Details for Patent: 10,442,847

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Which drugs does patent 10,442,847 protect, and when does it expire?

Patent 10,442,847 protects ZEGALOGUE and ZEGALOGUE (AUTOINJECTOR) and is included in one NDA.

This patent has thirty-six patent family members in twenty-seven countries.

Summary for Patent: 10,442,847

Title:	Glucagon analogues
Abstract:	The present invention relates to glucagon analogs and their medical use, for example in the treatment of hypoglycaemia. In particular, the present invention relates to stable glucagon analogs suitable for use in a liquid formulation.
Inventor(s):	Ditte Riber, Lise Giehm
Assignee:	Zealand Pharma AS
Application Number:	US14/417,074
Patent Claim Types: see list of patent claims	Composition;

United States Patent 10,442,847: Claim Scope, Exclusivity, and Patent Landscape

U.S. Patent No. 10,442,847 protects one defined peptide sequence and pharmaceutical compositions containing that peptide. Based on the two claims provided, the patent does not independently claim a broad genus of GLP-1 analogs, a treatment method, a dosage regimen, a formulation platform, or a manufacturing process. Its commercial value therefore depends on whether the claimed sequence is used in an approved or pipeline product and whether broader, unprovided claims exist in the issued patent or related family.

What does U.S. Patent 10,442,847 claim?

The supplied claims cover:

Claim	Subject matter	Scope
1	The peptide Hy-HSQGTFTSDYSKYLD-Aib-ARAEEFVKWLEST-OH, identified as SEQ ID NO: 22, or a pharmaceutically acceptable salt	Exact compound protection
2	A pharmaceutical composition containing the claim 1 compound or salt and a pharmaceutically acceptable carrier	Composition protection

Claim 1 is the principal commercial claim. Claim 2 is a conventional composition claim that extends protection to drug products containing the exact peptide.

The patent issued on October 15, 2019, as U.S. Patent No. 10,442,847. The claims provided do not identify the assignee, priority application, patent family, or FDA product to which the patent is directed. Those details must be determined from the complete patent record and related prosecution history. (U.S. Patent No. 10,442,847, 2019).

How broad is the compound claim?

Claim 1 is narrow in chemical scope but potentially strong against an identical product.

Exact sequence requirement

The claim requires the specified sequence, including:

• The N-terminal residue represented by “Hy”
• The sequence HSQGTFTSDYSKYLD
• The non-natural amino acid Aib
• The sequence ARAEEFVKWLEST
• The terminal hydroxyl group represented by -OH

A product that differs by one amino acid, changes the position of Aib, removes a residue, adds a residue, or uses a different terminal modification would generally fall outside the literal sequence limitation unless the patent’s claim-construction record supports an equivalent.

The sequence listing is important. “Hy” is not a conventional three-letter amino acid abbreviation used in standard peptide nomenclature. The patent’s specification and sequence listing should control its meaning. If “Hy” represents a defined residue, the claim covers that defined residue. If it is a transcription or sequence-formatting issue, the prosecution record may affect claim interpretation.

Aib limitation

Aib is alpha-aminoisobutyric acid, also called 2-amino-2-methylpropanoic acid. It is a non-proteinogenic amino acid commonly used to increase alpha-helical structure and modify receptor activity or metabolic stability.

The location of Aib is material. The claim does not cover all GLP-1 analogs containing Aib. It covers the specified sequence with Aib at the position shown in SEQ ID NO: 22.

Salt coverage

The phrase “or a pharmaceutically acceptable salt thereof” covers salt forms of the claimed peptide. Depending on the specification and applicable claim construction, this may include peptide salts formed with pharmaceutically acceptable acids or bases.

Salt coverage ordinarily does not automatically extend to:

• Covalent lipid conjugates
• PEGylated derivatives
• Prodrugs
• Peptide fragments
• Esterified analogs
• Amide-terminal analogs
• Radiolabeled versions
• Conjugates with materially different molecular structures

Those variants require separate claim language or an equivalence analysis.

What does the composition claim protect?

Claim 2 requires a pharmaceutical composition containing:

1. The exact claim 1 peptide or its pharmaceutically acceptable salt; and
2. A pharmaceutically acceptable carrier.

The carrier limitation is broad. It can include excipients used in injectable, liquid, lyophilized, oral, nasal, or other dosage forms, provided the composition satisfies the patent’s pharmaceutical-composition requirements.

The claim does not, based on the language supplied, require:

• A specific concentration
• A specific dose
• A particular route of administration
• A particular buffer
• A specific pH
• A defined stabilizer
• A particular device
• A specific indication
• A particular pharmacokinetic profile

This makes claim 2 broader than a narrowly defined formulation claim, but it remains dependent on the presence of the exact peptide.

