Details for Patent: 7,790,755

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Which drugs does patent 7,790,755 protect, and when does it expire?

Patent 7,790,755 protects DEXILANT and is included in one NDA.

Protection for DEXILANT has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty-one patent family members in twenty-nine countries.

Summary for Patent: 7,790,755

Title:	Controlled release preparation
Abstract:	A controlled release preparation wherein the release of active ingredient is controlled, which releases an active ingredient for an extended period of time by staying or slowly migrating in the gastrointestinal tract, is provided by means such as capsulating a tablet, granule or fine granule wherein the release of active ingredient is controlled and a gel-forming polymer. Said tablet, granule or fine granule has a release-controlled coating-layer formed on a core particle containing an active ingredient.
Inventor(s):	Yohko Akiyama, Takashi Kurasawa, Hiroto Bando, Naoki Nagahara
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US10/531,069
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,790,755
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

United States Drug Patent 7,790,755: Claim Scope, Dexlansoprazole Protection, Expiration and Patent Landscape

US Patent 7,790,755 protects a dual-release capsule containing an imidazole-class proton-pump inhibitor, particularly lansoprazole or dexlansoprazole, delivered through two distinct multiparticulate populations. One population releases drug at approximately pH 5.0-6.0. The other uses a higher-pH release-controlled coating that releases at approximately pH 6.0-7.5, with a preferred range of pH 6.5-7.0. The patent is directed to the formulation architecture used for delayed, sequential PPI release rather than to the active ingredient alone.

The commercial relevance is strongest for Dexilant, formerly Kapidex, Takeda's dexlansoprazole delayed-release capsule. The patent does not create a monopoly over lansoprazole, dexlansoprazole, enteric-coated PPIs, or all dual-release capsules. Infringement depends on whether a competing product contains both required release populations and satisfies the specified pH-dependent coating limitations.

What does US Patent 7,790,755 protect?

US 7,790,755 protects a capsule containing two types of drug-containing tablets, granules, or fine granules:

Required element	Claim 1 requirement
Dosage form	Capsule
Active ingredient	An imidazole compound of formula I', its salt, or an optically active isomer
First composition	A release-controlled tablet, granule, or fine granule
First release mechanism	A pH-dependent coating soluble at pH 6.0-7.5
First coating materials	Listed cellulose derivatives, methacrylate copolymers, polyvinyl acetate phthalate, shellac, or mixtures
Second composition	A tablet, granule, or fine granule with an enteric coat
Second release mechanism	Release at pH 5.0-6.0
Optional features	Intermediate layer, basic inorganic salt stabilizer, pH 6.5-7.0 coating, mixed methacrylate polymers, gel-forming polymer

The claim is a combination claim. A product must contain both composition (i) and composition (ii) to fall within claim 1. A formulation with only a conventional enteric-coated PPI population would not satisfy the full claim.

The use of “comprising” makes the claim open-ended. A capsule may contain additional excipients, coatings, stabilizers, or granule populations, provided it still contains the claimed elements.

How does the patent claim operate technically?

The patent uses different dissolution thresholds to create staged release.

The lower-pH population is designed to release in the upper intestinal environment beginning at approximately pH 5.0. The higher-pH population remains coated until a later intestinal pH, generally between 6.0 and 7.5. The formulation therefore can produce an initial dose followed by a later dose.

The technical design addresses the short plasma half-life and meal-related variability associated with conventional immediate or single-stage PPI delivery. Sequential release can extend acid suppression over a longer portion of the dosing interval.

The claim does not require a specific quantity of drug in either population. It also does not specify a particular ratio between the two populations, a particular capsule shell, a dissolution-test apparatus, or a specific release-time interval. Those omissions broaden the formulation space, but they leave substantial room for disputes over the meaning and testing of “release” within the stated pH ranges.

What coating polymers are covered?

Claim 1 identifies the following polymeric substances:

• Hydroxypropylmethyl cellulose phthalate
• Cellulose acetate phthalate
• Carboxymethylethyl cellulose
• Methyl methacrylate-methacrylic acid copolymer
• Methacrylic acid-ethyl acrylate copolymer
• Methacrylic acid-methyl acrylate-methyl methacrylate copolymer
• Hydroxypropyl cellulose acetate succinate
• Polyvinyl acetate phthalate
• Shellac

The claim also permits mixtures of polymers with different release properties. Claim 8 narrows this concept to mixtures of two or more methyl methacrylate-methacrylic acid copolymers having different release characteristics.

