Scope, Claim Construction, and US Patent Landscape for Diclofenac Potassium Dispersible Liquid to Treat Acute Post-Bunionectomy Pain (US Patent 8,110,606)

US Patent 8,110,606 is a method-of-treatment patent focused on orally administered diclofenac potassium in a dispersible liquid formulation for acute post-bunionectomy pain, with claim scope anchored to tight dosing, schedule, and exposure-related pharmacokinetic/clinical efficacy parameters. The estate is likely to create infringement risk for generics attempting to copy the specific dose range (13 to 30 mg), total daily cap (≤100 mg), dosing interval (about every 4 to 8 hours), and duration (at least 24 hours), especially where clinical end points and PK markers are matched.

What does US Patent 8,110,606 claim and what is its core scope for diclofenac potassium post-bunionectomy pain?

Immediate answer (claim center of gravity):
The patent claims a specific oral method that treats acute post-bunionectomy pain by administering diclofenac potassium as a dispersible liquid formulation at 13–30 mg per dose on a 4–8 hour interval for at least 24 hours, with ≤100 mg/day, and with options that tighten to specific dosing schedules (e.g., 25 mg four times over ~24 hours) and PK/clinical performance (Tmax ~0.47 hours; relief onset within ~60–70 minutes; meaningful efficacy ~6 hours; elimination from plasma within first ~2 hours).

Claim dependency map (how breadth is built)

Independent Claim 1 is the broadest method frame. Dependent claims carve out:

Surgical context: Claim 2 requires internal fixation during bunionectomy.
Dosing interval tightening: Claims 3–4 restrict administration timing.
Treatment duration tightening: Claim 5 and Claim 6 expand to many longer durations (up to 7 days).
Dose-species selection: Claim 7 lists many discrete dose amounts from 13 mg through 30 mg.
Pharmacodynamic and PK-linked performance: Claims 8–11 introduce duration of analgesia and PK markers.
Data-anchored instantiations tied to a specific dose: Claims 12–17 focus on ~25 mg and replicate specific clinical outcomes and onset timing.
Dosage form wrapper: Claim 18 requires the dispersible liquid is contained in a capsule.
Pain severity banding: Claim 19 ties to mild-moderate to moderate-severe intensity.
No opioid co-administration: Claim 20 excludes opioid use.

Key claim elements (practical infringement triggers)

Indication: acute post-bunionectomy pain (method claim scope).
Active: diclofenac potassium.
Dosage form restriction: dispersible liquid formulation (composition is not claimed directly, but formulation requirement is a claim limitation).
Per-dose range: 13 to 30 mg.
Dosing interval: about every 4 to about 8 hours.
Minimum treatment duration: at least 24 hours.
Daily total cap: ≤ about 100 mg.
PK and clinical performance options: T(max) ~0.47 hours; early relief onset; elimination within first 2 hours; efficacy for ~6 hours.

Business implication: A product that matches the indication + route + formulation + dosing scheme is the highest-risk target. The PK/clinical parameters can also be used as evidentiary anchors even when not strictly required for literal infringement, depending on claim interpretation and how dependent claims are framed in the infringement analysis.

How do the claim terms narrow or broaden infringement risk (dispersible liquid, dosing interval, daily cap)?

“Dispersible liquid formulation” scope

The patent constrains infringement to diclofenac potassium delivered as a dispersible liquid formulation. In practice, this typically covers a dosage form where drug is dispersed in an aqueous medium prior to administration or is formulated for rapid dispersal in the GI tract, depending on claim construction. The claim does not require a specific excipient package in the text provided, but the formulation category itself is a major differentiator versus immediate-release tablets, enteric-coated formulations, or generic liquid syrups not designed as dispersible liquids.

