phenylephrine hydrochloride; tropicamide · Eyenovia · NDA 215352

Mydcombi

Earliest generic entry, as listed
15 Jul 2031

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 10839960, US 11398306, US 11839487. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 3 unexpired

PatentClaimsExpires
US 10839960use U-368515 Jul 2031
US 11398306use U-368515 Jul 2031
US 11839487use U-368515 Jul 2031

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 · 1

NDA · productFormStrengthListed expiry
215352 · 001 · RLD · discontinuedspray, metered, ophthalmic2.5%;1%15 Jul 2031
Expired or delisted (1)
  • NP · 5 May 2026