Details for Patent: 10,335,462

Which drugs does patent 10,335,462 protect, and when does it expire?

Patent 10,335,462 protects OZEMPIC and is included in one NDA.

This patent has thirty-two patent family members in sixteen countries.

Summary for Patent: 10,335,462

Title:	Use of long-acting GLP-1 peptides
Abstract:	The invention relates to use of long-acting GLP-1 peptides in certain dosage regimes for the treatment of type 2 diabetes, obesity, etc.
Inventor(s):	Christine Bjoern Jensen
Assignee:	Novo Nordisk AS
Application Number:	US15/656,042
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,335,462
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

United States Patent 10,335,462: Semaglutide Treatment Claims, Patent Scope, and Generic Entry Risk

United States Patent No. 10,335,462 protects a specific semaglutide treatment regimen for type 2 diabetes: 1.0 mg administered once weekly. Its dependent claims narrow the protection to parenteral, subcutaneous delivery and to an isotonic aqueous formulation containing phosphate buffer, with optional propylene glycol and phenol at pH 7.4. The patent does not broadly claim semaglutide as a molecule, all semaglutide doses, or every semaglutide formulation.

The patent is assigned to Novo Nordisk A/S and covers method-of-treatment and formulation limitations associated primarily with Ozempic. The nominal patent-term expiration is December 5, 2032, subject to the patent’s recorded term-adjustment and terminal-disclaimer data.[1]

What does U.S. Patent 10,335,462 protect?

The patent protects administering semaglutide once weekly at a 1.0 mg dose to a patient with type 2 diabetes. Claim 1 is the broadest independent claim:

“A method for treating type 2 diabetes, comprising administering semaglutide once weekly in an amount of 1.0 mg to a subject in need thereof.”

The claim has four material limitations:

1. The active ingredient must be semaglutide.
2. The patient must have type 2 diabetes.
3. The administration frequency must be once weekly.
4. The dose must be 1.0 mg.

The claim is not limited expressly to injection, a particular device, a specific brand, or the Ozempic trade name. A product or treatment protocol that satisfies all four limitations could fall within its literal scope even if the product is supplied by a different manufacturer.

The patent does not claim:

• Semaglutide generally as a chemical compound.
• A 0.25 mg or 0.5 mg dose.
• A 2.0 mg dose.
• Daily administration.
• Oral semaglutide.
• Treatment of obesity as such.
• Every use of semaglutide in type 2 diabetes.
• A composition without the claimed method of administration.

How do claims 1 through 10 differ?

Claim	Subject matter	Scope relative to claim 1
1	Semaglutide, 1.0 mg, once weekly, for type 2 diabetes	Broadest claim
2	Claim 1 with parenteral administration	Narrows route
3	Claim 2 with subcutaneous injection	Narrows route further
4	Claim 1 with isotonic aqueous solution, phosphate buffer, pH 7.0-9.0	Adds formulation limitations
5	Claim 4 with propylene glycol and phenol	Adds excipients
6	Claim 4 with pH 7.4	Narrows pH
7	Claim 6 with propylene glycol and phenol	Adds excipients and fixed pH
8	Claim 4 with sodium dihydrogen phosphate buffer	Narrows buffer identity
9	Claim 1 with subcutaneous injection, isotonic aqueous sodium dihydrogen phosphate solution, pH 7.0-9.0, propylene glycol and phenol	Broad formulation-dependent combination
10	Claim 9 with pH 7.4	Narrowest express combination

Claims 2 and 3 create a route-of-administration hierarchy. Claims 4 through 10 create a formulation hierarchy. Claim 10 is narrower than claim 1 but may be commercially important because it tracks the composition and administration profile associated with the marketed injectable product.

What is the scope of independent claim 1?

Claim 1 is a dose-and-regimen claim rather than a composition claim. Its commercial reach depends on how a generic or competing product is labeled, prescribed, dispensed, and used.

A generic semaglutide product could face claim 1 risk if its labeling recommends or permits:

• A 1.0 mg dose.
• Once-weekly administration.
• Treatment of adults with type 2 diabetes.

The claim does not require the patentee to prove that the accused product contains the exact Ozempic excipient profile. It also does not require subcutaneous injection. Those limitations appear only in dependent claims 2 through 10.

The principal design-around options for claim 1 would involve a legally meaningful difference in dose, frequency, indication, or active ingredient. A manufacturer could not avoid the claim merely by changing the injector, container, trade name, manufacturing site, or supplier if the resulting treatment still satisfies the claimed regimen.

What formulations are protected by Patent 10,335,462?

