Assyro AI

Orange Book product · Brand (NDA)

INBRIJA

LEVODOPA

Brand (NDA)NDA 209184RX MERZ

At a glance

Dec 21, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

6

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 21, 2018

    7 yr 7 mo ago

  2. Today

  3. Patent RE43711 expires

    Listed method-of-use patent (U-2484) expiration.

    Feb 03, 2029

    in 2 yr 8 mo

  4. Patent 8545878 expires

    Listed drug product patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  5. Patent 8685442 expires

    Listed drug product patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  6. Patent 8945612 expires

    Listed drug product patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  7. Patent 9393210 expires

    Listed drug product patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  8. Patent 12458615 expires

    Listed method-of-use patent (U-2484) expiration.

    Oct 21, 2033

    in 7 yr 5 mo

Pharmaceutical detail

Active ingredient

LEVODOPA

Strength

42MG

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 209184

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.

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
RE43711Feb 03, 2029in 2 yr 8 mo
U-2484
8545878Nov 16, 2032in 6 yr 6 mo
Product
8685442Nov 16, 2032in 6 yr 6 mo
Product
8945612Nov 16, 2032in 6 yr 6 mo
Product
9393210Nov 16, 2032in 6 yr 6 mo
Product
12458615Oct 21, 2033in 7 yr 5 mo
U-2484
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.