Details for Patent: 9,764,003

Which drugs does patent 9,764,003 protect, and when does it expire?

Patent 9,764,003 protects WEGOVY, WEGOVY FLEXTOUCH, and WEGOVY HD, and is included in one NDA.

This patent has twenty-four patent family members in fifteen countries.

Summary for Patent: 9,764,003

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 B. Jensen
Assignee:	Novo Nordisk AS
Application Number:	US14/409,493
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,764,003
Patent Claim Types: see list of patent claims	Use; Dosage form;

United States Patent 9,764,003: Semaglutide Weight-Loss Claims, Exclusivity, and Patent Landscape

US Patent No. 9,764,003 is a Novo Nordisk method-of-use patent covering once-weekly semaglutide for body-weight reduction at doses from 0.7 mg to 1.6 mg. Its most commercially important coverage is directed to the higher-dose regimen associated with Wegovy, while parts of claim 1 can also read on certain once-weekly Ozempic regimens when the treatment objective is weight reduction.

The patent issued on September 19, 2017, and has a reported expiration date of March 20, 2031. It is a use patent rather than a composition-of-matter patent. Its enforceability therefore depends on proving the claimed dosing regimen, treatment purpose, patient population, and administration conditions.

What does US Patent 9,764,003 claim?

US 9,764,003 claims a method of reducing body weight by administering semaglutide once weekly, without another therapeutic agent, at a dose of at least 0.7 mg and up to 1.6 mg.

Claim	Limitation	Commercial significance
1	Once-weekly semaglutide; 0.7 mg to 1.6 mg; body-weight reduction; no other therapeutic agent	Principal claim; broadest method claim
2	Dose of at least 0.8 mg per week	Covers doses from 0.8 mg through 1.6 mg
3	Parenteral administration	Covers injectable and other non-oral routes
4	Once-weekly semaglutide at about 0.8 mg	Narrow dose-specific claim
5	Subject has type 2 diabetes	Adds a diabetes-specific patient population
6	Subcutaneous injection	Narrows claim 5 to subcutaneous administration

The patent does not claim semaglutide as a chemical compound. It does not claim every use of semaglutide. It claims a defined therapeutic regimen.

What is the active ingredient covered by the patent?

The active ingredient is semaglutide, a long-acting glucagon-like peptide-1, or GLP-1, receptor agonist. Semaglutide is marketed by Novo Nordisk as:

• Ozempic for type 2 diabetes;
• Wegovy for chronic weight management; and
• Rybelsus as an oral product for type 2 diabetes.

The patent claims are most closely aligned with injectable semaglutide used for weight reduction. Rybelsus is administered orally and daily, so its ordinary labeled regimen does not meet the once-weekly limitation.

How broad is claim 1 of US 9,764,003?

Claim 1 has meaningful breadth within a narrow dosing and treatment corridor. It requires all of the following:

1. Semaglutide must be administered.
2. Administration must occur once weekly.
3. The dose must be at least 0.7 mg and no more than 1.6 mg per week.
4. The purpose must be reducing body weight.
5. The semaglutide must be administered without another therapeutic agent.
6. The subject must be a person in need of weight reduction.

The claim does not expressly require obesity, a particular body-mass index, subcutaneous injection, or type 2 diabetes. Those limitations appear only in dependent claims 3 through 6 or may arise from the factual context of treatment.

Does claim 1 cover Wegovy?

Yes, Wegovy's labeled maintenance doses fall within the central dosing range of claim 1. Wegovy is administered subcutaneously once weekly, with a maintenance dose of 2.4 mg once weekly under the current FDA label. A 2.4 mg regimen is outside the literal upper limit of 1.6 mg in claim 1. Earlier semaglutide weight-management regimens involving doses at or below 1.6 mg are more directly aligned with the patent claim.

The distinction matters. A product label or commercial use that states a 2.4 mg maintenance dose does not automatically establish infringement of a claim capped at 1.6 mg. Infringement analysis would focus on actual or induced use of the claimed 0.7 mg to 1.6 mg range, including titration, maintenance, or alternative dosing instructions.

