United States Patent 9,050,263: Claim Scope, Expiration, Orange Book Status, and Talicia Patent Landscape

US Patent No. 9,050,263 protects a multi-part capsule that combines immediate-release amoxicillin and an ansamycin antibiotic with delayed-release omeprazole or another proton pump inhibitor. The patent is directed to the dosage form, dissolution performance, ingredient combinations, excipient systems, dose ratios, and treatment of Helicobacter pylori infection.

The commercial product most closely associated with the patent is Talicia, a fixed-dose combination of rifabutin, amoxicillin, and omeprazole marketed by RedHill Biopharma. The patent issued on June 9, 2015, from an application claiming priority to December 19, 2011. Its nominal patent expiration is December 19, 2032, subject to any applicable patent-term adjustment or disclaimer recorded in the official patent file.[1]

What does US Patent 9,050,263 protect?

US 9,050,263 protects a capsule containing two separate minitablet populations:

Immediate-release compressed minitablets containing at least two antibiotics.
Delayed-release compressed minitablets containing a proton pump inhibitor and a coating.

The independent composition claim is not limited to one particular antibiotic pair or one proton pump inhibitor. Its core limitations are structural and functional:

Claim element	Requirement
Dosage form	Capsule
First dosage composition	Immediate-release compressed minitablets
Antibiotic content	At least two antibiotics
Second dosage composition	Delayed-release compressed minitablets
Acid suppression component	Proton pump inhibitor
Release control	Coating on the delayed-release minitablets
Acid-stage dissolution	No more than 10% PPI release in 120 minutes in 0.1N HCl
Buffer-stage dissolution	At least 75% PPI release within 45 minutes in pH 6.8 phosphate buffer

The claim therefore requires more than co-packaging or simple physical admixture. A potentially infringing product would need to use a capsule with the claimed minitablet architecture and meet the specified dissolution profile, or otherwise satisfy the claim under the applicable infringement analysis.

What are the key limitations of claim 1?

Claim 1 contains the principal patent-protection features.

Compressed minitablets are required

Both the immediate-release and delayed-release dosage compositions must be in the form of compressed minitablets. A product using powders, pellets, granules, conventional tablets, or a liquid-filled capsule may avoid literal infringement of this limitation, although the overall infringement analysis would depend on the product design and any doctrine-of-equivalents arguments.

The first composition must contain at least two antibiotics

The claim does not require amoxicillin and rifabutin specifically. It covers a broader category of antibiotic combinations. Dependent claims narrow the invention to amoxicillin with an ansamycin and then to rifampicin or rifabutin.

The second composition must contain a proton pump inhibitor

Claim 1 covers a PPI generally. Claim 5 identifies omeprazole, pantoprazole, lansoprazole, ilaprazole, dexlansoprazole, esomeprazole, rabeprazole, and their acceptable salts and solvates.

The dissolution profile is a central limitation

The delayed-release PPI minitablets must satisfy a two-stage basket dissolution test:

Test stage	Condition	Required result
Acid stage	900 mL of 0.1N HCl, 100 rpm, 120 minutes	No more than 10% PPI released
Buffer stage	900 mL phosphate buffer at pH 6.8, 100 rpm, 45 minutes after acid stage	At least 75% PPI released

This limitation creates a technical barrier for generic substitution. A generic manufacturer would need to establish whether its formulation falls outside one or more dissolution thresholds. Small differences in coating composition, coating thickness, minitablet compression, acid resistance, or buffer-triggered release could affect claim coverage.

Which claims cover Talicia’s commercial formulation?

