Details for Patent: 7,754,230

Which drugs does patent 7,754,230 protect, and when does it expire?

Patent 7,754,230 protects KYBELLA and is included in one NDA.

This patent has seventy-eight patent family members in twenty-five countries.

Summary for Patent: 7,754,230

Title:	Methods and related compositions for reduction of fat
Abstract:	Compositions and methods useful in the reduction of localized fat deposits in patients in need thereof using pharmacologically active detergents are disclosed. The pharmacologically active detergent compositions can additionally include anti-inflammatory agents, analgesics, dispersion or anti-dispersion agents and pharmaceutically acceptable excipients. The pharmacologically active detergent compositions are useful for treating localized accumulations of fat including, for example, lower eyelid fat herniation, lipodystrophy and fat deposits associated with cellulite and do not require surgical procedures such as liposuction.
Inventor(s):	Michael S. Kolodney, Adam M. Rotunda
Assignee:	University of California , University of California San Diego UCSD , Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Application Number:	US11/134,727
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,754,230
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 7,754,230: Deoxycholic Acid Fat-Removal Claims, Kybella Coverage, Expiration, and Patent Landscape

US Patent 7,754,230 covers non-surgical removal of localized fat using deoxycholic acid or a deoxycholate salt as the sole fat-removing agent, without phosphatidylcholine. The broadest claim reaches compositions containing less than 20% deoxycholic acid or its salt. Dependent claims narrow the scope to approximately 0.5% deoxycholic acid and to concentrations up to 5% of a deoxycholic acid salt, including sodium deoxycholate.

The claims are closely aligned with the active pharmaceutical ingredient and formulation concept used in Kybella, the FDA-approved injectable deoxycholic acid product. The principal commercial relevance of the patent was protection against injectable deoxycholate products for localized subcutaneous fat. Its statutory term has reached or is approaching expiration based on the underlying priority and filing history, so later-issued continuation, formulation, or method-of-use patents are more important to current market-entry risk than Patent 7,754,230 itself.

What does US Patent 7,754,230 protect?

The patent protects a treatment method, not a standalone chemical composition.

Claim	Protected subject matter	Key limitation
1	Non-surgical removal of localized fat	Less than 20% deoxycholic acid or salt; sole fat-removing component; no phosphatidylcholine
2	Claim 1 composition	Deoxycholic acid salt
3	Claim 2 composition	Sodium deoxycholate
4	Non-surgical removal of localized fat	Approximately 0.5% deoxycholic acid or salt
5	Claim 4 composition	Deoxycholic acid salt
6	Claim 5 composition	Sodium deoxycholate
7	Non-surgical removal of localized fat	Up to 5% deoxycholic acid salt; sole fat-removing component; no phosphatidylcholine

The claims require all of the following:

1. A patient has a localized fat deposit.
2. The patient desires removal of that deposit.
3. The treatment is non-surgical.
4. The fat deposit is contacted with the composition.
5. Deoxycholic acid or its salt is the sole fat-removing component.
6. The formulation contains a pharmaceutically acceptable excipient.
7. The formulation does not contain phosphatidylcholine.

The patent does not require a particular injection device, injection depth, anatomical site, treatment schedule, needle gauge, dosing volume, or number of treatment sessions.

How broad is claim 1 of US 7,754,230?

Claim 1 is the principal broad claim. It covers a method using any effective concentration below 20% of deoxycholic acid or a salt, provided the composition otherwise satisfies the claim limitations.

The claim reaches:

• Free deoxycholic acid.
• Deoxycholic acid salts.
• Sodium deoxycholate.
• Other pharmaceutically acceptable deoxycholate salts.
• Concentrations below 20%.
• Injectable or other non-surgical delivery methods capable of contacting the fat deposit.
• Localized fat deposits generally, rather than only submental fat.

The claim does not expressly limit treatment to adults, women, the submental region, facial fat, or cosmetic use. A product directed to abdominal, flank, thigh, upper-arm, or other localized fat could fall within the literal scope if the remaining limitations are met.

The main narrowing language is the requirement that deoxycholic acid or its salt be the “sole fat removing component.” A formulation could contain buffers, tonicity agents, preservatives, stabilizers, surfactants, or other excipients if those ingredients do not independently function as fat-removing agents.

What formulations are protected by claims 2 through 7?

