FDA Orange Book · active-ingredient family
Hydromorphone hydrochloride
Hydromorphone hydrochloride: 7 brands, 22 generics; first approved Jan 11, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
22
Listed patents
3
Next patent expiry
Apr 23, 2032
in 5 yr 8 mo
Brand (NDA) products
Originator applications
- HYDROMORPHONE HYDROCHLORIDERLDRSHIKMANDA 2178122023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/20ML (2MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx — - HYDROMORPHONE HYDROCHLORIDERLDHOSPIRA INCNDA 20040320235 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Rx AP 4MG/ML INJECTABLE INJECTION Rx AP 0.5MG/0.5ML INJECTABLE INJECTION Rx — 0.25MG/0.5ML INJECTABLE INJECTION Rx — - FRESENIUS KABI USANDA 01903420207 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP 250MG/VIAL INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Rx AP 4MG/ML INJECTABLE INJECTION Rx AP 0.2MG/ML INJECTABLE INJECTION Rx AP 0.5MG/0.5ML INJECTABLE INJECTION Rx AP - EXALGORLDSPECGX LLCNDA 02121720104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET, EXTENDED RELEASE ORAL Discontinued — 12MG TABLET, EXTENDED RELEASE ORAL Discontinued — 16MG TABLET, EXTENDED RELEASE ORAL Discontinued — 32MG TABLET, EXTENDED RELEASE ORAL Discontinued — - DILAUDIDRLDRHODES PHARMSNDA 01989220073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - RHODES PHARMSNDA 0198911992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - PURDUE PHARMA LPNDA 02104420044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 16MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 24MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 32MG CAPSULE, EXTENDED RELEASE ORAL Discontinued —
Generic (ANDA) products (22)
Abbreviated applications
- HYDROMORPHONE HYDROCHLORIDEHIKMAANDA 21689920244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP 0.5MG/0.5ML INJECTABLE INJECTION Rx AP 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Rx AP - HYDROMORPHONE HYDROCHLORIDEASCENT PHARMS INCANDA 21213320204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET, EXTENDED RELEASE ORAL Rx AB 12MG TABLET, EXTENDED RELEASE ORAL Rx AB 16MG TABLET, EXTENDED RELEASE ORAL Rx AB 32MG TABLET, EXTENDED RELEASE ORAL Rx AB - HYDROMORPHONE HYDROCHLORIDEGENUSANDA 2071082020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — - HYDROMORPHONE HYDROCHLORIDEHIKMAANDA 2021592018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - HYDROMORPHONE HYDROCHLORIDEASCENT PHARMS INCANDA 21050620183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB - HYDROMORPHONE HYDROCHLORIDEASCENT PHARMS INCANDA 2101762017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - HYDROMORPHONE HYDROCHLORIDEOSMOTICA PHARM USANDA 20562920165 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET, EXTENDED RELEASE ORAL Rx AB 12MG TABLET, EXTENDED RELEASE ORAL Rx AB 16MG TABLET, EXTENDED RELEASE ORAL Rx AB 32MG TABLET, EXTENDED RELEASE ORAL Rx AB 24MG TABLET, EXTENDED RELEASE ORAL Rx — - HYDROMORPHONE HYDROCHLORIDEAUROLIFE PHARMA LLCANDA 20581420163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB - HYDROMORPHONE HYDROCHLORIDEPADAGIS USANDA 20427820154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET, EXTENDED RELEASE ORAL Rx AB 12MG TABLET, EXTENDED RELEASE ORAL Rx AB 16MG TABLET, EXTENDED RELEASE ORAL Rx AB 32MG TABLET, EXTENDED RELEASE ORAL Rx AB - HYDROMORPHONE HYDROCHLORIDEACTAVIS LABS FL INCANDA 20214420144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET, EXTENDED RELEASE ORAL Discontinued — 12MG TABLET, EXTENDED RELEASE ORAL Discontinued — 16MG TABLET, EXTENDED RELEASE ORAL Discontinued — 32MG TABLET, EXTENDED RELEASE ORAL Discontinued — - HYDROMORPHONE HYDROCHLORIDERISINGANDA 0782282010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - HYDROMORPHONE HYDROCHLORIDERISINGANDA 0782612010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - HYDROMORPHONE HYDROCHLORIDEGENUSANDA 07747120093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - HYDROMORPHONE HYDROCHLORIDEHIKMAANDA 07459720092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - HYDROMORPHONE HYDROCHLORIDEHOSPIRA INCANDA 0785912008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - HYDROMORPHONE HYDROCHLORIDESPECGX LLCANDA 07685520073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB - HYDROMORPHONE HYDROCHLORIDENESHER PHARMSANDA 07731120053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — 8MG TABLET ORAL Discontinued — - HYDROMORPHONE HYDROCHLORIDEMPP PHARMAANDA 0767232005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8MG TABLET ORAL Discontinued — - HYDROMORPHONE HYDROCHLORIDEBARRANDA 0764442003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - HYDROMORPHONE HYDROCHLORIDEHIKMAANDA 0746531998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - HYDROMORPHONE HYDROCHLORIDEHOSPIRAANDA 0745981997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - HYDROMORPHONE HYDROCHLORIDEWATSON LABSANDA 0743171995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9731082 | in 5 yr 8 mo | Product | |
| 9248229 | in 7 yr 6 mo | Product | |
| 12653820 | in 16 yr 6 mo | ProductU-4571 |
Approval history
FDA approval span
First approval
43 yr 4 mo ago
Most recent approval
2 yr ago
Approvals span 1984–2024 across 29 FDA applications.
Brand (NDA) 724%
Generic (ANDA) 2276%
Hydromorphone 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.
