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Orange Book drug · Brand (NDA)

Hetlioz Lq

Tasimelteon

RLDNDA 214517 Vanda Pharms Inc
Approved
Dec 01, 2020
Strengths
1
Listed patents
27

What does the FDA Orange Book show for Hetlioz Lq?

Hetlioz Lq contains Tasimelteon and is the new drug FDA Orange Book record for NDA 214517. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 214517

New drug application identity from the Orange Book snapshot.

Application holder
Vanda Pharmaceuticals Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
27

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
1

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0014MG/MLSUSPENSIONORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Vanda Pharmaceuticals Inc

The Orange Book identifies this organization as the applicant responsible for NDA 214517.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

27 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Feb 21, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

3 other ANDAs and 1 other NDA found

3 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 214517 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Suspension · Oral

Tasimelteon

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-214517

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 214517
RLDRS
Strength
4MG/ML
Dosage form
SUSPENSION
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    5 yr 9 mo ago

  2. Today

  3. Exclusivity ends · ODE-329

    Orphan-drug exclusivity (7 years)

    in 1 yr 4 mo

  4. Patent 10149829 expires

    Listed method-of-use patent (U-3006) expiration.

    in 6 yr 7 mo

  5. Patent 10610510 expires

    Listed method-of-use patent (U-3009) expiration.

    in 6 yr 7 mo

  6. Patent 10980770 expires

    Listed method-of-use patent (U-3106) expiration.

    in 6 yr 7 mo

  7. Patent 11285129 expires

    Listed method-of-use patent (U-3342) expiration.

    in 6 yr 7 mo

  8. Patent 11633377 expires

    Listed method-of-use patent (U-3003) expiration.

    in 6 yr 7 mo

  9. Patent 11826339 expires

    Listed method-of-use patent (U-3342) expiration.

    in 6 yr 7 mo

  10. Patent 11833130 expires

    Listed method-of-use patent (U-3003) expiration.

    in 6 yr 7 mo

  11. Patent 11850229 expires

    Listed method-of-use patent (U-3342) expiration.

    in 6 yr 7 mo

  12. Patent 11918557 expires

    Listed method-of-use patent (U-3003) expiration.

    in 6 yr 7 mo

  13. Patent 12201604 expires

    Listed method-of-use patent (U-3003) expiration.

    in 6 yr 7 mo

  14. Patent 9539234 expires

    Listed method-of-use patent (U-3004) expiration.

    in 6 yr 7 mo

  15. Patent 11918556 expires

    Listed method-of-use patent (U-3342) expiration.

    in 6 yr 10 mo

  16. Patent 9730910 expires

    Listed method-of-use patent (U-3005) expiration.

    in 7 yr 11 mo

  17. Patent 10610511 expires

    Listed method-of-use patent (U-3007) expiration.

    in 8 yr 4 mo

  18. Patent 11141400 expires

    Listed method-of-use patent (U-3007) expiration.

    in 8 yr 4 mo

  19. Patent 11786502 expires

    Listed method-of-use patent (U-3007) expiration.

    in 8 yr 4 mo

  20. Patent 10071977 expires

    Listed drug substance patent expiration.

    in 8 yr 8 mo

  21. Patent 10829465 expires

    Listed drug substance patent expiration.

    in 8 yr 8 mo

  22. Patent 11566011 expires

    Listed drug substance patent expiration.

    in 8 yr 8 mo

  23. Patent 11760740 expires

    Listed drug substance patent expiration.

    in 8 yr 8 mo

  24. Patent 12049457 expires

    Listed drug substance patent expiration.

    in 8 yr 8 mo

  25. Patent 10376487 expires

    Listed method-of-use patent (U-3007) expiration.

    in 9 yr 2 mo

  26. Patent 10179119 expires

    Listed method-of-use patent (U-3003) expiration.

    in 9 yr 3 mo

  27. Patent 11266622 expires

    Listed method-of-use patent (U-3003) expiration.

    in 9 yr 3 mo

  28. Patent 11202770 expires

    Listed drug product patent expiration.

    in 14 yr 7 mo

  29. Patent 12447141 expires

    Listed method-of-use patent (U-3003) expiration.

    in 14 yr 7 mo

  30. Patent 11759446 expires

    Listed method-of-use patent (U-3003) expiration.

    in 14 yr 9 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayExclusivity ODE-329: 2027-12-01Exclusivity ODE-329Patent 10149829: 2033-01-25Patent 10149829Patent 10610510: 2033-01-25Patent 10610510Patent 10980770: 2033-01-25Patent 10980770Patent 11285129: 2033-01-25Patent 11285129Patent 11633377: 2033-01-25Patent 11633377Patent 11826339: 2033-01-25Patent 11826339Patent 11833130: 2033-01-25Patent 11833130Patent 11850229: 2033-01-25Patent 11850229Patent 11918557: 2033-01-25Patent 11918557Patent 12201604: 2033-01-25Patent 12201604Patent 9539234: 2033-01-25Patent 9539234Patent 11918556: 2033-04-07Patent 11918556Patent 9730910: 2034-05-17Patent 9730910Patent 10610511: 2034-10-10Patent 10610511Patent 11141400: 2034-10-10Patent 11141400Patent 11786502: 2034-10-10Patent 11786502Patent 10071977: 2035-02-12Patent 10071977Patent 10829465: 2035-02-12Patent 10829465Patent 11566011: 2035-02-12Patent 11566011Patent 11760740: 2035-02-12Patent 11760740Patent 12049457: 2035-02-12Patent 12049457Patent 10376487: 2035-07-27Patent 10376487Patent 10179119: 2035-08-29Patent 10179119Patent 11266622: 2035-08-29Patent 11266622Patent 11202770: 2040-12-11Patent 11202770Patent 12447141: 2040-12-11Patent 12447141Patent 11759446: 2041-02-21Patent 11759446
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

TASIMELTEON

Strength

4MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 214517

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • ODE-329Orphan-drug exclusivity (7 years)

    in 1 yr 4 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10149829in 6 yr 7 mo
U-3006
10610510in 6 yr 7 mo
U-3009
10980770in 6 yr 7 mo
U-3106
11285129in 6 yr 7 mo
U-3342
11633377in 6 yr 7 mo
U-3003
11826339in 6 yr 7 mo
U-3342
11833130in 6 yr 7 mo
U-3003
11850229in 6 yr 7 mo
U-3342
11918557in 6 yr 7 mo
U-3003
12201604in 6 yr 7 mo
U-3003
9539234in 6 yr 7 mo
U-3004
11918556in 6 yr 10 mo
U-3342
9730910in 7 yr 11 mo
U-3005
10610511in 8 yr 4 mo
U-3007
11141400in 8 yr 4 mo
U-3007
11786502in 8 yr 4 mo
U-3007
10071977in 8 yr 8 mo
SubstanceProduct
10829465in 8 yr 8 mo
SubstanceProduct
11566011in 8 yr 8 mo
SubstanceProduct
11760740in 8 yr 8 mo
SubstanceProduct
12049457in 8 yr 8 mo
SubstanceProduct
10376487in 9 yr 2 mo
U-3007
10179119in 9 yr 3 mo
U-3003
11266622in 9 yr 3 mo
U-3003
11202770in 14 yr 7 mo
Product
12447141in 14 yr 7 mo
U-3003
11759446in 14 yr 9 mo
U-3003

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Tasimelteon family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Hetlioz Lq: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 214517 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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