Details for Patent: 11,382,957

Which drugs does patent 11,382,957 protect, and when does it expire?

Patent 11,382,957 protects OZEMPIC, RYBELSUS, and WEGOVY, and is included in two NDAs.

This patent has thirty-eight patent family members in twenty-one countries.

Summary for Patent: 11,382,957

Title:	Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Abstract:	The present invention relates to solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine.
Inventor(s):	Per Sauerberg, Simon Bjerregaard, Flemming Seier Nielsen
Assignee:	Novo Nordisk AS
Application Number:	US17/180,370
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,382,957
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

United States Drug Patent 11,382,957: Claim Scope, Semaglutide Formulation Coverage, and Patent Landscape

US Patent No. 11,382,957 protects a solid oral semaglutide composition containing at least 60% by weight of an absorption-enhancing salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, principally sodium N-(8-(2-hydroxybenzoyl)amino)caprylate, known as SNAC. The patent is directed to the formulation architecture used in oral semaglutide tablets, rather than to semaglutide as a molecule.

The independent claim requires four core elements:

1. A solid composition for oral administration.
2. A GLP-1 agonist that is specifically semaglutide.
3. A salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
4. At least one lubricant, binder, or filler, with the salt comprising at least 60% by weight of the composition.

Claims 2 through 9 narrow the protection to tablets, SNAC, defined SNAC and semaglutide quantities, and specified excipients.

What does US Patent 11,382,957 claim?

Claim 1 creates a narrow but commercially important formulation genus

Claim 1 is composition-of-matter protection for a formulation, not a method-of-treatment claim. It is limited to semaglutide and does not cover every oral GLP-1 agonist formulation.

A potentially infringing product must satisfy each limitation:

Claim limitation	Scope
Solid composition	Tablets, powders, granules, capsules containing a solid formulation, subject to claim construction
Oral administration	The dosage form must be intended for oral delivery
GLP-1 agonist	Semaglutide specifically
Absorption enhancer	A salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Excipient	At least one lubricant, binder, or filler
Concentration	At least 60% w/w of the absorption-enhancer salt

The 60% threshold is the principal quantitative limitation. A product with SNAC below 60% by weight would fall outside literal infringement of claim 1, although it could remain exposed under other patents or under a doctrine-of-equivalents theory.

The claim language identifies the benzoyl compound with a typographical variation, "hydroxybenzyol," in the supplied text. The chemically recognized compound is N-(8-(2-hydroxybenzoyl)amino)caprylic acid. Claim interpretation would normally consider the issued patent, prosecution history, specification, and technical meaning rather than relying on the supplied transcription alone. [1]

Dependent claims add commercially relevant limitations

Claim	Added limitation	Commercial significance
2	Composition is a tablet	Directly targets the principal oral semaglutide dosage form
3	Salt is SNAC	Narrows the claim to the principal absorption enhancer used with oral semaglutide
4	Salt amount is 0.6-2.1 mmol	Captures a defined enhancer loading range
5	Semaglutide amount is 0.01-100 mg	Broad dose range
6	Semaglutide amount is 0.01-25 micromol	Defines the dose on a molar basis
7	Lubricant is magnesium stearate	Covers a common tablet excipient
8	Binder is povidone	Covers a common binder
9	Filler is microcrystalline cellulose	Covers a common tablet filler

Claims 7 through 9 are not independent alternatives to claim 1. Each retains every limitation of claim 1 and adds a specified excipient.

What formulation does US 11,382,957 cover?

The patent covers a high-SNAC solid oral semaglutide composition. A product most closely aligned with the claim set would be a tablet containing semaglutide, SNAC at or above 60% by weight, and one or more of magnesium stearate, povidone, or microcrystalline cellulose.

The claim does not require all three excipients. Claim 1 requires at least one member of the group consisting of a lubricant, binder, or filler. A tablet containing only SNAC and magnesium stearate could satisfy that limitation if all other requirements were met.

The claim also does not require:

• A particular tablet weight.
• A particular dissolution profile.
• A particular manufacturing process.
• A particular semaglutide crystal or amorphous form.
• A particular coating.
• A particular release profile.
• A particular therapeutic indication.
• A particular dosing frequency.

Those omissions limit the claim's reach in some respects but give it flexibility against formulation changes that preserve the core composition.

Why the 60% SNAC threshold matters

SNAC is not merely an excipient in this claim. It is the dominant mass component. This distinguishes the claim from conventional oral semaglutide formulations that use a smaller amount of absorption enhancer.