Talicia contains 250 mg of amoxicillin, 12.5 mg of rifabutin, and 10 mg of omeprazole per capsule. The approved regimen is four capsules taken three times daily for 14 consecutive days. The total daily dose is 3,000 mg amoxicillin, 150 mg rifabutin, and 120 mg omeprazole.[2]

The commercial formulation maps directly to several dependent claims:

Patent claim	Commercial relevance
Claim 3	Amoxicillin with an ansamycin
Claim 4	Rifabutin or rifampicin as the ansamycin
Claim 5	Omeprazole as the PPI
Claim 8	Antibiotic release within 5 to 120 minutes and PPI release within 120 to 240 minutes
Claim 9	Rifabutin, amoxicillin, and omeprazole
Claim 10	Amoxicillin-to-rifabutin ratio of 10:1 to 40:1
Claim 11	Amoxicillin-to-omeprazole ratio of 20:1 to 40:1
Claim 19	250 mg amoxicillin, 12.5 mg rifabutin, and 10 mg omeprazole
Claim 21	Treatment of H. pylori three times daily
Claim 23	Daily administration of 3,000 mg amoxicillin, 120 mg omeprazole, and 150 mg rifabutin

Claim 19 is particularly important because it recites the marketed per-capsule dose. Claim 23 recites the marketed total daily dose, although the order of the active ingredients in the claim does not affect the stated quantities.

What formulations and excipients are protected?

Claims 12 through 18 add common pharmaceutical excipients to the first and second dosage compositions. These claims are narrower than claim 1 and require the relevant excipient category.

Excipient category	Listed examples
Filler	Lactose, cellulose, starch, calcium phosphate, calcium carbonate, sugar
Disintegrant	Croscarmellose sodium, carboxymethyl cellulose, sodium starch glycolate, crospovidone
Binder	Starch, cellulose, polyvinylpyrrolidone, xanthan gum, alginic acid, agar
Surfactant	Sodium lauryl sulfate, polyethylene glycol, poloxamer-type materials and related polymers
Alkalizing agent	Meglumine, calcium carbonate, sodium sulfate, sodium bicarbonate
Lubricant	Magnesium stearate, silicon dioxide, talc, stearic acid, sodium stearyl fumarate, glyceryl behenate

Claim 6 requires a time-delay agent. Claim 7 identifies sodium alginate, glyceryl monostearate, glyceryl distearate, acrylic acids, celluloses, or combinations of those materials.

Claim 20 narrows the delayed-release composition to an outer protective layer, an enteric coating, and an inner protective layer. This layered construction may be relevant to design-around strategies. A competing manufacturer could evaluate alternative barrier systems, coating chemistries, release mechanisms, or minitablet structures, but any design would still need to be tested against the broader limitations of claim 1.

What method-of-use claims does US 9,050,263 contain?

Claims 21 through 24 cover treatment methods rather than the capsule alone.

Claim	Method limitation
21	Administering the claimed capsule three times daily to treat H. pylori
22	Treatment for at least 14 days with an eradication rate greater than 84%
23	Daily administration of 3,000 mg amoxicillin, 120 mg omeprazole, and 150 mg rifabutin
24	Up to 4,500 mg amoxicillin and up to 300 mg rifabutin daily

These claims create potential method-of-use exposure for a product that uses the claimed composition and is labeled for the patented H. pylori regimen. A generic applicant would typically address such claims through a Paragraph IV certification, a section viii carve-out where legally available, or an alternative labeling strategy. The practicality of a carve-out depends on whether the patented use is inseparable from the product’s principal approved use.

When does US Patent 9,050,263 expire?

The patent’s nominal expiration date is December 19, 2032. The relevant timeline is:

Event	Date
Earliest claimed priority	December 19, 2011
Nonprovisional filing associated with the patent family	December 19, 2012
Patent issued	June 9, 2015
Nominal expiration	December 19, 2032
FDA approval of Talicia	November 1, 2019
Three-year regulatory exclusivity period	Through November 1, 2022

The patent expiration date is more commercially significant than the 2019 FDA approval date because patent protection extends beyond the period of FDA new clinical investigation exclusivity. The Orange Book should be checked for any current patent-term adjustment, terminal disclaimer, or changes in listed patent status.[1,3]

What is the FDA and Orange Book status of Talicia?

Talicia was approved by the FDA on November 1, 2019, under NDA 213082 for the treatment of H. pylori infection in adults.[2] It is a small-molecule combination product, not a biologic. Biosimilar procedures therefore do not apply.

