Magnesium sulfate - Generic Drug Details
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What are the generic 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 216597-001 | Feb 15, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Braintree Labs | SUFLAVE | magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 215344-001 | Jun 15, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Exela Pharma | MAGNESIUM SULFATE | magnesium sulfate | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 206039-001 | Dec 18, 2014 | DISCN | 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 | |||
| Hq Spclt Pharma | MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 207350-002 | Dec 6, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hq Spclt Pharma | MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 207350-001 | Dec 6, 2017 | AP | 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 | |||
| >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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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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