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Last Updated: November 22, 2024

Pemetrexed - Generic Drug Details

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What are the generic sources for pemetrexed and what is the scope of freedom to operate?

Pemetrexed is the generic ingredient in five branded drugs marketed by Actavis, Eagle Pharms, Avyxa Holdings, Lilly, Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, Nang Kuang Pharm Co, Norvium Bioscience, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, Shilpa, and Sandoz, and is included in twenty-nine NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pemetrexed has seven patent family members in five countries.

There are twenty-nine drug master file entries for pemetrexed. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for pemetrexed

International Patents:	7
US Patents:	3
Tradenames:	5
Applicants:	24
NDAs:	29
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	963
Patent Applications:	7,467
Drug Prices:	Drug price trends for pemetrexed
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pemetrexed
What excipients (inactive ingredients) are in pemetrexed?	pemetrexed excipients list
DailyMed Link:	pemetrexed at DailyMed

Drug Prices for pemetrexed

See drug prices for pemetrexed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for pemetrexed

Generic Entry Date for pemetrexed^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for pemetrexed

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2
Istituto Oncologico Veneto IRCCS	Phase 2
MSD Italia S.r.l.	Phase 2

See all pemetrexed clinical trials

Generic filers with tentative approvals for PEMETREXED

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	500MG	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	500MG	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	100MG	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pemetrexed

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for pemetrexed

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for pemetrexed

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	203485-001	May 25, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	216582-001	Dec 11, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Jiangsu Hansoh Pharm	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	208696-002	May 25, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	PEMETREXED DITROMETHAMINE	pemetrexed ditromethamine	POWDER;INTRAVENOUS	208746-001	Jun 10, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Qilu Pharm Hainan	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	204890-001	May 25, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	090384-001	May 25, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for pemetrexed

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Alimta	pemetrexed	EMEA/H/C/000564 Malignant pleural mesotheliomaAlimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.Non-small-cell lung cancerAlimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.	Authorised	no	no	no	2004-09-20
KRKA d.d.	Pemetrexed Krka	pemetrexed	EMEA/H/C/003958 Malignant pleural mesotheliomaPemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	yes	no	no	2018-05-22
Menarini International Operations Luxembourg S.A.	Ciambra	pemetrexed	EMEA/H/C/003788 Malignant pleural mesothelioma, , Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer, , Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology., , Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy., , Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,	Authorised	yes	no	no	2015-12-02
Fresenius Kabi Deutschland GmbH	Pemetrexed Fresenius Kabi	pemetrexed	EMEA/H/C/003895 Malignant pleural mesotheliomaPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Fresenius Kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	yes	no	no	2016-07-22
medac Gesellschaft für klinische Spezialpräparate mbH	Pemetrexed medac	pemetrexed	EMEA/H/C/003905 Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer Pemetrexed medac in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology., , Pemetrexed medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy., , Pemetrexed medac is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,	Authorised	yes	no	no	2015-11-26
Actavis Group PTC ehf	Armisarte (previously Pemetrexed Actavis)	pemetrexed	EMEA/H/C/004109 Malignant pleural mesotheliomaPemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	no	no	no	2016-01-18
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for pemetrexed

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Country	Patent Number	Title	Estimated Expiration
Taiwan	I551603		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016068796		⤷ Sign Up
Canada	3015436	FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)	⤷ Sign Up
Canada	2962383	FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)	⤷ Sign Up
Israel	251405	צורות גבישיות של פמטרקסד די-חומצה ושיטות להכנתן (Crystalline forms of pemetrexed diacid and manufacturing processes therefor)	⤷ Sign Up
Taiwan	201619161	Crystalline forms of pemetrexed diacid and manufacture processes therefor	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for pemetrexed

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	7/2005	Austria	⤷ Sign Up	PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677	SPC/GB05/011	United Kingdom	⤷ Sign Up	PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.