Scope, Claims, and US Patent Landscape for U.S. Patent No. 11,918,689 (Extended-Release Oral Clonidine Aqueous Suspension with Ion-Exchange Resin Complex and pH-Independent Barrier Coating)

U.S. Patent 11,918,689 claims an extended-release (ER) oral clonidine aqueous suspension with a dual-clonidine system: a major ER fraction delivered by barrier-coated clonidine-cation exchange resin complex-matrix particles, plus a minor immediate-release (IR) clonidine fraction using (i) an IR clonidine-resin complex and/or (ii) uncomplexed clonidine (free base or salt) dispersed in an aqueous suspension base. The claim set narrows around particle architecture (ER vs IR split by weight), resin type and loading ratios, pH-independent water-insoluble barrier coating composition, optional excipient package (antioxidant/buffer), and specific pharmacokinetic (PK) targets and administration regimens (single dose at bedtime; fasting single peak).

What exactly does U.S. Patent 11,918,689 claim for extended-release oral clonidine suspension?

Core independent claim structure (Claim 1)

Claim 1 is a composition claim requiring all elements below in combination:

ER particle fraction (about 70% to about 95% of total clonidine)
- Modified-release barrier coated particles that are:
  - clonidine bound to a cation exchange resin complex in a matrix comprising a hydrophilic polymer or co-polymer
  - with a modified release barrier coating that:
    - is 50% w/w to about 80% w/w of the particle (barrier coating mass fraction)
    - forms “a layer over” the clonidine-cation exchange resin complex-matrix particles
    - is pH-independent and water-insoluble
    - includes a plasticizer
  - the hydrophilic polymer in the matrix is about 5% w/w to about 20% w/w of the particles
IR component fraction (about 5% to about 30% of total clonidine)
- immediate release clonidine component(s) selected from:
  - (1) an immediate release clonidine-cation exchange resin complex, or
  - (2) a combination of:
    - immediate release clonidine-cation exchange resin complex, and
    - clonidine uncomplexed to an ion exchange resin (free base or salt), or combinations thereof
Aqueous suspension base
- The ER particles and IR component(s) are formulated as an oral suspension.
Quantitative ER/IR split is claim-limiting
- Claim 1 uses clonidine-by-equivalent-to-clonidine-HCl to define the ER dominance and IR tail.

Legal scope implication: because Claim 1 requires the entire dual-system architecture (ER barrier-coated resin-complex matrix particles + specific IR fraction type + aqueous suspension) the claim is not “any clonidine ER using resin complexes.” It is limited to a particular particle design and blend design.

How broad is Claim 1 versus the narrower dependent claims in 11,918,689?

Dependent claims tighten composition parameters

Key narrowing elements:

Claim 2 (optional excipient package)
- antioxidant: 0.1% w/v to 0.5% w/v plus buffering component.
Claim 3 (antioxidant identity)
- EDTA (or water-soluble salt), ethyl maltol, or mixtures.
Claim 5-7 (resin ratio)
- clonidine to resin ratio ranges:
  - Claim 5: 1:300 (w/w)
  - Claim 6: 1:150
  - Claim 7: 1:25
    These ratios restrict the complex stoichiometry/load.
Claim 8-10 (barrier coating chemistry and mass fractions)
- barrier coating options (pH-independent, water-insoluble polymer + plasticizer):
  - ethylcellulose + plasticizer
  - cured polyvinyl acetate + plasticizer
  - pH-independent acrylate coating with optional plasticizer
  - mixtures
- Claim 9 adds preferred coating composition ranges:
  - polyvinyl acetate: 70% w/w to 90% w/w
  - plasticizer: 2.5% w/w to 20% w/w
- Claim 10 adds barrier coating loading limits:
  - coated particles comprise 49.5% w/w to 60.5% w/w of the barrier coating
    This is a second, different numerical tether on barrier coating fraction (note it sits within Claim 1’s broader 50%-80% particle fraction).
Claim 11-12 (hydrophilic matrix polymer)
- Claim 11: polyvinylpyrrolidone (PVP) in matrix.
- Claim 12: hydrophilic polymer amount 5% w/w to 10% w/w.
Claim 13 (cation exchange resin specification)
- sulfonated styrene/divinylbenzene copolymer with mobile cation sodium
- total cation exchange capacity ~5 meq/g
- particle size distribution:
  - average particle size: 0.075 mm to 0.150 mm range with “10% to 25%” in that range
  - no more than 1% > 0.150 mm
- resin composition specs:
  - sodium content 9.4% to 11.5%
  - potassium exchange capacity 110 to 135 mg/g
  - heavy metals < 10 ppm
Claim 14-16 (pharmacokinetics targets after dosing twice daily at 12-hour interval, 0.1 mg each; total 0.2 mg/day clonidine equivalent to clonidine HCl)
- Claim 14: single plasma concentration peak under fasting conditions.
- Claim 15: arithmetic mean ranges:
  - Cmax 326 to 508 pg/mL
  - AUC0-∞ 10,650 to 16,650 hr·pg/mL
  - Tmax 14 to 22 hr
- Claim 16: arithmetic mean ranges:
  - Cmax 350 to 450 pg/mL
  - AUC0-∞ 12,500 to 14,550 hr·pg/mL
  - Tmax 15.5 to 20.5 hr
Claim 17 (method claim)
- administer “single oral clonidine composition according to claim 1” prior to bed time to provide effective amount for 24 hours.
Claim 18 (pH)
- suspension pH about 3 to about 3.5.
Claim 19 (IR fraction specified)
- immediate release component(s) provide about 10% w/w of total clonidine (a sub-range fixed within Claim 1’s 5%-30%).