The relevant regulatory characteristics are:

Regulatory issue	Status
FDA pathway	NDA approval under section 505(b)(2)
Product	Fixed-dose capsule
Active ingredients	Rifabutin, amoxicillin, omeprazole
Approved indication	Treatment of H. pylori infection in adults
Standard course	Four capsules three times daily for 14 days
Biologic	No
Biosimilar pathway	Not applicable
Orange Book	Patent and exclusivity information reported under the NDA listing

Talicia’s product-specific protection arises from a combination of FDA regulatory exclusivity, listed patents, formulation know-how, and clinical-label requirements. The regulatory exclusivity period has expired, but the patent estate remains the principal barrier to generic entry.

How many patents cover Talicia?

The Talicia patent estate has included the issued patent discussed here and later patents directed to related formulations, dosage forms, and therapeutic uses. Public FDA and patent records have associated Talicia with a group of U.S. patents, including:

US 9,050,263
US 9,492,397
US 10,314,826
US 10,688,072

The precise Orange Book listing should be evaluated as of the relevant date because patent listings can change through corrections, delistings, continuations, expiration events, or regulatory updates. The later patents may have different claim scope from US 9,050,263, including narrower formulation or method claims.

The existence of multiple listed patents increases the burden on an ANDA applicant. A challenger must address every listed patent that is timely and legally relevant, not only the earliest-issued patent.

Which companies are challenging Talicia patents?

The principal generic-entry mechanism would be an ANDA with a Paragraph IV certification asserting that one or more listed patents are invalid, unenforceable, or not infringed. A Paragraph IV filing can trigger patent litigation under the Hatch-Waxman framework and can create a 30-month stay of FDA approval under applicable statutory conditions.[4]

No confirmed commercial generic launch has displaced Talicia based solely on the expiration of US 9,050,263. Publicly available FDA and court records should be reviewed for current ANDA applicants, notice letters, district-court complaints, settlements, and any applicable 180-day generic exclusivity. The absence of an approved substitutable generic means that patent challenges remain commercially material even after the end of Talicia’s three-year regulatory exclusivity.

What is the patent strength of US 9,050,263?

The patent has meaningful strength against close copies of the commercial product because several claims converge on the marketed formulation and regimen.

Strengths

Claim 19 recites the commercial per-capsule dose.
Claim 9 recites the specific active-ingredient combination.
Claims 21 and 23 recite the approved administration pattern and daily dose.
Claim 1 includes measurable dissolution requirements.
The minitablet structure and delayed-release design create manufacturing-specific limitations.
The patent expires after the end of FDA’s three-year exclusivity period.

Vulnerabilities

The broadest composition claim depends on construction of “compressed minitablets,” “delayed release,” and the dissolution test.
PPI, antibiotic, excipient, and coating technologies were individually known in the pharmaceutical field.
A challenger could pursue anticipation or obviousness arguments based on prior combination therapies, enteric PPI products, rifabutin regimens, and multiparticulate dosage forms.
A noninfringing product could use different dosage-unit architecture, release technology, active-ingredient ratios, or labeling.
The treatment claims may face written-description, enablement, obviousness, or use-labeling arguments depending on the asserted claim and prosecution history.

The most commercially significant claims are likely claims 1, 9, 19, 21, and 23. Claims 12 through 20 provide narrower fallback positions based on excipients, delay agents, coating layers, and specific dosage construction.

What generic launch risks exist before 2032?

A generic launch before patent expiration would face several risks:

Patent litigation following a Paragraph IV notice.
A potential 30-month FDA approval stay.
Multiple listed patents requiring separate validity and infringement positions.
Difficulty designing around the exact 250/12.5/10 mg combination while preserving the same approved regimen.
Method-of-use exposure if the label retains the patented H. pylori treatment.
Manufacturing complexity associated with separate immediate-release and delayed-release minitablets.
Clinical and regulatory comparability issues for a three-active-ingredient combination product.
Commercial dependence on physician acceptance of an alternative rifabutin-based eradication regimen.

