FDA Orange Book · active-ingredient family
Dexmedetomidine hydrochloride
Dexmedetomidine hydrochloride: 3 brands, 32 generics; first approved Dec 17, 1999; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 32 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
32
Listed patents
29
Next patent expiry
Jan 04, 2032
in 5 yr 5 mo
Brand (NDA) products
Originator applications
- BIOXCELNDA 21539020222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.12MG BASE FILM BUCCAL, SUBLINGUAL Rx — EQ 0.18MG BASE FILM BUCCAL, SUBLINGUAL Rx — - HOSPIRANDA 02103820205 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDERLDRSHQ SPCLT PHARMANDA 20662820154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION INTRAVENOUS Rx AP EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION INTRAVENOUS Rx AP EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) SOLUTION INTRAVENOUS Rx —
Generic (ANDA) products (32)
Abbreviated applications
- DEXMEDETOMIDINE HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 2081032026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEKNACKANDA 2186752026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Discontinued — - DEXMEDETOMIDINE HYDROCHLORIDEDR REDDYSANDA 22031520262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEHIKMAANDA 20640720253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDESOMERSETANDA 21811220242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION INTRAVENOUS Rx AP EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION INTRAVENOUS Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEMILLA PHARMSANDA 21730820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEAMNEALANDA 21660420232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEPIRAMAL CRITICALANDA 2147942021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Discontinued — - DEXMEDETOMIDINE HYDROCHLORIDEEUGIA PHARMAANDA 21032120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDETAGIANDA 21285720203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEPH HEALTHANDA 20826620202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEMYLAN LABS LTDANDA 21257120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEHENGRUI PHARMAANDA 20906520204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Discontinued — EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEGLANDANDA 20930720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEAMNEAL PHARMS COANDA 20755120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEWILSHIRE PHARMS INCANDA 21279120203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Discontinued — - DEXMEDETOMIDINE HYDROCHLORIDEMEITHEALANDA 2048432019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEFRESENIUS KABI USAANDA 20812920183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 20853220182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEZYDUS PHARMSANDA 2067982018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDETEVA PHARMS USAANDA 2052722017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEAM REGENTANDA 2037732017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Discontinued — - DEXMEDETOMIDINE HYDROCHLORIDEHIKMAANDA 2050462017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEACTAVIS INCANDA 2046862016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDECAPLINANDA 0914652016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Discontinued — - DEXMEDETOMIDINE HYDROCHLORIDEEUGIA PHARMAANDA 2058672016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEACCORD HLTHCAREANDA 2040232016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEFRESENIUS KABI USAANDA 2010722015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEGLANDANDA 2021262015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDERISINGANDA 2025852014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEMYLAN INSTITUTIONALANDA 2028812014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP - DEXMEDETOMIDINE HYDROCHLORIDEPH HEALTHANDA 2039722014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE INJECTION Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- M-82New use / labeling-change exclusivity (3 years)
in 2 yr 3 mo
- M-82New use / labeling-change exclusivity (3 years)
in 2 yr 3 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8455527 | in 5 yr 5 mo | U-421 | |
| 9616049 | in 5 yr 5 mo | Product | |
| 8242158 | in 5 yr 5 mo | Product | |
| 8338470 | in 5 yr 5 mo | Product | |
| 9320712 | in 5 yr 5 mo | Product | |
| 8648106 | in 5 yr 5 mo | Product | |
| 10016396 | in 5 yr 5 mo | Product | |
| 8648106*PED | in 5 yr 11 mo | ||
| 8242158*PED | in 5 yr 11 mo | ||
| 8455527*PED | in 5 yr 11 mo | ||
| 8338470*PED | in 5 yr 11 mo | ||
| 9320712*PED | in 5 yr 11 mo | ||
| 9616049*PED | in 5 yr 11 mo | ||
| 9717796 | in 9 yr 9 mo | Product | |
| 9649296 | in 9 yr 9 mo | Product | |
| 11786508 | in 11 yr 6 mo | U-3698 | |
| 11839604 | in 11 yr 6 mo | U-3756 | |
| 10792246 | in 13 yr | ProductU-3350 | |
| 11517524 | in 13 yr | ProductU-3645 | |
| 11497711 | in 13 yr | ProductU-3645 | |
| 11478422 | in 13 yr | Product | |
| 11998529 | in 14 yr 1 mo | U-3935 | |
| 12109196 | in 14 yr 1 mo | U-3935 | |
| 11890272 | in 14 yr 1 mo | U-3935 | |
| 12364683 | in 16 yr 7 mo | U-4029 | |
| 11998528 | in 16 yr 7 mo | U-3935 | |
| 11806334 | in 16 yr 7 mo | U-3725 | |
| 12090140 | in 16 yr 7 mo | U-3986 | |
| 12138247 | in 16 yr 7 mo | U-4029 |
Approval history
FDA approval span
First approval
27 yr 1 mo ago
Most recent approval
4 mo ago
Approvals span 1999–2026 across 35 FDA applications.
Brand (NDA) 39%
Generic (ANDA) 3291%
Dexmedetomidine 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
