US Patent 9,962,422: Vasopressin Formulation Claims, Scope, Expiration Risk, and Patent Landscape

US Patent No. 9,962,422 protects a narrow method of treating hypotension with a stored, diluted vasopressin formulation. The independent claim is not directed to vasopressin generally, a finished vial generally, or intravenous vasopressin administration generally. It requires a specific formulation, pH range, peptide content, storage period, concentration, dosing rate, and hypotensive patient population.

The principal commercial relevance is potential coverage of ready-to-use or premixed vasopressin products used in intensive-care settings, including vasodilatory, septic, and post-cardiotomy shock.

What does US Patent 9,962,422 claim?

Claim 1 combines formulation, storage, administration, dosage, and disease-state limitations. A potentially infringing method must satisfy all material limitations:

Claim element	Required scope
Active ingredient	Vasopressin or a pharmaceutically acceptable salt
Vasopressin concentration	About 0.1 to about 2 micrograms/mL
Dextrose	Required, with no concentration in claim 1
Buffer	About 1 to about 10 mM acetate buffer
Peptides	About 1.5% to about 12.9%
pH	3.6 to 3.9
Storage	At least about 24 hours at the specified vasopressin concentration
Administration	Intravenous
Dose rate	About 0.01 to about 0.1 units/minute
Patient	Hypotensive human
Therapeutic objective	Increasing blood pressure

The claim is therefore a combination claim. Omitting or changing one required element may avoid literal infringement, although the doctrine of equivalents could remain relevant depending on the asserted element and prosecution history.

How broad is the independent claim?

Claim 1 is technically narrow but commercially meaningful. Its breadth comes from the number of product configurations and clinical scenarios within the numerical ranges. Its vulnerability comes from the same feature: a challenger can potentially design around one or more formulation, storage, or dosing limitations.

Formulation limitations

The claimed composition includes:

Vasopressin or a pharmaceutically acceptable salt.
Dextrose.
Acetate buffer at approximately 1 to 10 mM.
A plurality of peptides at approximately 1.5% to 12.9%.
A pH between 3.6 and 3.9.

The pH range is especially restrictive. A formulation at pH 4.0 would be outside the literal scope of claim 1. The dependent claims narrow the pH further to 3.74 to 3.75, 3.7 to 3.9 with approximately 1 mM acetate, or 3.6 to 3.7 with approximately 10 mM acetate.

The peptide limitation may present the principal claim-construction issue. The supplied claim language does not define the identity, molecular-weight distribution, source, or analytical method for the “plurality of peptides.” A dispute may arise over whether the term refers to peptide impurities, degradation products, excipients, process-related species, or an intentionally added peptide mixture. The percentage basis also matters. A percentage measured by weight, mass balance, chromatographic area, or another analytical method could produce materially different infringement results.

Storage limitation

Claim 1 requires storage for at least approximately 24 hours at a vasopressin concentration of 0.1 to 2 micrograms/mL before administration. This limitation distinguishes the claim from a process in which vasopressin is diluted immediately before use.

The storage requirement creates several factual questions:

Whether the product must be stored by the manufacturer, hospital, pharmacy, or treating institution.
Whether refrigerated and room-temperature storage are treated identically.
Whether the product must remain within the claimed concentration throughout storage.
Whether a single administration from a stored container is sufficient.
Whether a hospital protocol or product label establishes the required storage step.

A product label that instructs dilution and use within 24 hours could create stronger method-of-use exposure than a vial administered immediately after preparation.

Administration limitations

The claimed dose is 0.01 to 0.1 units per minute. The formulation administered to the patient must also contain 0.1 to 2 micrograms/mL of vasopressin.

The claim does not require a particular total dose, infusion volume, pump type, treatment duration, or clinical endpoint beyond increasing blood pressure. It does require intravenous administration and a hypotensive patient.

Because the claimed dose is expressed in units per minute while concentration is expressed in micrograms per milliliter, an infringement analysis would need to evaluate both the preparation concentration and the infusion rate. A product could fall within the concentration range but be administered outside the claimed dose range.

What do dependent claims 2 through 17 add?

The dependent claims provide narrower fallback positions and identify the commercial and clinical embodiments most likely to be asserted.

