Scope, Claim Coverage, and U.S. Patent Landscape for Drug Patent US 10,076,494 (Compressed Orally Disintegrating Tablet with HPMCP Enteric Coating and Reverse-Enteric Polymer)
US 10,076,494 claims a specific architecture for a compressed orally disintegrating tablet (ODT) containing a proton pump inhibitor (PPI), combining (i) an enteric coating over PPI-containing cores using hydroxypropyl methylcellulose phthalate (HPMCP) at defined weight ranges, (ii) a “reverse enteric” polymer coating layer using methyl methacrylate–butyl methacrylate–dimethylaminoethyl methacrylate copolymer at defined weight ranges, and (iii) an ODT performance envelope tied to friability under defined compression-force conditions. The scope narrows tightly to tablet structures meeting those coating-material selections and quantitative coating loadings, plus process steps that produce a friability threshold. Enforcement leverage is highest against products that match the same two-layer polymer system (HPMCP enteric plus reverse enteric polymer) on PPI-loaded cores and achieve equivalent friability under similar compression forces.
What patents protect compressed orally disintegrating tablets with HPMCP enteric coatings and reverse-enteric polymers (US 10,076,494 scope)?
What is claimed in plain structural terms
At the highest level, claim 1 defines a compressed ODT with:
- PPI-loaded cores (therapeutically effective amount of a PPI).
- Enteric coating over the cores:
- Material: hydroxypropyl methylcellulose phthalate (HPMCP).
- Weight: 10% to 30% of total tablet weight over the cores.
- Reverse enteric polymer coating over the enteric coating:
- Material: methyl methacrylate–butyl methacrylate–dimethylaminoethyl methacrylate copolymer.
- Weight: 5% to 15% of total tablet weight over the enteric coating.
- Constraint: friability is ≤ 0.75% after compression using 10 kN to 50 kN.
- ODT character: claim 12 adds a disintegration endpoint: substantially disintegrates in the oral cavity in <60 seconds.
Key dependent claim add-ons that matter for design-around
- Core embodiment (claims 2–3): each core can include an inert seed (granule, pellet, bead, powder) coated with an active ingredient coating containing the PPI.
- Subcoating option (claims 5–6): subcoating between inert seeds and enteric coating can include HPMC/hypromellose, PVP, PEG, PVA, etc.
- PPI universe (claim 4): omeprazole, lansoprazole, pantoprazole, rabeprazole, tenatoprazole, ilaprazole, or mixtures.
- Reverse-enteric composition ratio (claims 7–8):
- Reverse enteric polymer is 70% to 100% of the reverse enteric coating mass.
- The coating ratio of reverse enteric polymer coating to enteric coating is about 0.4:1.
- Disintegrant selection and loading (claims 9, 13):
- Disintegrant includes crospovidone/croscarmellose sodium/cellulose derivatives/cross-linked starch variants/etc.
- Disintegrant is 2% to 25% by weight of total tablet weight.
- Mechanical property and manufacturability (claims 11, 12):
- Hardness 20 N to 100 N.
- Friability and <60s oral disintegration define an ODT profile.
Process claim 15: where infringement proof can focus
Claim 15 ties the structure to a manufacturing method that:
- Generates PPI cores,
- Applies HPMCP enteric coating,
- Applies methyl methacrylate–butyl methacrylate–dimethylaminoethyl methacrylate copolymer reverse enteric coating,
- Mixes with a disintegrant-containing excipient blend,
- Compresses using 10–50 kN, yielding friability ≤0.75%,
- Produces tablets with the same coating weight ranges.
For litigation leverage, a patentee can pursue either:
- Product-by-structure theories using claim 1/2/… coverage, and/or
- Product-by-process support via claim 15 to confirm the process-created property envelope (friability under compression).
Tightest claim limitations (highest patent “needlepoints”)
- HPMCP selection and amount: the enteric layer must be HPMCP and be 10–30% by total tablet weight.
- Reverse enteric polymer selection and amount: the reverse layer must be the specific copolymer and be 5–15% by total tablet weight.
- Compression-force-linked friability: friability must be ≤0.75% after compression at 10–50 kN.
- ODT disintegration: <60 seconds in the oral cavity (claim 12).
These four elements are the most likely to be the basis of validity challenges and the most likely to be the basis of infringement non-matching in design-arounds.
How broad is US 10,076,494 across proton pump inhibitors and core formats?
PPI breadth: broad in molecule, narrow in placement
Claim 4 is broad as to which PPI is used. But the PPI must be:
- In the cores of the tablet,
- At a therapeutically effective amount,
- With the specific enteric and reverse-enteric coating architecture.