Dose and schedule: the mathematical boundary

Claim 1 enforces an interacting triad:

Per-dose: 13–30 mg
Interval: 4–8 hours
Total daily: ≤100 mg
Treatment duration: ≥24 hours

Highest-risk template within Claim 1: 25 mg dosing four times in 24 hours:

Claim 17 states: 25 mg four times over ~24 hours.
This schedule yields 100 mg/day, hitting the daily ceiling.

“About” and discrete embodiments

Claim 7 lists discrete dose amounts as alternate embodiments. This is important because it reduces design-around options: even if a competitor argues “about 25 mg” vs 25 mg, the claim already enumerates 27.5, 28, etc. The “about” term plus enumeration increases literal coverage for near-neighbor dose strengths.

Duration expansion: Claim 6 multiplies covered timelines

Claim 6 enumerates durations up to 7 days. If the method is used beyond the first day and still fits the daily cap and interval framework, the risk remains.

What pharmacokinetic and clinical endpoints are built into the claim set (Tmax ~0.47h, elimination in first 2 hours, onset 60–70 minutes)?

Claims 8–16 introduce performance characteristics that can matter in:

literal infringement (if each limitation is interpreted as required),
equivalency arguments in some jurisdictions,
and evidentiary framing in Hatch-Waxman litigation.

PK anchors

Claim 9: plasma diclofenac concentrations 670–1500 ng/mL in <30 minutes with concomitant onset of relief.
Claim 10: immediate increase in plasma concentration with Tmax ~0.47 hours.
Claim 11: substantially eliminated from plasma in the first 2 hours.

These parameters imply a formulation enabling rapid absorption and short exposure persistence, consistent with an orally administered dispersible system rather than slower release forms.

Clinical anchors (pain scales and timing)

Claim 8: relief lasts ~6–8 hours after administration.
Claim 12: ~25 mg embodiment.
Claim 13: average 48-hour NPRS pain score ~2.49.
Claim 14: median time to ≥30% pain reduction ~60 minutes in an 8-hour initial dosing period.
Claim 15: median time to meaningful pain relief ~70 minutes in an 8-hour period.
Claim 16: clinically significant analgesic efficacy ~6 hours.

Business implication: Any generic attempting to “slot in” with the same dosage but with slower onset is more exposed to these dependent claim embodiments, especially the time-to-effect measures.

Which related dependent claims create the tightest design-around barriers (internal fixation, capsule, no opioid)?

Claim 2: internal fixation during bunionectomy

This limitation can reduce coverage if an accused method does not include internal fixation, but it also offers a fallback claim path. If clinical practice in the studied trial population includes internal fixation, the patentee’s enforcement record may align to that setting.

Claim 18: capsule containment

If a generic uses a different packaging concept (e.g., sachet or tablet) while still meeting “dispersible liquid formulation,” enforceability will hinge on how “contained in a capsule” is construed. Many generics could be designed around capsule packaging, but that depends on product design.

Claim 20: no opioid co-administration

If the method of treatment includes opioid rescue or co-medication, literal infringement could be challenged. However, in pain trials, “no opioid” language can be complicated by rescue allowances; the claim text you provided implies the method requires no opioid co-administration. That becomes a factual and protocol-specific issue.

What is the patent landscape around US 8,110,606 for diclofenac formulations and buinionectomy pain? (relationships and typical coverage patterns)

The provided claim set is method-centric. In the broader landscape for diclofenac-based acute pain, typical patent families include:

API polymorph/solvate/particle size patents,
formulation patents for rapid dispersal, absorption enhancement, taste-masking, and stability,
dose regimen patents (interval, duration, total daily maximum),
indication and method-of-use patents tied to surgical procedures like bunionectomy and associated pain management windows,
and clinical/PK-driven formulation-to-exposure claims.

How US 8,110,606 likely fits: it is written to preserve enforceable coverage even if competitors produce a generic diclofenac potassium product that matches drug identity but misses a specific regimen, timing, or formulation presentation. The “dispersible liquid formulation” plus PK/clinical endpoints indicates the patentee is using trial performance to distinguish.

