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FDA Orange Book · active-ingredient family

Tasimelteon

Tasimelteon is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HETLIOZ LQ · NDA 214517

2

Brand (NDA)

3

Generics (ANDA)

33

Listed patents

2

Exclusivity periods

Brand (NDA) products · capsule, suspension

ProductApplicantApplicationTEApproved
HETLIOZ LQRLDVANDA PHARMS INCNDA 214517—Dec 01, 2020
HETLIOZRLDVANDA PHARMS INCNDA 205677ABJan 31, 2014

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
TASIMELTEONMSNANDA 211654ABJan 12, 2023
TASIMELTEONAPOTEXANDA 211607ABDec 20, 2022
TASIMELTEONTEVA PHARMS USA INCANDA 211601ABDec 12, 2022

Marketing exclusivity (2)

  • ODE-330Orphan-drug exclusivity (7 years)

    Dec 01, 2027

    in 1 yr 6 mo

  • ODE-329Orphan-drug exclusivity (7 years)

    Dec 01, 2027

    in 1 yr 6 mo

Listed patents (33)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9539234Jan 25, 2033in 6 yr 8 mo
U-1934
9855241Jan 25, 2033in 6 yr 8 mo
U-2149
RE46604Jan 25, 2033in 6 yr 8 mo
U-2147
10149829Jan 25, 2033in 6 yr 8 mo
U-2477
9060995Jan 25, 2033in 6 yr 8 mo
U-1710
10449176Jan 25, 2033in 6 yr 8 mo
U-2149
10945988Jan 25, 2033in 6 yr 8 mo
U-2149
11633377Jan 25, 2033in 6 yr 8 mo
U-2149
10610510Jan 25, 2033in 6 yr 8 mo
U-3009
12201604Jan 25, 2033in 6 yr 8 mo
U-3003
10980770Jan 25, 2033in 6 yr 8 mo
U-3106
11850229Jan 25, 2033in 6 yr 8 mo
U-3342
11833130Jan 25, 2033in 6 yr 8 mo
U-2149
11918557Jan 25, 2033in 6 yr 8 mo
U-3003
11826339Jan 25, 2033in 6 yr 8 mo
U-3342
11285129Jan 25, 2033in 6 yr 8 mo
U-3342
9549913Jan 25, 2033in 6 yr 8 mo
U-1486
11918556Apr 07, 2033in 6 yr 11 mo
U-3342
9730910May 17, 2034in 8 yr
U-2085
11141400Oct 10, 2034in 8 yr 5 mo
U-2615
10610511Oct 10, 2034in 8 yr 5 mo
U-3007
11786502Oct 10, 2034in 8 yr 5 mo
U-3007
11566011Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
12049457Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
10829465Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
11760740Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
10071977Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
10376487Jul 27, 2035in 9 yr 3 mo
U-2615
11266622Aug 29, 2035in 9 yr 4 mo
U-3003
10179119Aug 29, 2035in 9 yr 4 mo
U-3003
12447141Dec 11, 2040in 14 yr 8 mo
U-3003
11202770Dec 11, 2040in 14 yr 8 mo
Product
11759446Feb 21, 2041in 14 yr 11 mo
U-3003

Tasimelteon — 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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