Does claim 1 cover Ozempic?

Potentially, but only for particular uses and doses. Ozempic is administered once weekly at maintenance doses of 0.5 mg, 1 mg, or 2 mg. The 1 mg regimen falls within claim 1's 0.7 mg to 1.6 mg range. The 2 mg regimen does not.

Ozempic's FDA-approved indication is treatment of type 2 diabetes and reduction of certain cardiovascular risks, not chronic weight management. A claim directed to reducing body weight requires evidence that the accused use has the claimed purpose. The patent may therefore be more relevant to weight-loss use of semaglutide than to ordinary diabetes treatment with Ozempic.

What is the patent term and expiration date?

Event	Date
Earliest reported priority date	March 20, 2009
US patent grant	September 19, 2017
Patent number	US 9,764,003 B2
Reported expiration date	March 20, 2031
Patent type	Method of use
Applicant/assignee	Novo Nordisk entities

The reported March 20, 2031 expiration date reflects the patent-family term associated with the underlying filing date. A terminal disclaimer, patent-term adjustment, patent-term extension, reexamination certificate, or other USPTO event could affect the operative term. The USPTO patent record and FDA Orange Book remain the controlling sources for enforceability and listing status. (U.S. Patent and Trademark Office, 2017; U.S. Food and Drug Administration, n.d.-a)

What is the Orange Book status of US 9,764,003?

US 9,764,003 has been associated with FDA-listed semaglutide products, including injectable semaglutide products marketed by Novo Nordisk. The commercial relevance of an Orange Book listing depends on the NDA to which the patent is attached and the FDA use code.

An Orange Book listing can create a statutory basis for an ANDA applicant to submit a Paragraph IV certification alleging that the listed patent is invalid, unenforceable, or not infringed. The listing does not establish validity. It also does not automatically block a 505(b)(2) product or a non-ANDA competitor.

Orange Book implications by product

Product	Route	Main use	Relevance of US 9,764,003
Wegovy	Subcutaneous, once weekly	Chronic weight management	Directly relevant to the claimed weight-loss method, subject to dose and use-code analysis
Ozempic	Subcutaneous, once weekly	Type 2 diabetes	Potential relevance at covered doses where weight reduction is the claimed use
Rybelsus	Oral, daily	Type 2 diabetes	Limited relevance because ordinary labeling does not meet once-weekly administration

FDA listing status should be reviewed by NDA and use code rather than by patent number alone. A patent may appear in more than one product record, and the scope of the use code may be narrower than the full text of the patent claims.

What formulation patents protect semaglutide products?

US 9,764,003 does not principally protect a formulation. It protects a therapeutic use and dosing schedule. Novo Nordisk's semaglutide estate also includes separate patent families directed to:

• semaglutide compositions and analog structures;
• pharmaceutical formulations;
• injectable delivery systems;
• oral semaglutide formulations;
• absorption-enhancing excipients;
• manufacturing and purification processes;
• treatment methods for diabetes, obesity, and related conditions.

The distinction between formulation and use patents affects generic strategy. A generic injectable applicant may challenge a composition or formulation patent even if it does not practice the weight-loss method claimed in US 9,764,003. Conversely, a formulation design-around does not necessarily avoid a method claim if the applicant's labeling induces use of the patented dosing regimen.

What does the "without another therapeutic agent" limitation do?

This limitation narrows the claim to semaglutide administered without another therapeutic agent. It can create both infringement and validity issues.

For infringement, a regimen that instructs patients to use semaglutide together with insulin, metformin, another GLP-1 agonist, or another active treatment may fall outside the literal scope of the limitation, depending on how the phrase is construed and how the treatment is actually prescribed.

For validity, the limitation may distinguish prior-art combination regimens, but it can also raise questions about whether the specification adequately supports the full scope of monotherapy treatment. The practical result is a claim with substantial commercial relevance but a narrower enforcement perimeter than a claim covering semaglutide weight reduction generally.

What is the patent strength of US 9,764,003?

