FDA Orange Book · active-ingredient family
Melphalan hydrochloride
Melphalan hydrochloride: 4 brands, 18 generics; first approved Nov 18, 1992; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
4
Generics (ANDA)
18
Listed patents
18
Next patent expiry
Mar 13, 2029
in 2 yr 6 mo
Brand (NDA) products
Originator applications
- APOTEXNDA 2171102023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 90MG BASE/ML (EQ 90MG BASE/ML) SOLUTION INTRAVENOUS Rx — - DELCATH SYSTEMS INCNDA 2018482023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL POWDER INTRA-ARTERIAL Rx — - ACROTECH BIOPHARMANDA 2071552016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL POWDER INTRAVENOUS Rx — - ALKERANRLDAPOTEXNDA 0202071992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (18)
Abbreviated applications
- MELPHALAN HYDROCHLORIDEAVET LIFESCIENCESANDA 2065232024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEHETERO LABSANDA 2150242024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEMEITHEALANDA 2129602021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEBPI LABSANDA 2091972020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEACTAVIS LLCANDA 2093232020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - MELPHALAN HYDROCHLORIDEINGENUS PHARMS LLCANDA 2109472020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - MELPHALAN HYDROCHLORIDEARTHUR GRPANDA 2114632019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEGLANDANDA 2098262019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEALMAJECTANDA 2048172019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - MELPHALAN HYDROCHLORIDEUSWMANDA 2070322019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - MELPHALAN HYDROCHLORIDEFRESENIUS KABI USAANDA 2033932017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEDR REDDYSANDA 2036552017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDESAGENT PHARMS INCANDA 2013792017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEACTAVIS LLCANDA 2060182016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEPH HEALTHANDA 2047732016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - MELPHALAN HYDROCHLORIDEHIKMAANDA 0903032010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - MELPHALAN HYDROCHLORIDEMYLAN INSTITUTIONALANDA 0902992009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - MELPHALAN HYDROCHLORIDERSMYLAN INSTITUTIONALANDA 0902702009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPNew product exclusivity (3 years)
2 mo ago
- ODE-438Orphan-drug exclusivity (7 years)
in 3 yr 11 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9200088 | in 2 yr 6 mo | Product | |
| 8410077 | in 2 yr 6 mo | Product | |
| 11020363 | in 3 yr 8 mo | Product | |
| 10864183 | in 3 yr 8 mo | Product | |
| 10940128 | in 3 yr 9 mo | ProductU-3086 | |
| 11633528 | in 6 yr 2 mo | U-3675 | |
| 10569004 | in 6 yr 2 mo | U-3680 | |
| 10369264 | in 6 yr 2 mo | Product | |
| 10098997 | in 6 yr 2 mo | Product | |
| 11241522 | in 6 yr 2 mo | Product | |
| 11833286 | in 6 yr 4 mo | Product | |
| 11083831 | in 6 yr 4 mo | Product | |
| 10195334 | in 6 yr 4 mo | Product | |
| 9493582 | in 6 yr 6 mo | Product | |
| 10040872 | in 7 yr 5 mo | Product | |
| 9314561 | in 7 yr 5 mo | Product | |
| 9707331 | in 8 yr 1 mo | Product | |
| 10537520 | in 9 yr 10 mo | Product |
Approval history
FDA approval span
First approval
34 yr 5 mo ago
Most recent approval
2 yr ago
Approvals span 1992–2024 across 22 FDA applications.
Brand (NDA) 418%
Generic (ANDA) 1882%
Melphalan 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.