Rybelsus tablets contain semaglutide and SNAC. Public labeling identifies SNAC as an inactive ingredient and states that the 3 mg, 7 mg, and 14 mg tablets contain 300 mg of SNAC per tablet. [2] The resulting SNAC percentage depends on total tablet mass, but the marketed product is technically relevant to a claim requiring a high concentration of SNAC.

The dependent 0.6-2.1 mmol range is also important. SNAC has a molecular weight of approximately 356 g/mol. The claimed range corresponds roughly to 214 mg to 748 mg of SNAC, subject to the molecular form and salt calculation used in the patent. A 300 mg SNAC tablet is approximately 0.84 mmol, placing it within claim 4's range.

How does US 11,382,957 compare with Rybelsus?

Rybelsus is the leading commercial product associated with the claim concept. It is an oral semaglutide tablet marketed by Novo Nordisk. FDA approved Rybelsus on September 20, 2019, for adults with type 2 diabetes as an adjunct to diet and exercise. [2,3]

Product characteristic	US 11,382,957 claim architecture	Rybelsus
Active ingredient	Semaglutide	Semaglutide
Route	Oral	Oral
Dosage form	Solid, including tablet under claim 2	Tablet
Absorption enhancer	Salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid	SNAC
SNAC amount	0.6-2.1 mmol under claim 4	300 mg per tablet, approximately within the claimed molar range
Excipient requirement	Lubricant, binder, or filler	Product contains tablet excipients
High-SNAC threshold	At least 60% w/w under claim 1	Potentially relevant, depending on the total tablet mass and claim construction
Semaglutide dose	0.01-100 mg under claim 5	3 mg, 7 mg, and 14 mg marketed strengths
Therapeutic indication	Not required by composition claims	Type 2 diabetes

The overlap is technically substantial. The patent's claim scope is not limited to Rybelsus branding, approved labeling, or a specific indication. A generic or follow-on product could face risk even if it uses a different tablet coating, manufacturing process, or excipient combination.

What patents protect oral semaglutide and SNAC?

The oral semaglutide patent landscape is divided into four principal groups:

1. Core oral semaglutide/SNAC composition patents.
2. High-SNAC formulation patents, including US 11,382,957.
3. Manufacturing and process patents.
4. Method-of-use, dosing, and treatment patents.

US 11,382,957 is most significant in the second category. Its value is tied to the combination of semaglutide, SNAC, a solid oral dosage form, and high SNAC loading.

Core composition patents

Earlier oral semaglutide patents generally address the use of semaglutide with absorption-enhancing delivery agents, including SNAC. These patents may have earlier priority dates and may expire before later-issued formulation patents, depending on patent-family continuity, patent-term adjustment, terminal disclaimers, and any patent-term extension.

A generic company must evaluate the entire family tree rather than treating US 11,382,957 as the only relevant patent. A product can avoid one claim and still infringe an earlier composition patent or a later process patent.

Formulation patents

Formulation patents typically claim:

• Specific ratios of semaglutide to SNAC.
• SNAC concentration or molar loading.
• Tablet composition.
• Excipient combinations.
• Stability characteristics.
• Dissolution or absorption performance.
• Manufacturing conditions that preserve peptide activity.

US 11,382,957 is stronger against a formulation that reproduces the claimed high-SNAC design. It is less direct against an oral semaglutide product that uses a different absorption enhancer, a lower SNAC concentration, or a non-solid dosage form.

Method-of-use patents

Method-of-use claims may cover treatment of type 2 diabetes, obesity, cardiovascular risk, glycemic control, weight reduction, or particular dosing regimens. They are distinct from the composition claims in US 11,382,957.

A generic applicant may attempt a section viii "skinny label" approach for method-of-use patents by excluding patented indications from labeling. That strategy does not avoid a formulation patent whose claims cover the product itself. FDA labeling carve-outs therefore have limited value against a composition claim of the type issued in US 11,382,957.

When does US 11,382,957 lose exclusivity?

US 11,382,957 issued on July 12, 2022. [1] The patent's exact expiration date cannot be determined solely from the patent number or the issued claims. The controlling calculation requires the patent's earliest effective nonprovisional filing date, continuity data, patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.

The ordinary statutory term for a modern US utility patent is generally 20 years from the earliest effective nonprovisional application filing date, subject to statutory adjustments. [4]

Exclusivity issue	Assessment
Patent type	US utility patent
Grant date	July 12, 2022
Regulatory product	Oral semaglutide, including Rybelsus-related formulations
Patent-term calculation	Requires continuity and USPTO term data
FDA NCE exclusivity	Not expected to provide a new five-year period for semaglutide because semaglutide was previously approved in injectable products
FDA three-year exclusivity	May apply to an approved supplement or new dosage form, but is separate from patent expiration
Orange Book effect	Relevant only if the patent is listed for the approved drug and applicable product information

Rybelsus was approved in 2019. Any three-year exclusivity associated with the new oral dosage form would not itself determine the patent expiry of US 11,382,957. Patent protection and FDA regulatory exclusivity operate independently. [2,3,5]

What is the Orange Book status of US 11,382,957?

