FDA Orange Book · active-ingredient family
Sapropterin dihydrochloride
Sapropterin dihydrochloride is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KUVAN · NDA 205065
2
Brand (NDA)
13
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KUVANRLD×2 | BIOMARIN PHARM | NDA 205065 | AB | Dec 19, 2013 | |
| KUVANRLD | BIOMARIN PHARM | NDA 022181 | AB | Dec 13, 2007 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE×2 | MICRO LABS | ANDA 219511 | AB | Jan 08, 2026 | |
| SAPROPTERIN DIHYDROCHLORIDE×2 | TP ANDA HOLDINGS | ANDA 216432 | AB | Sep 03, 2025 | |
| SAPROPTERIN DIHYDROCHLORIDE | ZENARA | ANDA 218797 | AB | Jun 11, 2025 | |
| SAPROPTERIN DIHYDROCHLORIDE | AUROBINDO PHARMA | ANDA 216797 | AB | Jun 09, 2025 | |
| ZELVYSIA×2 | AUCTA | ANDA 218645 | AB | Apr 29, 2025 | |
| SAPROPTERIN DIHYDROCHLORIDE | ANNORA PHARMA | ANDA 215534 | AB | Aug 23, 2022 | |
| SAPROPTERIN DIHYDROCHLORIDE×2 | ANNORA PHARMA | ANDA 215420 | AB | Aug 18, 2022 | |
| SAPROPTERIN DIHYDROCHLORIDE | DR REDDYS | ANDA 215798 | AB | May 13, 2022 | |
| SAPROPTERIN DIHYDROCHLORIDE | DR REDDYS | ANDA 207685 | AB | Jun 15, 2021 | |
| SAPROPTERIN DIHYDROCHLORIDE | DR REDDYS | ANDA 209452 | AB | Mar 30, 2021 | |
| SAPROPTERIN DIHYDROCHLORIDE | PH HEALTH | ANDA 207207 | AB | Aug 20, 2019 | |
| SAPROPTERIN DIHYDROCHLORIDE | PH HEALTH | ANDA 210027 | AB | Aug 20, 2019 | |
| SAPROPTERIN DIHYDROCHLORIDE | PH HEALTH | ANDA 207200 | AB | May 10, 2019 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7566462 | Nov 16, 2025 | 7 mo ago | Product |
| 8003126 | Nov 16, 2025 | 7 mo ago | |
| 7566462*PED | May 16, 2026 | 1 mo ago | |
| 8003126*PED | May 16, 2026 | 1 mo ago | |
| 9216178 | Nov 01, 2032 | in 6 yr 6 mo | Product |
| 9216178*PED | May 01, 2033 | in 7 yr |
Sapropterin dihydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
