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FDA Orange Book · active-ingredient family

Lutetium lu 177 dotatate

Lutetium lu 177 dotatate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:LUTATHERA · NDA 208700

1

Brand (NDA)

0

Generics (ANDA)

18

Listed patents

4

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
LUTATHERARLDAAA USA INCNDA 208700—Jan 26, 2018

Marketing exclusivity (4)

  • NPPNew patient population exclusivity (3 years)

    Apr 23, 2027

    in 10 mo

  • ODE-479Orphan-drug exclusivity (7 years)

    Apr 23, 2031

    in 4 yr 11 mo

  • PEDPediatric exclusivity (adds 6 months)

    Oct 23, 2027

    in 1 yr 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    Oct 23, 2031

    in 5 yr 5 mo

Listed patents (18)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12168063Jul 25, 2038in 12 yr 3 mo
ProductU-4036
12415003Jul 25, 2038in 12 yr 3 mo
U-4036
12491272Jul 25, 2038in 12 yr 3 mo
U-4036
12144873Jul 25, 2038in 12 yr 3 mo
U-4036
12151003Jul 25, 2038in 12 yr 3 mo
ProductU-4036
12161732Jul 25, 2038in 12 yr 3 mo
ProductU-4036
10596278Jul 25, 2038in 12 yr 3 mo
Product
10596276Jul 25, 2038in 12 yr 3 mo
Product
11904027Jul 25, 2038in 12 yr 3 mo
Product
12415003*PEDJan 25, 2039in 12 yr 9 mo
12144873*PEDJan 25, 2039in 12 yr 9 mo
12151003*PEDJan 25, 2039in 12 yr 9 mo
12491272*PEDJan 25, 2039in 12 yr 9 mo
10596278*PEDJan 25, 2039in 12 yr 9 mo
10596276*PEDJan 25, 2039in 12 yr 9 mo
12161732*PEDJan 25, 2039in 12 yr 9 mo
11904027*PEDJan 25, 2039in 12 yr 9 mo
12168063*PEDJan 25, 2039in 12 yr 9 mo

Lutetium lu 177 dotatate — 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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