FDA Orange Book · active-ingredient family
Minocycline hydrochloride
Minocycline hydrochloride: 12 brands, 28 generics; first approved Aug 10, 1982; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 28 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
12
Generics (ANDA)
28
Listed patents
29
Next patent expiry
Mar 07, 2027
in 5 mo
Brand (NDA) products
Originator applications
- JOURNEYNDA 2190152024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx — - JOURNEYNDA 2136902020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1.5% BASE AEROSOL, FOAM TOPICAL Rx — - JOURNEYNDA 2123792019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4% BASE AEROSOL, FOAM TOPICAL Rx — - SOLODYNRLDBAUSCHNDA 05080820068 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 65MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 115MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 80MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 55MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - ORAPHARMANDA 0507812001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE POWDER, EXTENDED RELEASE DENTAL Rx — - MINOCINRLDBAUSCHNDA 05064919903 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDERLDTRIAX PHARMSNDA 05045119822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — - REMPEXNDA 050444—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx — - EPI HLTHNDA 20926920172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - JOURNEYNDA 20192220125 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued — EQ 67.5MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued — EQ 90MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued — EQ 112.5MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued — EQ 135MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued — - TRIAX PHARMSNDA 050315—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — EQ 50MG BASE CAPSULE ORAL Discontinued — - BAUSCHNDA 050445—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/5ML SUSPENSION ORAL Discontinued —
Generic (ANDA) products (28)
Abbreviated applications
- MINOCYCLINE HYDROCHLORIDEREGCON HOLDINGSANDA 21546620223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Rx AB EQ 75MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - MINOCYCLINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 21366220203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Rx AB EQ 75MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - MINOCYCLINE HYDROCHLORIDERISINGANDA 20344320193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 55MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 80MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDERISINGANDA 20146720192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 65MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 115MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDEZYDUS PHARMSANDA 20355320178 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 55MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 65MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 80MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 115MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDEALKEM LABS LTDANDA 20445320168 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 80MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 65MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 115MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 55MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 09021720163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Discontinued — EQ 75MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDESUN PHARMANDA 20439420157 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 55MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 65MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 80MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 115MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDESUN PHARM INDS LTDANDA 09111820147 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 65MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 80MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 115MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDESUN PHARM INDS INCANDA 09086720133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued — EQ 75MG BASE CAPSULE ORAL Discontinued — EQ 100MG BASE CAPSULE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 20226120128 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 65MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 115MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 80MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 55MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDELUPINANDA 09142420114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 55MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDEPHARMOBEDIENTANDA 09091120103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDESANDOZANDA 09042220093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDEBARR LABS INCANDA 06548520097 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 65MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 115MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 80MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 105MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDEIMPAX LABS INCANDA 09002420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 45MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 90MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 135MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - MINOCYCLINE HYDROCHLORIDEAUROBINDO PHARMAANDA 06547020083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDECHARTWELL RXANDA 06543620073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Rx AB EQ 75MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - MINOCYCLINE HYDROCHLORIDETORRENTANDA 06515620043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Rx AB EQ 75MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - MINOCYCLINE HYDROCHLORIDEZYDUSANDA 06300920032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 06513120033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Rx AB EQ 75MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - MINOCYCLINE HYDROCHLORIDETORRENTANDA 06506220003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDEWATSON LABSANDA 06306519992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDEIMPAX LABSANDA 06500519993 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB EQ 75MG BASE CAPSULE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDEZYDUSANDA 0630111992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Rx AB - MINOCYCLINE HYDROCHLORIDEWATSON LABS TEVAANDA 0631811991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Rx AB - ALVOGENANDA 06306719903 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — EQ 75MG BASE CAPSULE ORAL Discontinued — EQ 50MG BASE CAPSULE ORAL Discontinued — - LEDERLEANDA 062139—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPNew product exclusivity (3 years)
in 1 yr 1 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7919483 | in 5 mo | U-124 | |
| 7541347 | in 6 mo | U-917 | |
| 7544373 | in 6 mo | Product | |
| 10137200 | in 4 yr | U-2647 | |
| 8865139 | in 4 yr | ProductU-2647 | |
| 9675700 | in 4 yr | ProductU-2647 | |
| 8992896 | in 4 yr | ProductU-2647 | |
| 10086080 | in 4 yr | U-2647 | |
| 10213512 | in 4 yr | ProductU-2647 | |
| 10517882 | in 4 yr | U-2647 | |
| 10821187 | in 4 yr | U-2647 | |
| 8945516 | in 4 yr | Product | |
| 10265404 | in 4 yr | Product | |
| 10322186 | in 4 yr | U-1631 | |
| 10946101 | in 4 yr | U-1631 | |
| 12138311 | in 4 yr | U-1631 | |
| 12661407 | in 4 yr | U-1631 | |
| 9084802 | in 4 yr 8 mo | U-282 | |
| 9278105 | in 4 yr 8 mo | U-282 | |
| 12161656 | in 4 yr 8 mo | Product | |
| 9192615 | in 5 yr 2 mo | Product | |
| 11944634 | in 6 yr 1 mo | Product | |
| 11103517 | in 9 yr 8 mo | Product | |
| 10398641 | in 11 yr 1 mo | U-2647 | |
| 10849847 | in 11 yr 1 mo | U-2647 | |
| 11364212 | in 12 yr 5 mo | U-4043 | |
| 11191740 | in 12 yr 5 mo | U-4043 | |
| 10905664 | in 12 yr 5 mo | U-4043 | |
| 12594252 | in 12 yr 5 mo | U-4043 |
Approval history
FDA approval span
First approval
44 yr 10 mo ago
Most recent approval
2 yr ago
Approvals span 1982–2024 across 40 FDA applications.
Brand (NDA) 1230%
Generic (ANDA) 2870%
Minocycline hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
