Viewing data from:

JYLAMVO

NDA

METHOTREXATE | N212479 | SHORLA PHARMA LTD

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

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2033

2034

2035

2036

Today

11129833

Oct. 28, 2035

11771701

Oct. 29, 2034

12605385

Oct. 25, 2035

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain8 active DMFs9 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

FERMION OYMETHOTREXATE

DMF 42461981

EXCELLA GMBH AND CO KGMETHOTREXATE

DMF 117041995

HUZHOU ZHANWANG PHARMACEUTICAL CO LTDMETHOTREXATE USP

DMF 202552007

FERMION OYMETHOTREXATE DISODIUM

DMF 235322010

CF PHARMA LTDMETHOTREXATE

DMF 259572012

SICHUAN ELIXIR PHARMACEUTICAL CO LTDMETHOTREXATE

DMF 397582024

RAVI BIOLIFE PRIVATE LTDMETHOTREXATE USP

DMF 399972024

SHILPA PHARMA LIFESCIENCES LTDMETHOTREXATE USP

DMF 420562025

MONSANTO COInactiveMETHOTREXATE

DMF 30471977

PFANSTIEHL LABORATORIES INCInactiveMETHOTREXATE

DMF 31891978

PFIZER LTDInactiveMETHOTREXATE

DMF 40181980

ORION CORP FARMOS CHEMICAL PLANTInactiveMETHOTREXATE 2,5 MG TABLET

DMF 68991987

SUMIKA FINE CHEMICALS CO LTDInactiveMETHOTREXATE

DMF 81851989

LIANYUNGANG PHARMACEUTICAL FACTORYInactiveMETHOTREXATE USP, NON-STERILE BULK DRUG

DMF 128331998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveMETHOTREXATE USP

DMF 211182007

BENZOCHEM LIFESCIENCES PVT LTDInactiveMETHOTREXATE USP

DMF 212702008

SEACROSS PHARMA USA INCInactiveMETHOTREXATE

DMF 383142023

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
May 29, 2026	SUPPL -9	View Letter (PDF)
Oct 24, 2024	SUPPL -2	View Letter (PDF)
Oct 24, 2024	SUPPL -3	View Letter (PDF)
Nov 30, 2022	ORIG -1	View Letter (PDF)
Nov 30, 2022	ORIG -4	View Letter (PDF)
Nov 30, 2022	ORIG -2	View Letter (PDF)
Nov 30, 2022	ORIG -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG/ML

RLD

3 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Nov 29, 2022

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11129833	Oct 28, 2035	—	—	Yes	—	—
11771701	Oct 29, 2034	—	—	Yes		—
12605385	Oct 25, 2035	—	—	Yes	—	—

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

JYLAMVO (methotrexate) listed patent 12605385 in the Orange Book for NDA 212479.

New: New record