Overall breadth read-through

Claim 1 is relatively broad on the barrier coating polymer class (pH-independent, water-insoluble polymer with plasticizer) but is narrowed by:
- barrier coating mass fraction (50%-80%)
- defined ER/IR clonidine weight split
- requirement of clonidine bound to cation exchange resin within a hydrophilic polymer matrix
Dependent claims then sharply narrow by:
- specific polymers (PVP; polyvinyl acetate vs alternatives)
- specific resin grade/specification
- exact numeric excipient and pH windows
- quantitative PK windows tied to a specific dosing design.

Litigation leverage implication: Claim 1 gives a base infringement path for products that match the ER/IR architecture with barrier-coated resin-complex particles. Dependent claims provide additional “fallback” infringement hooks if a generic tries to argue partial mismatch.

What are the likely infringement “hinge points” (where generics can design around)?

1) ER/IR weight split

The product must deliver:

70%-95% ER clonidine via barrier-coated particles and
5%-30% IR clonidine via IR resin complex and/or uncomplexed clonidine.

A generic may attempt:

shifting the IR percentage outside 5%-30% (e.g., higher IR loading), or
eliminating an IR resin-complex fraction and using only one IR mechanism.

This is high-risk for equivalence because clonidine ER profiles are sensitive to formulation.

2) “Barrier coated” particle architecture

Claim 1 requires a pH-independent, water-insoluble polymer barrier coating that is a distinct layer over the resin complex-matrix particles and includes plasticizer.

Design-around levers:

using a pH-dependent polymer system (though pH-dependent may still work in vitro)
using water-soluble coatings or matrix mechanisms that do not form a barrier coating “layer over” the resin-complex core

3) Hydrophilic matrix polymer loading

Claim 1 requires hydrophilic polymer/copolymer at 5%-20% of the particle.

Dependent Claim 11 locks to PVP.
Dependent Claim 12 narrows to 5%-10%.

4) Barrier coating mass fraction

Claim 1: coating is 50%-80% w/w of particle. Dependent Claim 10: 49.5%-60.5% w/w of coated particles.

A generic that reduces coating thickness/coverage can miss both.

5) Resin specification

Claim 13 is a very specific resin grade and particle size/composition spec. Even if a competitor uses a similar sulfonated styrene/divinylbenzene resin, failure to meet those quantitative resin parameters may avoid Claim 13 but not necessarily Claim 1.

6) pH and antioxidant

Claim 18 and Claims 2-3 provide additional restrictions:

pH 3-3.5
antioxidant EDTA/ethyl maltol window and buffering.

If a generic avoids the disclosed antioxidant/buffer package, it may still infringe Claim 1 unless those excipients are required by Claim 1 (they are not). This mainly affects dependent-claim coverage.

7) PK targets and single-peak behavior

Claims 14-16 are tied to arithmetic mean Cmax/AUC/Tmax ranges under a specified dosing regimen (0.1 mg twice daily spaced 12 hours; fasting; total daily 0.2 mg equivalent to HCl).

Competitors can attempt to show their product does not meet those PK ranges.
Whether PK ranges are treated as product-by-result limitations varies by jurisdiction and claim interpretation, but from a practical litigation standpoint these dependent claims act as evidence amplifiers rather than primary composition hooks.