Typical adjacent claim families to expect in parallel

Even without listing other patent numbers here, the claim wording signals adjacency to:

a formulation enablement family (how diclofenac potassium is made dispersible, stabilized, and rapidly available),
a clinical protocol family (timing and analgesic outcome measures for the post-bunionectomy acute pain population),
and potentially a capsule and dosing-strength family (if capsule packaging is integral).

When does US 8,110,606 lose exclusivity (expiration timeline framework for a method patent)?

The exact expiration date depends on the patent’s filing date, priority, and any patent term adjustments under US law. Those data are not provided in the prompt, so a precise date cannot be calculated from the claim text alone.

Actionable enforcement window concept: For a method-of-treatment patent, exclusivity is governed by the patent’s legal life in the US. Even after expiration, generics can practice the same method if not blocked by other active patents (for example, formulation patents or additional method-of-use patents that do not expire simultaneously).

What Paragraph IV and litigation risks exist for generics challenging diclofenac potassium post-bunionectomy pain dosing?

Why Paragraph IV exposure is high even for “same dose” products

Hatch-Waxman litigation risk is not limited to copying the active ingredient. For US 8,110,606, the following can be infringement hinges:

using a different diclofenac potassium presentation (tablet vs dispersible liquid),
altering dose interval so the regimen falls outside 4–8 hours,
exceeding the daily cap (≤100 mg),
shortening or extending the duration outside the claimed window,
using opioid co-administration (to avoid Claim 20),
changing time-to-effect and exposure profile (to avoid PK/clinical dependent claims).

What a generic must design around

The design-around should be evaluated against each limitation in order:

indication (method of treating acute post-bunionectomy pain),
dispersible liquid formulation requirement,
dosing dose range and daily cap,
interval and minimum duration,
capsule containment (Claim 18),
internal fixation (Claim 2),
no opioid co-administration (Claim 20),
PK/clinical endpoints embedded in dependent claims.

Practical note: A generic label may not need to instruct physicians to follow a covered method, but if the product is marketed and prescribed in a way that fits the method claim, infringement theories can still arise through induced/contributory infringement under the right facts.

What formulations are protected by US 8,110,606 (capsule dispersible liquid) and how does it compare to tablet or enteric-coated diclofenac?

Direct formulation constraint

US 8,110,606 is limited to a diclofenac potassium dispersible liquid formulation. That is narrower than “any oral diclofenac potassium.”

Comparison: likely outside scope

Immediate-release diclofenac potassium tablets: may fail the “dispersible liquid formulation” limitation.
Enteric-coated diclofenac potassium: likely fails both the formulation category and the PK profile (Tmax ~0.47 hours; early high plasma levels in <30 min).
Sustained-release diclofenac: would likely fail the “eliminated in first 2 hours” and onset timing constraints.

Comparison: capsule embodiment

Even if a competitor uses dispersible liquid chemistry, it may still avoid Claim 18 if the dispersible liquid is not “contained in a capsule.”

How strong is the patent estate for this regimen (claim structure and enforceability signals)?

Based on the claim text alone, the enforceability strength comes from three features:

Multiple independent levers: dose, schedule, duration, daily cap, formulation type, surgical context, and “no opioid” condition.
Trial-anchored endpoints: PK and pain score/timing parameters provide objective performance anchors that can distinguish the claimed method from close alternatives.
Embedded numeric embodiments: enumerated dose strengths and durations reduce the ability to argue substantial deviation.

Potential weakness (infringement defensibility):

If a challenger uses a non-capsule packaging, adds opioid rescue, or treats a different procedural subset (no internal fixation), it could attack specific dependent claims. But the independent claim still captures the core regimen if those conditions are met.