Does the patent claim a GLP-1 treatment method?

Not in the claims supplied.

There is no express claim to:

• Treating diabetes
• Treating obesity
• Reducing body weight
• Improving glycemic control
• Activating the GLP-1 receptor
• Activating both GLP-1 and glucagon receptors
• Administering the peptide at a specified dose
• Treating a defined patient population

Any method-of-use protection would have to appear in other claims, a continuation, a divisional, or a related patent family member. The two supplied claims alone do not create method-of-use exclusivity.

What is the likely pharmacological significance of the sequence?

The sequence is a modified peptide related to the GLP-1 peptide family. It contains Aib, a residue frequently used in long-acting incretin and incretin-related peptide programs.

The sequence has several characteristics associated with engineered peptide receptor agonists:

Structural element	Potential development purpose
Aib substitution	Increased helical stability and altered receptor activity
Aromatic residues	Receptor-binding contribution and structural stabilization
Glutamate-rich segment	Changes in charge, solubility, and receptor interaction
Defined C-terminal sequence	Preservation or modification of receptor pharmacology
Peptide salt coverage	Support for pharmaceutical isolation and formulation

The sequence alone does not establish whether the compound is a GLP-1 receptor agonist, a dual agonist, a glucagon receptor agonist, or another peptide with incretin-related activity. Functional activity must be established from the specification, examples, assay data, and prosecution record.

When does U.S. Patent 10,442,847 lose exclusivity?

The statutory patent term is generally 20 years from the earliest effective U.S. nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory adjustments. The issue date of October 15, 2019, is not the relevant expiration-date anchor. (35 U.S.C. §§ 154, 156, 2024).

Exclusivity element	Status based on supplied information
Patent issue date	October 15, 2019
Statutory term	Generally 20 years from earliest effective nonprovisional filing date
Patent-term adjustment	Must be checked in the USPTO patent record
Patent-term extension under 35 U.S.C. § 156	No extension established from the supplied claims
Terminal disclaimer	Not established from the supplied claims
FDA regulatory exclusivity	Not established
Exact expiration date	Requires the priority and USPTO term records

A patent expiration date cannot be inferred from the two claim texts. The controlling analysis requires the earliest priority date, continuation history, PTA, PTE, and any terminal disclaimer.

Can FDA exclusivity extend beyond patent expiration?

Potentially. If the peptide were approved under an NDA, it could receive FDA regulatory exclusivity independent of patent protection. Relevant forms may include:

• Five-year new chemical entity exclusivity
• Three-year exclusivity for certain changes to an approved drug
• Seven-year orphan-drug exclusivity
• Six-month pediatric exclusivity

No FDA regulatory exclusivity can be attributed to this patent from the claims alone. FDA exclusivity attaches to an approved application and indication, not to a patent number. (U.S. Food and Drug Administration, 2024a).

What is the Orange Book status of U.S. Patent 10,442,847?

The Orange Book does not automatically list every patent that claims a pharmaceutical compound. Listing generally requires an approved NDA holder to submit the patent for an approved drug product and for the patent to fall within FDA listing categories, such as drug substance, drug product, or approved method of use.

The supplied claims do not establish that Patent 10,442,847 is listed in the Orange Book.

Orange Book question	Assessment
Is the patent automatically Orange Book-listed?	No
Does claim 1 resemble a drug-substance claim?	Yes
Does claim 2 resemble a drug-product claim?	Potentially
Is a listed NDA established?	No
Is a Paragraph IV challenge established?	No
Is a 30-month stay established?	No

If the patent is listed against an approved product, a generic applicant could address it in an ANDA certification. A Paragraph IV certification would assert that the patent is invalid, unenforceable, or not infringed. A Paragraph IV notice could trigger patent litigation under the Hatch-Waxman Act. (21 U.S.C. § 355; 21 C.F.R. § 314.107).

What generic entry risks exist?

The generic entry risk is different for an exact peptide drug than for a conventional small-molecule medicine.

Exact-copy risk

If the reference product contains the claimed peptide, an ANDA applicant would face a direct infringement risk for an exact active ingredient. Claim 1 would be the principal asserted patent.

Claim 2 could be asserted against the finished dosage form if the generic product contains the peptide with a pharmaceutical carrier.

Design-around risk

The narrow sequence claim creates design-around opportunities. A competitor could investigate:

• A single-residue substitution
• Relocation or replacement of Aib
• A different terminal group
• A lipidated version
• A PEGylated version
• A prodrug
• A different peptide backbone
• A nonpeptide receptor agonist

Whether a modified product avoids infringement would depend on literal claim scope and the doctrine of equivalents. A material change in sequence or covalent structure would generally improve design-around prospects, but may also change receptor potency, selectivity, stability, or manufacturability.

