Is there a generic for Methotrexate sodium?

Yes. The FDA Orange Book lists 52 approved generic (ANDA) applications for Methotrexate sodium, referencing the brand XATMEP. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Methotrexate sodium?

XATMEP (NDA 208400, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Methotrexate sodium?

The Orange Book lists 7 patents against Methotrexate sodium products, with the earliest listed expiry in 2033. 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.

What dosage forms of Methotrexate sodium are approved?

Methotrexate sodium is approved in the following dosage forms: injectable, solution, tablet.

FDA Orange Book · active-ingredient family

Methotrexate sodium

Methotrexate sodium is approved as 3 brand and 52 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:XATMEP · NDA 208400

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, solution, tablet

Product	Applicant	Application	TE	Approved
XATMEPRLD	AZURITY	NDA 208400	—	Apr 25, 2017
METHOTREXATE LPFRLD×12	HOSPIRA	NDA 011719	—	Mar 31, 1982
METHOTREXATE SODIUMRLD	STRIDES PHARMA INTL	NDA 008085	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (52)

Product	Applicant	Application	TE	Approved
METHOTREXATE SODIUM	HETERO LABS LTD VI	ANDA 219865	AP	Apr 30, 2026
METHOTREXATE SODIUM×2	ALEMBIC	ANDA 220225	AP	Apr 15, 2026
METHOTREXATE SODIUM	ALEMBIC	ANDA 217552	AB	Jun 03, 2024
METHOTREXATE SODIUM	ELITE LABS INC	ANDA 216453	AB	May 16, 2024
METHOTREXATE SODIUM	DAITO	ANDA 213362	—	Aug 07, 2023
METHOTREXATE SODIUM	LOTUS PHARM CO LTD	ANDA 209787	—	Apr 23, 2021
METHOTREXATE SODIUM	EUGIA PHARMA	ANDA 210454	AB	Jan 30, 2020
METHOTREXATE SODIUM	ACCORD HLTHCARE	ANDA 213343	AB	Jan 24, 2020
METHOTREXATE SODIUM PRESERVATIVE FREE×3	SAGENT PHARMS INC	ANDA 203407	AP	Aug 09, 2018
METHOTREXATE SODIUM	AMNEAL PHARMS	ANDA 210040	—	Dec 22, 2017
METHOTREXATE SODIUM	ZYDUS PHARMS	ANDA 207812	AB	Jan 13, 2017
METHOTREXATE SODIUM	SUN PHARM	ANDA 201749	AB	May 21, 2015
METHOTREXATE SODIUM PRESERVATIVE FREE×4	EUGIA PHARMA SPECLTS	ANDA 201529	AP	Mar 29, 2012
METHOTREXATE SODIUM PRESERVATIVE FREE	EXTROVIS	ANDA 201530	—	Mar 29, 2012
METHOTREXATE SODIUM PRESERVATIVE FREE×4	PHARMACHEMIE BV	ANDA 040843	AP	Jan 11, 2010
METHOTREXATE SODIUM PRESERVATIVE FREE	CAPLIN ONE LABS	ANDA 090029	—	Mar 31, 2009
METHOTREXATE SODIUM PRESERVATIVE FREE×2	CAPLIN ONE LABS	ANDA 090039	—	Mar 31, 2009
METHOTREXATE SODIUM PRESERVATIVE FREE	ACCORD HLTHCARE	ANDA 040716	AP	Apr 30, 2007
