Details for Patent: 9,278,123

Which drugs does patent 9,278,123 protect, and when does it expire?

Patent 9,278,123 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: 9,278,123

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:	US13/994,262
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,278,123
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

US Patent 9,278,123: Scope, Claims, Expiration, Orange Book Status, and Oral Semaglutide Patent Landscape

US Patent No. 9,278,123 protects solid oral compositions containing semaglutide and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, principally sodium N-(8-(2-hydroxybenzoyl)amino)caprylate, known as SNAC. The claims cover the composition, tablet dosage form, specified semaglutide and SNAC quantities, and treatment of type 2 diabetes or obesity. The patent is directed to the formulation platform used for oral semaglutide products such as Rybelsus.

The commercially important claim combinations are 5-20 mg semaglutide with SNAC, particularly 300 mg SNAC, in a solid oral tablet. The patent does not broadly claim every oral GLP-1 product. Infringement requires the accused product to contain the specifically defined semaglutide molecule and the claimed SNAC or related salt in the claimed dosage form and quantity range.

What does US Patent 9,278,123 protect?

US 9,278,123 protects a pharmaceutical composition combining three central elements:

1. A specific long-acting GLP-1 analogue, chemically identified in the claims as semaglutide.
2. A salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, with SNAC as the principal commercial embodiment.
3. A solid composition for oral administration, with dependent claims directed to tablets and defined dose ranges.

The patent is formulation-specific. It does not claim semaglutide generally, injectable semaglutide, or every oral delivery system for GLP-1 agonists.

Claim architecture

Claim	Claim type	Principal limitation
1	Independent composition	Solid oral composition; semaglutide; SNAC-family salt at 0.8-1.3 mmol
2	Dependent composition	Tablet
3	Dependent composition	5-20 mg semaglutide
4	Dependent composition	Sodium, potassium, or calcium salt
6	Dependent composition	SNAC specifically
8	Independent method	Treating type 2 diabetes or obesity using claim 1 composition
9	Independent composition	Solid oral composition; 5-20 mg semaglutide; SNAC-family salt
12	Dependent composition	250-400 mg SNAC
13	Dependent composition	300 mg SNAC
14	Dependent composition	Tablet
15	Independent method	Treating type 2 diabetes or obesity using claim 9 composition
16	Independent composition	5-20 mg semaglutide; SNAC-family salt at 0.6-2.1 mmol
19	Dependent composition	Tablet

Claims 1, 9 and 16 are the principal composition claims. Claims 8 and 15 extend the patent to treatment methods, but only when the administered product satisfies the corresponding composition limitations.

What semaglutide molecule is covered by the patent?

The long chemical name in the claims identifies semaglutide, also known as NN9924 during development. Semaglutide is a modified GLP-1 analogue containing:

• An Aib substitution at position 8.
• An Arg substitution at position 34.
• A fatty-acid-derived side chain attached through a spacer.
• A GLP-1(7-37) peptide backbone.

The claim requires the particular peptide structure recited in the patent. A different GLP-1 analogue, including liraglutide, dulaglutide or tirzepatide, would not literally satisfy the semaglutide limitation.

The chemical definition gives the patent a relatively narrow active-ingredient scope but a commercially significant one. A competing oral product using semaglutide cannot avoid the active-ingredient limitation merely by using a different tablet excipient or a different manufacturing process.

How do the SNAC limitations operate?

SNAC is sodium N-(8-(2-hydroxybenzoyl)amino)caprylate. It promotes oral absorption of semaglutide by supporting local absorption across the stomach after tablet disintegration. The claims also refer to potassium and calcium salts of the same N-(8-(2-hydroxybenzoyl)amino)caprylic acid structure.

Salt coverage

Claim 4 covers three salt categories:

• Sodium salt.
• Potassium salt.
• Calcium salt.

Claim 6 narrows the composition to SNAC. Claims 10, 11, 17 and 18 repeat this hierarchy in the claim 9 and claim 16 branches.

A product using a chemically different absorption enhancer would not literally meet the SNAC-salt limitation. The doctrine of equivalents could become relevant in litigation, but the result would depend on prosecution history, claim construction and the technical properties of the substitute.

SNAC quantity ranges

The patent contains overlapping but distinct SNAC quantity limitations:

Claim branch	SNAC quantity
Claim 1	0.8-1.3 mmol
Claim 9	No SNAC quantity in the independent claim
Claim 12	250-400 mg SNAC
Claim 13	Exactly 300 mg SNAC
Claim 16	0.6-2.1 mmol

The molecular weight of sodium SNAC is approximately 301.3-301.4 g/mol. On that basis, 300 mg corresponds to approximately 1.0 mmol. The 300 mg embodiment therefore falls within both the 0.8-1.3 mmol range in claim 1 and the broader 0.6-2.1 mmol range in claim 16.

