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FDA Orange Book · active-ingredient family

Oxymetazoline hydrochloride

Oxymetazoline hydrochloride is approved as 4 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:UPNEEQ · NDA 212520

4

Brand (NDA)

1

Generics (ANDA)

20

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream, solution/drops

ProductApplicantApplicationTEApproved
UPNEEQRLDRVL PHARMSNDA 212520—Jul 08, 2020
RHOFADERLDMAYNE PHARMANDA 208552ABJan 18, 2017
VISINE L.R.RLDKENVUE BRANDSNDA 019407—Mar 31, 1989
OCUCLEARBAYER HEALTHCARE LLCNDA 018471—May 30, 1986

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
OXYMETAZOLINE HYDROCHLORIDESUN PHARMA CANADAANDA 213584ABOct 04, 2021

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 11 mo
U-1959
8357714Aug 26, 2031in 5 yr 3 mo
U-2849
9867808Aug 26, 2031in 5 yr 3 mo
U-2849
10912765Aug 26, 2031in 5 yr 3 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

Oxymetazoline hydrochloride — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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