Claims	Added limitation	Commercial significance
2	Peptides at approximately 1.5% to 5%	Narrows the peptide range
3	pH-adjusting agent	Captures formulation adjustment
4	Hydrochloric acid	Specific acidifying agent
5	Sodium hydroxide	Specific alkalinizing agent
6	Dextrose at 5%	Aligns with common dextrose solution practice
7	Administration over approximately one day	Supports short-course infusion
8	Administration over approximately one week	Covers prolonged infusion
9	Mean arterial pressure increases within 15 minutes	Adds an early clinical response
10	Vasodilatory shock	Defines the principal disease category
11	Post-cardiotomy shock	Covers cardiac-surgery-related shock
12	0.03 to 0.1 units/minute for post-cardiotomy shock	Higher dosing range
13	Septic shock	Covers sepsis-associated hypotension
14	0.01 to 0.07 units/minute for septic shock	Lower septic-shock range
15	pH 3.74 to 3.75	Very narrow pH fallback
16	Approximately 1 mM acetate and pH 3.7 to 3.9	Low-buffer formulation
17	Approximately 10 mM acetate and pH 3.6 to 3.7	High-buffer formulation

Claims 10 through 14 are important for product-label and clinical-protocol analysis. A vasopressin product used in septic shock may fall within claim 14 if the formulation and storage conditions also satisfy claim 1. A post-cardiotomy protocol may implicate claim 12 at higher infusion rates.

What formulations are protected by US 9,962,422?

The strongest apparent formulation target is a diluted vasopressin infusion containing dextrose, acetate buffer, and a specified peptide population at acidic pH. Claim 6 makes a 5% dextrose embodiment particularly important.

The claims do not require a particular container, closure, preservative, surfactant, tonicity agent, or manufacturing process. They also do not expressly require a commercial vial, premixed bag, or syringe. The protected subject matter can therefore reach multiple dosage forms if they meet the claimed composition and clinical-use limitations.

Likely covered formulation profiles

A formulation is more likely to fall within the literal scope if it has all of the following characteristics:

Vasopressin concentration between 0.1 and 2 micrograms/mL.
Dextrose, especially 5% dextrose.
Acetate buffer between 1 and 10 mM.
pH between 3.6 and 3.9.
Peptide content between 1.5% and 12.9%.
Storage for at least 24 hours before intravenous use.

Potential design-around profiles

Potential design-around approaches include:

Using a pH outside 3.6 to 3.9.
Replacing acetate with another buffer.
Using a vasopressin concentration outside 0.1 to 2 micrograms/mL.
Administering the product immediately after preparation.
Avoiding the claimed peptide content or using a formulation with a different analytical profile.
Administering outside the claimed units-per-minute range.
Using a nonintravenous route, where clinically appropriate.
Using a formulation without dextrose.

Each approach carries technical and regulatory consequences. A change that avoids the patent may require new stability data, compatibility studies, container-closure work, or a different FDA submission strategy.

Does US 9,962,422 cover vasopressin itself?

No. The claims do not claim vasopressin as a molecule. They claim a method of using a particular vasopressin-containing formulation in a defined treatment setting.

A competing manufacturer could therefore use the same active ingredient and potentially avoid the patent if its formulation, storage conditions, concentration, dose, or clinical-use instructions fall outside the claimed combination.

The patent is best characterized as a formulation-linked method-of-treatment patent rather than a compound patent.

What is the FDA and Orange Book relevance?

Vasopressin products are regulated as prescription drugs, and the FDA-approved labeling determines the labeled concentration, preparation instructions, storage conditions, indications, and dosing information relevant to induced infringement and regulatory exposure.

For an NDA product, Orange Book-listed patents can support a Paragraph IV certification by an ANDA applicant. The Orange Book status of US 9,962,422 cannot be established from the claim text alone. A current Orange Book record and the relevant NDA patent listing would control that determination. The patent’s inclusion, if any, would not by itself establish validity or infringement.

Regulatory facts relevant to analysis

The key regulatory documents are:

The approved product label.
The NDA’s patent listing in the Orange Book.
Any approved supplements affecting concentration, preparation, or storage.
ANDA certifications and FDA approval dates.
Any pediatric-exclusivity or patent-term-adjustment entries.

A generic applicant’s risk depends heavily on whether its label instructs the same preparation, storage, dose range, and disease-specific administration described in claims 1, 10, 11, 13, and 14.

When does US 9,962,422 lose exclusivity?

The precise expiration date cannot be calculated from the patent number and claims alone. Patent term ordinarily runs 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and applicable priority claims under 35 U.S.C. §§ 154 and 156.

The patent issued in 2018. The statutory expiration date must therefore be taken from the USPTO patent record and any terminal-disclaimer or patent-term-adjustment data. An issue date is not the same as an expiration date.