The patent has moderate commercial strength and a narrower legal scope than a semaglutide composition patent.

Strength factor	Assessment
Commercial alignment	Strong for once-weekly injectable weight-loss use
Chemical coverage	None; the patent does not protect semaglutide as a molecule
Dose coverage	Limited to 0.7 mg through 1.6 mg
Route coverage	Broad in claim 1; parenteral and subcutaneous routes are added in dependent claims
Combination coverage	Narrowed by the "without another therapeutic agent" limitation
Orange Book utility	Potentially significant if listed with an applicable use code
Design-around potential	Moderate; alternative doses, indications, combinations, and schedules may avoid literal coverage
Vulnerability to invalidity challenge	Depends on prior art, written description, enablement, and claim construction

The strongest infringement theory would target a product label or prescribing protocol that instructs once-weekly semaglutide at 0.7 mg to 1.6 mg for weight reduction as monotherapy. A product limited to 2.4 mg maintenance dosing presents a more difficult literal-infringement case because of the express 1.6 mg ceiling.

When does semaglutide lose exclusivity?

Semaglutide does not have a single universal loss-of-exclusivity date. The date depends on the product, patent family, regulatory exclusivity, and the type of challenger.

Exclusivity component	Approximate position
US 9,764,003 method patent	Reported expiration: March 20, 2031
Semaglutide composition and related patents	Multiple expiration dates, some earlier and some later than 2031
New chemical entity exclusivity	Expired for earlier semaglutide approvals
Wegovy regulatory exclusivity	Separate from patent term and subject to the NDA approval date and statutory category
ANDA launch timing	Depends on Paragraph IV notice, litigation, 30-month stay, and settlement terms
Biosimilar pathway	Not applicable to semaglutide as a synthetic peptide drug under the ordinary biologics pathway

The March 20, 2031 date is therefore important but not necessarily dispositive for all semaglutide products. A generic could face other patents after US 9,764,003 expires. An ANDA applicant could also obtain an earlier launch date through a successful Paragraph IV challenge or a settlement.

Which companies are challenging semaglutide patents?

Publicly reported challenges to semaglutide exclusivity have focused on prospective ANDA activity and litigation involving generic manufacturers. Novo Nordisk has stated in public filings that it is defending its semaglutide intellectual-property portfolio against potential generic and other competitors. The existence of an ANDA challenge does not establish that the challenger can launch.

A complete company-by-company assessment requires current PACER, FDA Paragraph IV, and Orange Book data. The available patent record alone does not establish a final, adjudicated challenge specifically invalidating or clearing US 9,764,003.

What is the Paragraph IV risk?

A Paragraph IV certification against US 9,764,003 would generally allege one or more of the following:

• the claims are invalid;
• the claims are unenforceable; or
• the proposed product or labeling does not infringe.

For this patent, likely dispute points include:

1. Whether prior art disclosed once-weekly semaglutide at the claimed dose range.
2. Whether the claimed weight-loss result was predictable from earlier GLP-1 research.
3. Whether the specification supports the entire 0.7 mg to 1.6 mg range.
4. Whether "without another therapeutic agent" is definite and adequately supported.
5. Whether a generic label induces the claimed weight-reduction method.
6. Whether doses used during titration or maintenance fall within the claimed range.

A generic applicant seeking approval only for a diabetes indication may attempt a section viii skinny-label strategy that omits weight reduction. That approach could reduce exposure to the method claim, although actual labeling, promotional activity, and prescribing behavior would remain relevant.

What patent litigation affects US 9,764,003?

The principal litigation risk is prospective ANDA litigation under the Hatch-Waxman Act. A Paragraph IV notice can trigger a patent-infringement action by Novo Nordisk and a statutory 30-month stay of FDA approval, subject to statutory exceptions.

No final judgment should be inferred from an Orange Book listing, a patent challenge, or a complaint. The key case-status questions are:

• whether US 9,764,003 was included in the asserted patents;
• whether the court construed the dose and monotherapy limitations;
• whether the patent survived invalidity attacks;
• whether the parties entered a settlement;
• whether the settlement provides a licensed launch date; and
• whether the generic applicant may launch under a restricted label.

