FDA Orange Book
Generic for Tiglutik Kit
Tiglutik Kit contains riluzole. 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 Tiglutik Kit is riluzole. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tiglutik Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 50MG/10ML | Marketed (Rx) | AB | 1 | AB |
NDA 209080, held by ITALFARMACO SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic riluzole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALKEM LABORATORIES LTD | 216035 | AB (A-rated, therapeutically equivalent) | August 22, 2024 | 50MG/10ML |
Tiglutik Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8765150 | March 12, 2029 | Drug product | U-2401 | 209080 |
Tiglutik Kit NDC codes
Questions
Is there a generic for Tiglutik Kit?
Yes. The generic name for Tiglutik Kit is riluzole. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Tiglutik Kit?
The active ingredient in Tiglutik Kit is riluzole, per the FDA Orange Book.
When does the Tiglutik Kit patent expire?
The last patent listed for Tiglutik Kit in the Orange Book expires March 12, 2029. 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.