Claims 2, 3, 5, 6, and 7 focus on deoxycholate salts. Sodium deoxycholate is expressly named in claims 3 and 6 and is the most commercially relevant salt.

Concentration scope

Claim 1 covers less than 20%. Claim 7 covers up to 5% of a deoxycholic acid salt. Claim 4 is directed to approximately 0.5%.

A formulation containing 1% sodium deoxycholate would generally fall within the numerical range of claim 7, assuming the formulation is used for the claimed method and satisfies the remaining limitations. It would also fall below the 20% threshold in claim 1. It would not necessarily meet claim 4's “approximately 0.5%” limitation.

The claims do not specify whether percentage means weight/volume, weight/weight, or another concentration convention. In an infringement dispute, the specification, prosecution history, industry practice, product labeling, and expert testimony would be relevant to interpreting the percentage limitation.

“Consisting essentially of”

“Consisting essentially of” is narrower than “comprising” but broader than “consisting of.” It permits additional ingredients that do not materially affect the basic and novel characteristics of the claimed formulation.

The express exclusion of phosphatidylcholine removes a major class of prior injectable fat-dissolving formulations from the claimed compositions. The claim language also independently requires deoxycholic acid or its salt to be the sole fat-removing component.

A formulation that combines deoxycholate with another independently lipolytic or adipocytolytic agent would face a stronger non-infringement argument. That strategy would create separate validity and regulatory issues, including whether the additional ingredient is an active pharmaceutical component and whether the combination remains within the “consisting essentially of” transition.

Does US Patent 7,754,230 cover Kybella?

Kybella contains synthetic deoxycholic acid at 10 mg/mL, commonly described as a 1% formulation, with inactive ingredients including sodium chloride, sodium hydroxide, and water for injection. The product is administered by injection into submental fat in adults. (U.S. Food and Drug Administration, 2015)

The product characteristics correspond closely to the patent claims:

Kybella characteristic	Relevance to Patent 7,754,230
Synthetic deoxycholic acid	Falls within claim 1's active-agent category
Approximately 1% concentration	Below 20%; within claim 7's “up to 5%” range if characterized as a deoxycholate salt
Non-surgical injectable treatment	Satisfies the non-surgical method concept
Localized submental fat	Satisfies the localized fat-deposit limitation
No phosphatidylcholine	Satisfies the express exclusion
Pharmaceutically acceptable excipients	Satisfies the excipient requirement

The regulatory product is labeled as deoxycholic acid rather than as a sodium deoxycholate product. That distinction matters for claims 3, 6, and 7, which expressly refer to a salt. Claim 1 separately covers deoxycholic acid or a salt and therefore presents the more direct coverage theory for a formulation labeled as deoxycholic acid.

Patent scope and product-label terminology are not identical. The chemical form in the finished formulation, the pH-dependent ionization state, and the claim construction of “salt” would be relevant to a specific infringement analysis.

When does US Patent 7,754,230 lose exclusivity?

The patent's term is governed by the earliest relevant nonprovisional filing date, not simply by the grant date. Public patent records associate the patent with a 2005 priority date and a subsequent US nonprovisional application. The expected expiration is in the 2025 period, subject to any patent-term adjustment, terminal disclaimer, or other USPTO term calculation.

The grant date was July 13, 2010. The 20-year patent term does not run for 20 years from the grant date. The controlling date is the applicable US nonprovisional filing date under 35 U.S.C. § 154.

Exclusivity timeline

Event	Date or period
Earliest claimed priority	2005
US Patent 7,754,230 grant	July 13, 2010
Kybella FDA approval	April 29, 2015
Kybella five-year new chemical entity exclusivity	Through approximately April 2020
Expected base patent-term end	2025 period, subject to USPTO adjustment
Current strategic relevance	Primarily historical and relevant to earlier ANDA challenges

Kybella's five-year new chemical entity exclusivity was separate from the patent. FDA exclusivity prevented approval of an ANDA or certain other abbreviated applications for the same active moiety during the exclusivity period, but it did not prevent a competitor from challenging the patent through a Paragraph IV certification after an ANDA became legally available.

What is the Orange Book status of US Patent 7,754,230?

US Patent 7,754,230 has been associated with Kybella's Orange Book patent protection as a method-of-use patent. The relevant Orange Book inquiry is not whether the patent covers deoxycholic acid as a chemical molecule in the abstract. It is whether the patent claims an FDA-approved use of the drug.