The absence of a reported final judgment against this patent does not eliminate litigation risk. It indicates that commercial launch timing may depend more on settlements and other semaglutide patents than on a single adjudication.

Are there settlement agreements or licensing deals?

Novo Nordisk has entered commercial relationships involving semaglutide supply, development, distribution, and manufacturing. Those arrangements should not be treated as licenses to US 9,764,003 unless the agreement expressly grants patent rights.

No generally disclosed license has been established that broadly permits third-party commercial use of the specific weight-loss regimen claimed in US 9,764,003. Settlement agreements in ANDA litigation may contain confidential or product-specific launch provisions. A settlement can permit an earlier launch without invalidating the patent and without granting a general license to the market.

What generic launch scenarios exist?

Scenario 1: Launch after March 2031

A generic or authorized generic could launch after the patent's reported expiration, subject to surviving formulation, process, composition, and regulatory barriers.

Scenario 2: Earlier launch under a settlement

Novo Nordisk and a challenger could agree to an entry date before March 2031. The settlement could restrict the launch to a particular indication, dose, formulation, or supply arrangement.

Scenario 3: Paragraph IV victory

A challenger could obtain an earlier launch after prevailing on invalidity, unenforceability, or noninfringement. The result could be limited to US 9,764,003 and would not necessarily clear other semaglutide patents.

Scenario 4: Skinny-label launch

A generic could omit the weight-loss indication and seek approval for type 2 diabetes. This route would reduce direct exposure to the weight-reduction method claims but would not eliminate risk if the label or marketing materials encourage the patented use.

Scenario 5: Non-infringing dosing strategy

A competitor could use a dosing schedule outside 0.7 mg to 1.6 mg, combine semaglutide with another therapeutic agent, or use a non-weekly regimen. Such strategies may avoid literal infringement of claim 1 but could encounter other patents or induced-infringement theories.

How does US 9,764,003 compare with competing GLP-1 patent estates?

Drug	Sponsor	Main US product	Patent-estate profile
Semaglutide	Novo Nordisk	Ozempic, Wegovy, Rybelsus	Broad compound, formulation, oral-delivery, manufacturing, and method-of-use families
Tirzepatide	Eli Lilly	Mounjaro, Zepbound	Compound, formulation, dosing, and method patents; dual GIP/GLP-1 mechanism
Liraglutide	Novo Nordisk	Victoza, Saxenda	Earlier GLP-1 estate with more mature generic exposure
Dulaglutide	Eli Lilly	Trulicity	Biologic-like peptide/protein product estate with formulation and method protection
Exenatide	Amylin/AstraZeneca and others	Byetta, Bydureon	Older estate with substantially earlier loss-of-exclusivity issues

Semaglutide's competitive advantage is protected by an estate rather than by US 9,764,003 alone. The most important barriers include the active-ingredient family, injectable formulation claims, oral absorption technology, and manufacturing patents.

What geographic coverage does the patent have?

US 9,764,003 has effect only in the United States. Corresponding foreign applications may have been filed in Europe, Japan, Canada, China, and other jurisdictions, but each national or regional right has its own prosecution history, claim scope, term, opposition record, and validity status.

A US design-around does not establish freedom to operate elsewhere. Conversely, expiration or invalidation of a foreign counterpart does not affect the US patent. Global semaglutide launch planning requires a country-by-country family review.

What manufacturing and intellectual-property barriers remain?

Even after a method patent expires, a competing manufacturer may face:

• difficulty reproducing semaglutide purity and impurity controls;
• peptide synthesis and conjugation know-how;
• injectable formulation and device requirements;
• scale-up and batch consistency requirements;
• analytical comparability obligations;
• device patents and human-factors requirements;
• manufacturing process patents;
• supply constraints for peptide intermediates;
• FDA inspection and quality-system requirements.

