Assyro AI

Orange Book product · Brand (NDA)

MINOCIN

MINOCYCLINE HYDROCHLORIDE

Brand (NDA)NDA 050444RX REMPEX

At a glance

Approved Prior to Jan 1, 1982

Approved

Brand (NDA)

Application

Not listed

TE code

4

Listed patents

Key dates

  1. Today

  2. Patent 12161656 expires

    Listed drug product patent expiration.

    May 12, 2031

    in 5 yr

  3. Patent 9084802 expires

    Listed method-of-use patent (U-282) expiration.

    May 12, 2031

    in 5 yr

  4. Patent 9278105 expires

    Listed method-of-use patent (U-282) expiration.

    May 12, 2031

    in 5 yr

  5. Patent 11944634 expires

    Listed drug product patent expiration.

    Oct 16, 2032

    in 6 yr 5 mo

Pharmaceutical detail

Active ingredient

MINOCYCLINE HYDROCHLORIDE

Strength

EQ 100MG BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 050444

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12161656May 12, 2031in 5 yr
Product
9084802May 12, 2031in 5 yr
U-282
9278105May 12, 2031in 5 yr
U-282
11944634Oct 16, 2032in 6 yr 5 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.