Claims 4 through 10 protect formulations used in the claimed 1.0 mg weekly treatment method. The formulation limitations include:

• An isotonic aqueous solution.
• A phosphate buffer.
• A pH from 7.0 to 9.0.
• Sodium dihydrogen phosphate in claim 8 and the claims depending from it.
• Propylene glycol and phenol in claims 5, 7, 9, and 10.
• pH 7.4 in claims 6, 7, and 10.
• Subcutaneous injection in claims 3, 9, and 10.

The claims are drafted as treatment-method claims. They do not independently prohibit making or selling an unadministered solution that contains semaglutide and the listed excipients. Liability would generally turn on whether the claimed method is performed, induced, or contributed to.

The formulation claims are commercially significant because a generic injectable designed to reproduce the marketed product’s buffer, preservative, tonicity, and pH profile could satisfy several dependent claims at the same time. A materially different formulation may avoid claims 4 through 10 but could remain exposed to claim 1.

How does the patent compare with a semaglutide composition patent?

Patent 10,335,462 should be separated from three other categories of semaglutide protection:

Patent category	Typical protected subject matter	Relevance to a generic
Active-ingredient patents	Semaglutide structure, analogues, salts, or related compounds	Blocks use of the active ingredient before expiration
Formulation patents	Buffers, preservatives, stabilizers, concentrations, pH, and delivery systems	Blocks copying of injectable or oral product composition
Method-of-use patents	Dose, frequency, indication, titration, or patient population	Blocks labeled or induced use
Device and manufacturing patents	Pens, cartridges, filling, purification, peptide production, and analytical processes	Creates manufacturing and supply-chain barriers

The '462 patent is principally a method-of-use patent with formulation-dependent claims. It is not the entire Ozempic patent estate. A generic applicant must assess the active-ingredient, formulation, manufacturing, device, and method-of-use families separately.

What is the Orange Book status of Patent 10,335,462?

The U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, is the controlling public source for patents listed against approved small-molecule drug products.[2]

Patent 10,335,462 is associated with the Ozempic regulatory franchise and is relevant to an abbreviated new drug application for injectable semaglutide. Its practical effect depends on:

• Whether the patent is listed against the relevant Ozempic NDA.
• The associated use code.
• Whether the ANDA applicant makes a Paragraph IV certification.
• Whether Novo Nordisk files suit within the statutory period.
• Whether the applicant seeks approval for all or only some protected uses.

A patent may be listed against an NDA without every claim covering every commercial use of the product. The use code and the actual claim language must be read together. For an ANDA applicant, a Paragraph IV certification directed to the '462 patent could trigger patent litigation and a 30-month approval stay if the statutory requirements are met.[3]

When does Patent 10,335,462 lose exclusivity?

The patent issued on July 2, 2019. Its nominal expiration date is December 5, 2032, based on the relevant priority and patent-term framework.[1]

Event	Date or status
Earliest reported priority date	December 5, 2012
U.S. grant	July 2, 2019
Nominal 20-year term endpoint	December 5, 2032
Potential adjustment	Must be confirmed from the USPTO patent-term calculation
Regulatory exclusivity	Separate from patent term
Generic approval before expiration	Possible through Paragraph IV litigation, settlement, invalidity, noninfringement, or authorized entry

Patent expiration does not automatically produce generic market entry. FDA approval, regulatory exclusivity, litigation outcomes, settlement terms, manufacturing readiness, and injunction risk also determine the effective launch date.

For semaglutide, the commercial launch date may also differ by indication. Ozempic, Rybelsus, and Wegovy are separate approved products with different NDAs, dosage forms, indications, and patent listings.

What FDA regulatory exclusivity applies to Ozempic?

Ozempic is an FDA-approved injectable semaglutide product for adults with type 2 diabetes, used with diet and exercise to improve glycemic control. The FDA-approved product is supplied in prefilled injection pens and is administered subcutaneously once weekly.[4]

The principal dosage strengths are 0.25 mg, 0.5 mg, 1 mg, and 2 mg administered once weekly. The 0.25 mg dose is used for treatment initiation and is not a maintenance dose under the FDA labeling. The 1 mg dose is specifically relevant to the '462 claims.[4]

New chemical entity exclusivity is not the principal remaining barrier for semaglutide because semaglutide is an analogue of an established GLP-1 class. Patent protection, listed patents, formulation rights, manufacturing know-how, and litigation are more important to generic timing.

Rybelsus is an oral semaglutide product. Wegovy is an injectable semaglutide product approved for chronic weight management. A competitor targeting those products must analyze different claims and regulatory pathways even though all contain semaglutide.

Which companies are challenging Ozempic and semaglutide patents?

Generic and alternative semaglutide manufacturers have commercial incentives to challenge Novo Nordisk’s patent estate, particularly as the market approaches the early 2030s. Publicly reported and litigated challenges have involved companies pursuing abbreviated or competing semaglutide products, including major generic manufacturers and peptide suppliers.

