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FDA Orange Book · active-ingredient family

Abaloparatide

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

Reference-listed drug:TYMLOS · NDA 208743

1

Brand (NDA)

0

Generics (ANDA)

9

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
TYMLOSRLDRADIUSNDA 208743—Apr 28, 2017

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8748382Oct 03, 2027in 1 yr 4 mo
U-3543
8148333Nov 08, 2027in 1 yr 5 mo
Product
7803770Apr 28, 2031in 4 yr 11 mo
U-2009
RE49444Apr 28, 2031in 4 yr 11 mo
U-2009
11782041Apr 30, 2038in 12 yr
ProductU-2009
11977067Apr 30, 2038in 12 yr
Product
10996208Apr 30, 2038in 12 yr
Product
11680942Jan 10, 2040in 13 yr 9 mo
U-3322
11255842Jan 10, 2040in 13 yr 9 mo
U-3322

Abaloparatide — 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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