Key Takeaways

US 8,110,606 claims a tightly defined oral dosing method using diclofenac potassium in a dispersible liquid formulation for acute post-bunionectomy pain.
The core cover includes 13–30 mg per dose, every 4–8 hours, ≥24 hours treatment, and ≤100 mg/day, plus dependent claims that narrow to specific regimens (including 25 mg four times over ~24 hours).
Dependent claims embed objective PK (Tmax ~0.47h; early elimination) and clinical timing/efficacy measures (onset ~60–70 minutes; meaningful relief ~6 hours; NPRS ~2.49 at 48 hours for the ~25 mg embodiment).
Design-around pathways center on changing formulation category, dosing schedule and total daily dose, duration, capsule packaging, opioid co-administration, and potentially the internal fixation subset.

FAQs

1) Does US 8,110,606 cover diclofenac potassium tablets for post-bunionectomy pain?
Not on the claim text provided. The method requires a diclofenac potassium dispersible liquid formulation.

2) What dose regimen in the patent is the most explicit?
The strongest numeric embodiment is 25 mg four times over ~24 hours (Claim 17), aligning with the ≤100 mg/day cap in Claim 1.

3) Can a generic avoid infringement by using opioid rescue?
Claim 20 requires no opioid co-administration in the claimed method. If opioid use is truly part of the administered regimen, Claim 20 could be avoided, but other claims may still read depending on facts.

4) How do the PK limitations affect generic risk?
Dependent claims target fast absorption (Tmax ~0.47 hours; measurable plasma levels within 30 minutes) and rapid elimination (substantially eliminated within first 2 hours). A generic with a slower profile is more exposed to performance-matching arguments.

5) Is internal fixation required to practice the patented method?
Internal fixation is a limitation of Claim 2 (dependent). It is not required by Claim 1.

References

US Patent 8,110,606 (claims provided in prompt).

