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

2032

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

500 trials from ClinicalTrials.gov, 39 active, 461 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia NCT03164057	Phase 2	Active	St. Jude Children's Research Hospital	206	2017-06-15 → 2027-06
Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia NCT02003222	Phase 3	Active	National Cancer Institute (NCI)	488	2014-05-19 → 2027-02-25
Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors NCT02114229	Phase 2	Active	St. Jude Children's Research Hospital	125	2014-05-14 → 2027-09
Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia NCT04329325	Phase 2	Active	Memorial Sloan Kettering Cancer Center	17	2020-03-30 → 2027-03
Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia NCT01424982	Phase 2	Active	M.D. Anderson Cancer Center	88	2011-10-05 → 2027-10-31
Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma NCT00470223	Phase 3	Active	UNICANCER	318	2007-03 → 2026-12
Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia NCT00792948	Phase 2	Active	National Cancer Institute (NCI)	97	2009-09-01 → 2027-01-06
Methotrexate and Metformin in Rheumatoid Arthritis Patients NCT04196868	Phase 2	Active	University Hospital, Bordeaux	128	2020-12-03 → 2026-06
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I NCT02553460	Phase 1/2	Active	St. Jude Children's Research Hospital	50	2016-01-29 → 2031-10
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders NCT00544115	Phase 2	Active	City of Hope Medical Center	260	2001-10-16 → 2027-03-29

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$595.50

Highest Price

$595.50

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
81927-0204-01JYLAMVO 2MG/ML SOLN,ORAL	$595.50	FSS	Shorla Oncology	08/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain10 active DMFs9 inactive

9 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

PFANSTIEHL INCMETHOTREXATE, HIGH PURITY LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, ChP (M-166-1)

DMF 399882024

RAVI BIOLIFE PRIVATE LTDMETHOTREXATE USP

DMF 399972024

SHILPA PHARMA LIFESCIENCES LTDMETHOTREXATE USP

DMF 420562025

MSN LABORATORIES PRIVATE LTDMETHOTREXATE USP

DMF 434332026

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) · 5 use codes

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	—	—