A product using a different polymer may avoid literal infringement of the express composition limitation. The doctrine of equivalents could remain relevant, but equivalence would depend on the specific polymer, dissolution behavior, prosecution history, and any narrowing amendments.

What drugs fall within the claimed imidazole compound definition?

Lansoprazole and dexlansoprazole

Claim 3 expressly identifies lansoprazole. Claims 4 and 5 identify the optically active R- and S-isomers. The R-isomer of lansoprazole is dexlansoprazole, the active pharmaceutical ingredient in Dexilant.

The patent's practical commercial value is therefore concentrated in dexlansoprazole dual delayed-release capsules. Claims 3-5 narrow the broad Markush structure of claim 1 to the racemate and its individual stereoisomers.

Claim	Compound scope
Claim 1	Broad formula I' imidazole compounds, salts, and optically active isomers
Claim 3	Lansoprazole
Claim 4	R-isomer of lansoprazole, commercially dexlansoprazole
Claim 5	S-isomer of lansoprazole
Claim 6	Any claimed active ingredient with a basic inorganic salt stabilizer
Claims 7-8	Narrower higher-pH release system
Claim 9	Capsule containing a gel-forming polymer

A generic dexlansoprazole product could face claim risk even if it uses a different active-ingredient manufacturing process. The asserted issue would be the final dosage-form structure and dissolution profile.

How strong is the patent estate for Dexilant?

US 7,790,755 is a strong formulation patent when a competing product uses the same two-stage pH-release concept. Its strengths are:

1. It covers the capsule architecture rather than a narrow excipient ratio.
2. It expressly covers dexlansoprazole through claims 3-5.
3. It covers multiple coating families.
4. It includes both single-polymer and mixed-polymer embodiments.
5. It does not require a specific manufacturing process.

Its principal limitations are equally important:

• Both release populations are required.
• The pH windows are central claim limitations.
• The claim requires specified coating materials or covered polymer mixtures.
• The patent does not broadly cover every delayed-release dexlansoprazole formulation.
• A formulation designed to release both populations at the same pH may fall outside the sequential pH architecture.
• A formulation using a nonlisted coating system may present a noninfringement position.

The patent is stronger against a close copy of the Dexilant formulation than against a redesigned dexlansoprazole product using a single enteric population, a different polymer system, or a different release mechanism.

What are the dependent-claim limitations?

What does claim 2 add?

Claim 2 requires the pH-dependent release-controlled coating to be formed on an intermediate layer over the active-containing core. This limitation can protect a multilayer pellet or granule structure in which the active core, intermediate seal layer, and pH-dependent outer coat perform separate functions.

The intermediate layer can reduce incompatibility between the active ingredient and the enteric polymer. It can also improve coating uniformity and prevent migration of alkaline stabilizers.

What does claim 6 add?

Claim 6 requires a basic inorganic salt stabilizer in the active-containing core particles of both compositions.

The limitation is commercially relevant because benzimidazole PPIs are chemically sensitive. Common stabilizing approaches for PPI formulations use alkaline materials such as magnesium compounds, carbonate salts, or other basic inorganic excipients. The claim does not cover every alkaline stabilizer unless it qualifies as a basic inorganic salt.

What do claims 7 and 8 add?

Claim 7 narrows the high-pH coating to a release range of pH 6.5-7.0. Claim 8 further requires a mixture of two or more methyl methacrylate-methacrylic acid copolymers with different release properties.

These claims are potentially easier to design around than claim 1 because they impose narrower pH and polymer requirements. They may still be important where a commercial product uses a mixed methacrylate coating system to achieve a targeted dissolution curve.

What does claim 9 add?

Claim 9 requires a gel-forming polymer. The claim does not identify a single polymer, so its scope depends on the construction of “gel-forming polymer” and the role of that material in the capsule.

Possible design-arounds include omitting a gel-forming polymer, using a non-gelling viscosity modifier, or locating the polymer outside the claimed composition. The effectiveness of those approaches depends on whether the product still meets claim 1.

What is the FDA and Orange Book status of US 7,790,755?

Dexilant was approved by the FDA under NDA 022287. The product was initially marketed as Kapidex and later renamed Dexilant. The FDA approved dexlansoprazole delayed-release capsules for acid-related indications, including healing and maintenance of healed erosive esophagitis and treatment of symptomatic nonerosive gastroesophageal reflux disease. The approved dosage form uses two types of enteric-coated granules designed for different release points [2].