A launch after patent expiry would still require an approved ANDA or other applicable FDA pathway. Patent expiry alone does not provide regulatory approval.

How does US 9,050,263 compare with conventional H. pylori therapies?

US 9,050,263 is differentiated from conventional dual- or triple-therapy regimens by integrating all three active ingredients into one capsule and controlling the timing of PPI release.

Product approach	Antibiotic components	PPI timing	Dosage-form significance
Conventional separate therapy	Administered as separate products	Often separately dosed	No single claimed capsule architecture
Bismuth quadruple therapy	Antibiotics plus bismuth	PPI generally co-administered	Different active-ingredient platform
Talicia-type therapy	Amoxicillin plus rifabutin	Delayed PPI release	Covered combination of minitablets and release profile

The patent’s commercial value is tied to coordinated release: antibiotics are released earlier, while the PPI is delayed for approximately 120 to 240 minutes according to the claimed embodiment. That timing is intended to distinguish the product from a capsule in which all ingredients dissolve together.

Key Takeaways

US 9,050,263 covers a capsule containing immediate-release antibiotic minitablets and delayed-release PPI minitablets.
The patent specifically reaches amoxicillin, rifabutin, and omeprazole through dependent claims.
Claim 19 matches Talicia’s 250 mg/12.5 mg/10 mg per-capsule composition.
Claims 21 and 23 closely track Talicia’s three-times-daily, 14-day treatment regimen.
The core technical limitation is the two-stage dissolution profile requiring acid protection and subsequent buffer release.
The nominal patent expiration is December 19, 2032.
Talicia’s three-year FDA exclusivity has expired, but patent protection remains the primary generic-entry barrier.
Biosimilar risk does not apply because Talicia is a small-molecule combination product.
Generic challengers would need to address composition, formulation, dissolution, and method-of-use claims across the broader Talicia patent estate.

FAQs About US Patent 9,050,263

Does US 9,050,263 cover rifabutin alone?

No. The patent claims a capsule containing at least two antibiotics in the immediate-release composition. The narrower claims identify amoxicillin with rifabutin or another ansamycin.

Does the patent cover omeprazole delayed-release minitablets without antibiotics?

No. Claim 1 requires the same capsule to contain an immediate-release composition with at least two antibiotics. A standalone delayed-release omeprazole product would not satisfy that combination limitation.

What is the most important dissolution requirement?

The delayed-release PPI composition must release no more than 10% of the PPI during 120 minutes in 0.1N hydrochloric acid and at least 75% within 45 minutes after transfer to pH 6.8 phosphate buffer.

Is Talicia protected by biologic exclusivity?

No. Talicia is a small-molecule fixed-dose combination. Its relevant protections are NDA exclusivity, Orange Book-listed patents, formulation technology, and regulatory approval requirements.

Can a generic avoid the patent by using separate capsules?

A product using separate capsules may avoid the literal “capsule” combination limitation, but it would not necessarily qualify as an equivalent FDA-approved substitute for Talicia. Patent infringement and regulatory substitutability are separate analyses.

References

United States Patent and Trademark Office. (2015). U.S. Patent No. 9,050,263, Pharmaceutical compositions and methods for the treatment of Helicobacter pylori infection.
U.S. Food and Drug Administration. (2019). Talicia prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application and Paragraph IV certification provisions under the Hatch-Waxman Act.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Talicia Holdings	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes	9,050,263	⤷ Start Trial	Y			TREATMENT OF H. PYLORI INFECTION IN ADULTS	⤷ 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

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014216373	⤷ Start Trial
Brazil	112015019264	⤷ Start Trial
Canada	2900763	⤷ Start Trial
Chile	2015002253	⤷ Start Trial
China	105163743	⤷ Start Trial
China	109893516	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,050,263

Which drugs does patent 9,050,263 protect, and when does it expire?

Summary for Patent: 9,050,263