FDA Orange Book
Generic for Qbrelis
Qbrelis contains lisinopril. 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 Qbrelis is lisinopril. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Qbrelis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 1MG/ML | Marketed (Rx) | AA | 1 | AA |
NDA 208401, 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.
Approved generic lisinopril
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANNORA PHARMA PRIVATE LTD | 218419 | AA (A-rated, therapeutically equivalent) | August 20, 2026 | 1MG/ML |
Qbrelis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9616096 | November 6, 2035 | Method of use | U-3 | 208401 |
| 10039800 | November 6, 2035 | Method of use | U-8 | 208401 |
| 10039800 | November 6, 2035 | Method of use | U-1864 | 208401 |
| 10039800 | November 6, 2035 | Method of use | U-1991 | 208401 |
| 10039800 | November 6, 2035 | Method of use | U-71 | 208401 |
| 10039800 | November 6, 2035 | Method of use | U-1723 | 208401 |
| 9616096 | November 6, 2035 | Method of use | U-185 | 208401 |
| 10406199 | November 6, 2035 | Method of use | U-1864 | 208401 |
| 10406199 | November 6, 2035 | Method of use | U-185 | 208401 |
| 10406199 | November 6, 2035 | Method of use | U-1723 | 208401 |
| 10406199 | November 6, 2035 | Method of use | U-71 | 208401 |
| 10406199 | November 6, 2035 | Method of use | U-1991 | 208401 |
| 10406199 | November 6, 2035 | Method of use | U-3 | 208401 |
| 10406199 | November 6, 2035 | Method of use | U-8 | 208401 |
| 9616096 | November 6, 2035 | Method of use | U-1723 | 208401 |
| 9616096 | November 6, 2035 | Method of use | U-1864 | 208401 |
| 10039800 | November 6, 2035 | Method of use | U-3 | 208401 |
| 12433931 | November 6, 2035 | Method of use | U-1723 | 208401 |
| 12433931 | November 6, 2035 | Method of use | U-1864 | 208401 |
| 12433931 | November 6, 2035 | Method of use | U-3 | 208401 |
| 10039800 | November 6, 2035 | Method of use | U-185 | 208401 |
| 9616096 | November 6, 2035 | Method of use | U-1991 | 208401 |
| 9616096 | November 6, 2035 | Method of use | U-8 | 208401 |
| 9616096 | November 6, 2035 | Method of use | U-71 | 208401 |
| 10265370 | November 6, 2035 | Drug product | None | 208401 |
| 9463183 | November 6, 2035 | Drug product | None | 208401 |
| 11179434 | November 6, 2035 | Drug product | None | 208401 |
| 9814751 | November 6, 2035 | Drug product | None | 208401 |
| 10940177 | November 6, 2035 | Drug product | None | 208401 |
| 11771733 | November 6, 2035 | Drug product | None | 208401 |
| 12186360 | November 6, 2035 | Drug product | None | 208401 |
| 12128083 | November 6, 2035 | Drug product | None | 208401 |
Qbrelis NDC codes
Questions
Is there a generic for Qbrelis?
Yes. The generic name for Qbrelis is lisinopril. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Qbrelis?
The active ingredient in Qbrelis is lisinopril, per the FDA Orange Book.
When does the Qbrelis patent expire?
The last patent listed for Qbrelis in the Orange Book expires November 6, 2035. 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.