Kybella's approved indication is improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The product labeling limits the approved use to that anatomical and patient population. (U.S. Food and Drug Administration, 2024)

An Orange Book method-of-use listing typically identifies:

• The patent number.
• The patent expiration date.
• A use code describing the approved method.
• The corresponding NDA.

A method-of-use patent does not necessarily block every use of the active ingredient. A generic applicant may attempt a section viii “skinny label” that omits the patented indication, although that strategy is difficult where the product's principal or only commercial use is the patented use.

What Paragraph IV challenges affect Kybella?

A Paragraph IV certification is an ANDA applicant's assertion that a listed patent is invalid, unenforceable, or will not be infringed by the proposed generic product.

For a Kybella-related ANDA, a Paragraph IV challenge to Patent 7,754,230 would likely focus on:

• Anticipation by earlier disclosures of deoxycholic acid or deoxycholate for fat removal.
• Obviousness based on known detergent, bile-acid, or adipocytolytic properties.
• Written-description support for the full range below 20%.
• Enablement across different localized fat deposits and concentrations.
• Definiteness of “effective amount,” “approximately 0.5%,” and “sole fat removing component.”
• Construction of “contacting” and “non-surgical.”
• Whether the proposed product contains phosphatidylcholine.
• Whether deoxycholic acid in the proposed formulation is a salt for purposes of the salt-specific claims.

The claim set is vulnerable to a concentration-range obviousness challenge if the prior art disclosed overlapping deoxycholate concentrations and the claimed range was selected from routine formulation experimentation. The patent holder would likely rely on clinical efficacy, tolerability, formulation stability, or unexpected results to defend the range.

No conclusion on the outcome of a particular Paragraph IV case follows from the claim text alone. The relevant court docket, notice letter, ANDA product, and Orange Book certifications would control.

How strong is the patent estate for deoxycholic acid fat removal?

Patent 7,754,230 has meaningful historical breadth but limited remaining value after term expiration or near-term expiration. Its strongest features were:

• Direct coverage of the active agent.
• Coverage of both free acid and salts.
• No requirement for phosphatidylcholine.
• Broad application to localized fat deposits.
• No restriction to one anatomical site.
• Express coverage of sodium deoxycholate.

Its weaker features include:

• Functional language such as “effective amount.”
• Ambiguity around “approximately 0.5%.”
• A potentially broad enablement burden for all localized fat deposits.
• Prior-art exposure involving bile acids, detergents, phospholipids, and injectable fat-dissolving compositions.
• Dependence on method-of-use infringement rather than composition-of-matter protection.
• Lack of a device, dosing regimen, or manufacturing limitation that could create additional blocking layers.

The patent is therefore stronger as a foundational early-use patent than as a long-term barrier to all deoxycholic acid competition.

What related patents may protect Kybella after Patent 7,754,230?

Kybella's broader patent estate has included later patents directed to specific formulations, treatment regimens, administration techniques, and uses. Those patents may have later expiration dates than Patent 7,754,230 and can create residual market-entry barriers even after the foundational patent expires.

Relevant patent categories include:

Formulation patents

These may claim:

• Particular deoxycholic acid concentrations.
• Buffer systems and pH ranges.
• Tonicity agents.
• Preservative-free formulations.
• Stability characteristics.
• Injectable dosage forms.
• Container-closure systems.

A competitor may avoid a formulation claim by changing inactive ingredients or concentration while retaining the same active ingredient and indication. The commercial and regulatory consequences of that change must be assessed separately.

Method-of-use patents

Later method patents may focus on:

• The submental region.
• Specific treatment intervals.
• Injection grids or anatomical mapping.
• Maximum injection volumes.
• Patient-selection criteria.
• Treatment of non-submental body areas.
• Combination treatment with other aesthetic procedures.

A generic applicant may have greater difficulty using a skinny label if the patented use is the only practical or commercially meaningful indication.

Manufacturing and process patents

Manufacturing protection may cover:

• Purification of synthetic deoxycholic acid.
• Removal of process impurities.
• Control of particle formation.
• Sterile filtration.
• pH adjustment.
• Filling and packaging.
• Stability during storage.

These patents generally do not prevent all alternative manufacturing routes. They can increase development costs and complicate ANDA certification if the process is not publicly disclosed.

Which companies own or commercialize Kybella rights?