How does the method claim (Claim 17) expand the enforcement surface?

Claim 17 converts the composition of Claim 1 into a use instruction:

“administering… prior to bed time” to deliver an effective amount for a “twenty-four hour period.”

For enforcement, this matters because even if a product is sold broadly, an accused party’s labeling, physician instructions, or distribution for bedtime use can become relevant.

A generic that markets to clinicians with a bedtime dosing instruction risks claim capture even if composition matching is arguable.
Conversely, if labeling and promotional materials avoid “bed time” framing and 24-hour delivery messaging, a method-claim case can weaken.

What patent landscape issues arise around “clonidine resin complex + ER coating” claims?

Claim 1 sits at the intersection of multiple known formulation concepts

The claimed features map onto three common patentable formulation themes that are frequently crowded in Orange Book landscapes for CNS drugs:

Ion-exchange resin complexation
- Clonidine bound to cation exchange resin is the ER core mechanism.
Barrier coatings for pH-independent ER
- Water-insoluble barrier layer with plasticizer is used to modulate hydration and diffusion.
Suspension dosage form
- ER suspensions are harder to execute due to settling, agglomeration, and coating integrity.

Why crowding matters for freedom-to-operate

Even without enumerating all citations around 11,918,689, the practical risk profile for an NDA/ANDA competitor is that:

earlier patents likely cover clonidine-resin ER systems broadly
while 11,918,689 narrows to specific coating types, particle composition ranges, and the dual ER/IR blend architecture

Result: the “scope” of 11,918,689 is less likely to be fully novel on the general concept, but more likely to be protectable on its specific combination of constraints and parameter ranges.

Which US claims most constrain generic entry risk for 11,918,689?

Highest-risk claim set (composition scope)

Claim 1 (independent) is the primary constraint.
Claims 8-10 (barrier coating polymer and mass fraction) add meaningful limits.
Claims 11-13 (matrix polymer identity; specific resin specification) add product-specific constraints.
Claim 19 (10% w/w IR fraction) closes another numerical window.

Secondary risk (excipient and performance dependent)

Claims 2-3 (antioxidant and buffering package) and Claim 18 (pH) impact dependent-claim coverage and can be used to allege a near-match formulation rather than a full architectural match.
Claims 14-16 (PK windows) provide performance-based evidence tied to dosing conditions.

How long does 11,918,689 likely remain in force for US exclusivity planning?

No priority dates, filing date, or USPTO application history were provided with the claim text. Without those, it is not possible to compute expiration, terminal disclaimer effects, or whether PTA/adjustment applies with precision.

Key Takeaways

U.S. 11,918,689 protects a specific extended-release clonidine aqueous suspension design: barrier-coated resin-complex particles for the bulk of clonidine plus an immediate-release component to create the dual release profile.
The enforceable center of gravity is Claim 1: ER/IR clonidine weight split (70%-95% vs 5%-30%), barrier coating that is pH-independent and water-insoluble with plasticizer, and hydrophilic matrix polymer loading (5%-20%).
Dependent claims narrow on barrier coating polymer identities (ethylcellulose, cured polyvinyl acetate, acrylate), coating mass fraction, PVP matrix, a specific sulfonated styrene/divinylbenzene sodium resin spec (Claim 13), suspension pH, optional antioxidant/buffer, and PK windows after a specified dosing regimen.
For generic/competitor design-around, the most direct pressure points are the ER/IR weight split, presence and characteristics of the pH-independent water-insoluble barrier coating layer, and the particle composition percentages; method-claim exposure adds risk when labeling or use instructions emphasize bedtime dosing for 24-hour effect.

FAQs

Does 11,918,689 cover clonidine tablets, or only suspensions?
If a generic uses the same resin complex but a different coating polymer, does it avoid infringement?
How material is meeting the PK ranges in Claims 14-16 for infringement analysis?
Can a competitor avoid dependent-claim coverage by changing pH or antioxidant without changing the core ER/IR architecture?
Does Claim 17 create enforcement exposure through labeling and prescribing guidance, even if a product is a composition-only manufacture?

References

No sources were cited because no patent bibliographic data (publication/application numbers, priority dates, assignee, prosecution history, or family members) were provided beyond the claim text itself.

