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Last Updated: November 22, 2024

PEMETREXED Drug Patent Profile


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When do Pemetrexed patents expire, and what generic alternatives are available?

Pemetrexed is a drug marketed by Avyxa Holdings, Actavis, Shilpa, 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, and Sandoz. and is included in twenty-seven NDAs. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in PEMETREXED is pemetrexed ditromethamine. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed ditromethamine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pemetrexed

A generic version of PEMETREXED was approved as pemetrexed ditromethamine by HOSPIRA on June 10th, 2022.

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Drug patent expirations by year for PEMETREXED
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Recent Clinical Trials for PEMETREXED

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SponsorPhase
Regeneron PharmaceuticalsPhase 2
MSD Italia S.r.l.Phase 2
Istituto Oncologico Veneto IRCCSPhase 2

See all PEMETREXED clinical trials

Pharmacology for PEMETREXED

US Patents and Regulatory Information for PEMETREXED

PEMETREXED is protected by one US patents.

Patents protecting PEMETREXED

Pharmaceutical composition of pemetrexed
Patent Number: ⤷  Sign Up
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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
Meitheal PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 215479-003 Dec 13, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd Vi PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 215460-002 Jun 14, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Reliance Life PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 211899-002 May 25, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz PEMETREXED DISODIUM pemetrexed disodium SOLUTION;INTRAVENOUS 214657-003 May 26, 2022 RX Yes Yes ⤷  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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for PEMETREXED

See the table below for patents covering PEMETREXED around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2016151365 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PEMETREXED

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.