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Orange Book drug · Brand (NDA)

Leqvio

Inclisiran Sodium

RLDNDA 214012 Novartis
Approved
Dec 22, 2021
Strengths
1
Listed patents
10

What does the FDA Orange Book show for Leqvio?

Leqvio contains Inclisiran Sodium and is the new drug FDA Orange Book record for NDA 214012. 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 214012

New drug application identity from the Orange Book snapshot.

Application holder
Novartis Pharmaceuticals Corp

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
10

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

Exclusivity records
3

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
001EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)SOLUTIONSUBCUTANEOUSPrescriptionNone 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

Novartis Pharmaceuticals Corp

The Orange Book identifies this organization as the applicant responsible for NDA 214012.

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

10 listed patent expirations and 3 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Aug 25, 2036. 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 214012 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Subcutaneous

Inclisiran Sodium

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-214012

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 214012
RLDRS
Strength
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    4 yr 8 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    in 5 mo

  4. Patent 8809292 expires

    Listed drug substance patent expiration.

    in 10 mo

  5. Patent 8809292 expires

    Listed drug substance patent expiration.

    in 10 mo

  6. Patent 8809292 expires

    Listed drug substance patent expiration.

    in 10 mo

  7. Patent 8222222 expires

    Listed method-of-use patent (U-4249) expiration.

    in 1 yr 5 mo

  8. Patent 8222222 expires

    Listed method-of-use patent (U-4413) expiration.

    in 1 yr 5 mo

  9. Patent 8222222 expires

    Listed method-of-use patent (U-4414) expiration.

    in 1 yr 5 mo

  10. Patent 10131907 expires

    Listed drug substance patent expiration.

    in 2 yr 1 mo

  11. Patent 10131907 expires

    Listed drug substance patent expiration.

    in 2 yr 1 mo

  12. Patent 10131907 expires

    Listed drug substance patent expiration.

    in 2 yr 1 mo

  13. Patent 10806791 expires

    Listed drug substance patent expiration.

    in 2 yr 5 mo

  14. Patent 8828956 expires

    Listed drug substance patent expiration.

    in 2 yr 5 mo

  15. Patent 8828956 expires

    Listed drug substance patent expiration.

    in 2 yr 5 mo

  16. Patent 8828956 expires

    Listed drug substance patent expiration.

    in 2 yr 5 mo

  17. Patent 9370582 expires

    Listed drug substance patent expiration.

    in 2 yr 5 mo

  18. Patent 9370582 expires

    Listed drug substance patent expiration.

    in 2 yr 5 mo

  19. Patent 9370582 expires

    Listed drug substance patent expiration.

    in 2 yr 5 mo

  20. Exclusivity ends · I-985

    New indication exclusivity (3 years)

    in 2 yr 7 mo

  21. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    in 2 yr 7 mo

  22. Patent 8106022 expires

    Listed drug substance patent expiration.

    in 3 yr 5 mo

  23. Patent 8106022 expires

    Listed drug substance patent expiration.

    in 3 yr 5 mo

  24. Patent 8106022 expires

    Listed drug substance patent expiration.

    in 3 yr 5 mo

  25. Patent 10125369 expires

    Listed drug substance patent expiration.

    in 8 yr 2 mo

  26. Patent 10125369 expires

    Listed drug substance patent expiration.

    in 8 yr 2 mo

  27. Patent 10125369 expires

    Listed drug substance patent expiration.

    in 8 yr 2 mo

  28. Patent 12460206 expires

    Listed drug substance patent expiration.

    in 8 yr 2 mo

  29. Patent 10851377 expires

    Listed method-of-use patent (U-4413) expiration.

    in 10 yr 3 mo

  30. Patent 10851377 expires

    Listed method-of-use patent (U-4414) expiration.

    in 10 yr 3 mo

  31. Patent 10851377 expires

    Listed method-of-use patent (U-4249) expiration.

    in 10 yr 3 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036TodayExclusivity NCE: 2026-12-22Exclusivity NCEPatent 8809292: 2027-05-10Patent 8809292Patent 8809292: 2027-05-10Patent 8809292Patent 8809292: 2027-05-10Patent 8809292Patent 8222222: 2027-12-29Patent 8222222Patent 8222222: 2027-12-29Patent 8222222Patent 8222222: 2027-12-29Patent 8222222Patent 10131907: 2028-08-24Patent 10131907Patent 10131907: 2028-08-24Patent 10131907Patent 10131907: 2028-08-24Patent 10131907Patent 10806791: 2028-12-04Patent 10806791Patent 8828956: 2028-12-04Patent 8828956Patent 8828956: 2028-12-04Patent 8828956Patent 8828956: 2028-12-04Patent 8828956Patent 9370582: 2028-12-04Patent 9370582Patent 9370582: 2028-12-04Patent 9370582Patent 9370582: 2028-12-04Patent 9370582Exclusivity I-985: 2029-02-12Exclusivity I-985Exclusivity NPP: 2029-02-12Exclusivity NPPPatent 8106022: 2029-12-12Patent 8106022Patent 8106022: 2029-12-12Patent 8106022Patent 8106022: 2029-12-12Patent 8106022Patent 10125369: 2034-08-18Patent 10125369Patent 10125369: 2034-08-18Patent 10125369Patent 10125369: 2034-08-18Patent 10125369Patent 12460206: 2034-08-18Patent 12460206Patent 10851377: 2036-08-25Patent 10851377Patent 10851377: 2036-08-25Patent 10851377Patent 10851377: 2036-08-25Patent 10851377
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

INCLISIRAN SODIUM

Strength

EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 214012

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)

    in 5 mo

  • I-985New indication exclusivity (3 years)

    in 2 yr 7 mo

  • NPPNew patient population exclusivity (3 years)

    in 2 yr 7 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8809292in 10 mo
SubstanceProductU-4413
8809292in 10 mo
SubstanceProductU-4414
8809292in 10 mo
SubstanceProductU-4249
8222222in 1 yr 5 mo
U-4249
8222222in 1 yr 5 mo
U-4413
8222222in 1 yr 5 mo
U-4414
10131907in 2 yr 1 mo
SubstanceProductU-4413
10131907in 2 yr 1 mo
SubstanceProductU-4249
10131907in 2 yr 1 mo
SubstanceProductU-4414
10806791in 2 yr 5 mo
Substance
8828956in 2 yr 5 mo
SubstanceProductU-4413
8828956in 2 yr 5 mo
SubstanceProductU-4414
8828956in 2 yr 5 mo
SubstanceProductU-4249
9370582in 2 yr 5 mo
SubstanceProductU-4413
9370582in 2 yr 5 mo
SubstanceProductU-4414
9370582in 2 yr 5 mo
SubstanceProductU-4249
8106022in 3 yr 5 mo
SubstanceProductU-4249
8106022in 3 yr 5 mo
SubstanceProductU-4413
8106022in 3 yr 5 mo
SubstanceProductU-4414
10125369in 8 yr 2 mo
SubstanceProductU-4413
10125369in 8 yr 2 mo
SubstanceProductU-4414
10125369in 8 yr 2 mo
SubstanceProductU-4249
12460206in 8 yr 2 mo
SubstanceProduct
10851377in 10 yr 3 mo
U-4413
10851377in 10 yr 3 mo
U-4414
10851377in 10 yr 3 mo
U-4249

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 Inclisiran Sodium 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.

Leqvio: 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 214012 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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