent 8,367,649 cover all deoxycholic acid products?

No. The supplied claims require an aqueous formulation, approximately 0.5% to 1.5% w/v deoxycholate and a pH of about 8.3. Products outside those parameters may avoid literal infringement of the claims.

Can a competitor avoid the patent by using sodium deoxycholate?

Not automatically. "Deoxycholate" may encompass relevant deoxycholate forms depending on the patent specification, prosecution history and claim construction. Salt selection alone is not a reliable design-around.

Does the patent cover injection into the abdomen or thighs?

Claim 2 requires suitability for subcutaneous injection but does not specify an anatomical site. The claim therefore is not limited on its face to submental administration.

Can an ANDA applicant challenge patent 8,367,649 before expiration?

Yes. An ANDA applicant may file a Paragraph IV certification asserting that the patent is invalid, unenforceable or not infringed. The patent owner can bring Hatch-Waxman litigation, which may delay approval.

Does expiration of patent 8,367,649 guarantee generic Kybella entry?

No. Other Orange Book-listed patents, continuation patents, method-of-use claims, regulatory requirements and commercial manufacturing barriers can affect launch timing.

References

United States Patent and Trademark Office. (2013). U.S. Patent No. 8,367,649. Patent Center and Patent Assignment records.
U.S. Food and Drug Administration. (2015). Kybella (deoxycholic acid) injection prescribing information.
U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. § 355(j).
AbbVie Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Allergan plc. (2019). Annual report and transaction materials relating to the acquisition by AbbVie Inc.

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	⤷ Start Trial	⤷ Start Trial	Y				⤷ 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

Summary for Patent: 8,367,649