Orange Book product · Brand (NDA)
AMZEEQ
MINOCYCLINE HYDROCHLORIDE
At a glance
Oct 18, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 18, 2019
6 yr 9 mo ago
Today
Patent 10086080 expires
Listed method-of-use patent (U-2647) expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 10137200 expires
Listed method-of-use patent (U-2647) expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 10213512 expires
Listed drug product patent expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 10265404 expires
Listed drug product patent expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 10517882 expires
Listed method-of-use patent (U-2647) expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 10821187 expires
Listed method-of-use patent (U-2647) expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 8865139 expires
Listed drug product patent expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 8945516 expires
Listed drug product patent expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 8992896 expires
Listed drug product patent expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 9675700 expires
Listed drug product patent expiration.
Oct 01, 2030
in 4 yr 4 mo
Patent 10398641 expires
Listed method-of-use patent (U-2647) expiration.
Sep 08, 2037
in 11 yr 5 mo
Patent 10849847 expires
Listed method-of-use patent (U-2647) expiration.
Sep 08, 2037
in 11 yr 5 mo
Pharmaceutical detail
Active ingredient
MINOCYCLINE HYDROCHLORIDE
Strength
EQ 4% BASE
Dosage form
AEROSOL, FOAM
Route
TOPICAL
TE code
Not listed
Application
NDA 212379
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024EMROSIBrand (NDA)
NDA 219015 · JOURNEY
- 2020ZILXIBrand (NDA)
NDA 213690 · JOURNEY
- 2017MINOLIRABrand (NDA)
NDA 209269 · EPI HLTH
- 2012XIMINOBrand (NDA)
NDA 201922 · JOURNEY
- 2006SOLODYNBrand (NDA)
NDA 050808 · BAUSCH
- 2001ARESTINBrand (NDA)
NDA 050781 · ORAPHARMA
- 1990MINOCINBrand (NDA)
NDA 050649 · BAUSCH
- 1982MINOCYCLINE HYDROCHLORIDEBrand (NDA)
NDA 050451 · TRIAX PHARMS
- —MINOCINBrand (NDA)
NDA 050315 · TRIAX PHARMS
- —MINOCINBrand (NDA)
NDA 050444 · REMPEX
- —MINOCINBrand (NDA)
NDA 050445 · BAUSCH
- 2022MINOCYCLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215466 · REGCON HOLDINGS
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10086080 | Oct 01, 2030 | in 4 yr 4 mo | U-2647 |
| 10137200 | Oct 01, 2030 | in 4 yr 4 mo | U-2647 |
| 10213512 | Oct 01, 2030 | in 4 yr 4 mo | ProductU-2647 |
| 10265404 | Oct 01, 2030 | in 4 yr 4 mo | Product |
| 10517882 | Oct 01, 2030 | in 4 yr 4 mo | U-2647 |
| 10821187 | Oct 01, 2030 | in 4 yr 4 mo | U-2647 |
| 8865139 | Oct 01, 2030 | in 4 yr 4 mo | ProductU-2647 |
| 8945516 | Oct 01, 2030 | in 4 yr 4 mo | Product |
| 8992896 | Oct 01, 2030 | in 4 yr 4 mo | ProductU-2647 |
| 9675700 | Oct 01, 2030 | in 4 yr 4 mo | ProductU-2647 |
| 10398641 | Sep 08, 2037 | in 11 yr 5 mo | U-2647 |
| 10849847 | Sep 08, 2037 | in 11 yr 5 mo | U-2647 |