For commercial planning, the relevant exclusivity date is the later of:

The patent’s enforceable expiration date.
Any applicable FDA regulatory exclusivity.
The date on which a generic or competing product can lawfully enter after litigation or settlement.

A formulation patent may expire after earlier vasopressin patents, leaving a product exposed to a later method-of-use barrier even after earlier composition or manufacturing patents have expired.

How strong is the patent estate?

Based on the supplied claims, US 9,962,422 has moderate commercial value and mixed litigation strength.

Strengths

It combines multiple formulation and use limitations that may be present in a branded ready-to-use product.
The claims address actual hospital-use conditions, including storage before administration.
Dependent claims preserve narrower positions for 5% dextrose, specific pH values, septic shock, and post-cardiotomy shock.
The claim does not depend on a single brand name or a particular container configuration.
A label directing the claimed preparation, storage, and dosing could support an induced-infringement theory.

Weaknesses

The “plurality of peptides” limitation may create claim-construction and proof problems.
Numerical ranges invite invalidity challenges based on anticipation, obviousness, written description, and enablement.
The storage step may be difficult to attribute to a single actor if preparation and administration occur across a manufacturer, pharmacy, hospital, and clinician.
The claim requires several cumulative limitations, creating design-around opportunities.
The claim is vulnerable if prior art disclosed diluted vasopressin with dextrose, acidic buffer, storage, and intravenous treatment before the critical filing date.
Claims 7 and 8 may be difficult to apply where treatment duration varies by patient.

Which prior-art categories are most relevant?

The most important prior-art categories are:

Prior-art category	Relevance
Vasopressin injection labels	Dose, indication, concentration, route, and storage
Premixed vasopressin formulations	Composition and stability
Peptide-drug stability publications	Degradation and buffer selection
Hospital compounding protocols	Storage and administration practices
Shock-treatment guidelines	Dose ranges and disease populations
FDA-approved vasopressin products	Public use and labeling history
Earlier patent families	Formulation and method-of-use disclosures

A validity challenge would likely focus on whether the claimed combination was obvious from known vasopressin dosing, dextrose diluents, acetate buffering, acidic pH control, and peptide stability data. The strongest defense would depend on unexpected stability, improved shelf life, reduced degradation, or a clinically meaningful benefit tied to the claimed parameters.

Are Paragraph IV challenges likely?

A Paragraph IV challenge would be credible if an ANDA applicant could show that its product does not infringe because it uses a different pH, buffer, concentration, peptide profile, or storage instruction. It could also challenge validity under Sections 102 and 103 of the Patent Act.

The most probable certification strategies are:

Noninfringement based on a formulation outside the claimed pH or acetate range.
Noninfringement based on no 24-hour storage instruction.
Noninfringement based on a different vasopressin concentration.
Invalidity based on prior art concerning vasopressin dilution and stability.
Invalidity based on indefiniteness or inadequate written description for the peptide limitation.
A label carve-out for a disease state or dosing regimen, if FDA rules permit it.

The availability of a section viii statement would depend on the precise Orange Book-listed use code. A method claim covering the general treatment of hypotension may be harder to carve out than a narrowly identified indication.

What generic entry risks exist?

Generic entry risk is product-specific. A conventional vasopressin injection that is supplied at a different concentration or requires immediate dilution may avoid the patent. A ready-to-use diluted product with 5% dextrose, acetate buffer, acidic pH, and 24-hour storage instructions presents a higher risk.

Generic profile	Relative risk under the supplied claims
Undiluted vasopressin concentrate	Lower
Different buffer system	Lower
pH outside 3.6 to 3.9	Lower
Same formulation but immediate-use instructions	Potentially lower
Same formulation stored at least 24 hours	Higher
Same formulation, septic-shock dosing	Higher
Same formulation, post-cardiotomy dosing	Higher
Same formulation with 5% dextrose	Higher
Formulation with uncertain peptide content	Fact-dependent

The practical risk is highest where the generic label reproduces the branded product’s preparation and storage instructions. Under the Hatch-Waxman framework, FDA approval does not eliminate patent litigation risk.

What patent litigation and licensing issues matter?

The claim set alone does not establish whether US 9,962,422 has been asserted, challenged, settled, licensed, terminally disclaimed, or listed in the Orange Book. Those matters must be determined from PACER, USPTO prosecution records, FDA Orange Book data, and public settlement filings.

A licensing review should examine:

Assignments and security interests.
Exclusive or nonexclusive licenses.
Covenants not to sue.
ANDA litigation settlements.
Authorized-generic arrangements.
Royalty obligations.
Patent-term-extension rights.
Any terminal disclaimer with related patents.

