FDA Orange Book
Is there a generic for Tadliq?
Tadliq contains tadalafil. 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 Tadliq (tadalafil). The Orange Book shows its last listed patent expires December 24, 2038.
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Tadliq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 20MG/5ML | Marketed (Rx) | None | 0 | None |
NDA 214522, held by CMP DEVELOPMENT LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tadliq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11975006 | December 24, 2038 | Drug product | U-3397 | 214522 |
| 12186322 | December 24, 2038 | Drug product | U-3397 | 214522 |
| 11382917 | December 24, 2038 | Drug product | U-3397 | 214522 |
| 11666576 | December 24, 2038 | Drug product | U-3397 | 214522 |
| 12708626 | December 24, 2038 | Drug product | U-3397 | 214522 |
| 12691120 | December 24, 2038 | Drug product | U-3397 | 214522 |
| 12697338 | December 24, 2038 | Drug product | U-3397 | 214522 |
| 12721849 | December 24, 2038 | Drug product | U-3397 | 214522 |
| 12734175 | December 24, 2038 | Drug product | None | 214522 |
Tadliq NDC codes
Questions
Is there a generic for Tadliq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tadliq (tadalafil). The Orange Book shows its last listed patent expires December 24, 2038.
What is the generic name for Tadliq?
The active ingredient in Tadliq is tadalafil, per the FDA Orange Book.
When does the Tadliq patent expire?
The last patent listed for Tadliq in the Orange Book expires December 24, 2038. 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.