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Orange Book drug · Brand (NDA)

Lybalvi

Olanzapine; Samidorphan L-malate

RLDNDA 213378 4 strengths Alkermes Inc
Approved
May 28, 2021
Strengths
4
Listed patents
14

What does the FDA Orange Book show for Lybalvi?

Lybalvi contains Olanzapine; Samidorphan L-malate and is the new drug FDA Orange Book record for NDA 213378. The application has 4 presentations 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 213378

New drug application identity from the Orange Book snapshot.

Application holder
Alkermes Inc

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

Product presentations
4

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
14

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
0015MG;EQ 10MG BASETABLETORALPrescriptionNone posted
RLDRS
00210MG;EQ 10MG BASETABLETORALPrescriptionNone posted
RLD
00315MG;EQ 10MG BASETABLETORALPrescriptionNone posted
RLD
00420MG;EQ 10MG BASETABLETORALPrescriptionNone posted
RLD

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

Alkermes Inc

The Orange Book identifies this organization as the applicant responsible for NDA 213378.

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

4 presentations 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

14 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Nov 12, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 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 213378 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Olanzapine; Samidorphan L-malate

1 application
Product rows
4
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-213378

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.

Strengths & dosage forms

4 approved presentations · NDA 213378
RLDRS
Strength
5MG;EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    5 yr 3 mo ago

  2. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    2 mo ago

  3. Today

  4. Patent 10716785 expires

    Listed method-of-use patent (U-3136) expiration.

    in 5 yr 2 mo

  5. Patent 10716785 expires

    Listed method-of-use patent (U-3137) expiration.

    in 5 yr 2 mo

  6. Patent 11185541 expires

    Listed method-of-use patent (U-3140) expiration.

    in 5 yr 2 mo

  7. Patent 11241425 expires

    Listed method-of-use patent (U-3137) expiration.

    in 5 yr 2 mo

  8. Patent 11351166 expires

    Listed method-of-use patent (U-3140) expiration.

    in 5 yr 2 mo

  9. Patent 11351166 expires

    Listed method-of-use patent (U-3141) expiration.

    in 5 yr 2 mo

  10. Patent 11793805 expires

    Listed method-of-use patent (U-3734) expiration.

    in 5 yr 2 mo

  11. Patent 12194035 expires

    Listed method-of-use patent (U-3141) expiration.

    in 5 yr 2 mo

  12. Patent 9126977 expires

    Listed drug product patent expiration.

    in 5 yr 2 mo

  13. Patent 9126977 expires

    Listed drug product patent expiration.

    in 5 yr 2 mo

  14. Patent 9517235 expires

    Listed method-of-use patent (U-3139) expiration.

    in 5 yr 2 mo

  15. Patent 9517235 expires

    Listed method-of-use patent (U-3138) expiration.

    in 5 yr 2 mo

  16. Patent 9119848 expires

    Listed drug substance patent expiration.

    in 5 yr 2 mo

  17. Patent 8778960 expires

    Listed method-of-use patent (U-3136) expiration.

    in 5 yr 8 mo

  18. Patent 8778960 expires

    Listed method-of-use patent (U-3137) expiration.

    in 5 yr 8 mo

  19. Patent 10300054 expires

    Listed drug product patent expiration.

    in 6 yr 11 mo

  20. Patent 10300054 expires

    Listed drug product patent expiration.

    in 6 yr 11 mo

  21. Patent 11707466 expires

    Listed drug product patent expiration.

    in 15 yr 6 mo

  22. Patent 11951111 expires

    Listed method-of-use patent (U-3886) expiration.

    in 15 yr 6 mo

  23. Patent 11951111 expires

    Listed method-of-use patent (U-3887) expiration.

    in 15 yr 6 mo

  24. Patent 12390474 expires

    Listed drug product patent expiration.

    in 15 yr 6 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayExclusivity NCE: 2026-05-28Exclusivity NCEPatent 10716785: 2031-08-23Patent 10716785Patent 10716785: 2031-08-23Patent 10716785Patent 11185541: 2031-08-23Patent 11185541Patent 11241425: 2031-08-23Patent 11241425Patent 11351166: 2031-08-23Patent 11351166Patent 11351166: 2031-08-23Patent 11351166Patent 11793805: 2031-08-23Patent 11793805Patent 12194035: 2031-08-23Patent 12194035Patent 9126977: 2031-08-23Patent 9126977Patent 9126977: 2031-08-23Patent 9126977Patent 9517235: 2031-08-23Patent 9517235Patent 9517235: 2031-08-23Patent 9517235Patent 9119848: 2031-08-30Patent 9119848Patent 8778960: 2032-02-13Patent 8778960Patent 8778960: 2032-02-13Patent 8778960Patent 10300054: 2033-05-31Patent 10300054Patent 10300054: 2033-05-31Patent 10300054Patent 11707466: 2041-11-12Patent 11707466Patent 11951111: 2041-11-12Patent 11951111Patent 11951111: 2041-11-12Patent 11951111Patent 12390474: 2041-11-12Patent 12390474
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

OLANZAPINE; SAMIDORPHAN L-MALATE

Strength

5MG;EQ 10MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 213378

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NCENew chemical entity exclusivity (5 years)

    2 mo ago

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10716785in 5 yr 2 mo
U-3136
10716785in 5 yr 2 mo
U-3137
11185541in 5 yr 2 mo
U-3140
11241425in 5 yr 2 mo
U-3137
11351166in 5 yr 2 mo
U-3140
11351166in 5 yr 2 mo
U-3141
11793805in 5 yr 2 mo
U-3734
12194035in 5 yr 2 mo
U-3141
9126977in 5 yr 2 mo
ProductU-3136
9126977in 5 yr 2 mo
ProductU-3137
9517235in 5 yr 2 mo
U-3139
9517235in 5 yr 2 mo
U-3138
9119848in 5 yr 2 mo
Substance
8778960in 5 yr 8 mo
U-3136
8778960in 5 yr 8 mo
U-3137
10300054in 6 yr 11 mo
ProductU-3140
10300054in 6 yr 11 mo
ProductU-3141
11707466in 15 yr 6 mo
Product
11951111in 15 yr 6 mo
U-3886
11951111in 15 yr 6 mo
U-3887
12390474in 15 yr 6 mo
Product

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.

No other applications share this active ingredient.

View full Olanzapine; Samidorphan L-malate 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.

Lybalvi: 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 213378 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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