505(b)(2) risk

A 505(b)(2) applicant could face a different patent strategy from a conventional ANDA applicant if it relies on an existing product or published literature while introducing a modified formulation, route, indication, or delivery system. Patent exposure would depend on the approved product, listed patents, labeling, and the proposed product’s composition.

Are Paragraph IV challenges or patent litigation known?

No Paragraph IV certification, Hatch-Waxman lawsuit, or settlement agreement is established by the claim text.

A complete litigation review should distinguish among:

• ANDA litigation under 21 U.S.C. § 355(j)
• Declaratory-judgment actions
• Contract disputes involving licenses
• Inter partes review proceedings
• Post-grant review
• Opposition or revocation proceedings outside the United States
• Inventorship and ownership disputes

The absence of litigation information in the supplied material means the patent’s litigation status cannot be determined from the claims alone. Patent litigation databases and USPTO Patent Center records are required for a definitive status review.

Does biosimilar risk apply?

No. Biosimilar regulation applies to biological products licensed under the Public Health Service Act. A synthetic or chemically manufactured peptide would ordinarily be analyzed under the small-molecule drug framework, although regulatory classification can depend on the product’s manufacturing process and FDA determination.

If the claimed peptide is manufactured as a chemically synthesized drug substance, the relevant competitive pathways are more likely to be:

• ANDA approval under section 505(j)
• 505(b)(2) approval
• A stand-alone NDA
• A drug-device combination pathway where applicable

The Purple Book is not the primary database for a conventional synthetic peptide. (U.S. Food and Drug Administration, 2024b).

How does this patent compare with major GLP-1 patent estates?

Patent 10,442,847 should be viewed as a sequence-specific asset rather than as a complete GLP-1 franchise patent.

Patent estate type	Typical protection	Relative breadth
Exact peptide claim	Defined amino-acid sequence	Narrow but direct
Broad peptide genus	Multiple substitutions and sequence variants	Wider
Conjugate claim	Lipid, PEG, albumin-binding, or other covalent modification	Product-specific
Formulation claim	Concentration, buffer, stabilizer, device, or release profile	Product and dosage-form specific
Method-of-use claim	Diabetes, obesity, NASH, or cardiovascular indications	Indication-specific
Manufacturing claim	Solid-phase synthesis, purification, folding, or isolation	Process-specific
Device claim	Pen injector, cartridge, dose-control mechanism	Delivery-specific

Major GLP-1 products such as semaglutide, liraglutide, dulaglutide, and tirzepatide have multi-layered estates covering active compounds, conjugates, formulations, uses, devices, and manufacturing. A two-claim patent directed to one peptide sequence is unlikely, by itself, to create comparable franchise-level protection.

What formulations are protected by the patent?

Claim 2 potentially covers any pharmaceutical composition containing the claimed peptide and a pharmaceutically acceptable carrier. The claim, as supplied, does not require a particular formulation architecture.

Potentially covered products could include:

• Aqueous injectable solutions
• Lyophilized injectable products
• Pre-filled syringe formulations
• Cartridge formulations
• Multi-dose pen products
• Buffered peptide solutions
• Products containing stabilizing excipients

The claim does not necessarily cover a formulation that excludes the claimed compound, even if it has similar pharmacology. Nor does it establish protection for a specific device, concentration, release profile, or excipient combination.

Narrower formulation claims may exist elsewhere in the patent family. They should not be assumed from claim 2.

Are licensing deals associated with this patent?

No licensing deal can be established from the supplied claims.

A patent ownership review should examine:

• Assignment records at the USPTO
• Security interests
• Joint-development agreements
• Exclusive or nonexclusive licenses
• University or government funding rights
• Patent family assignments in Europe, Japan, China, and other jurisdictions
• Change-of-control transactions involving the patent owner

An assignment is not the same as a license. A recorded assignment transfers ownership; a license may remain confidential and may not appear in the public patent file.

What is the geographic coverage?

U.S. Patent 10,442,847 provides rights only in the United States. International protection depends on related applications and national-phase filings.

Relevant jurisdictions for a peptide drug typically include:

• European Patent Office
• China
• Japan
• South Korea
• Canada
• Australia
• Brazil
• India

Foreign family members may have different claim scope, prosecution outcomes, opposition histories, and expiration dates. A U.S. composition claim does not establish protection in any foreign market.

How strong is the patent estate?

Based only on the two supplied claims, the asset has high directness but limited breadth.

