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FDA Orange Book · active-ingredient family

Mometasone furoate; olopatadine hydrochloride

Mometasone furoate; olopatadine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:RYALTRIS · NDA 211746

1

Brand (NDA)

0

Generics (ANDA)

16

Listed patents

0

Exclusivity periods

Brand (NDA) products · spray, metered

ProductApplicantApplicationTEApproved
RYALTRISRLDGLENMARK SPECLTNDA 211746Jan 13, 2022

Listed patents (16)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10765686Sep 04, 2034in 8 yr 4 mo
U-3295
10758550Sep 04, 2034in 8 yr 4 mo
U-3296
10646500Sep 04, 2034in 8 yr 4 mo
U-3297
10548907Sep 04, 2034in 8 yr 4 mo
U-3297
11400101Sep 04, 2034in 8 yr 4 mo
U-3297
12064442Sep 04, 2034in 8 yr 4 mo
U-3297
10016443Sep 04, 2034in 8 yr 4 mo
U-3297
10517880Sep 04, 2034in 8 yr 4 mo
ProductU-3297
9750754Sep 04, 2034in 8 yr 4 mo
ProductU-3297
9078923Sep 04, 2034in 8 yr 4 mo
ProductU-3297
10561672Sep 04, 2034in 8 yr 4 mo
Product
9370483Sep 04, 2034in 8 yr 4 mo
Product
10376526Sep 04, 2034in 8 yr 4 mo
Product
9937189Sep 04, 2034in 8 yr 4 mo
Product
11679210Sep 03, 2038in 12 yr 5 mo
Product
12303635Apr 08, 2039in 13 yr
SubstanceProduct

Mometasone furoate; olopatadine 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.