Viewing data from:

PEMETREXED

NDA

PEMETREXED | N208419 | ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ELI LILLY AND COMPANY v. ACTAVIS LLC et al 1:2017cv00982 1 patentpemetrexed	INSD	2017-03-30	Terminated 2018-05-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Pemetrexed (2023)

Total Spending

$635K

Total Claims

891

Beneficiaries

314

ASP Price

$8.48

HCPCS: J9294 — Injection, pemetrexed (hospira) not therapeutically equivalent to j9305, 10 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain18 active DMFs3 inactive

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

TAPI NL BVPEMETREXED DIACID

DMF 211802008

GLAND CHEMICALS PRIVATE LTDPEMETREXED DISODIUM 2.5 HYDRATE

DMF 253992011

POLYMED THERAPEUTICS INCPEMETREXED DISODIUM 2.5 HYDRATE DRUG SUBSTANCE

DMF 278092013

MSN LABORATORIES PRIVATE LTDPEMETREXED DISODIUM HEPTAHYDRATE USP [ROUTE CODE "PT"]

DMF 280942014

MSN LABORATORIES PRIVATE LTDPEMETREXED DISODIUM USP HEMIPENTAHYDRATE [ROUTE CODE "PN"]

DMF 280992014

EMCURE PHARMACEUTICALS LTDPEMETREXED DISODIUM HEMIPENTAHYDRATE

DMF 285622014

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDPEMETREXED DIACID, NON-STERILE, BULK DRUG SUBSTANCE

DMF 287582014

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDPEMETREXED DISODIUM HEMIPENTAHYDRATE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 291832015

SHILPA PHARMA LIFESCIENCES LTDPEMETREXED DIPOTASSIUM (NONA HYDRATE) (PMN)

DMF 296522015

SCINOPHARM TAIWAN LTDPEMETREXED

DMF 298212015

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPEMETREXED ACID PMC

DMF 312152016

MSN LABORATORIES PRIVATE LTDPEMETREXED DIPOTASSIUM HEPTAHYDRATE

DMF 315712017

WUHAN CALMLAND PHARMACEUTICALS CO LTDPEMETREXED DISODIUM HEPTAHYDRATE

DMF 316432017

WUHAN CALMLAND PHARMACEUTICALS CO LTDPEMETREXED DISODIUM HEMIPENTAHYDRATE

DMF 319642017

CDYMAX (INDIA) PHARMA PRIVATE LTDPEMETREXED DISODIUM HEMIPENTA HYDRATE [DRUG SUBSTANCE (NON-STERILE)]

DMF 326392018

HETERO LABS LTDPEMETREXED DISODIUM 2.5 HYDRATE

DMF 349782020

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDPEMETREXED DISODIUM USP NON-STERILE

DMF 371502022

CHONGQING SINTAHO PHARMACEUTICAL CO LTDPEMETREXED DISODIUM HEPTAHYDRATE

DMF 423662025

CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTDInactivePEMETREXED DISODIUM, (NON-STERILE BULK DRUG SUBSTANCE)

DMF 221412008

SCINOPHARM TAIWAN LTDInactivePEMETREXED DISODIUM HEMIPENTAHYDRATE

DMF 243272010

MYLAN LABORATORIES LTDInactivePEMETREXED DISODIUM HEMIPENTAHYDRATE

DMF 300092015

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Nov 25, 2022	SUPPL -2	View Letter (PDF)
Nov 25, 2022	SUPPL -3	View Letter (PDF)
Nov 25, 2022	SUPPL -4	View Letter (PDF)
Aug 24, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG/4ML (25MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Aug 21, 2020

No patent or exclusivity listings for this strength.

#002 — 500MG/20ML (25MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 21, 2020

#003 — 1GM/40ML (25MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 21, 2020