Title:	Method of treating post-surgical acute pain
Abstract:	A method is provided for treating pain in patients recovering from post-surgical trauma by administering between about 13 to about 30 mg of diclofenac potassium in a liquid dispersible formulation over a period of at least 24 hours, wherein the daily total amount of diclofenac potassium administered is less than or equal to about 100 mg. The method is particularly useful in treating acute pain in bunionectomy patients.
Inventor(s):	Mark M. Kowalski, James L. Young, Keith A. Moore
Assignee:	Assertio Therapeutics Inc
Application Number:	US12/706,117
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,110,606
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;
Patent landscape, scope, and claims:	Scope, Claim Construction, and US Patent Landscape for Diclofenac Potassium Dispersible Liquid to Treat Acute Post-Bunionectomy Pain (US Patent 8,110,606) US Patent 8,110,606 is a method-of-treatment patent focused on orally administered diclofenac potassium in a dispersible liquid formulation for acute post-bunionectomy pain, with claim scope anchored to tight dosing, schedule, and exposure-related pharmacokinetic/clinical efficacy parameters. The estate is likely to create infringement risk for generics attempting to copy the specific dose range (13 to 30 mg), total daily cap (≤100 mg), dosing interval (about every 4 to 8 hours), and duration (at least 24 hours), especially where clinical end points and PK markers are matched. What does US Patent 8,110,606 claim and what is its core scope for diclofenac potassium post-bunionectomy pain? Immediate answer (claim center of gravity): The patent claims a specific oral method that treats acute post-bunionectomy pain by administering diclofenac potassium as a dispersible liquid formulation at 13–30 mg per dose on a 4–8 hour interval for at least 24 hours, with ≤100 mg/day, and with options that tighten to specific dosing schedules (e.g., 25 mg four times over ~24 hours) and PK/clinical performance (Tmax ~0.47 hours; relief onset within ~60–70 minutes; meaningful efficacy ~6 hours; elimination from plasma within first ~2 hours). Claim dependency map (how breadth is built) Independent Claim 1 is the broadest method frame. Dependent claims carve out: Surgical context: Claim 2 requires internal fixation during bunionectomy. Dosing interval tightening: Claims 3–4 restrict administration timing. Treatment duration tightening: Claim 5 and Claim 6 expand to many longer durations (up to 7 days). Dose-species selection: Claim 7 lists many discrete dose amounts from 13 mg through 30 mg. Pharmacodynamic and PK-linked performance: Claims 8–11 introduce duration of analgesia and PK markers. Data-anchored instantiations tied to a specific dose: Claims 12–17 focus on ~25 mg and replicate specific clinical outcomes and onset timing. Dosage form wrapper: Claim 18 requires the dispersible liquid is contained in a capsule. Pain severity banding: Claim 19 ties to mild-moderate to moderate-severe intensity. No opioid co-administration: Claim 20 excludes opioid use. Key claim elements (practical infringement triggers) Indication: acute post-bunionectomy pain (method claim scope). Active: diclofenac potassium. Dosage form restriction: dispersible liquid formulation (composition is not claimed directly, but formulation requirement is a claim limitation). Per-dose range: 13 to 30 mg. Dosing interval: about every 4 to about 8 hours. Minimum treatment duration: at least 24 hours. Daily total cap: ≤ about 100 mg. PK and clinical performance options: T(max) ~0.47 hours; early relief onset; elimination within first 2 hours; efficacy for ~6 hours. Business implication: A product that matches the indication + route + formulation + dosing scheme is the highest-risk target. The PK/clinical parameters can also be used as evidentiary anchors even when not strictly required for literal infringement, depending on claim interpretation and how dependent claims are framed in the infringement analysis. How do the claim terms narrow or broaden infringement risk (dispersible liquid, dosing interval, daily cap)? “Dispersible liquid formulation” scope The patent constrains infringement to diclofenac potassium delivered as a dispersible liquid formulation. In practice, this typically covers a dosage form where drug is dispersed in an aqueous medium prior to administration or is formulated for rapid dispersal in the GI tract, depending on claim construction. The claim does not require a specific excipient package in the text provided, but the formulation category itself is a major differentiator versus immediate-release tablets, enteric-coated formulations, or generic liquid syrups not designed as dispersible liquids. Dose and schedule: the mathematical boundary Claim 1 enforces an interacting triad: Per-dose: 13–30 mg Interval: 4–8 hours Total daily: ≤100 mg Treatment duration: ≥24 hours Highest-risk template within Claim 1: 25 mg dosing four times in 24 hours: Claim 17 states: 25 mg four times over ~24 hours. This schedule yields 100 mg/day, hitting the daily ceiling. “About” and discrete embodiments Claim 7 lists discrete dose amounts as alternate embodiments. This is important because it reduces design-around options: even if a competitor argues “about 25 mg” vs 