US 7,790,755 has been associated with the Dexilant delayed-release formulation patent estate in FDA and patent records. Orange Book listing status can change through delisting, expiration, administrative updates, or changes to the relevant NDA entry. The controlling sources for a current determination are the FDA Orange Book and the patent certifications submitted against NDA 022287 [2].

The patent was granted on August 10, 2010. Its nominal patent term depends on the earliest effective nonprovisional filing date, applicable priority claims, terminal disclaimers, and patent-term adjustment. Patent databases commonly report a mid-2020s expiration for this family. A precise enforceability date should be taken from the USPTO Patent Center term calculation and any FDA Orange Book entry, rather than inferred solely from the grant date [1, 2].

When does dexlansoprazole lose exclusivity?

Dexlansoprazole's regulatory exclusivity and patent exclusivity are separate.

Protection type	Relevance
New chemical entity exclusivity	Applied to the original FDA approval if FDA classified dexlansoprazole as an NCE
Pediatric exclusivity	Could add six months if granted for the applicable NDA
Formulation patents	Protect the delayed-release capsule architecture
API or stereochemistry patents	May protect compound identity or production, where applicable
Orange Book patents	Trigger patent certifications for ANDA applicants

The original NCE period would not prevent generic filing indefinitely. After the statutory filing window opened, an ANDA applicant could submit a Paragraph IV certification against listed patents. Patent litigation could then delay approval under the Hatch-Waxman 30-month stay, subject to statutory exceptions and court outcomes.

The commercial loss-of-exclusivity date is therefore determined by the latest enforceable listed patent, any pediatric extension, settlement terms, and the timing of FDA approval for an ANDA. It is not determined solely by the original 2009 approval date.

What Paragraph IV and generic entry risks exist?

A generic applicant seeking approval for dexlansoprazole delayed-release capsules would typically evaluate four certification positions:

• Paragraph I: no relevant patent information is listed.
• Paragraph II: the listed patent has expired.
• Paragraph III: approval is requested after patent expiration.
• Paragraph IV: the patent is invalid, unenforceable, or not infringed.

For US 7,790,755, the central Paragraph IV defenses would likely focus on:

1. Failure to include two distinct compositions.
2. Failure of one or both populations to meet the pH-release limitations.
3. Use of a coating polymer outside the claim.
4. Lack of lansoprazole or dexlansoprazole in the claimed form.
5. Invalidity based on anticipation or obviousness.
6. Indefiniteness or written-description challenges to the release terminology.
7. Noninfringement based on dissolution testing under the applicable FDA method.

A generic could also pursue a formulation design that avoids the claimed dual-release structure. That strategy may reduce litigation risk but can produce a product that is not therapeutically or regulatorily substitutable for Dexilant without additional clinical or bioequivalence work.

What patent litigation affects this patent?

The principal litigation risk would arise from ANDA challenges to Dexilant's listed patents. Public litigation searches should distinguish:

• Direct actions involving US 7,790,755.
• Actions involving other Dexilant patents.
• Cases involving lansoprazole or dexlansoprazole but different formulations.
• Settlements that permit an earlier generic launch without invalidating the patent.
• Cases dismissed after a patent expiration or regulatory resolution.

A Paragraph IV notice does not establish that the patent is weak. It indicates that the ANDA applicant has certified that the patent is invalid, unenforceable, or not infringed. The litigation record, claim-construction rulings, prosecution history, and settlement date determine practical risk.

No biosimilar pathway applies. Dexlansoprazole is a chemically synthesized small molecule, so the relevant competition is through ANDAs, not abbreviated biologics applications.

How does US 7,790,755 compare with competing PPI patent estates?

Product or class	Main protection focus	Relationship to US 7,790,755
Dexilant, dexlansoprazole	Dual delayed-release capsule and related formulation patents	Directly relevant
Prevacid, lansoprazole	Original compound, enteric formulations, and older dosage forms	Chemical and therapeutic predecessor; not necessarily the same formulation
Nexium, esomeprazole	S-isomer, formulation, and manufacturing patents	Different PPI and stereochemical estate
Protonix, pantoprazole	Compound, salt, formulation, and method patents	Different active ingredient
Omeprazole products	Compound and enteric-delivery patents	Earlier PPI estate; limited direct overlap
Generic dexlansoprazole	ANDA formulation and bioequivalence strategy	Main commercial challenge

The patent's differentiation is the combination of two pH-triggered populations. Conventional enteric-coated PPI products generally protect the active ingredient from gastric acid and release in the intestine, but they do not necessarily use the claimed sequential pH thresholds.

