Is there a generic for Melphalan hydrochloride?

Yes. The FDA Orange Book lists 18 approved generic (ANDA) applications for Melphalan hydrochloride, referencing the brand IVRA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Melphalan hydrochloride?

IVRA (NDA 217110, APOTEX) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Melphalan hydrochloride?

The Orange Book lists 18 patents against Melphalan hydrochloride products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Melphalan hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Melphalan hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Melphalan hydrochloride are approved?

Melphalan hydrochloride is approved in the following dosage forms: injectable, powder, solution.

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 Mar 13, 2029Latest exclusivity ends Aug 14, 2030

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 13, 2029

in 2 yr 5 mo

Brand (NDA) products

Originator applications

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IVRARLDRS
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 -
HEPZATORLDRS
DELCATH SYSTEMS INCNDA 2018482023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL POWDER INTRA-ARTERIAL Rx -
EVOMELARLDRS
ACROTECH BIOPHARMANDA 2071552016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL POWDER INTRAVENOUS Rx -
ALKERANRLD
APOTEXNDA 0202071992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 90MG BASE/ML (EQ 90MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	POWDER	INTRA-ARTERIAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	POWDER	INTRAVENOUS	Rx	-

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

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MELPHALAN HYDROCHLORIDE
AVET LIFESCIENCESANDA 2065232024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
HETERO LABSANDA 2150242024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
MEITHEALANDA 2129602021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
BPI LABSANDA 2091972020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
ACTAVIS LLCANDA 2093232020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL POWDER INTRAVENOUS Discontinued -
MELPHALAN HYDROCHLORIDE
INGENUS PHARMS LLCANDA 2109472020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued -
MELPHALAN HYDROCHLORIDE
ARTHUR GRPANDA 2114632019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
GLANDANDA 2098262019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
ALMAJECTANDA 2048172019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued -
MELPHALAN HYDROCHLORIDE
USWMANDA 2070322019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued -
MELPHALAN HYDROCHLORIDE
FRESENIUS KABI USAANDA 2033932017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
DR REDDYSANDA 2036552017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
SAGENT PHARMS INCANDA 2013792017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
ACTAVIS LLCANDA 2060182016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
PH HEALTHANDA 2047732016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued -
MELPHALAN HYDROCHLORIDE
HIKMAANDA 0903032010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP
MELPHALAN HYDROCHLORIDE
MYLAN INSTITUTIONALANDA 0902992009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued -
MELPHALAN HYDROCHLORIDERS
MYLAN INSTITUTIONALANDA 0902702009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	POWDER	INTRAVENOUS	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	-

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

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Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

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NPNew product exclusivity (3 years)
Aug 14, 2026
2 mo ago
ODE-438Orphan-drug exclusivity (7 years)
Aug 14, 2030
in 3 yr 10 mo

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9200088	Mar 13, 2029	in 2 yr 5 mo	Product
8410077	Mar 13, 2029	in 2 yr 5 mo	Product
11020363	May 28, 2030	in 3 yr 8 mo	Product
10864183	May 28, 2030	in 3 yr 8 mo	Product
10940128	Jun 14, 2030	in 3 yr 8 mo	ProductU-3086
11633528	Nov 07, 2032	in 6 yr 2 mo	U-3675
10569004	Nov 07, 2032	in 6 yr 2 mo	U-3680
10369264	Nov 07, 2032	in 6 yr 2 mo	Product
10098997	Nov 07, 2032	in 6 yr 2 mo	Product
11241522	Nov 07, 2032	in 6 yr 2 mo	Product
11833286	Dec 30, 2032	in 6 yr 3 mo	Product
11083831	Dec 30, 2032	in 6 yr 3 mo	Product
10195334	Jan 16, 2033	in 6 yr 4 mo	Product
9493582	Feb 27, 2033	in 6 yr 5 mo	Product
10040872	Jan 30, 2034	in 7 yr 5 mo	Product
9314561	Feb 07, 2034	in 7 yr 5 mo	Product
9707331	Sep 17, 2034	in 8 yr	Product
10537520	Jun 29, 2036	in 9 yr 10 mo	Product

Approval history

FDA approval span

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First approval

Nov 18, 1992

34 yr 5 mo ago

Most recent approval

Oct 29, 2024

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.

Ask AI about Melphalan hydrochloride

Key facts