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FDA Orange Book · active-ingredient family

Oxymetazoline hydrochloride

Oxymetazoline hydrochloride: 4 brands, 1 generic; first approved May 30, 1986; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 1 ANDA application approved.

Earliest patent expiry May 02, 2028
Brands (NDA)
4
Generics (ANDA)
1
Listed patents
20
Next patent expiry
May 02, 2028
in 1 yr 10 mo
Originator applications

Brand (NDA) products

UPNEEQRLDRS
NDA 2125202020
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.1%SOLUTION/DROPSOPHTHALMICRx—
RHOFADERLDRS
NDA 2085522017
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1%CREAMTOPICALRxAB
VISINE L.R.RLDRS
NDA 0194071989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.025%SOLUTION/DROPSOPHTHALMICOTC—
OCUCLEAR
NDA 0184711986
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.025%SOLUTION/DROPSOPHTHALMICDiscontinued—
Abbreviated applications

Generic (ANDA) products (1)

OXYMETAZOLINE HYDROCHLORIDE
ANDA 2135842021
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
1%CREAMTOPICALRxAB
Protection horizon

Patent & exclusivity timeline

20262028203020322034203620382040TodayPatent 7812049 — 2028-05-02Patent 7812049Patent 8357714 — 2031-08-26Patent 8357714Patent 9867808 — 2031-08-26Patent 9867808Patent 10912765 — 2031-08-26Patent 10912765Patent 8883838 — 2031-12-01Patent 8883838Patent 9974773 — 2035-06-11Patent 9974773Patent 10751325 — 2035-06-11Patent 10751325Patent 12350255 — 2035-06-11Patent 12350255Patent 10335391 — 2035-06-11Patent 10335391Patent 11517560 — 2035-06-11Patent 11517560Patent 11324722 — 2039-12-16Patent 11324722Patent 10940138 — 2039-12-16Patent 10940138Patent 10799481 — 2039-12-16Patent 10799481Patent 11701343 — 2039-12-16Patent 11701343Patent 10898573 — 2039-12-16Patent 10898573Patent 12605363 — 2039-12-16Patent 12605363Patent 10814001 — 2039-12-16Patent 10814001Patent 11311515 — 2039-12-16Patent 11311515Patent 11541036 — 2039-12-16Patent 11541036Patent 11103482 — 2039-12-16Patent 11103482
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (20)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7812049May 02, 2028in 1 yr 10 mo
U-1959
8357714Aug 26, 2031in 5 yr 2 mo
U-2849
9867808Aug 26, 2031in 5 yr 2 mo
U-2849
10912765Aug 26, 2031in 5 yr 2 mo
U-2849
8883838Dec 01, 2031in 5 yr 6 mo
Product
9974773Jun 11, 2035in 9 yr 1 mo
U-2306
10751325Jun 11, 2035in 9 yr 1 mo
U-2921
12350255Jun 11, 2035in 9 yr 1 mo
U-3494
10335391Jun 11, 2035in 9 yr 1 mo
U-2567
11517560Jun 11, 2035in 9 yr 1 mo
U-3494
11324722Dec 16, 2039in 13 yr 8 mo
U-2849
10940138Dec 16, 2039in 13 yr 8 mo
U-2849
10799481Dec 16, 2039in 13 yr 8 mo
U-2849
11701343Dec 16, 2039in 13 yr 8 mo
U-2849
10898573Dec 16, 2039in 13 yr 8 mo
Product
12605363Dec 16, 2039in 13 yr 8 mo
Product
10814001Dec 16, 2039in 13 yr 8 mo
Product
11311515Dec 16, 2039in 13 yr 8 mo
Product
11541036Dec 16, 2039in 13 yr 8 mo
Product
11103482Dec 16, 2039in 13 yr 8 mo
Product
FDA approval span

Approval history

First approval
May 30, 1986
40 yr 8 mo ago
Most recent approval
Oct 04, 2021
4 yr 10 mo ago

Approvals span 1986–2021 across 5 FDA applications.

Brand (NDA) 480%
Generic (ANDA) 120%

Oxymetazoline hydrochloride — 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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