So the claim covers multiple PPI actives, but not arbitrary oral delivery formulations.
Core format breadth: broad in inert seed type
Claims 2–3 let “inert seed” be granule/pellet/bead/powder, and the PPI is applied as an active ingredient coating to the seed. That is a meaningful breadth because it covers both:
- Pellet-based PPI layering, and
- Bead/granule/powder-based core architectures.
Subcoating breadth
Claims 5–6 allow a range of common coating excipients (HPMC/HP cellulose, PVP, PEG, PVA). This reduces design-around opportunities where teams add a subcoating step to improve film integrity.
What formulations are covered by US 10,076,494 (HPMCP and reverse-enteric polymer weight loading matrix)?
Formulation coverage map
Below is the minimal “must-match” matrix for claim 1, focusing on weight-based limitations:
| Layer |
Must be present? |
Polymer identity |
Weight constraint (of total tablet) |
| Core |
Yes |
PPI in cores |
Not specified as wt% in claim 1 |
| Enteric coating over cores |
Yes |
HPMCP |
10% to 30% |
| Reverse enteric polymer coating over enteric layer |
Yes |
methyl methacrylate–butyl methacrylate–dimethylaminoethyl methacrylate copolymer |
5% to 15% |
Ratio constraint (additional narrowness)
- Claim 8 adds a relationship: reverse polymer coating to enteric coating is about 0.4:1.
- Claim 7 restricts reverse polymer composition: reverse polymer is 70–100% of the reverse coating mass.
If a competitor uses the right polymer but alters the ratio materially, they may argue non-infringement for those dependent claims.
Performance constraints that affect both infringement and validity
- Friability ≤ 0.75% after compression at 10–50 kN.
- Hardness 20–100 N (claim 11).
- Oral cavity disintegration < 60 seconds (claim 12).
These are not just “soft” goals; they are claim limitations that can be dispositive in infringement.
When does US 10,076,494 expire and how does exclusivity stack with other IP for ODT PPIs?
No expiration computation possible from the claim text alone
A complete timeline requires at least one of:
- filing date,
- priority date(s),
- patent grant date and any terminal disclaimer,
- statutory PTA (if any),
- and jurisdictional term rules.
The claim text provided does not include these facts, so an expiration calendar cannot be produced without risking inaccuracy.
Accordingly, no exclusivity and expiration timeline is stated here.
Which companies are likely exposed by US 10,076,494 in the U.S. (PPI ODT with enteric coatings)?
No reliable exposure assessment can be produced from the claim text alone because it depends on:
- identifying the listed assignee(s),
- locating the Orange Book entries and product dossiers for PPI ODTs,
- mapping likely competitors by formulation and manufacturing architecture.
The provided information contains neither the patent bibliographic data nor the current FDA regulatory status of the covered product.
Accordingly, no company-by-company challenge or exposure list is included.
What generic entry risks exist for PPI orally disintegrating tablets with HPMCP enteric coatings?
Risk mechanism
Generic risk under U.S. practice typically tracks three factors:
- Claim match: does the generic use HPMCP enteric + the specific reverse-enteric polymer with the same weight ranges?
- Performance match: does it hit the friability ≤0.75% under compression 10–50 kN and disintegrate <60 seconds?
- Process/structure evidence: can a patentee obtain formulation/process discovery to show compliance with the claim limitations?
Where generics can design around
From the claim language, design-arounds with the best odds would change at least one of the “needlepoints”:
- Replace HPMCP with another enteric polymer, or materially change the enteric layer amount outside 10–30%.
- Replace the reverse enteric copolymer with a different polymer system, or move the reverse layer amount outside 5–15%.
- Tune compression strategy and composition such that friability under the defined compression range exceeds 0.75%, or the oral disintegration endpoint is not met.
Because claim 15 is tied to a defined manufacturing flow and compression-force range, altering process parameters and final mechanical properties can matter.
What is the Orange Book status of US 10,076,494 and how does it affect Paragraph IV strategy?
No Orange Book status can be stated from the claim text alone. Orange Book linkage requires:
- patent number-to-listing mapping under a specific NDA/ANDA,
- listed patents and expiration/eligibility identifiers,
- and whether the patent is listed for the specific dosage form (ODT) and strength.
No Orange Book status is provided.
How strong is the patent estate for US 10,076,494 (claim distinctiveness and potential invalidity angles)?
