Assyro AI

Orange Book product · Brand (NDA)

LYNKUET

ELINZANETANT

Brand (NDA)NDA 219469RX BAYER HLTHCARE

At a glance

Oct 24, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

6

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 24, 2025

    8 mo ago

  2. Today

  3. Patent 7683056 expires

    Listed drug substance patent expiration.

    Sep 15, 2027

    in 1 yr 3 mo

  4. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Oct 24, 2030

    in 4 yr 5 mo

  5. Patent 10195205 expires

    Listed method-of-use patent (U-3622) expiration.

    May 18, 2036

    in 10 yr 1 mo

  6. Patent 10774091 expires

    Listed drug product patent expiration.

    Mar 13, 2039

    in 12 yr 11 mo

  7. Patent 11787820 expires

    Listed method-of-use patent (U-3622) expiration.

    Mar 13, 2039

    in 12 yr 11 mo

  8. Patent 12264164 expires

    Listed method-of-use patent (U-3622) expiration.

    Mar 13, 2039

    in 12 yr 11 mo

  9. Patent 12533358 expires

    Listed method-of-use patent (U-4402) expiration.

    May 14, 2045

    in 19 yr 2 mo

Pharmaceutical detail

Active ingredient

ELINZANETANT

Strength

60MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 219469

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    Oct 24, 2030

    in 4 yr 5 mo

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7683056Sep 15, 2027in 1 yr 3 mo
SubstanceProduct
10195205May 18, 2036in 10 yr 1 mo
U-3622
10774091Mar 13, 2039in 12 yr 11 mo
Product
11787820Mar 13, 2039in 12 yr 11 mo
U-3622
12264164Mar 13, 2039in 12 yr 11 mo
U-3622
12533358May 14, 2045in 19 yr 2 mo
U-4402
Agent CTA Background

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