A settlement could permit entry before patent expiration while imposing restrictions on launch timing, product formulation, or authorized-generic competition. The absence of a reported litigation case would not establish that the patent is unasserted or commercially irrelevant.

How does this patent compare with compound and manufacturing patents?

US 9,962,422 occupies a different position from the principal patent categories in pharmaceutical portfolios.

Patent type	What it protects	Typical relevance
Compound patent	Vasopressin molecule or analog	Broadest chemical protection, if valid
Composition patent	Specific formulation	Protects product architecture
Method-of-use patent	Treatment of hypotension or shock	Protects clinical use
Manufacturing patent	Synthesis, purification, or filling	Creates process and supply-chain barriers
Device patent	Infusion container or delivery system	Protects administration hardware
Stability patent	Storage, pH, buffer, or degradation control	Relevant to ready-to-use products

This patent is a hybrid composition and method-of-treatment asset. It is narrower than a compound patent but may be more relevant to a commercial premixed product.

Key Takeaways

US 9,962,422 claims a method using a stored, diluted vasopressin formulation, not vasopressin itself.
Claim 1 requires all of the following: vasopressin, dextrose, acetate buffer, peptide content, pH 3.6 to 3.9, at least 24 hours of storage, intravenous administration, a specified infusion rate, and a hypotensive patient.
Claims 6, 10, 12, 13, 14, 16, and 17 identify commercially important embodiments.
The “plurality of peptides” limitation is likely to be central to claim construction, infringement proof, and validity analysis.
Ready-to-use products matching the claimed pH, buffer, dextrose, storage, and dosing conditions present the highest risk.
The exact patent expiration date and current Orange Book, litigation, and settlement status are not established by the supplied claim text.
Generic design-around opportunities exist through changes to pH, buffer, concentration, storage instructions, peptide profile, or dosing protocol.
The patent’s value depends more on the branded product label and formulation than on vasopressin’s active ingredient alone.

FAQs

Does US 9,962,422 cover a hospital-compounded vasopressin infusion?

Potentially. The claim does not limit the formulation to a manufacturer-prepared commercial product. A hospital-compounded infusion could fall within the claim if it satisfies the formulation, storage, concentration, pH, peptide, intravenous-use, and dosing limitations.

Can a generic avoid US 9,962,422 by changing only the acetate buffer?

Potentially, if the replacement buffer produces a formulation outside the claimed 1 to 10 mM acetate-buffer limitation. The generic would still need to evaluate the doctrine of equivalents and all other relevant patents.

Is the 24-hour storage requirement a major infringement limitation?

Yes. It distinguishes the claimed method from immediate dilution and administration. Evidence concerning product labeling, pharmacy protocols, hospital storage, and actual administration timing would be important.

Does a vasopressin product at 5% dextrose automatically infringe?

No. The 5% dextrose limitation appears in dependent claim 6. The product would also need to satisfy claim 1 and, for claim 6, the remaining limitations including acetate concentration, pH, peptide content, storage, intravenous administration, dose, and hypotension.

Could a product administered for septic shock fall outside the patent?

Yes. Septic shock alone does not establish infringement. The product and method must also meet the formulation, storage, concentration, pH, peptide, route, and dose requirements. Claim 14 narrows the septic-shock embodiment to approximately 0.01 to 0.07 units per minute.

References

United States Patent No. 9,962,422, claims 1-17. United States Patent and Trademark Office, 2018.
United States Patent Act, 35 U.S.C. §§ 102, 103, 112, 154, and 156.
United States Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
United States Food and Drug Administration. (n.d.). Hatch-Waxman amendments and abbreviated new drug applications.
United States Food and Drug Administration. (n.d.). Vasopressin injection prescribing information.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-005	Apr 21, 2021	AP	RX	Yes	Yes	9,962,422	⤷ Start Trial				TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES	⤷ Start Trial
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-003	Apr 15, 2020	AP	RX	Yes	Yes	9,962,422	⤷ Start Trial				TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES	⤷ Start Trial
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-006	Apr 12, 2023		DISCN	Yes	No	9,962,422	⤷ Start Trial				TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES	⤷ Start Trial
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-004	Apr 15, 2020		DISCN	Yes	No	9,962,422	⤷ Start Trial				TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Details for Patent: 9,962,422

Which drugs does patent 9,962,422 protect, and when does it expire?

Summary for Patent: 9,962,422