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FDA Orange Book · active-ingredient family

Vortioxetine hydrobromide

Vortioxetine hydrobromide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:TRINTELLIX · NDA 204447

1

Brand (NDA)

0

Generics (ANDA)

20

Listed patents

8

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
TRINTELLIXRLD×4TAKEDA PHARMS USANDA 204447—Sep 30, 2013

Marketing exclusivity (8)

  • M-232New use / labeling-change exclusivity (3 years)

    Aug 23, 2026

    in 2 mo

  • PEDPediatric exclusivity (adds 6 months)

    Feb 23, 2027

    in 8 mo

  • M-232New use / labeling-change exclusivity (3 years)

    Aug 23, 2026

    in 2 mo

  • PEDPediatric exclusivity (adds 6 months)

    Feb 23, 2027

    in 8 mo

  • M-232New use / labeling-change exclusivity (3 years)

    Aug 23, 2026

    in 2 mo

  • PEDPediatric exclusivity (adds 6 months)

    Feb 23, 2027

    in 8 mo

  • M-232New use / labeling-change exclusivity (3 years)

    Aug 23, 2026

    in 2 mo

  • PEDPediatric exclusivity (adds 6 months)

    Feb 23, 2027

    in 8 mo

Listed patents (20)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7144884Jun 17, 20262 d ago
SubstanceProductU-1439
7144884*PEDDec 17, 2026in 6 mo
9227946Jun 15, 2027in 1 yr
U-1668
9861630Jun 15, 2027in 1 yr
U-1668
9125908Jun 15, 2027in 1 yr
U-2309
9125910Jun 15, 2027in 1 yr
U-2309
9125909Jun 15, 2027in 1 yr
U-2309
11458134Jun 15, 2027in 1 yr
ProductU-3463
8969355Jun 15, 2027in 1 yr
U-1668
8969355*PEDDec 15, 2027in 1 yr 6 mo
9227946*PEDDec 15, 2027in 1 yr 6 mo
9125908*PEDDec 15, 2027in 1 yr 6 mo
9125909*PEDDec 15, 2027in 1 yr 6 mo
9125910*PEDDec 15, 2027in 1 yr 6 mo
9861630*PEDDec 15, 2027in 1 yr 6 mo
11458134*PEDDec 15, 2027in 1 yr 6 mo
8722684Jun 30, 2031in 5 yr 1 mo
SubstanceProduct
8722684*PEDDec 30, 2031in 5 yr 7 mo
9278096Mar 21, 2032in 5 yr 10 mo
U-2436
9278096*PEDSep 21, 2032in 6 yr 4 mo

Vortioxetine hydrobromide — 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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