methylphenidate hydrochloride · Ironshore Pharms · NDA 209311
Jornay Pm
Earliest generic entry, as listed · earliest of 5 marketed strengths
23 Mar 2032
Blocked by patent: US 10182995, US 10292937, US 10617651, US 10881618, US 10905652, US 11241391, US 11241392, US 11911518, US 8916588, US 8927010, US 9023389, US 9028868, US 9034902, US 9283214, US 9498447, US 9603809.
Listed patents · 16 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10182995 | drug product · sets the listed date | 23 Mar 2032 |
| US 10292937 | use U-2357 · sets the listed date | 23 Mar 2032 |
| US 10617651 | use U-2357 · sets the listed date | 23 Mar 2032 |
| US 10881618 | use U-2357 · sets the listed date | 23 Mar 2032 |
| US 10905652 | drug product · sets the listed date | 23 Mar 2032 |
| US 11241391 | use U-2357 · sets the listed date | 23 Mar 2032 |
| US 11241392 | drug product · sets the listed date | 23 Mar 2032 |
| US 11911518 | use U-2357 · sets the listed date | 23 Mar 2032 |
| US 8916588 | use U-2357 · sets the listed date | 23 Mar 2032 |
| US 8927010 | drug product · sets the listed date | 23 Mar 2032 |
| US 9023389 | drug product · sets the listed date | 23 Mar 2032 |
| US 9028868 | use U-2357 · sets the listed date | 23 Mar 2032 |
| US 9034902 | use U-2357 · sets the listed date | 23 Mar 2032 |
| US 9283214 | drug product · sets the listed date | 23 Mar 2032 |
| US 9498447 | drug product · sets the listed date | 23 Mar 2032 |
| US 9603809 | use U-2357 · sets the listed date | 23 Mar 2032 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209311 · 001 · RLD | capsule, extended release, oral | 20MG | 23 Mar 2032 |
| 209311 · 002 · RLD | capsule, extended release, oral | 40MG | 23 Mar 2032 |
| 209311 · 003 · RLD | capsule, extended release, oral | 60MG | 23 Mar 2032 |
| 209311 · 004 · RLD | capsule, extended release, oral | 80MG | 23 Mar 2032 |
| 209311 · 005 · RLD | capsule, extended release, oral | 100MG | 23 Mar 2032 |