METHOTREXATE SODIUM - Generic Drug Details
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What are the generic sources for methotrexate sodium and what is the scope of freedom to operate?
Methotrexate sodium
is the generic ingredient in twelve branded drugs marketed by Abic, Pharmacia And Upjohn, Hospira, Fresenius Kabi Usa, Abraxis Pharm, Hikma, Norbrook, Pharmachemie Usa, Accord Hlthcare, Eugia Pharma Speclts, Pharmachemie Bv, Rising, Sagent Pharms Inc, Sandoz, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Alembic, Amneal Pharms, Barr, Daito, Duramed Pharms Barr, Elite Labs Inc, Eugia Pharma, Lotus Pharm Co Ltd, Mylan, Strides Pharma, Sun Pharm, and Zydus Pharms, and is included in fifty-three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Methotrexate sodium has three patent family members in three countries.
There are three drug master file entries for methotrexate sodium. Twenty-eight suppliers are listed for this compound.
Summary for METHOTREXATE SODIUM
| International Patents: | 3 |
| US Patents: | 6 |
| Tradenames: | 12 |
| Applicants: | 30 |
| NDAs: | 53 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 28 |
| Raw Ingredient (Bulk) Api Vendors: | 40 |
| Clinical Trials: | 36 |
| Patent Applications: | 7,601 |
| What excipients (inactive ingredients) are in METHOTREXATE SODIUM? | METHOTREXATE SODIUM excipients list |
| DailyMed Link: | METHOTREXATE SODIUM at DailyMed |
Recent Clinical Trials for METHOTREXATE SODIUM
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| Sponsor | Phase |
|---|---|
| AstraZeneca | Phase 3 |
| Seoul National University Bundang Hospital | Phase 1 |
| Children's Cancer Research Fund | Phase 1 |
Pharmacology for METHOTREXATE SODIUM
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for METHOTREXATE SODIUM
US Patents and Regulatory Information for METHOTREXATE SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 210040-001 | Dec 22, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Accord Hlthcare | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040767-001 | Apr 30, 2007 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 040263-002 | Feb 26, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 040054-001 | Aug 1, 1994 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abic | ABITREXATE | methotrexate sodium | INJECTABLE;INJECTION | 089354-001 | Jul 17, 1987 | DISCN | 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 |
International Patents for METHOTREXATE SODIUM
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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.
ISSN: 2162-2639
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