Details for Patent: 10,500,214

Which drugs does patent 10,500,214 protect, and when does it expire?

Patent 10,500,214 protects KYBELLA and is included in one NDA.

Summary for Patent: 10,500,214

Title:	Formulations of deoxycholic acid and salts thereof
Abstract:	The present application is directed to an aqueous pharmaceutical formulation comprising less than about 5% w/v sodium deoxycholate maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate. Also disclosed herein, are methods for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising less than about 5% w/v of sodium deoxycholate, said method comprising maintaining pH of the solution of from at least about 8.0 to about 8.5.
Inventor(s):	Robert Emil Hodge, Jeffrey Douglas Webster
Assignee:	Allergan Sales LLC
Application Number:	US16/103,505
Patent Claim Types: see list of patent claims	Formulation; Compound;

US Patent 10,500,214 Landscape: What Claims 1-6 Cover for Sodium Deoxycholate Aqueous Formulations (pH 8.0-8.5) and Where Patent Risk Sits for SC Injection

US Drug Patent 10,500,214 claims a narrow but enabling formulation space: an aqueous, buffered, tonicity-controlled formulation containing sodium deoxycholate (0.05% to 2% w/v) at pH 8.0 to 8.5, with defined excipient roles (base, preservative, tonicity agent) and a subcutaneous injection suitability limitation. The estate is likely to function as a formulation “blocking” patent against at least some competitors trying to reuse the same excipient architecture and pH window, while leaving open multiple design-arounds that shift tonicity agents, preservative identity, pH outside the range, deoxycholate concentration, or the injection target profile.

What does US 10,500,214 claim cover, claim-by-claim?

Claim 1 is the independent claim and sets the protected formulation definition. Its scope is bounded by quantitative windows for active and key physicochemical parameters plus a fixed excipient framework.

Claim 1 (independent): formulation composition and pH window

Claim 1 recites:

• Aqueous pharmaceutical formulation
• Sodium deoxycholate: about 0.05% w/v to about 2% w/v
• Water
• Phosphate buffer
• Base
• Preservative
• Tonicity agent
• pH: about 8.0 to about 8.5

Claim 1 scope implication

• Carrier architecture is constrained: you need phosphate buffer plus a base plus a preservative plus a tonicity agent.
• Criticality is the pH band (8.0 to 8.5) and detergent loading (0.05% to 2% w/v sodium deoxycholate).
• It is not limited to a specific product name, API other than the deoxycholate excipient, or to a specific package, manufacturing method, or concentration of any additional drug substance. The claim text you supplied reads like a formulation that can be paired with other actives only if they do not take the composition outside the recited limitations.

Practical enforcement posture

• Claim 1 is likely to be asserted against compositions that match the excipient recipe and pH as much as against compositions that match the deoxycholate concentration.
• If a defendant formulation omits one of the required components (e.g., uses a different buffer system or removes preservative), literal infringement risk decreases.

Claim 2 (dependent): subcutaneous injection suitability

Claim 2 limits Claim 1 to formulations “suitable for subcutaneous injection.”

Scope implication

• “Suitable for” is often litigated as a functional limitation that can be satisfied if the formulation’s properties (including pH, tonicity, preservative, and viscosity if relevant) support SC use.
• If a competitor’s formulation has the same recipe but is intended for intramuscular or intravenous use only, they still may face infringement depending on whether it is “suitable” in objective terms.

Claim 3 (dependent): pH about 8.3

Claim 3 further narrows Claim 1 by requiring pH about 8.3.

Scope implication

• This is a narrower zone inside Claim 1’s broader pH band.
• A defendant with pH 8.1 or 8.45 could still fall under Claim 1 but not Claim 3.

Claim 4 (dependent): preservative is benzyl alcohol

Claim 4 limits the preservative to benzyl alcohol.

Scope implication

• Substituting a different preservative (e.g., phenol, m-cresol, parabens) can be a direct design-around to avoid Claim 4.
• If the claim chain is enforced through Claim 1, however, the preservative in Claim 1 is not limited to benzyl alcohol. Claim 4 is a dependent narrowing.

Claim 5 (dependent): base is sodium hydroxide

Claim 5 limits the base to sodium hydroxide.

Scope implication

• Switching from sodium hydroxide to other bases (e.g., tromethamine, potassium hydroxide, carbonate salts) can avoid Claim 5 while still potentially implicating Claim 1.

Claim 6 (dependent): tonicity agent is sodium chloride

Claim 6 limits the tonicity agent to sodium chloride.

Scope implication

• Substituting tonicity agents (glycerin, mannitol, sucrose, potassium chloride) can avoid Claim 6.
• Again, Claim 1 does not specify sodium chloride unless Claim 6 is asserted.

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How strong is the patent estate for this formulation space?

From the claim set provided (1–6 only), the estate strength sits in the combination of three anchors:

1. Sodium deoxycholate concentration window
2. Phosphate buffer requirement
3. pH 8.0 to 8.5 window

Dependent claims 4–6 tighten excipient identity, giving the patent multiple “rungs” for different infringement fact patterns. If competitors reproduce the core composition but change only preservative, base, or tonicity agent, infringement may still be possible under Claim 1 but not necessarily under Claims 4–6.

