FDA Orange Book
Is there a generic for Qlosi?
Qlosi contains pilocarpine. 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 Qlosi (pilocarpine). The Orange Book shows its last listed patent expires August 18, 2037 and its last listed exclusivity ends October 17, 2026.
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Qlosi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.4% | Marketed (Rx) | None | 0 | None |
NDA 217836, held by ORASIS PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Qlosi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11129812 | August 18, 2037 | Method of use | U-3741 | 217836 |
| 10639297 | August 18, 2037 | Drug product | U-3741 | 217836 |
| 11974986 | August 18, 2037 | Method of use | U-3741 | 217836 |
| 9867810 | August 18, 2037 | Drug product | U-3741 | 217836 |
Qlosi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | October 17, 2026 | 217836 |
Qlosi NDC codes
Questions
Is there a generic for Qlosi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qlosi (pilocarpine). The Orange Book shows its last listed patent expires August 18, 2037 and its last listed exclusivity ends October 17, 2026.
What is the generic name for Qlosi?
The active ingredient in Qlosi is pilocarpine, per the FDA Orange Book.
When does the Qlosi patent expire?
The last patent listed for Qlosi in the Orange Book expires August 18, 2037. 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.