The relevant legal issue is not only whether a company has filed an ANDA. The key questions are:

• Which patents received Paragraph IV certifications?
• Which claims did Novo Nordisk assert?
• Did the applicant stipulate to infringement?
• Was a 30-month stay triggered?
• Did the parties settle?
• Is an authorized launch date available?
• Does the case concern Ozempic, Rybelsus, Wegovy, or more than one product?

A company may challenge one patent family while conceding others. A successful invalidity or noninfringement ruling on the '462 patent would not eliminate separate composition, formulation, device, or manufacturing patents.

What patent litigation affects Patent 10,335,462?

The principal litigation risk concerns ANDA filings for injectable semaglutide products. Novo Nordisk can assert the patent under the Hatch-Waxman framework after receiving notice of a Paragraph IV certification.[3]

Potential causes of action include:

• Direct infringement based on performance of the claimed method.
• Induced infringement based on labeling, promotional materials, or instructions encouraging the 1.0 mg weekly treatment.
• Contributory infringement based on the supply of a specially adapted product.
• Declaratory judgment proceedings initiated by an ANDA applicant.
• Invalidity challenges based on anticipation, obviousness, written description, enablement, or indefiniteness.

The strongest infringement theory is likely to depend on the proposed label. A label that expressly recommends 1.0 mg once weekly for type 2 diabetes presents greater induced-infringement exposure than a label limited to a nonoverlapping indication or dose.

The formulation claims create a separate technical dispute. The parties would likely compare the generic’s actual formulation, pH, buffer species, excipients, tonicity, and injection route against claims 4 through 10. FDA chemistry, manufacturing, and controls documents could become important in litigation, although the relevant formulation details may remain confidential.

How strong is the patent estate for semaglutide?

The '462 patent is commercially meaningful but narrower than a compound patent. Its strengths are:

• It covers the principal 1.0 mg maintenance dose.
• It covers the once-weekly regimen used in clinical practice.
• Claim 1 is not limited to a particular brand or device.
• The dependent claims track a commercially recognizable injectable formulation.
• A generic seeking a full label may have difficulty avoiding the method claim without a skinny-label strategy.

Its limitations are:

• It does not cover all semaglutide doses.
• It does not cover oral semaglutide merely because the active ingredient is semaglutide.
• It does not independently claim every composition containing semaglutide.
• It may face obviousness challenges if the claimed dose and regimen were predictable from prior GLP-1 data.
• The formulation claims may be avoided through a noninfringing formulation.
• Method-of-use enforcement against physicians and patients can be more complex than enforcement against a product manufacturer.

The patent’s commercial strength therefore depends on the broader portfolio. The '462 patent is most valuable when combined with active-ingredient, formulation, device, manufacturing, and other use patents.

What generic launch scenarios exist for Ozempic?

Scenario	Likely commercial result
No successful challenge	Launch delayed until relevant patent barriers expire or Novo authorizes entry
Paragraph IV victory on the '462 patent only	Generic may still face other listed patents
Noninfringing skinny label	Entry may be limited to unclaimed indications or doses
Settlement with an agreed entry date	Commercial launch occurs under negotiated conditions
Authorized generic or license	Earlier entry may occur, subject to agreement terms
Patent invalidation across key families	Earlier broad market competition becomes possible
Formulation redesign	May avoid claims 4-10 but not necessarily claim 1
Manufacturing exclusivity remains	Legal clearance may not produce immediate supply capacity

A skinny-label strategy presents a particular problem for a claim covering the core type 2 diabetes maintenance regimen. If the generic label omits the protected 1.0 mg once-weekly use but physicians are still expected to prescribe that use, Novo Nordisk could pursue induced-infringement theories based on the totality of the label and product conduct.

What manufacturing and geographic barriers remain?

Semaglutide is a peptide analogue requiring specialized production, purification, analytical testing, formulation, sterile filling, and device assembly. Patent clearance alone does not establish commercial readiness.

Important barriers include:

• Peptide synthesis or recombinant production capacity.
• Control of impurities and aggregation.
• Semaglutide-specific analytical methods.
• Sterile injectable manufacturing.
• Pen and cartridge supply.
• Stability data for the proposed formulation.
• FDA inspection and approval of manufacturing sites.
• Capacity for commercial-scale supply.
• Potential process and manufacturing patents in the United States and other jurisdictions.

Patent rights are territorial. A U.S. patent does not directly block manufacture or sale in Europe, India, Brazil, or other markets. A global launch requires a country-by-country review of patent families, supplementary protection certificates, regulatory exclusivity, national litigation, and local compulsory licensing rules.

What licensing deals affect semaglutide competition?

Novo Nordisk has not publicly disclosed a broad license that would eliminate the core U.S. patent barriers for independent generic manufacturers. Any settlement or license involving an ANDA applicant could include:

• A fixed launch date.
• An authorized generic arrangement.
• Royalty or supply terms.
• Restrictions on indication or dosage.
• Covenants not to sue.
• Manufacturing or distribution rights.

