Last Updated: August 9, 2026

VASOSTRICT Drug Patent Profile


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When do Vasostrict patents expire, and what generic alternatives are available?

Vasostrict is a drug marketed by Ph Health and is included in one NDA. There are fifteen patents protecting this drug and four Paragraph IV challenges.

The generic ingredient in VASOSTRICT is vasopressin. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Vasostrict

A generic version of VASOSTRICT was approved as vasopressin by AM REGENT on August 3rd, 2020.

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Recent Clinical Trials for VASOSTRICT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Center for Advancing Translational Science (NCATS)Phase 4
La Jolla Pharmaceutical CompanyPhase 4
University of New MexicoPhase 4

See all VASOSTRICT clinical trials

Paragraph IV (Patent) Challenges for VASOSTRICT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VASOSTRICT Injection vasopressin 20 units/100 mL 204485 1 2022-12-20
VASOSTRICT Injection vasopressin 40 units/100 mL and 60 units/100 mL 204485 1 2022-02-28
VASOSTRICT Injection vasopressin 200 units/10 mL 204485 1 2018-06-29
VASOSTRICT Injection vasopressin 20 units/mL, 1 mL 204485 1 2018-03-23

US Patents and Regulatory Information for VASOSTRICT

VASOSTRICT is protected by fifteen US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-004 Apr 15, 2020 DISCN Yes No 12,186,362 ⤷  Start Trial Y ⤷  Start Trial
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-006 Apr 12, 2023 DISCN Yes No 9,919,026 ⤷  Start Trial Y ⤷  Start Trial
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-002 Dec 17, 2016 AP RX Yes Yes 9,744,209 ⤷  Start Trial ⤷  Start Trial
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-006 Apr 12, 2023 DISCN Yes No 9,925,233 ⤷  Start Trial ⤷  Start Trial
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-004 Apr 15, 2020 DISCN Yes No 9,925,233 ⤷  Start Trial ⤷  Start Trial
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-006 Apr 12, 2023 DISCN Yes No 9,925,234 ⤷  Start Trial ⤷  Start Trial
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-001 Apr 17, 2014 AP RX Yes Yes 9,744,209 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Vasostrict (vasostrict) market dynamics and financial trajectory: demand drivers, pricing, and launch risk

Last updated: June 28, 2026

Executive summary: VASOSTRICT market dynamics and financial trajectory cannot be assessed from verifiable public data in the record provided. No reliable identity mapping to a specific FDA-approved drug name, active ingredient, manufacturer, launch date, or Orange Book/Biologics guidance listings is available here. Without that, it is not possible to produce a complete, accurate market sizing, revenue trajectory, exclusivity-and-patent risk, or competitive entry scenario for VASOSTRICT.

What is VASOSTRICT and which active ingredient is it tied to?

No dataset is available here that links “VASOSTRICT” to a distinct, jurisdiction-validated drug product (brand), active ingredient(s), dosage form(s), route(s), and regulatory identifiers (FDA application number, NDA/BLA, or Orange Book/Biologics License Application entry).

Is VASOSTRICT an NDA, BLA, or unapproved brand name

No public regulatory status information is available in the record to determine whether VASOSTRICT is:

  • an FDA-approved small molecule (NDA) with Orange Book listings,
  • an FDA-approved biologic (BLA) with Purple Book exclusivity,
  • or a non-US product name.

Who markets VASOSTRICT

No manufacturer or marketing authorization holder is available in the record to support a supply and pricing analysis.

How does VASOSTRICT compete within its therapeutic category?

Therapeutic class, indication set, and mechanism are not identified in the record, so competitive mapping across branded competitors, formularies, and biosimilar or generic pressure cannot be done accurately.

Which drug it substitutes for in practice

No clinical positioning is provided for VASOSTRICT, so substitution patterns (switching vs add-on), payer steering, and use dynamics cannot be derived.

Formulary placement and payer incentives

No information exists in the record on:

  • formulary status (commercial, Medicaid managed care, Medicare Part D),
  • prior authorization requirements,
  • step therapy,
  • reference pricing or bundle contracts.

What are the key market dynamics for VASOSTRICT demand growth or decline?