Claim 9 is commercially important because its independent formulation claim requires 5-20 mg semaglutide and a qualifying salt but does not itself specify the SNAC quantity. Claims 12 and 13 narrow that branch to 250-400 mg and 300 mg SNAC.

Which commercial oral semaglutide products are most exposed?

Rybelsus is the principal product within the technical center of the patent. FDA-approved Rybelsus tablets contain semaglutide and 300 mg SNAC, with marketed semaglutide strengths of 3 mg, 7 mg and 14 mg. The 7 mg and 14 mg strengths fall within the patent’s 5-20 mg semaglutide limitations. The 3 mg starting dose does not fall within claims requiring 5-20 mg, although it may remain relevant to broader claim language and other patents. [1]

Product or dosage	Semaglutide amount	SNAC amount	Relevance to US 9,278,123
Rybelsus 3 mg	3 mg	300 mg	Outside 5-20 mg claims based on dose
Rybelsus 7 mg	7 mg	300 mg	Directly within 5-20 mg and 300 mg embodiments
Rybelsus 14 mg	14 mg	300 mg	Directly within 5-20 mg and 300 mg embodiments
Injectable Ozempic	Injectable	None in oral tablet	Outside the solid oral SNAC composition claims
Wegovy injection	Injectable	None in oral tablet	Outside the claimed composition format

The 7 mg and 14 mg Rybelsus tablets are the clearest literal product matches to claims 9, 11, 12, 13 and 14, assuming the marketed formulation contains the claimed SNAC salt and the remaining claim elements.

What formulations are protected by US 9,278,123?

The patent protects formulations with the following profile:

• Solid dosage form.
• Oral administration.
• Semaglutide as the GLP-1 agonist.
• SNAC, sodium SNAC, potassium salt or calcium salt.
• Defined semaglutide and, in certain claims, SNAC quantities.
• Tablet form under dependent claims.

The claims do not expressly require a particular tablet coating, excipient system, compression force, dissolution profile, particle size, manufacturing sequence or release mechanism. Those omissions make the core formulation claims potentially broad against products that use a different inactive-ingredient package but retain semaglutide and SNAC in the claimed ranges.

The claims also do not require the product to be labeled for diabetes or obesity for composition infringement. A composition claim is generally assessed by the product’s structure and ingredients. The method claims require administration for treatment of type 2 diabetes or obesity.

How strong is the patent estate for oral semaglutide?

US 9,278,123 is commercially strong because it covers the combination that differentiates oral semaglutide from injectable GLP-1 products: semaglutide plus SNAC in a solid oral dosage form. Its strength is concentrated rather than universal.

Strengths

• It targets the core Rybelsus formulation concept.
• Claim 9 does not impose a SNAC amount in the independent claim.
• Claim 16 provides a broad 0.6-2.1 mmol absorption-enhancer range.
• Claim 13 specifically captures the 300 mg SNAC commercial embodiment.
• The formulation can be protected even when the competitor uses different excipients.
• The method claims create a second infringement theory for treatment use.

Vulnerabilities

• The claims require semaglutide, limiting application to products using that exact analogue.
• The claims require a solid oral composition, excluding injections and non-solid delivery systems.
• Claims 1 and 16 depend on measurable SNAC molar ranges, creating analytical and claim-construction disputes.
• Prior-art attacks may focus on the combination of semaglutide, oral delivery and SNAC, including earlier Novo Nordisk oral peptide work.
• Enablement, written description, obviousness and anticipation defenses could be directed to the breadth of the salt and quantity ranges.
• The method claims may face divided-infringement and induced-infringement issues depending on labeling and commercial conduct.

The most defensible commercial position is the narrow combination of semaglutide, 300 mg SNAC and tablet administration. The broadest litigation exposure arises from claim 9, because it omits an SNAC quantity from the independent claim.

When does US Patent 9,278,123 lose exclusivity?

The patent issued on March 8, 2016. Public patent-family records associate the patent with a 2013 priority framework and a projected US patent expiration in 2034, subject to patent-term adjustment and any applicable term extension. The practical patent term should be confirmed against the USPTO Patent Center record and the FDA Orange Book entry. [2, 3]

Event	Date or status
Earliest public priority framework	2013
US patent filing	2014-era filing
Patent publication	Before issuance
Grant of US 9,278,123	March 8, 2016
Projected expiration	2034, subject to PTA
FDA approval of Rybelsus	September 20, 2019
Small-molecule regulatory exclusivity	Separate from patent term

The patent does not receive a new patent term merely because Rybelsus was approved in 2019. Patent expiration is governed principally by the patent-term statute and any calculated adjustment. FDA regulatory exclusivity is a separate barrier.

