crisaborole · Anacor Pharms Inc · NDA 207695
Eucrisa
Blocked by patent: US 8168614 (pediatric extension).
FDA has approved 1 generic application (ANDA) for Eucrisa, though its earliest generic-entry date is 20 Jul 2030 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 · 4 unexpired
8 Orange Book listing rows for 4 patents, including 4 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8168614 | use U-1932 | 20 Jul 2030 |
| US 8168614 listing row | use U-1932 | 20 Jan 2030 |
| US 8168614 listing row | pediatric extension · sets the listed date | 20 Jul 2030 |
| US 8039451 | drug substance, drug product | 29 Dec 2029 |
| US 8039451 listing row | drug substance, drug product | 29 Jun 2029 |
| US 8039451 listing row | pediatric extension | 29 Dec 2029 |
| US 8501712 | use U-1932 | 16 Aug 2027 |
| US 8501712 listing row | use U-1932 | 16 Feb 2027 |
| US 8501712 listing row | pediatric extension | 16 Aug 2027 |
| US 9682092 | use U-1932 | 16 Aug 2027 |
| US 9682092 listing row | use U-1932 | 16 Feb 2027 |
| US 9682092 listing row | pediatric extension | 16 Aug 2027 |
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
- First generic approved · ANDA 216242, Macleods Pharms · 207695-001Approved 24 Sep 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216242, Macleods Pharms · 207695-001Approved 24 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207695 · 001 · RLD | ointment, topical | 2% | 20 Jul 2030 |
Expired or delisted (1)
- D-191 · 3 Apr 2026