FDA Orange Book · active-ingredient family
Apomorphine hydrochloride
Apomorphine hydrochloride is approved as 3 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ONAPGO · NDA 214056
3
Brand (NDA)
1
Generics (ANDA)
12
Listed patents
1
Exclusivity periods
Brand (NDA) products · film, injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ONAPGORLD | MDD US | NDA 214056 | — | Feb 03, 2025 | |
| KYNMOBIRLD×5 | SUMITOMO PHARMA AM | NDA 210875 | — | May 21, 2020 | |
| APOKYNRLD×2 | MDD US | NDA 021264 | AP | Apr 20, 2004 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| APOMORPHINE HYDROCHLORIDE | TP ANDA HOLDINGS | ANDA 212025 | AP | Feb 23, 2022 |
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Feb 03, 2028
in 1 yr 8 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10821074 | Aug 07, 2029 | in 3 yr 2 mo | Product |
| 9669021 | Jun 11, 2030 | in 4 yr | U-2825 |
| 9669019 | Jun 11, 2030 | in 4 yr | ProductU-2825 |
| 9283219 | Jun 11, 2030 | in 4 yr | ProductU-2825 |
| 10420763 | Jun 11, 2030 | in 4 yr | ProductU-2825 |
| 9326981 | Jun 11, 2030 | in 4 yr | U-2825 |
| 9044475 | Jun 11, 2030 | in 4 yr | Product |
| 11419769 | Dec 16, 2031 | in 5 yr 7 mo | ProductU-2825 |
| 8414922 | Dec 16, 2031 | in 5 yr 7 mo | ProductU-2825 |
| 8846074 | Dec 16, 2031 | in 5 yr 7 mo | ProductU-2825 |
| 10449146 | Apr 19, 2036 | in 10 yr | U-2825 |
| 10959943 | Apr 19, 2036 | in 10 yr | U-2825 |
Apomorphine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
