METHOTREXATE SODIUM Drug Patent Profile
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Which patents cover Methotrexate Sodium, and when can generic versions of Methotrexate Sodium launch?
Methotrexate Sodium is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hikma, Hospira, Norbrook, Pharmachemie Usa, Epic Pharma Llc, Accord Hlthcare, Alembic, Amneal Pharms, Barr, Daito, Duramed Pharms Barr, Elite Labs Inc, Eugia Pharma, Lotus Pharm Co Ltd, Mylan, Strides Pharma, Sun Pharm, Zydus Pharms, Eugia Pharma Speclts, Pharmachemie Bv, Rising, Sagent Pharms Inc, and Sandoz. and is included in thirty-nine NDAs.
The generic ingredient in METHOTREXATE SODIUM is calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.
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Summary for METHOTREXATE SODIUM
| US Patents: | 0 |
| Applicants: | 25 |
| NDAs: | 39 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 40 |
| Clinical Trials: | 36 |
| Patent Applications: | 4,433 |
| What excipients (inactive ingredients) are in METHOTREXATE SODIUM? | METHOTREXATE SODIUM excipients list |
| DailyMed Link: | METHOTREXATE SODIUM at DailyMed |
Recent Clinical Trials for METHOTREXATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AstraZeneca | Phase 3 |
| Seoul National University Bundang Hospital | Phase 1 |
| Andrew E. Place | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040632-001 | Aug 12, 2005 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 201749-001 | May 21, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pharmachemie Bv | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040843-004 | Jan 11, 2010 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 011719-012 | Apr 13, 2005 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 201530-001 | Mar 29, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 090039-001 | Mar 31, 2009 | AP | RX | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