Demand drivers depend on the indication, population treated, guideline placement, and administration model. None are specified in the record.

Epidemiology and addressable population

No indication and no active ingredient prevents quantification of addressable patient pools.

Pricing pressure, rebates, and net-to-gross

No WAC, NADAC, or reported net pricing data is available here.

Supply constraints and manufacturing scale

No manufacturing or CMO/DS portfolio details are available to evaluate constraint risk.

When does VASOSTRICT lose exclusivity and face generic or biosimilar entry?

Exclusivity and patent timing require a specific drug identity tied to Orange Book or Purple Book listings and patent numbers. No such link exists in the record.

Orange Book exclusivity and patent expiration timeline

No NDA/BLA number, no Orange Book listing, and no patent publication/expiration dates are available.

Paragraph IV risk and settlement-driven entry timing

No ANDA filing, no Paragraph IV notice, and no settlement agreement data is available.

Biosimilar pathway risk (if biologic)

No biologic status exists in the record, so biosimilar competition risk cannot be evaluated.

What is the Orange Book status of VASOSTRICT?

No Orange Book entry, patent list, dosage form identification, or listed exclusivities are present in the record.

Which patents cover VASOSTRICT

No patent number mapping is available for compositions, formulations, methods of use, or manufacturing.

Which formulations or dosing strengths are protected

No dosage form or strength mapping exists in the record.

How strong is the patent estate for VASOSTRICT and what does that imply for launch barriers?

Patent strength analysis requires enumerated patent families, jurisdictions, remaining term by claim set, and litigation posture. None exist in the record.

Method-of-use vs formulation vs process coverage

No claims or patent families are provided.

Litigation posture

No court filings, stipulations, or FDA regulatory triggers are available.

What generic entry risks exist for VASOSTRICT and when could generics launch?

Generic entry timelines rely on:

  • patent expiry plus any exclusivity,
  • ANDA readiness,
  • FDA approval date sequencing,
  • litigation stay provisions and forfeiture mechanics.

No drug identity and no regulatory record exist in the record.

How has VASOSTRICT revenue been trending and what is the financial trajectory?

Financial trajectory requires at least one of:

  • company financial disclosures tied to the product,
  • external market research with traceable assumptions,
  • public wholesaler/dispensing datasets,
  • SEC segment reporting with product-level granularity.

No such product mapping or revenue disclosures are available in the record.

Net sales vs gross-to-net dynamics

No pricing and rebate data is available.

Geographic revenue split

No distribution and market footprint data is available.

Channel mix (hospital, specialty pharmacy, retail)

No administration and channel model is available.

Which companies are challenging VASOSTRICT and what are the litigation outcomes?

No ANDA/Biologics License competitor names, no Paragraph IV filings, and no litigation docket references are available in the record.

Settlement agreements and “at-risk” launch signals

No settlements or entry-forcing timelines are available.

Current injunction or FDA stay status

No docket events are available.

How does VASOSTRICT compare with alternative therapies on market adoption and price?

Comparison requires an identified therapeutic class and competitor set. None is available in the record.

Clinical differentiation and dosing convenience

No clinical or regimen information exists in the record.

Payer cost-effectiveness positioning

No payer evidence or economic analyses are available in the record.

Key Takeaways

  • VASOSTRICT’s market dynamics and financial trajectory cannot be evaluated from the information available in the record.
  • No verifiable mapping to FDA regulatory identifiers, active ingredient, therapeutic class, Orange Book/Biologics status, patent estate, competitive threats, or revenue disclosures is present.
  • Without that mapping, any exclusivity, generic/biosimilar entry timing, litigation-driven entry scenario, pricing pressure, or revenue trajectory would be speculative.

FAQs

  1. What FDA regulatory entry (NDA/BLA) corresponds to VASOSTRICT?
  2. Is VASOSTRICT listed in the Orange Book or Purple Book, and what are the listed expiration dates?
  3. Are there any ANDA Paragraph IV notices for VASOSTRICT, and who filed them?
  4. What is the expected generic or biosimilar launch date for VASOSTRICT under current exclusivity?
  5. Which companies market VASOSTRICT and what are the distribution channel dynamics?

References

No sources are provided or citable from the record.

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