Question 1

Is there a generic for Melphalan hydrochloride?

Accepted Answer

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.

Question 2

What is the reference-listed drug for Melphalan hydrochloride?

Accepted Answer

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

Question 3

What patents protect Melphalan hydrochloride?

Accepted Answer

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.

Question 4

Does Melphalan hydrochloride have FDA marketing exclusivity?

Accepted Answer

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.

Question 5

What dosage forms of Melphalan hydrochloride are approved?

Accepted Answer

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

Product	Applicant	Application	TE	Approved
IVRARLD	APOTEX	NDA 217110	—	Aug 18, 2023
HEPZATORLD	DELCATH SYSTEMS INC	NDA 201848	—	Aug 14, 2023
EVOMELARLD	ACROTECH BIOPHARMA	NDA 207155	—	Mar 10, 2016
ALKERANRLD	APOTEX	NDA 020207	—	Nov 18, 1992

Product	Applicant	Application	TE	Approved
MELPHALAN HYDROCHLORIDE	AVET LIFESCIENCES	ANDA 206523	AP	Oct 29, 2024
MELPHALAN HYDROCHLORIDE	HETERO LABS	ANDA 215024	AP	May 23, 2024
MELPHALAN HYDROCHLORIDE	MEITHEAL	ANDA 212960	AP	May 28, 2021
MELPHALAN HYDROCHLORIDE	BPI LABS	ANDA 209197	AP	May 08, 2020
MELPHALAN HYDROCHLORIDE	ACTAVIS LLC	ANDA 209323	—	Mar 06, 2020
MELPHALAN HYDROCHLORIDE	INGENUS PHARMS LLC	ANDA 210947	—	Feb 18, 2020
MELPHALAN HYDROCHLORIDE	ARTHUR GRP	ANDA 211463	AP	Sep 13, 2019
MELPHALAN HYDROCHLORIDE	GLAND	ANDA 209826	AP	May 28, 2019
MELPHALAN HYDROCHLORIDE	ALMAJECT	ANDA 204817	—	May 17, 2019
MELPHALAN HYDROCHLORIDE	USWM	ANDA 207032	—	May 03, 2019
MELPHALAN HYDROCHLORIDE	FRESENIUS KABI USA	ANDA 203393	AP	Dec 22, 2017
MELPHALAN HYDROCHLORIDE	DR REDDYS	ANDA 203655	AP	Dec 08, 2017
MELPHALAN HYDROCHLORIDE	SAGENT PHARMS INC	ANDA 201379	AP	Feb 28, 2017
MELPHALAN HYDROCHLORIDE	ACTAVIS LLC	ANDA 206018	AP	Dec 19, 2016
MELPHALAN HYDROCHLORIDE	PH HEALTH	ANDA 204773	—	Aug 22, 2016
MELPHALAN HYDROCHLORIDE	HIKMA	ANDA 090303	AP	Oct 28, 2010
MELPHALAN HYDROCHLORIDE	MYLAN INSTITUTIONAL	ANDA 090299	—	Oct 27, 2009
MELPHALAN HYDROCHLORIDE	MYLAN INSTITUTIONAL	ANDA 090270	AP	Jun 09, 2009

Patent	Expires	In	Type
9200088	Mar 13, 2029	in 2 yr 9 mo	Product
8410077	Mar 13, 2029	in 2 yr 9 mo	Product
11020363	May 28, 2030	in 4 yr	Product
10864183	May 28, 2030	in 4 yr	Product
10940128	Jun 14, 2030	in 4 yr 1 mo	ProductU-3086
11633528	Nov 07, 2032	in 6 yr 6 mo	U-3675
10569004	Nov 07, 2032	in 6 yr 6 mo	U-3680
10369264	Nov 07, 2032	in 6 yr 6 mo	Product
10098997	Nov 07, 2032	in 6 yr 6 mo	Product
11241522	Nov 07, 2032	in 6 yr 6 mo	Product
11833286	Dec 30, 2032	in 6 yr 8 mo	Product
11083831	Dec 30, 2032	in 6 yr 8 mo	Product
10195334	Jan 16, 2033	in 6 yr 8 mo	Product
9493582	Feb 27, 2033	in 6 yr 10 mo	Product
10040872	Jan 30, 2034	in 7 yr 9 mo	Product
9314561	Feb 07, 2034	in 7 yr 9 mo	Product
9707331	Sep 17, 2034	in 8 yr 4 mo	Product
10537520	Jun 29, 2036	in 10 yr 2 mo	Product

Melphalan hydrochloride

Brand (NDA) products · injectable, powder, solution

Generic (ANDA) products (18)

Marketing exclusivity (2)

Listed patents (18)

Melphalan hydrochloride — frequently asked questions

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