Details for Patent: 10,206,895

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Which drugs does patent 10,206,895 protect, and when does it expire?

Patent 10,206,895 protects SOTYLIZE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,206,895

Title:	Sotalol compositions and uses of the same
Abstract:	The present invention provides oral solutions containing sotalol hydrochloride which advantageously avoid swallowing while providing with improved stability. The present invention also relates to methods of using the oral solutions for treatment of diseases and disorders, such as delay in reoccurrence of atrial fibrillation/atrial flutter and/or ventricular arrhythmias.
Inventor(s):	H. Greg Thomas, Jeffrey S. Kiel
Assignee:	Arbor Pharmaceuticals LLC
Application Number:	US15/635,499
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

United States Patent 10,206,895 (Sotalol Hydrochloride Oral Solution): Scope of Claims and US Patent Landscape

Executive summary: U.S. Patent 10,206,895 claims a specific oral sotalol hydrochloride solution design space defined by osmolality (50–400 mOsm/kg), optional “free of polymers” restriction, pH (3–7), and sotalol concentration bands (notably ~0.5% w/w and broader 0.2–0.8% w/w in dependent claims). The independent claim is product-centric (composition defined by physiochemical parameters) and is paired with method-of-use claims for atrial fibrillation/atrial flutter recurrence delay and life-threatening ventricular arrhythmias. The enforceable US scope is therefore strongest against generics or branded entrants that copy both delivery form (oral solution) and these physicochemical parameter ranges, including excipient compositions that specify buffering (sodium citrate/citric acid), preservative (sodium benzoate), sweetener (sucralose), and artificial grape flavor, plus optional packaging/storage condition limitations.

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What does US Patent 10,206,895 claim: oral sotalol hydrochloride solution by osmolality, pH, and excipients?

Direct answer: The claims center on an oral solution of sotalol hydrochloride that satisfies osmolality 50–400 mOsm/kg. Dependent claims narrow to polymer-free, pH 3–7, osmolality 200–300 mOsm/kg, and defined sotalol concentrations (with further constraints through excipient selection and optional storage conditions). The later claims add methods for treating specific arrhythmias using the same composition.

Claim 1 scope: osmolality-defined sotalol oral solution

Claim 1 (independent, composition):

• “An oral solution comprising sotalol hydrochloride”
• osmolality: ~50 to ~400 mOsm/kg

Practical implication for coverage:

• A product that is not an oral solution (e.g., tablets, capsules, suspensions without being a solution) is outside claim 1’s phrasing.
• A product that is an oral solution but whose measured osmolality falls outside 50–400 mOsm/kg avoids claim 1.
• Because osmolality is a numeric range, a competitor’s formulation analytics and measurement method become central to infringement arguments (lab practice and test protocol matter, but claim language anchors the range).

Claim 2: “free of polymers” limitation

• “solution is free of polymers”

Scope effect:

• The moment a competitor uses polymer excipients (e.g., typical suspending/viscosity polymers or film-forming polymers used to stabilize content in liquids), claim 2 narrows away from them.
• Note claim 2 is dependent on claim 1, so “polymer-free” is an additional limitation only for that dependent claim. Even if polymer-containing formulations exist, claim 1 could still be asserted if they still meet osmolality 50–400 mOsm/kg.

Claim 3: pH window

• pH 3 to 7

Scope effect:

• A formulation outside this pH band avoids claim 3 but may still fall within claim 1 if osmolality remains in range.

Claim 4: tighter osmolality subgroup

• osmolality 200–300 mOsm/kg

Scope effect:

• Claim 4 is a narrower subset. A formulation tuned to osmolality in 50–199 or 301–400 may avoid claim 4 while still potentially meeting claim 1.

Claims 5–6: sotalol concentration bands

• Claim 5: sotalol hydrochloride present at about 5 mg/mL or about 0.5% by weight
• Claim 6: sotalol hydrochloride 0.2–0.8% by weight

Scope effect:

• Claim 5 is a point-ish target; claim 6 is a range.
• The breadth of claim 6 is more protective against design-around efforts that still keep sotalol within typical oral solution concentration regimes.

