Assyro AI

Orange Book product · Brand (NDA)

XDEMVY

LOTILANER

Brand (NDA)NDA 217603RX TARSUS

At a glance

Jul 24, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 24, 2023

    2 yr 11 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Jul 24, 2028

    in 2 yr 2 mo

  4. Patent 8383659 expires

    Listed drug substance patent expiration.

    Jan 17, 2030

    in 3 yr 8 mo

  5. Patent 10835517 expires

    Listed method-of-use patent (U-3674) expiration.

    Dec 14, 2038

    in 12 yr 8 mo

  6. Patent 11197847 expires

    Listed method-of-use patent (U-3674) expiration.

    Dec 14, 2038

    in 12 yr 8 mo

  7. Patent 11690826 expires

    Listed method-of-use patent (U-3674) expiration.

    Dec 14, 2038

    in 12 yr 8 mo

  8. Patent 11690827 expires

    Listed method-of-use patent (U-3674) expiration.

    Dec 14, 2038

    in 12 yr 8 mo

  9. Patent 11752137 expires

    Listed drug product patent expiration.

    Dec 14, 2038

    in 12 yr 8 mo

  10. Patent 12171750 expires

    Listed method-of-use patent (U-3674) expiration.

    Dec 14, 2038

    in 12 yr 8 mo

  11. Patent 12213964 expires

    Listed drug product patent expiration.

    Dec 14, 2038

    in 12 yr 8 mo

  12. Patent 12364685 expires

    Listed drug product patent expiration.

    Dec 14, 2038

    in 12 yr 8 mo

Pharmaceutical detail

Active ingredient

LOTILANER

Strength

0.25%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 217603

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)

    Jul 24, 2028

    in 2 yr 2 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8383659Jan 17, 2030in 3 yr 8 mo
SubstanceProduct
10835517Dec 14, 2038in 12 yr 8 mo
U-3674
11197847Dec 14, 2038in 12 yr 8 mo
U-3674
11690826Dec 14, 2038in 12 yr 8 mo
U-3674
11690827Dec 14, 2038in 12 yr 8 mo
U-3674
11752137Dec 14, 2038in 12 yr 8 mo
Product
12171750Dec 14, 2038in 12 yr 8 mo
U-3674
12213964Dec 14, 2038in 12 yr 8 mo
Product
12364685Dec 14, 2038in 12 yr 8 mo
Product
Agent CTA Background

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