Most defensible elements
- Polymer identity pairing: HPMCP for the enteric layer plus a specific reverse-enteric polymer copolymer is an identifiable technical combination.
- Quantitative coating loading ranges: 10–30% and 5–15% of total tablet weight are concrete boundaries.
- Compression-force-linked friability: requiring friability ≤0.75% after 10–50 kN compression adds a measurable manufacturing-property tether.
- ODT endpoint: <60 second oral disintegration is a performance constraint aligned with ODT functionality.
Potential vulnerability points for challengers
While no validity analysis is tied to prior art citations here (not supplied), the claim structure suggests typical contention zones:
- Whether the polymer combination and coating weight ranges were previously disclosed for ODT PPI tablets.
- Whether the reverse enteric polymer use was known for controlling dissolution behavior with enteric structures.
- Whether the friability under a defined compression-force range is an obvious optimization or a genuine distinguishing feature.
Without prior-art references, no specific invalidity conclusion can be made.
Does claim 15 create additional enforceable leverage (method claims for manufacturing ODT PPI with dual coatings)?
Yes, claim 15 creates a parallel infringement path:
- Even if a generic challenges structural equivalence, the manufacturing method provides an evidence anchor, especially where production records, process validation batches, or discovery show:
- the same coating application steps with HPMCP and the specified reverse enteric polymer,
- and compression at 10–50 kN resulting in friability ≤0.75%.
Practically, method claims can increase settlement leverage when process information is accessible.
Key Claim Coverage Scenarios (practical matching logic for product teams)
Scenario A: Matches all “needlepoints”
A product that:
- uses HPMCP as the enteric polymer at 10–30% loading,
- uses the specified reverse copolymer at 5–15% loading,
- is a compressed ODT with disintegration <60 seconds,
- and hits friability ≤0.75% after 10–50 kN compression,
is strongly within claim 1.
Scenario B: Same polymers, altered loading
- Staying within polymer identity but moving enteric coating outside 10–30% or reverse coating outside 5–15% breaks claim 1 coverage.
- Dependent claims (7–8) add ratio-based narrowing.
Scenario C: Same loading, different enteric polymer
Replacing HPMCP with another enteric polymer typically avoids the core claim limitation that “enteric coating comprises HPMCP.”
Scenario D: Same coatings, mechanical property differs
If friability after compression at 10–50 kN is above 0.75% or oral disintegration is not <60 seconds, dependent claim coverage may collapse even if structure is close.
Key Takeaways
- US 10,076,494’s claim scope is anchored on a dual-coating polymer system: HPMCP enteric (10–30% wt) plus methyl methacrylate–butyl methacrylate–dimethylaminoethyl methacrylate reverse enteric polymer (5–15% wt) over PPI cores in a compressed ODT.
- The most enforceable boundaries are quantitative: coating load ranges, the reverse polymer mass ratio/composition (claims 7–8), and a friability ≤0.75% under compression 10–50 kN plus <60s oral disintegration.
- Design-around is most plausible by altering either (i) enteric polymer identity, (ii) reverse polymer identity, or (iii) the coating loadings and/or performance endpoints tied to friability and disintegration.
- A defensible enforcement narrative is supported by claim 15’s manufacturing steps that pair polymer selection with the compression-force friability threshold.
FAQs
1) Does US 10,076,494 cover buffered tablets or only neutral excipient blends?
Claim 10 allows buffering substances and other excipients generally, but coverage still requires the HPMCP enteric + specific reverse-enteric polymer coatings with the claimed weight ranges and friability/disintegration limitations.
2) Can a product infringe if it uses a different inert seed geometry?
Claims 2–3 cover granules/pellets/beads/powders. Different seed shape can still fall within “inert seed” if it functions equivalently, but infringement turns on whether the core is constructed as claimed (inert seed with PPI active ingredient coating).
3) Is the reverse enteric polymer required to be 70–100% of the reverse coating?
Only dependent claim 7 imposes that range. Independent claim 1 requires the reverse enteric polymer to be present as specified and the reverse layer weight range to be met.
4) Does claim 15 require specific equipment for compression?
Claim 15 specifies the compression force range (10–50 kN) and the resulting friability endpoint. It does not require a particular machine in the claim text provided, but it does require the process to achieve the defined property.
5) What happens if a product disintegrates in 70 seconds instead of less than 60?
That breaks dependent claim 12. If disintegration is a required limitation in the asserted claim set, infringement risk decreases; if only claim 1 is asserted, claim 1 does not expressly include the <60 seconds limitation in the provided text.
References (APA)
- United States Patent US 10,076,494.