The absence of a publicly confirmed license should not be treated as proof that no private settlement exists. Hatch-Waxman settlements can become visible through court filings, FTC review, SEC disclosures, or later regulatory events. The commercial impact depends on whether the agreement authorizes entry before December 2032 and whether other patents remain enforceable.

What is the revenue exposure from Patent 10,335,462?

Ozempic is one of Novo Nordisk’s largest products, and semaglutide-related products account for a substantial share of the company’s diabetes and obesity revenue. Novo Nordisk reported DKK 120.3 billion in Ozempic sales for 2023 and DKK 125.4 billion for 2024.[5][6]

The revenue exposure is broader than the '462 patent alone because Ozempic sales are protected by a portfolio of patents and regulatory rights. A successful challenge to one patent would not necessarily produce immediate erosion. The financial impact would depend on:

• The number of remaining enforceable patents.
• The timing of FDA approvals.
• Generic manufacturing capacity.
• The number of approved competitors.
• Payer substitution and formulary access.
• Whether competitors launch at risk.
• Whether Wegovy and Rybelsus remain protected by separate rights.

Key Takeaways

• Patent 10,335,462 claims a 1.0 mg once-weekly semaglutide treatment for type 2 diabetes.
• Claim 1 is the commercially dominant claim because it does not require subcutaneous delivery or the claimed excipient system.
• Claims 2 through 10 narrow the patent to parenteral or subcutaneous administration and specified injectable formulations.
• The patent does not broadly claim semaglutide, every semaglutide dose, or oral semaglutide.
• The nominal expiration date is December 5, 2032, subject to the USPTO’s final term calculation.
• A Paragraph IV challenge could trigger Hatch-Waxman litigation and a 30-month FDA approval stay.
• A successful challenge to the '462 patent would not eliminate separate semaglutide composition, formulation, device, manufacturing, or method patents.
• The highest-risk generic label is one that expressly includes 1.0 mg once-weekly treatment for type 2 diabetes.
• The patent is a material component of the Ozempic estate, but market entry depends on the full patent portfolio and manufacturing readiness.

FAQs About U.S. Patent 10,335,462

Does Patent 10,335,462 cover the Ozempic 0.5 mg dose?

No. The claims require administration of semaglutide in an amount of 1.0 mg. A 0.5 mg regimen does not literally satisfy claim 1, although other semaglutide patents may cover that dose or its formulation.

Does the patent cover Wegovy?

The patent claims treatment of type 2 diabetes, not obesity treatment generally. Wegovy’s approved indication is chronic weight management. The patent’s relevance to Wegovy depends on the actual use, label, and applicable Orange Book listing.

Can a generic sell semaglutide with a different pH?

A different pH may avoid the claims that require pH 7.0-9.0 or pH 7.4. It would not automatically avoid claim 1 because claim 1 has no express formulation or pH limitation.

Does Patent 10,335,462 block compounded semaglutide?

The patent creates potential method-of-use and inducement risk, but the legal analysis for compounding depends on the entity, statutory exemption, source of the active ingredient, labeling, supply activity, and actual use. Patent rights and the FDA compounding framework are separate issues.

What is the main invalidity risk for the '462 patent?

The principal potential challenges are obviousness of the 1.0 mg weekly regimen, anticipation by prior clinical or patent disclosures, enablement, written description, and claim construction. The method claim’s commercial specificity can support infringement, but it also concentrates validity analysis on whether the claimed dose and regimen were adequately disclosed and nonobvious.

References

1. United States Patent and Trademark Office. (2019). U.S. Patent No. 10,335,462: Use of semaglutide for treating type 2 diabetes.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
3. U.S. Food and Drug Administration. (2024). Abbreviated new drug application submissions: Refuse-to-receive standards.
4. U.S. Food and Drug Administration. (2024). Ozempic (semaglutide) injection prescribing information. Novo Nordisk A/S.
5. Novo Nordisk A/S. (2024). Annual report 2023.
6. Novo Nordisk A/S. (2025). Annual report 2024.

Drugs Protected by US Patent 10,335,462

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	SOLUTION;SUBCUTANEOUS	209637-007	May 5, 2026		RX	Yes	Yes	10,335,462					METHOD OF TREATING TYPE 2 DIABETES
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017		DISCN	Yes	No	10,335,462					A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes	10,335,462		Y			A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes	10,335,462					A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF

Foreign Priority and PCT Information for Patent: 10,335,462

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	12174535	Jul 1, 2012
	12186781	Oct 1, 2012

International Family Members for US Patent 10,335,462

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013286177
Australia	2018202504
Australia	2020202573
Brazil	112014032938
Canada	2877056