sapropterin dihydrochloride · Biomarin Pharm · NDA 022181, 205065
Kuvan
1 of 3 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 9216178 (pediatric extension).
FDA has approved 1 generic application (ANDA) for Kuvan, though its earliest generic-entry date is 1 May 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9216178 | drug product | 1 May 2033 |
| US 9216178 listing row | drug product | 1 Nov 2032 |
| US 9216178 listing row | pediatric extension · sets the listed date | 1 May 2033 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 219511, Micro Labs · 205065-001Approved 8 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022181 · 001 · RLD | tablet, oral | 100MG | open |
| 205065 · 001 · RLD | for solution, oral | 100MG/PACKET | 1 May 2033 |
| 205065 · 002 · RLD | for solution, oral | 500MG/PACKET | 1 May 2033 |
Expired or delisted (4)
- US 7566462 · — · 16 May 2026
- US 8003126 · — · 16 May 2026
- US 7566462 · product · 16 Nov 2025
- US 8003126 · — · 16 Nov 2025