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, Annora Pharma, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma, and Taro, and is included in thirty-three 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: | 20 |
NDAs: | 33 |
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 |
⤷ Subscribe | ⤷ Subscribe | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baxter Hlthcare Corp | MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 211966-003 | Jun 1, 2020 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Baxter Hlthcare Corp | MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 211966-002 | Jun 1, 2020 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
B Braun Medical Inc | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 207966-001 | Oct 27, 2020 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Gland Pharma Ltd | MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 213917-001 | Jul 10, 2020 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Baxter Hlthcare Corp | MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 211966-001 | Jun 1, 2020 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
MAGNESIUM SULFATE Market Analysis and Financial Projection Experimental
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