A patent grant does not automatically establish Orange Book listing. FDA listing depends on whether the patent is submitted for an approved drug and whether it claims the drug substance, drug product, or an approved method of use under FDA's listing standards. [5]

For a formulation patent, the relevant listing question is whether the claims read on the approved Rybelsus drug product. A patent directed to a formulation may qualify as a drug-product patent if the approved product falls within the claims.

The Orange Book may identify:

• Patent number.
• Patent expiration date.
• Product and strength to which the patent applies.
• Use code for method-of-use patents.
• Delisting or correction information.

The claims supplied for US 11,382,957 do not establish listing status. They establish technical scope. Orange Book status must be determined from the FDA's current patent listing for the relevant semaglutide product. [5]

Which companies are challenging oral semaglutide patents?

Generic companies challenging Rybelsus can use an ANDA with one of four principal certification strategies:

• Paragraph I: no patent information has been submitted.
• Paragraph II: the listed patent has expired.
• Paragraph III: the applicant will wait until patent expiration.
• Paragraph IV: the patent is invalid, unenforceable, or will not be infringed.

A paragraph IV certification creates litigation risk if the patent owner sues within 45 days. A timely suit can trigger a 30-month stay of final FDA approval under the Hatch-Waxman framework, subject to statutory exceptions. [6]

No conclusion about a particular company's paragraph IV filing, district-court case, settlement, or launch date follows from the patent claims alone. Patent litigation status must be tied to an FDA certification notice, a filed complaint, or a court docket.

What would a paragraph IV challenge to US 11,382,957 target?

A challenger would likely focus on:

1. Written description and enablement for the full semaglutide/SNAC composition range.
2. Obviousness based on prior oral GLP-1 and SNAC formulations.
3. The meaning and support for the 60% w/w limitation.
4. Whether the accused product contains the claimed salt in the claimed chemical form.
5. Whether excipients qualify as a lubricant, binder, or filler.
6. Claim construction of the solid-composition and oral-administration limitations.
7. Terminal-disclaimer or double-patenting issues within the patent family.
8. Patent-term calculations and any Orange Book listing defects.

The 60% threshold can create a validity issue if the prior art discloses SNAC broadly but does not teach or suggest the claimed high-concentration range. It can also create an infringement defense if a product is formulated just below the threshold.

How strong is the patent estate for oral semaglutide?

US 11,382,957 has moderate-to-strong product relevance because it targets a formulation architecture closely associated with oral semaglutide. Its practical strength depends on three factors:

Technical overlap

The claim is commercially important because it combines semaglutide and SNAC in a tablet-type solid dosage form. A conventional generic replication may encounter substantial literal-overlap risk.

Claim breadth

The claim is narrower than a broad semaglutide/SNAC composition claim because it requires at least 60% SNAC by weight and at least one specified functional excipient category. A design-around using lower SNAC loading or a different absorption-enhancer system could avoid literal infringement.

Patent-family layering

The strength of the broader estate depends on overlapping claims from related patents covering composition, dosage form, manufacturing, stability, and treatment. A single patent cannot be assessed independently from continuation and divisional applications.

What generic launch scenarios exist for oral semaglutide?

Launch scenario	Technical approach	Patent risk
Direct Rybelsus copy	Semaglutide tablet with SNAC and similar excipients	High risk under claims 1-9 if SNAC is at least 60% w/w
Lower-SNAC formulation	SNAC below 60% w/w	Reduced risk under claim 1; other patents remain relevant
Alternative enhancer	Uses a different absorption enhancer	Potentially avoids claims 1-4, subject to other patents
Non-tablet solid form	Capsule, granule, or other solid dosage form	May still fall within claim 1; claim 2 may be avoided
Different excipient system	Omits claimed lubricant, binder, and filler categories	Difficult if any equivalent functional excipient qualifies under claim construction
Injectable semaglutide	Subcutaneous dosage form	Outside the supplied claims
505(b)(2) product	Relies partly on FDA findings for an approved product	Patent and regulatory strategy depends on product design and listed patents

The cleanest literal design-around would generally require changing the high-SNAC formulation architecture, not merely changing a minor excipient or tablet coating.

Does US 11,382,957 create biosimilar risk?

No conventional biosimilar pathway applies. Semaglutide is a synthetic peptide drug, and Rybelsus is regulated as a small-molecule drug product for ANDA purposes rather than as a biologic under the biosimilar pathway.