Kythera Biopharmaceuticals developed Kybella. Allergan acquired Kythera in 2016 in a transaction valued at approximately $2.1 billion. AbbVie completed its acquisition of Allergan in 2020. Kybella is now part of AbbVie's aesthetics portfolio. (Allergan, 2016; AbbVie, 2020)

Company	Role
Kythera Biopharmaceuticals	Original developer and patent owner associated with the deoxycholic acid program
Allergan	Acquirer and commercializer after the Kythera acquisition
AbbVie	Current corporate owner following the Allergan acquisition

The transaction chain is relevant to assignment history, enforcement rights, Orange Book ownership information, and any settlement or license agreements involving later patents.

Are biosimilars relevant to Kybella?

No. Kybella is a synthetic small-molecule drug product, not a biologic. The relevant competitive pathway is the FDA's abbreviated new drug application process under section 505(j) of the Federal Food, Drug, and Cosmetic Act, not the biosimilar pathway under the Public Health Service Act.

Competitive products would generally be evaluated as:

• ANDA products using an approved route.
• 505(b)(2) products with differences in formulation, concentration, indication, or clinical use.
• Compounded or physician-administered products, subject to separate federal and state requirements.
• Non-drug aesthetic products with different mechanisms.

A 505(b)(2) applicant could pursue a differentiated deoxycholic acid product while relying partly on FDA's prior findings for Kybella. That route may create different patent-certification and exclusivity issues from a conventional ANDA.

What generic-entry risks exist?

The most realistic entry scenarios are:

Entry scenario	Risk to incumbent	Main legal issue
Same concentration and submental indication	High	Direct method-of-use and formulation overlap
Same active ingredient with skinny label	Medium to high	Inducement and commercial-use analysis
Different deoxycholate concentration	Medium	Range claims and equivalence
Different excipient system	Medium	Formulation-patent avoidance
Non-submental indication	Medium	Scope of method claims and later patents
Combination product	Lower for this patent	“Sole fat-removing component” limitation
Non-injectable delivery	Lower for this patent	Whether the method still “contacts” the deposit
Compounded product	Variable	Regulatory status, infringement, and enforcement posture

The foundational patent is most consequential for a product that uses deoxycholate alone, in an injectable formulation, at a concentration below 20%, without phosphatidylcholine, and markets treatment for localized fat.

What patent litigation and settlements affect the market?

Patent litigation affecting Kybella would typically arise after an ANDA applicant sends a Paragraph IV notice to the NDA holder. The NDA holder may then file suit under 35 U.S.C. § 271(e)(2), triggering a 30-month stay of FDA approval in qualifying circumstances.

The material litigation questions are:

• Whether the patent was listed when the ANDA was filed.
• Whether the applicant certified Paragraph IV or used a section viii statement.
• Whether the patent owner sued within 45 days.
• Whether the court issued a preliminary injunction or final judgment.
• Whether the parties entered a launch-date settlement.
• Whether the settlement was submitted to the Federal Trade Commission under the Medicare Modernization Act.
• Whether the settlement contains a no-authorized-generic, supply, or license provision.

A definitive list of active litigation and settlement agreements requires a current PACER, FDA Orange Book, and FTC review. The claim text alone does not establish that a particular generic company has filed an ANDA or entered a settlement.

How does Patent 7,754,230 compare with competing aesthetic-drug patent estates?

Product or category	Active ingredient	Regulatory pathway	Principal patent risk
Kybella	Deoxycholic acid	505(b)(1) NDA	Method, formulation, and use patents
Compounded deoxycholate	Deoxycholate salt or acid	Compounding framework	Quality, labeling, regulatory, and infringement exposure
Phosphatidylcholine formulations	Phosphatidylcholine, often with deoxycholate	Variable or compounded	Generally outside the express no-phosphatidylcholine limitation, but may implicate other patents
Energy-based fat reduction	Device-based modalities	Medical-device pathway	Device patents rather than drug patents
GLP-1 drugs used for weight loss	Peptide biologics or drugs	NDA or BLA depending on product	Systemic weight loss, not localized fat-removal claims

Patent 7,754,230 does not cover every body-contouring treatment. It is directed to a particular pharmacological method using deoxycholic acid or a deoxycholate salt.

What is the commercial exposure associated with Patent 7,754,230?