Strength factor	Assessment
Identity of protected compound	Strong if SEQ ID NO: 22 is unambiguous
Literal coverage of exact product	Potentially strong
Coverage of analogs	Weak
Coverage of methods of use	None shown
Coverage of formulations	Broad carrier claim, but compound-dependent
Coverage of manufacturing	None shown
Design-around exposure	Material
Orange Book value	Unknown without NDA linkage
Biosimilar relevance	Low for a conventional synthetic peptide
Franchise-level blocking power	Not established

The most important diligence issue is whether the patent is one member of a broader family containing genus, conjugate, formulation, method, or manufacturing claims. The supplied claims alone describe a narrow composition patent, not a comprehensive product estate.

What revenue exposure can be attributed to this patent?

No revenue exposure can be reliably assigned from the patent number alone.

A revenue analysis would require a demonstrated link between:

1. The claimed peptide;
2. A clinical or commercial product;
3. The product’s sponsor or licensee;
4. An approved indication;
5. Sales attributable to the protected formulation; and
6. The patent’s remaining enforceable term.

If the peptide is not an approved or advanced clinical product, the patent’s current revenue exposure may be limited to pipeline value, licensing leverage, or blocking value against a competing development program.

Key Takeaways

• Claim 1 covers one specified peptide sequence, SEQ ID NO: 22, and pharmaceutically acceptable salts.
• Claim 2 covers pharmaceutical compositions containing that exact peptide or salt with a pharmaceutically acceptable carrier.
• The supplied claims do not cover a broad GLP-1 analog genus, treatment methods, dosing regimens, manufacturing methods, devices, or defined formulations.
• Aib is a material structural limitation and may provide a clear design-around point.
• The patent issued October 15, 2019, but its expiration date requires the priority, PTA, PTE, and terminal-disclaimer records.
• Orange Book listing, Paragraph IV activity, litigation, settlements, and licensing cannot be established from the supplied claims.
• Biosimilar analysis is generally not the principal risk framework for a chemically synthesized peptide.
• The patent’s value depends on whether the claimed sequence is present in an approved or pipeline product and whether broader family claims exist.

FAQs

Is U.S. Patent 10,442,847 a patent on semaglutide?

The supplied claims do not identify semaglutide. They cover the sequence identified as SEQ ID NO: 22. Sequence identity must be compared directly against the active ingredient and any conjugated form of the relevant product.

Can a competitor avoid claim 1 by changing one amino acid?

Potentially. A one-residue substitution may avoid literal infringement of an exact-sequence claim, although the doctrine of equivalents and other patent claims could remain relevant.

Does claim 2 cover every injectable formulation of the peptide?

Potentially, if the injectable product contains the claimed peptide or salt and a pharmaceutically acceptable carrier. The supplied claim does not require a particular injectable excipient or concentration.

Can this patent block a different GLP-1 peptide?

Not automatically. A different peptide would need to satisfy the exact sequence limitations of claim 1 or fall within an applicable equivalents analysis. Separate genus or method claims could produce a broader blocking position.

Is the patent still enforceable after FDA approval?

Potentially. FDA approval does not eliminate patent rights. Enforceability depends on the patent’s term, maintenance fees, validity, ownership, and any applicable regulatory exclusivity.

References

1. United States Patent No. 10,442,847. (2019). Patent document and issued claims. United States Patent and Trademark Office.

2. U.S. Food and Drug Administration. (2024a). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (2024b). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov/

4. 21 U.S.C. § 355. (2024). New drugs and abbreviated new drug applications.

5. 35 U.S.C. § 154. (2024). Contents and term of patent; provisional rights.

6. 35 U.S.C. § 156. (2024). Extension of patent term.

7. 21 C.F.R. § 314.107. (2024). Date of approval of an application or abbreviated application.

Drugs Protected by US Patent 10,442,847

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		DISCN	Yes	No	10,442,847		Y	Y
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		DISCN	Yes	No	10,442,847		Y	Y

Foreign Priority and PCT Information for Patent: 10,442,847

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	PA 2013 00360	Jun 14, 2013

PCT Information
PCT Filed	July 23, 2013	PCT Application Number:	PCT/EP2013/065519
PCT Publication Date:	January 30, 2014	PCT Publication Number:	WO2014/016300

International Family Members for US Patent 10,442,847

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2875043		301294	Netherlands
European Patent Office	2875043		CR 2024 00043	Denmark
European Patent Office	2875043		122024000057	Germany
European Patent Office	2875043		C20240034	Finland
European Patent Office	2875043		24C1043	France
European Patent Office	2875043		2490313-0	Sweden
European Patent Office	2875043		C202430042	Spain