Claim 7: excipient selection

• further comprising excipient selected from:
  • buffering substances
  • preservatives
  • high potency sweeteners
  • flavoring agents
  • or combinations

Scope effect:

• This claim does not require any specific excipient unless further limited by dependent claims 8–12.
• A competitor adding unrelated excipients is still potentially within claim 7 if they also include excipients falling in those categories.

Claims 8–12: specific excipient exemplars

• buffering substance: sodium citrate or citric acid (alone or combination)
• preservative: sodium benzoate
• sweetener: sucralose
• flavoring: artificial grape flavor

Scope effect:

• These dependent claims are more “litigation-friendly” because they identify concrete excipients.
• A competitor can potentially avoid these dependent claims by substituting buffering agents, preservatives, sweeteners, or flavors. However, claim 7 does not require these exact selections.

Claim 12: water mass fraction

• water about 95% to 99% by weight

Scope effect:

• A formulation with lower water content (e.g., higher cosolvent content) may avoid claim 12 while still meeting other constraints like osmolality and pH.

Claim 15: storage conditions

• stored at 25–40°C and RH 60–75%

Scope effect:

• This is a product/storage limitation. Liability typically hinges on whether the accused product is stored under the claimed conditions (by manufacturer, distributor, or label-controlled storage). If storage is outside, claim 15 may be harder to assert.

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How broad are the method-of-use claims: recurrence delay for atrial fibrillation and treatment of ventricular arrhythmias?

Direct answer: Claims 13–14 claim methods defined by administering an effective amount of the same osmolality-restricted oral solution to a host for:

1. Delaying recurrence of atrial fibrillation/atrial flutter, and
2. Treating documented life-threatening ventricular arrhythmias.

Claim 13: delay recurrence of AF/atrial flutter

• administer effective amount of oral solution
• osmolality 50–400 mOsm/kg

Claim 14: treat life-threatening ventricular arrhythmias

• same administration concept
• osmolality 50–400 mOsm/kg

Scope effect and litigation posture:

• Even if a competitor uses a different excipient package, method claims still depend on the accused product’s osmolality and whether it is the “oral solution comprising sotalol hydrochloride” as claimed.
• In practice, method-of-use claims can be leveraged through label, prescribing instructions, and clinical use patterns to align accused administration with the claimed therapeutic indication and “documented life-threatening” framing.

Claims 17–18 and 20–21: dose and dosing frequency

• Claim 17: 80 mg daily dose
• Claim 18: administration once, twice, or three times per day
• Claim 20: 80 mg daily dose (for claim 14)
• Claim 21: once/twice/three times per day (for claim 14)

Scope effect:

• These are dependent on method claims. If an accused use or product labeling differs on dose regimen, it can weaken the dependent method claims even if the base method claim scope remains.

Claims 19 and 22: further composition limits within methods

• Claim 19: oral solution with:
  • water about 95–99%
  • sotalol HCl about 0.2–8% by weight
• Claim 22: same for claim 14 framework

Scope effect:

• Note the wider sotalol band (0.2–8% by weight) in method dependent claims versus claim 6’s 0.2–0.8% in the composition dependent claim. This can matter if an accused product uses higher concentration within the method-dependent broader band while still being an oral solution with osmolality in-range.

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What is the key infringement “design-around” surface: osmolality is the core, excipients and pH are secondary?

Direct answer: The strongest technical lever is osmolality 50–400 mOsm/kg. Secondary levers are pH 3–7, polymer-free, water 95–99%, and the dependent excipient set (sodium citrate/citric acid, sodium benzoate, sucralose, artificial grape flavor). Concentration bands (0.2–0.8% or 0.2–8% depending on claim) also shape risk.

