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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Summary for PEMETREXED
| International Patents: | 1 |
| US Patents: | 1 |
| Applicants: | 22 |
| NDAs: | 27 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 963 |
| Patent Applications: | 5,239 |
| Drug Prices: | Drug price information 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 |
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 |
Pharmacology for PEMETREXED
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PEMETREXED
US Patents and Regulatory Information for PEMETREXED
| 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 | ||||
| Prinston Inc | PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 216582-001 | Dec 11, 2023 | 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
| 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 | |
| >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 | SPC/GB05/011 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920 |
| 0432677 | 7/2005 | Austria | ⤷ Sign Up | PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: 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.
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DrugPatentWatch Alternatives
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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