Generic entry timeline

VASOPRESSIN generics — when can they launch?

VASOPRESSIN (VASOPRESSIN) · · 49 active US patents · 0 expired

Earliest patent expiry

2035-01-30

9 years remaining

Full patent estate to

2044-09-27

complete protection through 2044

FDA approval

2014

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Where VASOPRESSIN sits in the generic timeline

Long-dated protection: earliest active US patent for VASOPRESSIN extends to 2035 (~9 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.

Patent estate by type — active patents

Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.

Method of Use — 37 patents
Formulation — 12 patents

FDA U-codes carved out by VASOPRESSIN patents

Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.

U-code	Description
`U-1857`	(no description)

Sample patent estate

Showing 6 of 49 active US patents. View full estate on the VASOPRESSIN drug page →

US9919026 Formulation · expires 2035-01-30

This patent protects peptide formulations that use polymers as stabilizing agents to decrease degradation of the peptides.

USPTO title: Vasopressin formulations for use in treatment of hypotension
US12186362 Formulation · expires 2035-01-30

This patent protects peptide formulations that use polymers as stabilizing agents to decrease degradation of the peptides.

USPTO title: Vasopressin formulations for use in treatment of hypotension
US9962422 Method of Use · expires 2035-01-30

This patent protects peptide formulations that use polymers as stabilizing agents to decrease degradation of the peptides.

USPTO title: Vasopressin formulations for use in treatment of hypotension
US9974827 Method of Use · expires 2035-01-30

This patent protects peptide formulations that use polymers as stabilizing agents to decrease degradation of the peptides.

USPTO title: Vasopressin formulations for use in treatment of hypotension
US9919026 Formulation · expires 2035-01-30

This patent protects peptide formulations that use polymers as stabilizing agents to decrease degradation of the peptides.

USPTO title: Vasopressin formulations for use in treatment of hypotension
US9981006 Method of Use · expires 2035-01-30

This patent protects peptide formulations that use polymers as stabilizing agents to decrease degradation of the peptides.

USPTO title: Vasopressin formulations for use in treatment of hypotension

Sources

FDA Orange Book — patents listed against VASOPRESSIN (NDA filed 2014)
VASOPRESSIN drug profile — full patent estate, indications, clinical trials, pricing
Patent cliff 2035 — every drug losing US exclusivity that year

Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.

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