Title:	Liquid clonidine extended release composition
Abstract:	An oral clonidine dosage unit providing a twenty-four hour extended release profile following a single dose administration is provided. The dosage unit comprises a pharmaceutically effective amount of a coated complex comprising clonidine bound to a cationic exchange resin, which is characterized by a twenty-four hour release profile. Dosage units may also provide an immediate release component.
Inventor(s):	Grishma Patel
Assignee:	PROVIDENT BANK
Application Number:	US17/387,517
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;
Patent landscape, scope, and claims:	Scope, Claims, and US Patent Landscape for U.S. Patent No. 11,918,689 (Extended-Release Oral Clonidine Aqueous Suspension with Ion-Exchange Resin Complex and pH-Independent Barrier Coating) U.S. Patent 11,918,689 claims an extended-release (ER) oral clonidine aqueous suspension with a dual-clonidine system: a major ER fraction delivered by barrier-coated clonidine-cation exchange resin complex-matrix particles, plus a minor immediate-release (IR) clonidine fraction using (i) an IR clonidine-resin complex and/or (ii) uncomplexed clonidine (free base or salt) dispersed in an aqueous suspension base. The claim set narrows around particle architecture (ER vs IR split by weight), resin type and loading ratios, pH-independent water-insoluble barrier coating composition, optional excipient package (antioxidant/buffer), and specific pharmacokinetic (PK) targets and administration regimens (single dose at bedtime; fasting single peak). What exactly does U.S. Patent 11,918,689 claim for extended-release oral clonidine suspension? Core independent claim structure (Claim 1) Claim 1 is a composition claim requiring all elements below in combination: ER particle fraction (about 70% to about 95% of total clonidine) Modified-release barrier coated particles that are: clonidine bound to a cation exchange resin complex in a matrix comprising a hydrophilic polymer or co-polymer with a modified release barrier coating that: is 50% w/w to about 80% w/w of the particle (barrier coating mass fraction) forms “a layer over” the clonidine-cation exchange resin complex-matrix particles is pH-independent and water-insoluble includes a plasticizer the hydrophilic polymer in the matrix is about 5% w/w to about 20% w/w of the particles IR component fraction (about 5% to about 30% of total clonidine) immediate release clonidine component(s) selected from: (1) an immediate release clonidine-cation exchange resin complex, or (2) a combination of: immediate release clonidine-cation exchange resin complex, and clonidine uncomplexed to an ion exchange resin (free base or salt), or combinations thereof Aqueous suspension base The ER particles and IR component(s) are formulated as an oral suspension. Quantitative ER/IR split is claim-limiting Claim 1 uses clonidine-by-equivalent-to-clonidine-HCl to define the ER dominance and IR tail. Legal scope implication: because Claim 1 requires the entire dual-system architecture (ER barrier-coated resin-complex matrix particles + specific IR fraction type + aqueous suspension) the claim is not “any clonidine ER using resin complexes.” It is limited to a particular particle design and blend design. How broad is Claim 1 versus the narrower dependent claims in 11,918,689? Dependent claims tighten composition parameters Key narrowing elements: Claim 2 (optional excipient package) antioxidant: 0.1% w/v to 0.5% w/v plus buffering component. Claim 3 (antioxidant identity) EDTA (or water-soluble salt), ethyl maltol, or mixtures. Claim 5-7 (resin ratio) clonidine to resin ratio ranges: Claim 5: 1:300 (w/w) Claim 6: 1:150 Claim 7: 1:25 These ratios restrict the complex stoichiometry/load. Claim 8-10 (barrier coating chemistry and mass fractions) barrier coating options (pH-independent, water-insoluble polymer + plasticizer): ethylcellulose + plasticizer cured polyvinyl acetate + plasticizer pH-independent acrylate coating with optional plasticizer mixtures Claim 9 adds preferred coating composition ranges: polyvinyl acetate: 70% w/w to 90% w/w plasticizer: 2.5% w/w to 20% w/w Claim 10 adds barrier coating loading limits: coated particles comprise 49.5% w/w to 60.5% w/w of the barrier coating This is a second, different numerical tether on barrier coating fraction (note it sits within Claim 1’s broader 50%-80% particle fraction). Claim 11-12 (hydrophilic matrix polymer) Claim 11: polyvinylpyrrolidone (PVP) in matrix. Claim 12: hydrophilic polymer amount 5% w/w to 10% w/w. Claim 13 (cation exchange resin specification) sulfonated styrene/divinylbenzene copolymer with mobile cation sodium total cation exchange capacity ~5 meq/g particle size distribution: average particle size: 0.075 mm to 0.150 mm range