FDA Orange Book
Generic for Hetlioz
Hetlioz 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
Yes. The generic name for Hetlioz is tasimelteon. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Hetlioz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 20MG | Marketed (Rx) | AB | 3 | AB |
NDA 205677, 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.
Approved generic tasimelteon
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 211601 | AB (A-rated, therapeutically equivalent) | December 12, 2022 | 20MG |
| APOTEX INC | 211607 | AB (A-rated, therapeutically equivalent) | December 20, 2022 | 20MG |
| MSN LABORATORIES PRIVATE LTD | 211654 | AB (A-rated, therapeutically equivalent) | January 12, 2023 | 20MG |
Hetlioz patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9539234 | January 25, 2033 | Method of use | U-1934 | 205677 |
| 9855241 | January 25, 2033 | Method of use | U-2149 | 205677 |
| RE46604 | January 25, 2033 | Method of use | U-2147 | 205677 |
| 10149829 | January 25, 2033 | Method of use | U-2477 | 205677 |
| 9060995 | January 25, 2033 | Method of use | U-1710 | 205677 |
| 10449176 | January 25, 2033 | Method of use | U-2149 | 205677 |
| 10945988 | January 25, 2033 | Method of use | U-2149 | 205677 |
| 11633377 | January 25, 2033 | Method of use | U-2149 | 205677 |
| 11633377 | January 25, 2033 | Method of use | U-3003 | 205677 |
| 9539234 | January 25, 2033 | Method of use | U-3004 | 205677 |
| 10149829 | January 25, 2033 | Method of use | U-3006 | 205677 |
| 10610510 | January 25, 2033 | Method of use | U-3009 | 205677 |
| 12201604 | January 25, 2033 | Method of use | U-3003 | 205677 |
| 12201604 | January 25, 2033 | Method of use | U-3865 | 205677 |
| 10610510 | January 25, 2033 | Method of use | U-2805 | 205677 |
| 10980770 | January 25, 2033 | Method of use | U-3106 | 205677 |
| 10980770 | January 25, 2033 | Method of use | U-3107 | 205677 |
| 11850229 | January 25, 2033 | Method of use | U-3342 | 205677 |
| 11850229 | January 25, 2033 | Method of use | U-3343 | 205677 |
| 11833130 | January 25, 2033 | Method of use | U-2149 | 205677 |
| 11833130 | January 25, 2033 | Method of use | U-3003 | 205677 |
| 11918557 | January 25, 2033 | Method of use | U-3003 | 205677 |
| 11918557 | January 25, 2033 | Method of use | U-3865 | 205677 |
| 11826339 | January 25, 2033 | Method of use | U-3342 | 205677 |
| 11826339 | January 25, 2033 | Method of use | U-3343 | 205677 |
| 11285129 | January 25, 2033 | Method of use | U-3342 | 205677 |
| 11285129 | January 25, 2033 | Method of use | U-3343 | 205677 |
| 9549913 | January 25, 2033 | Method of use | U-1486 | 205677 |
| 11918556 | April 7, 2033 | Method of use | U-3342 | 205677 |
| 11918556 | April 7, 2033 | Method of use | U-3343 | 205677 |
| 9730910 | May 17, 2034 | Method of use | U-2085 | 205677 |
| 9730910 | May 17, 2034 | Method of use | U-3005 | 205677 |
| 11141400 | October 10, 2034 | Method of use | U-2615 | 205677 |
| 11141400 | October 10, 2034 | Method of use | U-3007 | 205677 |
| 10610511 | October 10, 2034 | Method of use | U-3007 | 205677 |
| 10610511 | October 10, 2034 | Method of use | U-2615 | 205677 |
| 11786502 | October 10, 2034 | Method of use | U-3007 | 205677 |
| 11786502 | October 10, 2034 | Method of use | U-3739 | 205677 |
| 11566011 | February 12, 2035 | Drug substance, Drug product | None | 205677 |
| 12049457 | February 12, 2035 | Drug substance, Drug product | None | 205677 |
| 10829465 | February 12, 2035 | Drug substance, Drug product | None | 205677 |
| 11760740 | February 12, 2035 | Drug substance, Drug product | None | 205677 |
| 10071977 | February 12, 2035 | Drug substance, Drug product | None | 205677 |
| 10376487 | July 27, 2035 | Method of use | U-2615 | 205677 |
| 10376487 | July 27, 2035 | Method of use | U-3007 | 205677 |
| 11266622 | August 29, 2035 | Method of use | U-3003 | 205677 |
| 10179119 | August 29, 2035 | Method of use | U-3003 | 205677 |
| 11759446 | February 21, 2041 | Method of use | U-3003 | 205677 |
Hetlioz exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-330 | Orphan drug exclusivity | December 1, 2027 | 205677 |
Hetlioz NDC codes
Questions
Is there a generic for Hetlioz?
Yes. The generic name for Hetlioz is tasimelteon. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Hetlioz?
The active ingredient in Hetlioz is tasimelteon, per the FDA Orange Book.
When does the Hetlioz patent expire?
The last patent listed for Hetlioz 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.