The principal competitive threat is therefore generic or hybrid competition, not biosimilar substitution. Injectable semaglutide products, including products approved under separate regulatory pathways, do not automatically establish an ANDA route for oral semaglutide.

What licensing and commercial issues matter?

Novo Nordisk is the central commercial party associated with semaglutide and oral semaglutide products. SNAC technology has historically been associated with Emisphere Technologies and its delivery platform. [7]

Commercial diligence should distinguish:

• Ownership of the semaglutide formulation patents.
• Ownership or licensing of SNAC-related technology.
• Royalty obligations.
• Patent-family prosecution control.
• Geographic rights.
• Manufacturing rights.
• Settlement restrictions on generic entry.
• Regulatory exclusivity separate from patent rights.

The value of US 11,382,957 is concentrated in the United States. Parallel patents may exist in Europe, Japan, China, Canada, Australia, and other markets, but foreign claims, prosecution outcomes, and expiry dates must be evaluated separately. A US patent does not create rights outside the United States.

Key Takeaways

• US 11,382,957 is a formulation patent covering solid oral semaglutide compositions with at least 60% w/w of a specified absorption-enhancer salt.
• SNAC is the principal practical target of the claim set.
• Claims 2 through 9 narrow the invention to tablets, defined SNAC and semaglutide amounts, and common excipients.
• Rybelsus has substantial technical overlap because it is an oral semaglutide/SNAC tablet product.
• A lower-SNAC formulation or alternative absorption enhancer may provide a design-around, but other oral semaglutide patents could remain blocking.
• The patent's exact expiration date requires the official USPTO continuity, term-adjustment, and terminal-disclaimer record.
• Patent grant status and Orange Book listing status are separate issues.
• Generic entry would most likely proceed through an ANDA and could involve paragraph IV litigation.
• Biosimilar risk is not the primary competitive pathway for oral semaglutide.
• The commercial impact depends on the full Novo Nordisk patent family, not US 11,382,957 alone.

FAQs

Does US 11,382,957 cover injectable semaglutide?

No. The supplied claims require a solid composition for oral administration. Injectable semaglutide products fall outside those limitations.

Can a tablet avoid the patent by replacing SNAC with another absorption enhancer?

Potentially. A formulation that does not contain the claimed salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid would not meet the express absorption-enhancer limitation, although other patents may apply.

Is 300 mg of SNAC within the claimed range?

Approximately yes. A 300 mg amount is roughly 0.84 mmol based on SNAC's molecular weight, within the 0.6-2.1 mmol range in claim 4.

Does omitting microcrystalline cellulose avoid infringement?

Not necessarily. Claim 1 requires at least one lubricant, binder, or filler, not specifically microcrystalline cellulose. Claims 7 through 9 are narrower dependent claims.

Can an ANDA applicant launch after FDA approval if US 11,382,957 remains active?

FDA approval and patent freedom to operate are separate. A product may receive approval but remain subject to an injunction, 30-month stay, settlement restriction, or post-launch patent litigation.

What is the main invalidity vulnerability in the patent?

The principal potential challenges are obviousness, written description, enablement, claim construction, and support for the high-SNAC threshold. The outcome depends on the full prior-art and prosecution record.

References

1. United States Patent and Trademark Office. (2022). U.S. Patent No. 11,382,957, solid composition comprising a GLP-1 agonist.
2. U.S. Food and Drug Administration. (2024). Rybelsus prescribing information. Novo Nordisk A/S.
3. U.S. Food and Drug Administration. (2019, September 20). FDA approves first oral GLP-1 treatment for type 2 diabetes.
4. United States Code. 35 U.S.C. §§ 154, 156.
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
6. United States Code. 21 U.S.C. § 355(j).
7. U.S. Securities and Exchange Commission. (2020). Novo Nordisk and Emisphere Technologies transaction disclosures concerning oral semaglutide and SNAC technology.

Drugs Protected by US Patent 11,382,957

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-004	Dec 9, 2024		RX	Yes	Yes			Y	Y
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-005	Dec 9, 2024		RX	Yes	Yes			Y	Y
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-006	Dec 9, 2024		RX	Yes	Yes			Y	Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-001	Sep 20, 2019		RX	Yes	Yes			Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019		RX	Yes	Yes			Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes			Y
Novo	WEGOVY	semaglutide	TABLET;ORAL	218316-001	Dec 22, 2025		RX	Yes	Yes			Y

International Family Members for US Patent 11,382,957

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011343190
Brazil	112013014942
Canada	2821886
China	103260608
China	105963685
Cyprus	1121118
Denmark	2651398