Assyro AI

Orange Book product · Brand (NDA)

ZEJULA

NIRAPARIB TOSYLATE

Brand (NDA)NDA 214876RX GLAXOSMITHKLINE

At a glance

Apr 26, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 26, 2023

    3 yr 2 mo ago

  2. Today

  3. Patent 8071579 expires

    Listed method-of-use patent (U-2655) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  4. Patent 8143241 expires

    Listed method-of-use patent (U-2655) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  5. Patent 8436185 expires

    Listed drug substance patent expiration.

    Apr 24, 2029

    in 2 yr 11 mo

  6. Patent 8071623 expires

    Listed drug substance patent expiration.

    Mar 27, 2031

    in 4 yr 10 mo

  7. Patent 8859562 expires

    Listed method-of-use patent (U-2655) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  8. Patent 11091459 expires

    Listed drug product patent expiration.

    Mar 27, 2038

    in 11 yr 11 mo

  9. Patent 11673877 expires

    Listed drug product patent expiration.

    Mar 27, 2038

    in 11 yr 11 mo

  10. Patent 11673877 expires

    Listed drug product patent expiration.

    Mar 27, 2038

    in 11 yr 11 mo

  11. Patent 11730725 expires

    Listed drug product patent expiration.

    Jan 25, 2039

    in 12 yr 9 mo

Pharmaceutical detail

Active ingredient

NIRAPARIB TOSYLATE

Strength

EQ 100MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 214876

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8071579Aug 12, 2027in 1 yr 2 mo
U-2655
8143241Aug 12, 2027in 1 yr 2 mo
U-2655
8436185Apr 24, 2029in 2 yr 11 mo
Substance
8071623Mar 27, 2031in 4 yr 10 mo
SubstanceProduct
8859562Aug 04, 2031in 5 yr 2 mo
U-2655
11091459Mar 27, 2038in 11 yr 11 mo
Product
11673877Mar 27, 2038in 11 yr 11 mo
ProductU-3646
11673877Mar 27, 2038in 11 yr 11 mo
ProductU-3647
11730725Jan 25, 2039in 12 yr 9 mo
Product
Agent CTA Background

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