FDA Orange Book
Is there a generic for Suflave?
Suflave contains magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride and sodium sulfate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Suflave (magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride and sodium sulfate). The Orange Book shows its last listed patent expires August 2, 2044 and its last listed exclusivity ends June 15, 2026.
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Suflave products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT | Marketed (Rx) | None | 0 | None |
NDA 215344, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Suflave patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12433914 | June 14, 2044 | Method of use | U-4143 | 215344 |
| 12239659 | June 14, 2044 | Method of use | U-4143 | 215344 |
| 12594298 | June 14, 2044 | Drug product | None | 215344 |
| 12290529 | August 2, 2044 | Drug product | None | 215344 |
Suflave exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | June 15, 2026 | 215344 |
Questions
Is there a generic for Suflave?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Suflave (magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride and sodium sulfate). The Orange Book shows its last listed patent expires August 2, 2044 and its last listed exclusivity ends June 15, 2026.
What is the generic name for Suflave?
The active ingredient in Suflave is magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride and sodium sulfate, per the FDA Orange Book.
When does the Suflave patent expire?
The last patent listed for Suflave in the Orange Book expires August 2, 2044. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.