with “10% to 25%” in that range no more than 1% > 0.150 mm resin composition specs: sodium content 9.4% to 11.5% potassium exchange capacity 110 to 135 mg/g heavy metals < 10 ppm Claim 14-16 (pharmacokinetics targets after dosing twice daily at 12-hour interval, 0.1 mg each; total 0.2 mg/day clonidine equivalent to clonidine HCl) Claim 14: single plasma concentration peak under fasting conditions. Claim 15: arithmetic mean ranges: Cmax 326 to 508 pg/mL AUC0-∞ 10,650 to 16,650 hr·pg/mL Tmax 14 to 22 hr Claim 16: arithmetic mean ranges: Cmax 350 to 450 pg/mL AUC0-∞ 12,500 to 14,550 hr·pg/mL Tmax 15.5 to 20.5 hr Claim 17 (method claim) administer “single oral clonidine composition according to claim 1” prior to bed time to provide effective amount for 24 hours. Claim 18 (pH) suspension pH about 3 to about 3.5. Claim 19 (IR fraction specified) immediate release component(s) provide about 10% w/w of total clonidine (a sub-range fixed within Claim 1’s 5%-30%). Overall breadth read-through Claim 1 is relatively broad on the barrier coating polymer class (pH-independent, water-insoluble polymer with plasticizer) but is narrowed by: barrier coating mass fraction (50%-80%) defined ER/IR clonidine weight split requirement of clonidine bound to cation exchange resin within a hydrophilic polymer matrix Dependent claims then sharply narrow by: specific polymers (PVP; polyvinyl acetate vs alternatives) specific resin grade/specification exact numeric excipient and pH windows quantitative PK windows tied to a specific dosing design. Litigation leverage implication: Claim 1 gives a base infringement path for products that match the ER/IR architecture with barrier-coated resin-complex particles. Dependent claims provide additional “fallback” infringement hooks if a generic tries to argue partial mismatch. What are the likely infringement “hinge points” (where generics can design around)? 1) ER/IR weight split The product must deliver: 70%-95% ER clonidine via barrier-coated particles and 5%-30% IR clonidine via IR resin complex and/or uncomplexed clonidine. A generic may attempt: shifting the IR percentage outside 5%-30% (e.g., higher IR loading), or eliminating an IR resin-complex fraction and using only one IR mechanism. This is high-risk for equivalence because clonidine ER profiles are sensitive to formulation. 2) “Barrier coated” particle architecture Claim 1 requires a pH-independent, water-insoluble polymer barrier coating that is a distinct layer over the resin complex-matrix particles and includes plasticizer. Design-around levers: using a pH-dependent polymer system (though pH-dependent may still work in vitro) using water-soluble coatings or matrix mechanisms that do not form a barrier coating “layer over” the resin-complex core 3) Hydrophilic matrix polymer loading Claim 1 requires hydrophilic polymer/copolymer at 5%-20% of the particle. Dependent Claim 11 locks to PVP. Dependent Claim 12 narrows to 5%-10%. 4) Barrier coating mass fraction Claim 1: coating is 50%-80% w/w of particle. Dependent Claim 10: 49.5%-60.5% w/w of coated particles. A generic that reduces coating thickness/coverage can miss both. 5) Resin specification Claim 13 is a very specific resin grade and particle size/composition spec. Even if a competitor uses a similar sulfonated styrene/divinylbenzene resin, failure to meet those quantitative resin parameters may avoid Claim 13 but not necessarily Claim 1. 6) pH and antioxidant Claim 18 and Claims 2-3 provide additional restrictions: pH 3-3.5 antioxidant EDTA/ethyl maltol window and buffering. If a generic avoids the disclosed antioxidant/buffer package, it may still infringe Claim 1 unless those excipients are required by Claim 1 (they are not). This mainly affects dependent-claim coverage. 7) PK targets and single-peak behavior Claims 14-16 are tied to arithmetic mean Cmax/AUC/Tmax ranges under a specified dosing regimen (0.1 mg twice daily spaced 12 hours; fasting; total daily 0.2 mg equivalent to HCl). Competitors can attempt to show their product does not meet those PK ranges. Whether PK ranges are treated as product-by-result limitations varies by jurisdiction and claim interpretation, but from a practical litigation standpoint these dependent claims act as evidence amplifiers rather than primary composition hooks. How does the method claim (Claim 17) expand the enforcement surface? Claim 17 converts the composition of Claim 1 into a use instruction: “administering… prior to bed time” to deliver an effective amount for a “twenty-four hour period.” For enforcement, this matters because even if a product is sold broadly, an accused party’s labeling, physician instructions, or distribution for bedtime use can become relevant. A generic that markets to clinicians with a bedtime dosing instruction risks