FDA Orange Book
Generic for Osmoprep
Osmoprep contains sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous. 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
Yes. The generic name for Osmoprep is sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Osmoprep products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.398GM;1.102GM | Discontinued | None | 1 | None |
NDA 021892, held by SALIX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVEL LABORATORIES INC | 079247 | None (No TE code listed) | December 30, 2011 | 0.398GM;1.102GM |
Osmoprep patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7687075 | June 22, 2028 | Drug substance, Drug product | None | 021892 |
Questions
Is there a generic for Osmoprep?
Yes. The generic name for Osmoprep is sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Osmoprep?
The active ingredient in Osmoprep is sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous, per the FDA Orange Book.
When does the Osmoprep patent expire?
The last patent listed for Osmoprep in the Orange Book expires June 22, 2028. 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.