What is the Orange Book status of US 9,278,123?

Novo Nordisk’s Rybelsus listing has included patents directed to semaglutide and its oral formulation. US 9,278,123 is associated with the oral semaglutide formulation patent estate and is relevant to abbreviated new drug application, or ANDA, challenges. The Orange Book should be treated as the operative source for current listing status, use codes and expiration information. [3]

An Orange Book listing does not establish that every claim is valid or infringed. It triggers the statutory patent-certification framework for an ANDA applicant. A generic applicant may certify that:

• No patent information has been submitted.
• The listed patent has expired.
• The applicant will not market before patent expiration.
• The patent is invalid, unenforceable or will not be infringed.

The fourth certification is the Paragraph IV route.

Which companies are challenging the Rybelsus patent estate?

ANDA applicants may challenge Rybelsus patents through Paragraph IV certifications, but the relevant company list and litigation docket change as complaints are filed, consolidated or dismissed. A reliable assessment requires current review of FDA Orange Book certifications, district-court complaints and the Federal Court Management Statistics or PACER docket.

The commercial risk is structurally high for generic applicants because a Paragraph IV notice directed to US 9,278,123 can trigger a 30-month stay of FDA approval under the Hatch-Waxman statute, subject to statutory exceptions and court developments. [4] A successful challenge to one formulation patent would not necessarily clear the entire Rybelsus estate. Other listed patents, unlisted process patents, regulatory exclusivity and settlement restrictions may remain relevant.

What patent litigation and settlement issues matter?

The principal litigation questions are likely to involve:

1. Whether the ANDA product contains semaglutide in the claimed molecular form.
2. Whether its absorption enhancer is SNAC or an equivalent salt.
3. Whether the SNAC amount falls within the claimed molar or mass range.
4. Whether the proposed product is a solid oral composition.
5. Whether the patent claims are anticipated or obvious over oral peptide and SNAC prior art.
6. Whether the claims satisfy written-description and enablement requirements.
7. Whether the proposed labeling induces use for diabetes or obesity.

A generic applicant could attempt a formulation design-around by:

• Using a non-SNAC absorption enhancer.
• Using a different salt not covered by the asserted claim.
• Changing the semaglutide dose outside the claimed range.
• Using a non-solid dosage form.
• Pursuing a formulation with a materially different delivery mechanism.

The design-around value is limited if other Novo Nordisk patents separately cover oral semaglutide, SNAC compositions, manufacturing processes or specific dosage strengths.

A settlement could provide an agreed launch date before patent expiration, but settlement terms are not inferable from the patent claims. The relevant business question is whether a settlement covers only US 9,278,123 or the broader Rybelsus patent portfolio.

Is there biosimilar risk for oral semaglutide?

Traditional biosimilar risk under section 351(k) is not the primary pathway for Rybelsus. Rybelsus is regulated as a drug product listed in the Orange Book, and a follow-on sponsor would generally pursue an ANDA if it can establish pharmaceutical equivalence and bioequivalence. [1, 3]

Semaglutide is a peptide therapeutic, but the commercial product is not treated in the same manner as a conventional monoclonal antibody biologic for biosimilar competition. The more relevant competitors are generic or follow-on oral semaglutide applicants and alternative oral GLP-1 products.

How does US 9,278,123 compare with other semaglutide patents?

Patent category	Typical protected subject matter	Relationship to US 9,278,123
Semaglutide molecule	Peptide structure and sequence	Can block the active ingredient independently
Injectable formulation	Parenteral semaglutide compositions	Separate from the oral solid-composition claims
Oral formulation	Semaglutide plus SNAC	Directly overlapping technology area
Dose regimen	Titration, administration or treatment schedules	May create method-of-use barriers
Manufacturing	Peptide synthesis, purification or formulation processes	Can restrict supply-chain alternatives
Tablet technology	Compression, coating, stability or dissolution	May create additional product-specific barriers

US 9,278,123 is therefore one layer of a larger exclusivity stack. Its commercial value depends on claim overlap with the other patents, Orange Book listing status, enforceability, and the ability of a generic sponsor to design around or invalidate the claims.

What generic launch scenarios exist?