25 mg, the claim already enumerates 27.5, 28, etc. The “about” term plus enumeration increases literal coverage for near-neighbor dose strengths. Duration expansion: Claim 6 multiplies covered timelines Claim 6 enumerates durations up to 7 days. If the method is used beyond the first day and still fits the daily cap and interval framework, the risk remains. What pharmacokinetic and clinical endpoints are built into the claim set (Tmax ~0.47h, elimination in first 2 hours, onset 60–70 minutes)? Claims 8–16 introduce performance characteristics that can matter in: literal infringement (if each limitation is interpreted as required), equivalency arguments in some jurisdictions, and evidentiary framing in Hatch-Waxman litigation. PK anchors Claim 9: plasma diclofenac concentrations 670–1500 ng/mL in <30 minutes with concomitant onset of relief. Claim 10: immediate increase in plasma concentration with Tmax ~0.47 hours. Claim 11: substantially eliminated from plasma in the first 2 hours. These parameters imply a formulation enabling rapid absorption and short exposure persistence, consistent with an orally administered dispersible system rather than slower release forms. Clinical anchors (pain scales and timing) Claim 8: relief lasts ~6–8 hours after administration. Claim 12: ~25 mg embodiment. Claim 13: average 48-hour NPRS pain score ~2.49. Claim 14: median time to ≥30% pain reduction ~60 minutes in an 8-hour initial dosing period. Claim 15: median time to meaningful pain relief ~70 minutes in an 8-hour period. Claim 16: clinically significant analgesic efficacy ~6 hours. Business implication: Any generic attempting to “slot in” with the same dosage but with slower onset is more exposed to these dependent claim embodiments, especially the time-to-effect measures. Which related dependent claims create the tightest design-around barriers (internal fixation, capsule, no opioid)? Claim 2: internal fixation during bunionectomy This limitation can reduce coverage if an accused method does not include internal fixation, but it also offers a fallback claim path. If clinical practice in the studied trial population includes internal fixation, the patentee’s enforcement record may align to that setting. Claim 18: capsule containment If a generic uses a different packaging concept (e.g., sachet or tablet) while still meeting “dispersible liquid formulation,” enforceability will hinge on how “contained in a capsule” is construed. Many generics could be designed around capsule packaging, but that depends on product design. Claim 20: no opioid co-administration If the method of treatment includes opioid rescue or co-medication, literal infringement could be challenged. However, in pain trials, “no opioid” language can be complicated by rescue allowances; the claim text you provided implies the method requires no opioid co-administration. That becomes a factual and protocol-specific issue. What is the patent landscape around US 8,110,606 for diclofenac formulations and buinionectomy pain? (relationships and typical coverage patterns) The provided claim set is method-centric. In the broader landscape for diclofenac-based acute pain, typical patent families include: API polymorph/solvate/particle size patents, formulation patents for rapid dispersal, absorption enhancement, taste-masking, and stability, dose regimen patents (interval, duration, total daily maximum), indication and method-of-use patents tied to surgical procedures like bunionectomy and associated pain management windows, and clinical/PK-driven formulation-to-exposure claims. How US 8,110,606 likely fits: it is written to preserve enforceable coverage even if competitors produce a generic diclofenac potassium product that matches drug identity but misses a specific regimen, timing, or formulation presentation. The “dispersible liquid formulation” plus PK/clinical endpoints indicates the patentee is using trial performance to distinguish. Typical adjacent claim families to expect in parallel Even without listing other patent numbers here, the claim wording signals adjacency to: a formulation enablement family (how diclofenac potassium is made dispersible, stabilized, and rapidly available), a clinical protocol family (timing and analgesic outcome measures for the post-bunionectomy acute pain population), and potentially a capsule and dosing-strength family (if capsule packaging is integral). When does US 8,110,606 lose exclusivity (expiration timeline framework for a method patent)? The exact expiration date depends on the patent’s filing date, priority, and any patent term adjustments under US law. Those data are not provided in the prompt, so a precise date cannot be calculated from the claim text alone. Actionable enforcement window concept: For a method-of-treatment patent, exclusivity is governed by the patent’s legal life in the US. Even after expiration, generics can practice the same method if not blocked by other active patents (for example, formulation patents or additional method-of-use patents that do not expire simultaneously). What Paragraph IV and litigation risks exist for generics challenging diclofenac potassium post-bunionectomy pain dosing? Why Paragraph IV exposure is high even for “same dose” products Hatch-Waxman litigation risk is not limited to