MAGNESIUM SULFATE - Generic Drug Details
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What are the generic drug sources for magnesium sulfate and what is the scope of freedom to operate?
Magnesium sulfate
is the generic ingredient in eleven branded drugs marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Amneal, Gland Pharma Ltd, Milla Pharms, Exela Pharma, Braintree Labs, Baxter Hlthcare, Gator Pharms, Alkem Labs Ltd, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma, and Taro, and is included in thirty-two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for magnesium sulfate. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for MAGNESIUM SULFATE
US Patents: | 4 |
Tradenames: | 11 |
Applicants: | 19 |
NDAs: | 32 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 17 |
Raw Ingredient (Bulk) Api Vendors: | 137 |
Clinical Trials: | 324 |
Patent Applications: | 1,386 |
What excipients (inactive ingredients) are in MAGNESIUM SULFATE? | MAGNESIUM SULFATE excipients list |
DailyMed Link: | MAGNESIUM SULFATE at DailyMed |
Recent Clinical Trials for MAGNESIUM SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Oklahoma | Early Phase 1 |
Daewoong Pharmaceutical Co. LTD. | Phase 3 |
Cairo University | Phase 1/Phase 2 |
Generic filers with tentative approvals for MAGNESIUM SULFATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 1.6GM/BOT; 3.13GM/BOT; 17.5GM/BOT | SOLUTION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for MAGNESIUM SULFATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alkem Labs Ltd | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | magnesium sulfate; potassium sulfate; sodium sulfate | SOLUTION;ORAL | 213924-001 | Dec 29, 2023 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hospira | MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 020309-005 | Jan 18, 1995 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 206485-002 | Mar 15, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Baxter Hlthcare | TIS-U-SOL | magnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphate | SOLUTION;IRRIGATION | 018508-001 | Feb 19, 1982 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hospira | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 020488-001 | Jul 11, 1995 | AP | 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 |
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