For R&D and licensing purposes, US 9,764,003 is best treated as one layer of a multilayered exclusivity structure. Avoiding the claimed weight-loss regimen does not necessarily establish freedom to operate for semaglutide products.

Key Takeaways

• US 9,764,003 is a Novo Nordisk method-of-use patent for once-weekly semaglutide used to reduce body weight.
• Claim 1 covers 0.7 mg to 1.6 mg per week and requires administration without another therapeutic agent.
• Claim 4 specifically covers approximately 0.8 mg once weekly.
• Claims 5 and 6 add type 2 diabetes and subcutaneous injection limitations.
• The reported patent expiration date is March 20, 2031.
• The patent does not protect semaglutide as a molecule or broadly protect every semaglutide product.
• Wegovy is commercially relevant, but its current 2.4 mg maintenance dose is above claim 1's express 1.6 mg ceiling.
• Ozempic's 1 mg once-weekly regimen falls within the numeric range, but infringement depends on whether the claimed weight-reduction use is practiced or induced.
• Rybelsus is less directly exposed because its labeled regimen is oral and daily.
• Paragraph IV and skinny-label strategies could reduce or postpone the patent's blocking effect.
• Later semaglutide composition, formulation, manufacturing, and device patents may remain relevant after this patent expires.

FAQs About US Patent 9,764,003

Does US 9,764,003 cover semaglutide at 2.4 mg?

Not literally under claim 1, which ends at 1.6 mg. A separate patent or infringement theory could still apply to a 2.4 mg regimen.

Can a generic sell semaglutide for diabetes before March 2031?

Possibly. A diabetes-only label, a successful patent challenge, or a settlement could allow earlier entry. US 9,764,003 alone does not determine the full launch date.

Is US 9,764,003 a composition-of-matter patent?

No. It is a method-of-use patent. It claims a treatment regimen rather than the semaglutide molecule itself.

Does combining semaglutide with metformin avoid the patent?

It may avoid the literal "without another therapeutic agent" limitation, but the outcome depends on claim construction, prescribing instructions, actual use, and other asserted patents.

Is a biosimilar pathway available for Ozempic or Wegovy?

Semaglutide products are regulated as drugs rather than as conventional FDA biologics eligible for the ordinary biosimilar pathway. Competitors would generally pursue an ANDA, a 505(b)(2) application, or another applicable drug pathway.

References

1. U.S. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

2. U.S. Food and Drug Administration. (n.d.-b). Wegovy prescribing information. Novo Nordisk/FDA. https://www.accessdata.fda.gov/

3. U.S. Food and Drug Administration. (n.d.-c). Ozempic prescribing information. Novo Nordisk/FDA. https://www.accessdata.fda.gov/

4. U.S. Food and Drug Administration. (n.d.-d). Rybelsus prescribing information. Novo Nordisk/FDA. https://www.accessdata.fda.gov/

5. U.S. Patent and Trademark Office. (2017). US Patent No. 9,764,003 B2, Use of GLP-1 compounds. https://patents.google.com/patent/US9764003B2

6. Novo Nordisk A/S. (2025). Annual report 2024. https://www.novonordisk.com/investors/annual-report.html

Drugs Protected by US Patent 9,764,003

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	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-001	Jun 4, 2021		RX	Yes	Yes						METHOD FOR WEIGHT MANAGEMENT ACCORDING TO A DOSE ESCALATION SCHEDULE
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-007	May 5, 2026		RX	Yes	Yes						METHOD FOR WEIGHT MANAGEMENT ACCORDING TO A DOSE ESCALATION SCHEDULE
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-002	Jun 4, 2021		RX	Yes	Yes						METHOD FOR WEIGHT MANAGEMENT ACCORDING TO A DOSE ESCALATION SCHEDULE

Foreign Priority and PCT Information for Patent: 9,764,003

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

PCT Information
PCT Filed	June 21, 2013	PCT Application Number:	PCT/EP2013/063004
PCT Publication Date:	January 09, 2014	PCT Publication Number:	WO2014/005858

International Family Members for US Patent 9,764,003

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013286177
Australia	2018202504
Australia	2020202573