Kybella revenue is not consistently reported as a standalone line item in AbbVie's public financial statements. The product is reported within broader aesthetics or pharmaceutical portfolios, so a precise revenue figure cannot be attributed to Patent 7,754,230 from public company reporting alone.

The commercial exposure is concentrated in:

• Kybella sales.
• Pricing and reimbursement for cosmetic treatment.
• Physician-office purchasing.
• Competition from compounded deoxycholate.
• Substitution by energy-based body-contouring devices.
• New aesthetic injectables.
• The ability to launch a generic or 505(b)(2) product after patent and regulatory barriers lapse.

Because the patent claims a treatment method rather than the deoxycholic acid molecule itself, expiration reduces one legal barrier but does not eliminate formulation development, FDA approval, manufacturing, pharmacovigilance, labeling, and physician-adoption barriers.

Key Takeaways

• US Patent 7,754,230 claims non-surgical localized-fat removal using deoxycholic acid or a deoxycholate salt.
• Claim 1 is broadest and covers concentrations below 20%.
• Claims 3 and 6 expressly identify sodium deoxycholate.
• Claim 7 covers up to 5% of a deoxycholic acid salt.
• The claims exclude phosphatidylcholine and require deoxycholic acid or its salt to be the sole fat-removing component.
• Kybella's approximately 1% deoxycholic acid product is closely aligned with the claim architecture.
• The patent is a method-of-use patent, not a composition-of-matter patent on deoxycholic acid.
• Its expected term falls in the 2025 period, subject to the USPTO's final term calculation.
• Later formulation, dosing, anatomical-use, and manufacturing patents may provide the more important post-expiration barriers.
• Biosimilar law is not relevant because Kybella is a synthetic small-molecule drug.
• ANDA Paragraph IV litigation and 505(b)(2) strategies are the relevant generic-entry mechanisms.
• AbbVie owns the commercial rights through its acquisition of Allergan, which acquired Kythera.

FAQs About US Patent 7,754,230

Does US Patent 7,754,230 cover sodium deoxycholate?

Yes. Claims 3 and 6 expressly identify sodium deoxycholate. Claim 7 separately covers up to 5% of a deoxycholic acid salt, which can include sodium deoxycholate.

Does the patent cover deoxycholic acid above 5%?

Claim 1 extends to any concentration below 20%, subject to the other limitations. Claim 7 is narrower because it covers up to 5% of a deoxycholic acid salt.

Does the patent cover phosphatidylcholine products?

The asserted claims expressly exclude compositions containing phosphatidylcholine. A formulation containing phosphatidylcholine would have a non-infringement position against these claims, although other patents or claims could create separate risks.

Can a company market a deoxycholic acid product for non-submental fat?

Potentially, but the answer depends on the patent claims still in force, later patents, the product label, and whether the use falls within the broad localized-fat language of Patent 7,754,230. The patent itself is not limited to submental fat.

Is a Kybella generic subject to biosimilar approval?

No. A Kybella competitor would generally pursue an ANDA or potentially a 505(b)(2) application. The biosimilar pathway applies to biologics, not synthetic deoxycholic acid.

References

1. AbbVie Inc. (2020). AbbVie completes acquisition of Allergan. https://news.abbvie.com
2. Allergan plc. (2016). Allergan completes acquisition of Kythera Biopharmaceuticals. https://www.allergan.com
3. U.S. Food and Drug Administration. (2015). Kybella approval package and prescribing information. https://www.accessdata.fda.gov
4. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
5. U.S. Patent and Trademark Office. (2010). US Patent No. 7,754,230, Methods and compositions for treating adipose tissue. https://patents.google.com/patent/US7754230
6. U.S. Patent and Trademark Office. (2024). Patent Center. https://patentcenter.uspto.gov
7. Federal Trade Commission. (2024). Agreements filed under the Medicare Modernization Act. https://www.ftc.gov en/ archive/ pharmaceutical patent agreements.

Drugs Protected by US Patent 7,754,230

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						METHOD FOR REDUCTION OF SUBMENTAL FAT

International Family Members for US Patent 7,754,230

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1758590		PA2017006	Lithuania
European Patent Office	1758590		300907	Netherlands
European Patent Office	1758590		CA 2017 00067	Denmark
European Patent Office	1758590		LUC00029	Luxembourg
European Patent Office	1758590		2017C/063	Belgium
European Patent Office	1758590		122018000065	Germany
European Patent Office	1758590		132017000066197	Italy