Where competitors can reduce infringement risk

At a product formulation level, common carve-outs are:

• Shift pH outside 8.0–8.5.
• Use a non-phosphate buffer system (the independent claim calls for phosphate buffer).
• Change deoxycholate concentration below ~0.05% w/v or above ~2% w/v.
• Change excipient identities:
  • Preserve with something other than benzyl alcohol (avoid Claim 4)
  • Adjust pH using something other than sodium hydroxide (avoid Claim 5)
  • Use a tonicity agent other than sodium chloride (avoid Claim 6)
• If the formulation is engineered for a route where it is not “suitable” for SC use, Claim 2 risk can be reduced, but the “suitable” standard is objective.

What is likely the most litigated limitation

If you look at typical formulation patent disputes, the pH window and buffer system are usually the highest-meaning leverage because they are easy to measure and can be achieved by formulation adjustment. The sodium deoxycholate loading is also measurable and may be central to detergent function and stability.

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What patents cover adjacent formulation space: sodium deoxycholate buffers and pH 8.0-8.5?

A complete US landscape requires the actual patent record (family, continuations, related applications, citations, and claims). The prompt only provides the claims text and the patent number, not the full bibliographic data (assignee, filing date, priority date, CPC codes), nor the surrounding family members. Under the operating constraints, a complete and accurate multi-patent landscape cannot be produced from the supplied material alone.

Accordingly: no cross-patent enumeration is provided.

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When does US 10,500,214 lose exclusivity (patent expiration timing)?

A complete exclusivity timing analysis requires the patent’s priority and filing dates, whether it had patent term adjustments, terminal disclaimers, and whether it is tied to any regulatory exclusivity or method-of-use exclusivity.

The prompt provides only claim text and the patent number. Without the bibliographic dates, an accurate expiration timeline cannot be produced.

Accordingly: no exclusivity or expiration dates are provided.

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What Orange Book status applies to US 10,500,214?

Orange Book status requires identifying the drug product and application number associated with the formulation described by the patent. The prompt does not provide the drug identity, NDA/BLA/ANDA number, dosage form, or listed patents.

Accordingly: no Orange Book status is provided.

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What generic entry risks exist for formulations matching Claims 1-6?

Literal infringement risk scenarios

Risk rises if a generic (or biosimilar) formulation:

• Uses aqueous formulation with phosphate buffer
• Contains sodium deoxycholate in 0.05%–2% w/v
• Sets pH within 8.0–8.5
• Includes a base, preservative, and tonicity agent within the claim framework
• Is suitable for subcutaneous injection

Even if preservative/base/tonicity identities differ from dependent claims (4–6), Claim 1 can still be implicated.

Design-around paths that reduce risk

• Switch to non-phosphate buffering
• Move pH outside 8.0–8.5
• Move deoxycholate concentration outside the cited window
• Remove or replace preservative/base/tonicity agent identities aligned to Claims 4–6

Litigation posture

If asserted, the factual disputes typically center on:

• Actual formulation composition at release and throughout shelf life (including pH measurement)
• Whether the accused product is “suitable for subcutaneous injection”
• Whether “about” accommodates the accused values (depends on claim construction and evidence)

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How does US 10,500,214 compare with typical surfactant/drug product formulation patents?

US 10,500,214 is a formulation composition patent with parameterized constraints, not a method-of-manufacture claim and not a pure chemistry patent on sodium deoxycholate itself. Its scope is best understood as:

• Detergent-mediated solubilization/stability formulation space
• Tight pH and buffer constraints
• Excipient-architecture constraints via dependent claim fallbacks

Relative to broader formulation patents, it appears narrower because it requires:

• phosphate buffer
• a specific pH range
• a defined detergent loading range

Relative to narrower pH-only or ingredient-only patents, it is broader because it combines ingredient concentration and physicochemical constraints with injection suitability.

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Key Takeaways

• Claim 1 protects an aqueous phosphate-buffered formulation with sodium deoxycholate 0.05%–2% w/v and pH 8.0–8.5, with a base, preservative, and tonicity agent included.
• Claims 2–6 add route and excipient-specific fallbacks: SC suitability, pH about 8.3, benzyl alcohol preservative, sodium hydroxide base, and sodium chloride tonicity agent.
• Infringement risk is highest for products that match the pH band and phosphate buffer + deoxycholate concentration. Excipient swaps primarily mitigate risk under dependent claims, not necessarily Claim 1.
• A full US landscape (other patents, Orange Book listings, expiration dates, and Paragraph IV/biosimilar challenges) cannot be compiled from the provided inputs alone.

FAQs

1. Does changing sodium deoxycholate concentration avoid Claim 1?
   Risk can drop if the formulation moves outside about 0.05%–about 2% w/v, since that is a hard numerical limitation in Claim 1.

2. Can a different buffer system avoid infringement?
   Likely yes for Claim 1 because phosphate buffer is required in the independent claim.

3. If pH is 8.6, does it still infringe?
   Claim 1 is limited to about 8.0 to about 8.5, so a pH beyond that range is a direct avoidance path, subject to claim construction of “about.”

4. What excipient substitutions matter most?
   Preservative, base, and tonicity agent identities map to Claims 4–6. Substitution helps if those dependent claims are asserted, but Claim 1 does not specify specific identities.

5. Is “suitable for subcutaneous injection” a product label requirement?
   It is a functional limitation that can be satisfied by objective formulation properties, not just intended-use language.

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References

1. United States Patent 10,500,214, claims 1–6 (provided in prompt).

Drugs Protected by US Patent 10,500,214

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	10,500,214		Y