PEMETREXED DISODIUM Drug Patent Profile
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When do Pemetrexed Disodium patents expire, and when can generic versions of Pemetrexed Disodium launch?
Pemetrexed Disodium is a drug marketed by 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-three NDAs.
The generic ingredient in PEMETREXED DISODIUM is pemetrexed disodium. There are twenty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pemetrexed Disodium
A generic version of PEMETREXED DISODIUM was approved as pemetrexed disodium by ACCORD HLTHCARE on May 25th, 2022.
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Questions you can ask:
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Summary for PEMETREXED DISODIUM
| US Patents: | 0 |
| Applicants: | 19 |
| NDAs: | 23 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 109 |
| Patent Applications: | 6,227 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PEMETREXED DISODIUM |
| DailyMed Link: | PEMETREXED DISODIUM at DailyMed |
Recent Clinical Trials for PEMETREXED DISODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme Corp. | Phase 3 |
| Guangdong Association of Clinical Trials | Phase 3 |
| Tianjin Medical University Cancer Institute and Hospital | Phase 2 |
Pharmacology for PEMETREXED DISODIUM
| Drug Class | Folate Analog Metabolic Inhibitor Antiarrhythmic |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for PEMETREXED DISODIUM
Anatomical Therapeutic Chemical (ATC) Classes for PEMETREXED DISODIUM
Paragraph IV (Patent) Challenges for PEMETREXED DISODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ALIMTA | For Injection | pemetrexed disodium | 750 mg/vial | 021462 | 1 | 2016-10-06 |
| ALIMTA | For Injection | pemetrexed disodium | 1000 mg/vial | 021462 | 1 | 2012-06-27 |
| ALIMTA | For Injection | pemetrexed disodium | 100 mg/vial | 021462 | 1 | 2008-07-01 |
| ALIMTA | For Injection | pemetrexed disodium | 500 mg/vial | 021462 | 2 | 2008-02-04 |
US Patents and Regulatory Information for PEMETREXED DISODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reliance Life | PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 211899-002 | May 25, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 215479-002 | Dec 13, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | PEMETREXED DISODIUM | pemetrexed disodium | SOLUTION;INTRAVENOUS | 214218-003 | Jun 22, 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 |