METHOTREXATE SODIUM PRESERVATIVE FREE	ACCORD HLTHCARE	ANDA 040767	AP	Apr 30, 2007
METHOTREXATE SODIUM PRESERVATIVE FREE	ACCORD HLTHCARE	ANDA 040768	AP	Apr 30, 2007
METHOTREXATE SODIUM PRESERVATIVE FREE	HIKMA	ANDA 040632	AP	Aug 12, 2005
TREXALL×4	BARR	ANDA 040385	—	Mar 21, 2001
METHOTREXATE SODIUM	DURAMED PHARMS BARR	ANDA 040233	—	Jun 17, 1999
METHOTREXATE PRESERVATIVE FREE	FRESENIUS KABI USA	ANDA 040266	AP	Feb 26, 1999
METHOTREXATE PRESERVATIVE FREE	FRESENIUS KABI USA	ANDA 040265	—	Feb 26, 1999
METHOTREXATE SODIUM×2	FRESENIUS KABI USA	ANDA 040263	AP	Feb 26, 1999
METHOTREXATE SODIUM	HIKMA	ANDA 040054	AB	Aug 01, 1994
METHOTREXATE SODIUM	MYLAN	ANDA 081235	AB	May 15, 1992
FOLEX PFS	PHARMACIA AND UPJOHN	ANDA 081242	—	Aug 23, 1991
METHOTREXATE SODIUM	BARR	ANDA 081099	AB	Oct 15, 1990
MEXATE-AQ PRESERVED	BRISTOL MYERS SQUIBB	ANDA 089887	—	Apr 14, 1989
METHOTREXATE SODIUM	PHARMACHEMIE USA	ANDA 089158	—	Jul 08, 1988
ABITREXATE	ABIC	ANDA 089354	—	Jul 17, 1987
ABITREXATE	ABIC	ANDA 089355	—	Jul 17, 1987
ABITREXATE	ABIC	ANDA 089356	—	Jul 17, 1987
ABITREXATE	ABIC	ANDA 089161	—	Mar 10, 1987
METHOTREXATE SODIUM	HIKMA	ANDA 089341	AP	Sep 16, 1986
METHOTREXATE SODIUM	HIKMA	ANDA 089342	AP	Sep 16, 1986
METHOTREXATE SODIUM PRESERVATIVE FREE	HIKMA	ANDA 089340	AP	Sep 16, 1986
METHOTREXATE SODIUM PRESERVATIVE FREE	HIKMA	ANDA 089343	AP	Sep 16, 1986
METHOTREXATE SODIUM	ABRAXIS PHARM	ANDA 089323	—	Jun 13, 1986
METHOTREXATE SODIUM	ABRAXIS PHARM	ANDA 089263	—	Jun 13, 1986
METHOTREXATE SODIUM	ABRAXIS PHARM	ANDA 089322	—	Jun 13, 1986
METHOTREXATE SODIUM	NORBROOK	ANDA 088648	—	May 09, 1986
FOLEX PFS	PHARMACIA AND UPJOHN	ANDA 089180	—	Jan 03, 1986
FOLEX	PHARMACIA AND UPJOHN	ANDA 088954	—	Oct 24, 1985
METHOTREXATE SODIUM	ABRAXIS PHARM	ANDA 088935	—	Oct 11, 1985
METHOTREXATE SODIUM	ABRAXIS PHARM	ANDA 088936	—	Oct 11, 1985
METHOTREXATE SODIUM	ABRAXIS PHARM	ANDA 088937	—	Oct 11, 1985
MEXATE-AQRLD	BRISTOL MYERS	ANDA 088760	—	Feb 14, 1985
FOLEXRLD×3	PHARMACIA AND UPJOHN	ANDA 087695	—	Apr 08, 1983
MEXATERLD×4	BRISTOL	ANDA 086358	—	Approved Prior to Jan 1, 1982

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10231927	Jan 02, 2033	in 6 yr 8 mo	U-1699
11116724	Jan 02, 2033	in 6 yr 8 mo	U-1349
11969503	Jan 02, 2033	in 6 yr 8 mo	Product
12396947	Jan 02, 2033	in 6 yr 8 mo	Product
10610485	Jan 02, 2033	in 6 yr 8 mo	Product
9855215	Jan 02, 2033	in 6 yr 8 mo	Product
9259427	Jan 02, 2033	in 6 yr 8 mo	Product

Methotrexate sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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

Book a Demo