Design-around map (claim elements vs. likely formulation choices)

Claim element	Range / requirement	Practical design-around risk
Oral solution	Must be a solution form	High if dosage form differs (tablets avoid).
Osomolality	50–400 mOsm/kg (independent)	Highest sensitivity. Targeting outside range avoids broad coverage.
pH	3–7 (dependent)	Moderate: formulation can adjust pH, but osmolality may shift too.
Polymer-free	No polymers (dependent)	Moderate: polymer use could avoid dependent claims but not claim 1.
Osomolality narrow	200–300 mOsm/kg (dependent)	Moderate: tune outside 200–300 while staying inside 50–400 if possible.
Sotalol concentration	0.2–0.8% w/w (dependent) or 0.5%/5 mg/mL (dependent)	Moderate: adjust concentration to avoid dependent concentration claims.
Excipient set	buffering/preservative/sweetener/flavor (dependent)	Moderate: specific exemplars avoid narrower dependent claims.
Storage	25–40°C, RH 60–75% (dependent)	Low-to-moderate: depends on actual distribution/storage compliance.
Dose regimen and frequency	80 mg/day and 1–3x/day (dependent)	Moderate for method dependent claims; less for composition claims.
Water fraction	95–99% (dependent)	Moderate: higher cosolvent content changes weight fraction and may shift osmolality.

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What patents likely overlap with US 10,206,895: where does the prior art usually attack?

Direct answer: For a formulation patent that locks osmolality, pH, and specific excipient sets for sotalol hydrochloride oral solutions, overlapping patent space typically falls into four buckets:

1. Sotalol oral liquid formulations (concentration, pH, stabilizers, preservatives, sweeteners, flavors)
2. Physicochemical target selection (osmolality control in oral liquids)
3. Methods for arrhythmia treatment using oral sotalol (AF/flutter recurrence and ventricular arrhythmias)
4. Manufacturing and stability methods for oral liquid solutions and storage condition management

Why this matters for enforcement:

• If earlier patents exist with similar osmolality/pH/excipient frameworks, 10,206,895’s enforceability can be tied to claim-specific narrowing that differentiates it from earlier liquid formulations.
• Where method-of-use is concerned, novelty often turns on whether the specific therapeutic effect framing and patient populations are claimed as such, versus broad sotalol indications already known.

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How strong is US 10,206,895’s patent estate for blocking generics: what generic entry risks exist?

Direct answer: The patent can block entry only if a competitor’s product is an oral sotalol hydrochloride solution that meets the claim-defined osmolality window (and, for narrower dependents, the additional constraints). A generic that materially changes osmolality, pH, polymer usage, water fraction, or specific excipient package can reduce infringement risk, at least for dependent claims. If a competitor still keeps osmolality 50–400 mOsm/kg, the remaining risk concentrates on measurable physicochemical parameters and the selected excipients.

Risk outcomes by competitor strategy

Competitor approach	Likely impact on claim coverage
Keep osmolality within 50–400, change excipients	High risk for claim 1 and method claims; medium risk for excipient-dependent dependents.
Tune osmolality outside 50–400 (while keeping oral liquid usability)	Lower risk for claim 1 and method claims; may still face other patents.
Keep osmolality in range, change pH outside 3–7	Avoids claim 3 but not claim 1.
Use polymer excipients	Avoids claim 2 but not claim 1.
Change sweetener/preservative/flavor	Avoids claims 8–12 but not claim 7 or claim 1.
Change water fraction outside 95–99%	Avoids claim 12 (and dependent method 19/22 constraints).
Use different dose regimen	Impacts dependent method claims 17–18/20–21.

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What is the Orange Book status likely to be relevant for: how does 10,206,895 tie to FDA listings?

Direct answer: For a US formulation patent like 10,206,895, the operational question for generic risk is whether it is listed in the FDA Orange Book against a corresponding NDA/ANDA for an oral sotalol solution product. If it is listed, Paragraph IV certifications and FDA litigation triggers become the main pathway for a generic strategy.

However: this prompt does not supply the underlying NDA/ANDA number, Orange Book listing details, or the patent’s “listed for” status, and those facts are required to determine whether the patent is enforceable via Orange Book timing and certification.

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Patent litigation and challenges: what matters for 10,206,895 if a generic files a Paragraph IV?

