FDA Orange Book
Is there a generic for Hetlioz Lq?
Hetlioz Lq contains tasimelteon. 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 Hetlioz Lq (tasimelteon). The Orange Book shows its last listed patent expires February 21, 2041 and its last listed exclusivity ends December 1, 2027.
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Hetlioz Lq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 4MG/ML | Marketed (Rx) | None | 0 | None |
NDA 214517, held by VANDA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Hetlioz Lq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10980770 | January 25, 2033 | Method of use | U-3106 | 214517 |
| 11633377 | January 25, 2033 | Method of use | U-3003 | 214517 |
| 10149829 | January 25, 2033 | Method of use | U-3006 | 214517 |
| 9539234 | January 25, 2033 | Method of use | U-3004 | 214517 |
| 10610510 | January 25, 2033 | Method of use | U-3009 | 214517 |
| 12201604 | January 25, 2033 | Method of use | U-3003 | 214517 |
| 11833130 | January 25, 2033 | Method of use | U-3003 | 214517 |
| 11850229 | January 25, 2033 | Method of use | U-3342 | 214517 |
| 11826339 | January 25, 2033 | Method of use | U-3342 | 214517 |
| 11918557 | January 25, 2033 | Method of use | U-3003 | 214517 |
| 11285129 | January 25, 2033 | Method of use | U-3342 | 214517 |
| 11918556 | April 7, 2033 | Method of use | U-3342 | 214517 |
| 9730910 | May 17, 2034 | Method of use | U-3005 | 214517 |
| 11141400 | October 10, 2034 | Method of use | U-3007 | 214517 |
| 10610511 | October 10, 2034 | Method of use | U-3007 | 214517 |
| 11786502 | October 10, 2034 | Method of use | U-3007 | 214517 |
| 12049457 | February 12, 2035 | Drug substance, Drug product | None | 214517 |
| 10829465 | February 12, 2035 | Drug substance, Drug product | None | 214517 |
| 10071977 | February 12, 2035 | Drug substance, Drug product | None | 214517 |
| 11566011 | February 12, 2035 | Drug substance, Drug product | None | 214517 |
| 11760740 | February 12, 2035 | Drug substance, Drug product | None | 214517 |
| 10376487 | July 27, 2035 | Method of use | U-3007 | 214517 |
| 11266622 | August 29, 2035 | Method of use | U-3003 | 214517 |
| 10179119 | August 29, 2035 | Method of use | U-3003 | 214517 |
| 12447141 | December 11, 2040 | Method of use | U-3003 | 214517 |
| 11202770 | December 11, 2040 | Drug product | None | 214517 |
| 11759446 | February 21, 2041 | Method of use | U-3003 | 214517 |
Hetlioz Lq exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-329 | Orphan drug exclusivity | December 1, 2027 | 214517 |
Hetlioz Lq NDC codes
Questions
Is there a generic for Hetlioz Lq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hetlioz Lq (tasimelteon). The Orange Book shows its last listed patent expires February 21, 2041 and its last listed exclusivity ends December 1, 2027.
What is the generic name for Hetlioz Lq?
The active ingredient in Hetlioz Lq is tasimelteon, per the FDA Orange Book.
When does the Hetlioz Lq patent expire?
The last patent listed for Hetlioz Lq in the Orange Book expires February 21, 2041. 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.