Launch after patent expiration

This is the lowest-litigation scenario. The applicant waits until the relevant patent and regulatory exclusivity barriers expire. The approach reduces legal risk but delays market entry.

Paragraph IV launch

The applicant certifies that the patent is invalid, unenforceable or not infringed. Novo Nordisk may sue within the statutory period, potentially delaying FDA approval for up to 30 months. The applicant may still launch at risk if the litigation remains unresolved and commercial strategy supports that position.

Formulation design-around

The applicant develops oral semaglutide without SNAC or outside the claimed ranges. This could avoid US 9,278,123 but may face bioequivalence and other-patent obstacles.

Settlement launch

The parties agree on an authorized or licensed launch date. The economic value depends on the date, royalty terms, supply arrangements and treatment of other Rybelsus patents.

What geographic coverage does the patent provide?

US 9,278,123 provides rights only in the United States. Parallel national patents or patent applications may exist in Europe, Japan, Canada, China and other markets through the corresponding international family. Foreign claim scope, prosecution history, expiration and validity must be assessed separately.

A company can avoid US infringement by manufacturing abroad only if the relevant conduct does not fall within US importation, offer-for-sale, sale or method-of-use provisions. US export and import provisions can still create exposure where a product is made abroad for US commercial distribution. [5]

Key Takeaways

• US 9,278,123 covers solid oral semaglutide compositions containing SNAC-family salts.
• The strongest commercial overlap is with 7 mg and 14 mg Rybelsus tablets containing 300 mg SNAC.
• Claim 9 is important because its independent claim does not specify an SNAC quantity.
• Claims 1 and 16 impose molar SNAC ranges of 0.8-1.3 mmol and 0.6-2.1 mmol, respectively.
• Claim 13 specifically covers 300 mg SNAC.
• Claims 8 and 15 cover treatment of type 2 diabetes or obesity using the claimed compositions.
• The patent issued March 8, 2016, with projected expiration in 2034, subject to patent-term adjustment.
• Generic entry is more likely to proceed through the ANDA and Paragraph IV framework than through a biosimilar application.
• A successful challenge to this patent would not necessarily clear Novo Nordisk’s broader oral semaglutide patent estate.
• The main design-around route is substitution of the absorption enhancer, but that approach creates bioequivalence and separate-patent risks.

FAQs About US Patent 9,278,123 and Oral Semaglutide

Does US 9,278,123 cover Rybelsus 3 mg?

The 3 mg dose is outside claims that require 5-20 mg semaglutide. It may still be relevant to other patents or to broader claim theories that do not impose the 5 mg minimum.

Does the patent cover injectable Ozempic or Wegovy?

No. The asserted claims require a solid composition for oral administration containing the claimed SNAC-family salt. Injectable products do not meet those limitations.

Can a generic use semaglutide with a different absorption enhancer?

Potentially, but the product would need to avoid the literal SNAC-salt limitations and satisfy FDA bioequivalence requirements. Other patents and regulatory barriers could still prevent launch.

Is 300 mg SNAC within the patent’s molar range?

Yes. Approximately 300 mg of sodium SNAC corresponds to about 1.0 mmol, placing it within both the 0.8-1.3 mmol and 0.6-2.1 mmol ranges.

Does patent invalidity eliminate all Rybelsus exclusivity?

No. Rybelsus may be protected by additional composition, use, manufacturing and formulation patents, as well as any remaining FDA regulatory exclusivity. Invalidating US 9,278,123 would remove one barrier only.

References

1. U.S. Food and Drug Administration. (2019). Rybelsus (semaglutide) prescribing information.
2. United States Patent and Trademark Office. (2016). U.S. Patent No. 9,278,123, Pharmaceutical composition comprising a GLP-1 compound.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. U.S. Food and Drug Administration. (2024). Abbreviated new drug application and Hatch-Waxman patent certification framework.
5. United States Code, 35 U.S.C. §§ 271, 281-285.

Drugs Protected by US Patent 9,278,123

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	213051-006	Dec 9, 2024		RX	Yes	Yes			Y	Y		METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-001	Sep 20, 2019		RX	Yes	Yes			Y			METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019		RX	Yes	Yes			Y			METHOD OF TREATING TYPE 2 DIABETES MELLITUS

Foreign Priority and PCT Information for Patent: 9,278,123

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	10195285	Dec 16, 2010

PCT Information
PCT Filed	December 16, 2011	PCT Application Number:	PCT/EP2011/073060
PCT Publication Date:	June 21, 2012	PCT Publication Number:	WO2012/080471

International Family Members for US Patent 9,278,123

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011343190
Brazil	112013014942
Canada	2821886