Question 1

Is there a generic for Mechlorethamine hydrochloride?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Mechlorethamine hydrochloride. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Mechlorethamine hydrochloride?

Accepted Answer

VALCHLOR (NDA 202317, HELSINN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Mechlorethamine hydrochloride?

Accepted Answer

The Orange Book lists 6 patents against Mechlorethamine hydrochloride products, with the earliest listed expiry in 2026. 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

What dosage forms of Mechlorethamine hydrochloride are approved?

Accepted Answer

Mechlorethamine hydrochloride is approved in the following dosage forms: gel, injectable.

Product	Applicant	Application	TE	Approved
VALCHLORRLD	HELSINN	NDA 202317	—	Aug 23, 2013
MUSTARGENRLD	RECORDATI RARE	NDA 006695	—	Approved Prior to Jan 1, 1982

Patent	Expires	In	Type
8501819	Mar 07, 2026	3 mo ago	U-1427
8450375	Mar 07, 2026	3 mo ago	Product
8501818	Mar 07, 2026	3 mo ago	Product
7838564	Mar 07, 2026	3 mo ago	Product
9382191	Mar 07, 2026	3 mo ago	Product
7872050	Jul 08, 2029	in 3 yr 1 mo	U-1427

Mechlorethamine hydrochloride

Brand (NDA) products · gel, injectable

Listed patents (6)

Mechlorethamine hydrochloride — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.