What manufacturing and IP barriers remain after patent expiration?

After expiration of the relevant patent, technical barriers can still affect generic entry:

• Reproducible coating thickness across multiple granule populations.
• Consistent dissolution at both pH thresholds.
• Stability of lansoprazole or dexlansoprazole in the presence of excipients.
• Uniform distribution of the two granule types within the capsule.
• Scale-up of multilayer coating processes.
• Bioequivalence against a product with two release phases.
• Control of moisture, alkalinity, and capsule fill weight.
• Freedom-to-operate issues under later patents.

A later patent may cover a specific ratio of granules, excipient combination, coating process, dissolution profile, or manufacturing method. Expiration of US 7,790,755 therefore does not automatically eliminate every patent-based barrier to a Dexilant-like product.

What is the geographic coverage?

US 7,790,755 provides rights only in the United States. Related applications may exist in other jurisdictions through the same international or national patent family, but foreign rights require separate review of each national phase.

The relevant geographic questions include:

• Whether the European, Japanese, Canadian, and Australian counterparts remain in force.
• Whether claim scope was amended during national prosecution.
• Whether opposition or post-grant proceedings narrowed foreign claims.
• Whether local regulatory exclusivity applies independently of patent rights.
• Whether a manufacturing step occurs in a jurisdiction where process claims remain enforceable.

A US generic launch does not determine freedom to operate in Europe or other markets.

Key Takeaways

• US 7,790,755 is a formulation patent centered on a two-population, sequential pH-release capsule.
• Claim 1 requires both a pH 5.0-6.0 enteric population and a pH 6.0-7.5 release-controlled population.
• Claims 3-5 make lansoprazole, dexlansoprazole, and the opposite stereoisomer expressly relevant.
• Claims 2, 6, 7, 8, and 9 add intermediate layers, basic inorganic stabilizers, narrower pH ranges, mixed methacrylate polymers, and gel-forming polymers.
• The patent is most relevant to Dexilant, NDA 022287.
• It does not cover every dexlansoprazole product or every enteric-coated PPI.
• The principal generic strategy is either a Paragraph IV challenge or a formulation design-around.
• Biosimilar risk is irrelevant because dexlansoprazole is a small-molecule drug.
• Patent expiration must be assessed with the USPTO term calculation, Orange Book listing, terminal disclaimer information, and any later Dexilant patents.
• Expiration of this patent would not eliminate separate patents covering ratios, processes, dissolution profiles, or other formulation features.

FAQs About US Patent 7,790,755 and Dexlansoprazole

Does US 7,790,755 cover ordinary lansoprazole capsules?

Not automatically. The claim requires the specific two-composition capsule architecture and the stated pH-dependent release limitations. A conventional single-population lansoprazole capsule would generally lack at least one required element.

Is dexlansoprazole the same compound identified in claim 4?

Yes. Dexlansoprazole is the R-enantiomer of lansoprazole. Claim 4 expressly covers the optically active R-isomer.

Can a generic avoid the patent by changing the capsule shell?

Usually, changing only the capsule shell would not address the core limitations. The claim focuses on the internal tablets, granules, fine granules, coatings, active ingredient, and pH-release behavior.

Does a different enteric polymer eliminate infringement?

It may support a noninfringement position if the substitute polymer is outside the listed polymer categories and the product does not meet the claim under an equivalents theory. The analysis depends on the exact material and prosecution history.

Does patent expiration permit immediate generic substitution?

No. FDA approval, state substitution rules, remaining Orange Book patents, regulatory exclusivity, and any settlement restrictions can still affect the launch and substitution date.

References

1. United States Patent and Trademark Office. (2010). US Patent No. 7,790,755, Pharmaceutical composition. https://patents.google.com/patent/US7790755B2/en
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
3. U.S. Food and Drug Administration. (2009). Dexilant (dexlansoprazole) delayed-release capsules, NDA 022287. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
4. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application submissions and patent certifications. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/anda-submissions
5. U.S. Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/

Drugs Protected by US Patent 7,790,755

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No					Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 7,790,755

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2002-301876	Oct 16, 2002
Japan	2003-066336	Mar 12, 2003

PCT Information
PCT Filed	October 15, 2003	PCT Application Number:	PCT/JP03/13155
PCT Publication Date:	April 29, 2004	PCT Publication Number:	WO2004/035020

International Family Members for US Patent 7,790,755

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	041562
Argentina	103296
Australia	2003272098
Australia	2009243408
Brazil	0315142
Brazil	122016030094