Direct answer: The key litigation hooks for a potential Paragraph IV or infringement case would be:

• Whether the accused generic product has an oral solution with osmolality 50–400 mOsm/kg.
• Whether measured pH and polymer presence align with dependent claims.
• Whether excipient composition matches any dependent exemplars (sodium citrate/citric acid, sodium benzoate, sucralose, artificial grape flavor).
• Whether the generic’s method-use exposure aligns with clinical use for the claimed indications (AF/flutter recurrence delay; documented life-threatening ventricular arrhythmias).

Litigation posture typically follows: product testing, formulation comparison, and expert testimony on osmolality measurement and stability. The narrow numeric ranges increase the likelihood that infringement/non-infringement turns on lab results.

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Commercial and competitive implications: where sotalol oral solutions create patent leverage

Direct answer: Sotalol is widely used as an antiarrhythmic, but liquid formulations matter for:

• pediatric or swallowing-impaired populations,
• patients needing dose flexibility,
• and settings where oral liquids are practical.

If 10,206,895 maps to an NDA/ANDA that covers an oral liquid version, it can become a targeted barrier to substitution. If competitors can move to a different liquid design that shifts osmolality or excipients, they can potentially accelerate availability.

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Key Takeaways

• Core protected subject matter: an oral sotalol hydrochloride solution with osmolality 50–400 mOsm/kg (Claim 1) plus method-of-use administration of that same osmolality-defined solution for AF/flutter recurrence delay and life-threatening ventricular arrhythmias treatment (Claims 13–14).
• Most actionable claim limits for infringement design-around: osmolality, then pH (3–7), polymer-free, water fraction (95–99%), and selected excipients (sodium citrate/citric acid, sodium benzoate, sucralose, artificial grape flavor).
• Concentration-dependent narrowing: Claim 6 targets 0.2–0.8% w/w (composition), while method dependent claims 19/22 expand sotalol concentration to 0.2–8% w/w with the water constraint.
• Risk for generic entrants: if the generic keeps osmolality inside 50–400, it keeps exposure to both composition and method claims; changing excipients or pH may only reduce dependent claim coverage.
• Litigation likely hinges on formulation analytics: lab measurement of osmolality (and compliance with pH/water/polymer/excipient limitations) is the center of gravity.

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FAQs

1) What single claim element most affects infringement exposure for US 10,206,895?
Osmoality: 50–400 mOsm/kg.

2) Can a polymer-containing sotalol oral solution avoid the patent entirely?
It can avoid Claim 2 (“free of polymers”) but not necessarily Claim 1 or the method claims if osmolality still falls within 50–400 mOsm/kg.

3) Do excipients like sucralose or sodium benzoate need to be present to infringe?
Not for Claim 1. They are tied to narrower dependent claims (Claims 10 and 9, respectively).

4) How do dose regimen changes affect method-of-use claims?
They can reduce risk for dependent method claims that recite 80 mg daily dose (Claims 17 and 20) while base method claims 13–14 still turn primarily on the composition/osmolality.

5) What formulation changes most plausibly reduce risk if a competitor wants to stay an oral liquid?
Tuning osmolality outside 50–400 mOsm/kg is the most direct approach; secondary tuning includes pH, water fraction, and polymer/excipient selection.

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References (APA)

1. United States Patent 10,206,895. Claims provided in the prompt.

Drugs Protected by US Patent 10,206,895

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	SOTYLIZE	sotalol hydrochloride	SOLUTION;ORAL	205108-001	Oct 22, 2014		RX	Yes	Yes			Y			SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
Azurity	SOTYLIZE	sotalol hydrochloride	SOLUTION;ORAL	205108-001	Oct 22, 2014		RX	Yes	Yes			Y			INDICATED FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS, SUCH AS SUSTAINED VENTRICULAR TACHYCARDIA, THAT IN THE JUDGEMENT OF THE PHYSICIAN ARE LIFE-THREATENING

International Family Members for US Patent 10,206,895

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2015153762