copying the active ingredient. For US 8,110,606, the following can be infringement hinges: using a different diclofenac potassium presentation (tablet vs dispersible liquid), altering dose interval so the regimen falls outside 4–8 hours, exceeding the daily cap (≤100 mg), shortening or extending the duration outside the claimed window, using opioid co-administration (to avoid Claim 20), changing time-to-effect and exposure profile (to avoid PK/clinical dependent claims). What a generic must design around The design-around should be evaluated against each limitation in order: indication (method of treating acute post-bunionectomy pain), dispersible liquid formulation requirement, dosing dose range and daily cap, interval and minimum duration, capsule containment (Claim 18), internal fixation (Claim 2), no opioid co-administration (Claim 20), PK/clinical endpoints embedded in dependent claims. Practical note: A generic label may not need to instruct physicians to follow a covered method, but if the product is marketed and prescribed in a way that fits the method claim, infringement theories can still arise through induced/contributory infringement under the right facts. What formulations are protected by US 8,110,606 (capsule dispersible liquid) and how does it compare to tablet or enteric-coated diclofenac? Direct formulation constraint US 8,110,606 is limited to a diclofenac potassium dispersible liquid formulation. That is narrower than “any oral diclofenac potassium.” Comparison: likely outside scope Immediate-release diclofenac potassium tablets: may fail the “dispersible liquid formulation” limitation. Enteric-coated diclofenac potassium: likely fails both the formulation category and the PK profile (Tmax ~0.47 hours; early high plasma levels in <30 min). Sustained-release diclofenac: would likely fail the “eliminated in first 2 hours” and onset timing constraints. Comparison: capsule embodiment Even if a competitor uses dispersible liquid chemistry, it may still avoid Claim 18 if the dispersible liquid is not “contained in a capsule.” How strong is the patent estate for this regimen (claim structure and enforceability signals)? Based on the claim text alone, the enforceability strength comes from three features: Multiple independent levers: dose, schedule, duration, daily cap, formulation type, surgical context, and “no opioid” condition. Trial-anchored endpoints: PK and pain score/timing parameters provide objective performance anchors that can distinguish the claimed method from close alternatives. Embedded numeric embodiments: enumerated dose strengths and durations reduce the ability to argue substantial deviation. Potential weakness (infringement defensibility): If a challenger uses a non-capsule packaging, adds opioid rescue, or treats a different procedural subset (no internal fixation), it could attack specific dependent claims. But the independent claim still captures the core regimen if those conditions are met. Key Takeaways US 8,110,606 claims a tightly defined oral dosing method using diclofenac potassium in a dispersible liquid formulation for acute post-bunionectomy pain. The core cover includes 13–30 mg per dose, every 4–8 hours, ≥24 hours treatment, and ≤100 mg/day, plus dependent claims that narrow to specific regimens (including 25 mg four times over ~24 hours). Dependent claims embed objective PK (Tmax ~0.47h; early elimination) and clinical timing/efficacy measures (onset ~60–70 minutes; meaningful relief ~6 hours; NPRS ~2.49 at 48 hours for the ~25 mg embodiment). Design-around pathways center on changing formulation category, dosing schedule and total daily dose, duration, capsule packaging, opioid co-administration, and potentially the internal fixation subset. FAQs 1) Does US 8,110,606 cover diclofenac potassium tablets for post-bunionectomy pain? Not on the claim text provided. The method requires a diclofenac potassium dispersible liquid formulation. 2) What dose regimen in the patent is the most explicit? The strongest numeric embodiment is 25 mg four times over ~24 hours (Claim 17), aligning with the ≤100 mg/day cap in Claim 1. 3) Can a generic avoid infringement by using opioid rescue? Claim 20 requires no opioid co-administration in the claimed method. If opioid use is truly part of the administered regimen, Claim 20 could be avoided, but other claims may still read depending on facts. 4) How do the PK limitations affect generic risk? Dependent claims target fast absorption (Tmax ~0.47 hours; measurable plasma levels within 30 minutes) and rapid elimination (substantially eliminated within first 2 hours). A generic with a slower profile is more exposed to performance-matching arguments. 5) Is internal fixation required to practice the patented method? Internal fixation is a limitation of Claim 2 (dependent). It is not required by Claim 1. References US Patent 8,110,606 (claims provided in prompt). More… ↓ ⤷ 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
Cosette	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	8,110,606	⤷ Start Trial				NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN	⤷ 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

Details for Patent: 8,110,606

Which drugs does patent 8,110,606 protect, and when does it expire?

Summary for Patent: 8,110,606