Question 1

Is there a generic for Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate?

Accepted Answer

SUFLAVE (NDA 215344, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate?

Accepted Answer

The Orange Book lists 4 patents against Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate products, with the earliest listed expiry in 2044. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate are approved?

Accepted Answer

Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate is approved in the following dosage form: for solution.

Patent	Expires	In	Type
12433914	Jun 14, 2044	in 18 yr 3 mo	U-4143
12239659	Jun 14, 2044	in 18 yr 3 mo	U-4143
12594298	Jun 14, 2044	in 18 yr 3 mo	Product
12290529	Aug 02, 2044	in 18 yr 5 mo	Product

Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

Brand (NDA) products · for solution

Marketing exclusivity (1)

Listed patents (4)

Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate — frequently asked questions

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