pemetrexed disodium - Profile
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What are the generic drug sources for pemetrexed disodium and what is the scope of freedom to operate?
Pemetrexed disodium
is the generic ingredient in three branded drugs marketed by 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, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, Shilpa, and Sandoz, and is included in twenty-five NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Pemetrexed disodium has one patent family member in one country.
Summary for pemetrexed disodium
| International Patents: | 1 |
| US Patents: | 1 |
| Tradenames: | 3 |
| Applicants: | 21 |
| NDAs: | 25 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-002 | Sep 7, 2007 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Accord Hlthcare | PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 203485-003 | May 25, 2022 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Accord Hlthcare | PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 203485-001 | May 25, 2022 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for pemetrexed disodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2016151365 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for pemetrexed disodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0432677 | 7/2005 | Austria | ⤷ Start Trial | PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920 |
| 0432677 | SPC/GB05/011 | United Kingdom | ⤷ Start Trial | 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 |