claim capture even if composition matching is arguable. Conversely, if labeling and promotional materials avoid “bed time” framing and 24-hour delivery messaging, a method-claim case can weaken. What patent landscape issues arise around “clonidine resin complex + ER coating” claims? Claim 1 sits at the intersection of multiple known formulation concepts The claimed features map onto three common patentable formulation themes that are frequently crowded in Orange Book landscapes for CNS drugs: Ion-exchange resin complexation Clonidine bound to cation exchange resin is the ER core mechanism. Barrier coatings for pH-independent ER Water-insoluble barrier layer with plasticizer is used to modulate hydration and diffusion. Suspension dosage form ER suspensions are harder to execute due to settling, agglomeration, and coating integrity. Why crowding matters for freedom-to-operate Even without enumerating all citations around 11,918,689, the practical risk profile for an NDA/ANDA competitor is that: earlier patents likely cover clonidine-resin ER systems broadly while 11,918,689 narrows to specific coating types, particle composition ranges, and the dual ER/IR blend architecture Result: the “scope” of 11,918,689 is less likely to be fully novel on the general concept, but more likely to be protectable on its specific combination of constraints and parameter ranges. Which US claims most constrain generic entry risk for 11,918,689? Highest-risk claim set (composition scope) Claim 1 (independent) is the primary constraint. Claims 8-10 (barrier coating polymer and mass fraction) add meaningful limits. Claims 11-13 (matrix polymer identity; specific resin specification) add product-specific constraints. Claim 19 (10% w/w IR fraction) closes another numerical window. Secondary risk (excipient and performance dependent) Claims 2-3 (antioxidant and buffering package) and Claim 18 (pH) impact dependent-claim coverage and can be used to allege a near-match formulation rather than a full architectural match. Claims 14-16 (PK windows) provide performance-based evidence tied to dosing conditions. How long does 11,918,689 likely remain in force for US exclusivity planning? No priority dates, filing date, or USPTO application history were provided with the claim text. Without those, it is not possible to compute expiration, terminal disclaimer effects, or whether PTA/adjustment applies with precision. Key Takeaways U.S. 11,918,689 protects a specific extended-release clonidine aqueous suspension design: barrier-coated resin-complex particles for the bulk of clonidine plus an immediate-release component to create the dual release profile. The enforceable center of gravity is Claim 1: ER/IR clonidine weight split (70%-95% vs 5%-30%), barrier coating that is pH-independent and water-insoluble with plasticizer, and hydrophilic matrix polymer loading (5%-20%). Dependent claims narrow on barrier coating polymer identities (ethylcellulose, cured polyvinyl acetate, acrylate), coating mass fraction, PVP matrix, a specific sulfonated styrene/divinylbenzene sodium resin spec (Claim 13), suspension pH, optional antioxidant/buffer, and PK windows after a specified dosing regimen. For generic/competitor design-around, the most direct pressure points are the ER/IR weight split, presence and characteristics of the pH-independent water-insoluble barrier coating layer, and the particle composition percentages; method-claim exposure adds risk when labeling or use instructions emphasize bedtime dosing for 24-hour effect. FAQs Does 11,918,689 cover clonidine tablets, or only suspensions? If a generic uses the same resin complex but a different coating polymer, does it avoid infringement? How material is meeting the PK ranges in Claims 14-16 for infringement analysis? Can a competitor avoid dependent-claim coverage by changing pH or antioxidant without changing the core ER/IR architecture? Does Claim 17 create enforcement exposure through labeling and prescribing guidance, even if a product is a composition-only manufacture? References No sources were cited because no patent bibliographic data (publication/application numbers, priority dates, assignee, prosecution history, or family members) were provided beyond the claim text itself. 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
Tris Pharma Inc	ONYDA XR	clonidine hydrochloride	SUSPENSION, EXTENDED RELEASE;ORAL	217645-001	May 24, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			METHOD FOR DELIVERING AN EFFECTIVE AMOUNT OF CLONIDINE FOR A 24-HOUR PERIOD USING A SINGLE ORAL CLONIDINE COMPOSITION ACCORDING TO CLAIM 1 PRIOR TO BED TIME	⤷ 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: 11,918,689

Which drugs does patent 11,918,689 protect, and when does it expire?

Summary for Patent: 11,918,689