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FDA Orange Book · active-ingredient family

Vasopressin

Vasopressin: 4 brands, 10 generics; first approved Apr 17, 2014; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 10 ANDA applications approved.

Earliest patent expiry Jan 30, 2035
Brands (NDA)
4
Generics (ANDA)
10
Listed patents
16
Next patent expiry
Jan 30, 2035
in 8 yr 8 mo
Originator applications

Brand (NDA) products

VASOPRESSIN IN SODIUM CHLORIDE 0.9%RLDRS
NDA 21776620243 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/100ML (0.2UNITS/ML)SOLUTIONINTRAVENOUSRx—
40UNITS/100ML (0.4UNITS/ML)SOLUTIONINTRAVENOUSRx—
50UNITS/50ML (1UNIT/ML)SOLUTIONINTRAVENOUSDiscontinued—
VASOPRESSIN IN SODIUM CHLORIDE 0.9%RLDRS
NDA 21756920232 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/100ML (0.2UNITS/ML)SOLUTIONINTRAVENOUSRx—
40UNITS/100ML (0.4UNITS/ML)SOLUTIONINTRAVENOUSRx—
VASOPRESSINRLDRS
NDA 21259320202 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSRx—
200UNITS/10ML (20UNITS/ML)SOLUTIONINTRAVENOUSRx—
VASOSTRICTRLDRS
NDA 20448520146 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
200UNITS/10ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
40UNITS/100ML (0.4UNITS/ML)SOLUTIONINTRAVENOUSRxAP
60UNITS/100ML (0.6UNITS/ML)SOLUTIONINTRAVENOUSDiscontinued—
20UNITS/100ML (0.2UNITS/ML)SOLUTIONINTRAVENOUSRxAP
50UNITS/50ML (1UNITS/ML)SOLUTIONINTRAVENOUSDiscontinued—
Abbreviated applications

Generic (ANDA) products (10)

VASOPRESSIN
ANDA 2120682026
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
VASOPRESSIN
ANDA 2120692026
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
200UNITS/10ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
VASOPRESSIN
ANDA 21398820242 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
40UNITS/100ML (0.4UNITS/ML)SOLUTIONINTRAVENOUSRxAP
VASOPRESSIN
ANDA 21696320242 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
40UNITS/100ML (0.4UNITS/ML)SOLUTIONINTRAVENOUSRxAP
VASOPRESSIN
ANDA 2179872023
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/100ML (0.2UNITS/ML)SOLUTIONINTRAVENOUSRxAP
VASOPRESSIN
ANDA 2132062023
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
VASOPRESSIN
ANDA 2143142022
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
VASOPRESSIN
ANDA 2129442022
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
VASOPRESSIN
ANDA 2118572022
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSRxAP
VASOPRESSIN
ANDA 2115382021
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20UNITS/ML (20UNITS/ML)SOLUTIONINTRAVENOUSDiscontinued—
Protection horizon

Patent & exclusivity timeline

2026202820302032203420362038204020422044TodayPatent 9744209 — 2035-01-30Patent 9744209Patent 9375478 — 2035-01-30Patent 9375478Patent 9744239 — 2035-01-30Patent 9744239Patent 9687526 — 2035-01-30Patent 9687526Patent 9750785 — 2035-01-30Patent 9750785Patent 10010575 — 2035-01-30Patent 10010575Patent 9981006 — 2035-01-30Patent 9981006Patent 9974827 — 2035-01-30Patent 9974827Patent 9968649 — 2035-01-30Patent 9968649Patent 9962422 — 2035-01-30Patent 9962422Patent 9925234 — 2035-01-30Patent 9925234Patent 9925233 — 2035-01-30Patent 9925233Patent 12186362 — 2035-01-30Patent 12186362Patent 9919026 — 2035-01-30Patent 9919026Patent 9937223 — 2035-01-30Patent 9937223Patent 12447190 — 2044-09-27Patent 12447190
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (16)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9744209Jan 30, 2035in 8 yr 8 mo
U-1857
9375478Jan 30, 2035in 8 yr 8 mo
U-1857
9744239Jan 30, 2035in 8 yr 8 mo
U-1857
9687526Jan 30, 2035in 8 yr 8 mo
U-1857
9750785Jan 30, 2035in 8 yr 8 mo
Product
10010575Jan 30, 2035in 8 yr 8 mo
U-1857
9981006Jan 30, 2035in 8 yr 8 mo
U-1857
9974827Jan 30, 2035in 8 yr 8 mo
U-1857
9968649Jan 30, 2035in 8 yr 8 mo
U-1857
9962422Jan 30, 2035in 8 yr 8 mo
U-1857
9925234Jan 30, 2035in 8 yr 8 mo
U-1857
9925233Jan 30, 2035in 8 yr 8 mo
U-1857
12186362Jan 30, 2035in 8 yr 8 mo
Product
9919026Jan 30, 2035in 8 yr 8 mo
Product
9937223Jan 30, 2035in 8 yr 8 mo
U-1857
12447190Sep 27, 2044in 18 yr 6 mo
Product
FDA approval span

Approval history

First approval
Apr 17, 2014
12 yr 5 mo ago
Most recent approval
Jun 03, 2026
1 mo ago

Approvals span 2014–2026 across 14 FDA applications.

Brand (NDA) 429%
Generic (ANDA) 1071%

Vasopressin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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