nitroglycerin · Pohl Boskamp · NDA 018705
Nitrolingual Pumpspray
Earliest generic entry, as listed
12 Mar 2029
Blocked by patent: US 7872049.
FDA has approved 1 generic application (ANDA) for Nitrolingual Pumpspray, though its earliest generic-entry date is 12 Mar 2029 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
| Patent | Claims | Expires |
|---|---|---|
| US 7872049 | drug product, use U-2223 · sets the listed date | 12 Mar 2029 |
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 204681, Epic Pharma Llc · 018705-002Approved 21 Aug 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018705 · 002 · RLD | spray, metered, sublingual | 0.4MG/SPRAY | 12 Mar 2029 |