FDA Orange Book · active-ingredient family
Teriparatide
Teriparatide is approved as 3 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TERIPARATIDE · NDA 218771
3
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TERIPARATIDERLD | ALMAJECT | NDA 218771 | AP | Jun 04, 2024 | |
| FORTEORLD×2 | LILLY | NDA 021318 | AP | Jun 25, 2008 | |
| BONSITY | ALVOGEN | NDA 211939 | — | Oct 04, 2019 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TERIPARATIDE | AMPHASTAR PHARMS INC | ANDA 213641 | AP | Dec 12, 2025 | |
| TERIPARATIDE | APOTEX | ANDA 211097 | AP | Nov 16, 2023 | |
| TERIPARATIDE | TEVA PHARMS USA | ANDA 208569 | AP | Nov 16, 2023 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Teriparatide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
