Assyro AI

Orange Book product · Brand (NDA)

ZURAMPIC

LESINURAD

Brand (NDA)NDA 207988DISCN IRONWOOD PHARMS INC

At a glance

Dec 22, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

11

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 22, 2015

    10 yr 8 mo ago

  2. Today

  3. Patent 10183012 expires

    Listed method-of-use patent (U-2311) expiration.

    Nov 26, 2028

    in 2 yr 6 mo

  4. Patent 8283369 expires

    Listed method-of-use patent (U-1804) expiration.

    Nov 26, 2028

    in 2 yr 6 mo

  5. Patent 8283369 expires

    Listed method-of-use patent (U-1802) expiration.

    Nov 26, 2028

    in 2 yr 6 mo

  6. Patent 8546437 expires

    Listed method-of-use patent (U-1803) expiration.

    Apr 29, 2029

    in 2 yr 11 mo

  7. Patent 8084483 expires

    Listed method-of-use patent (U-1801) expiration.

    Aug 17, 2029

    in 3 yr 3 mo

  8. Patent 8357713 expires

    Listed drug product patent expiration.

    Dec 22, 2029

    in 3 yr 7 mo

  9. Patent 8357713 expires

    Listed drug product patent expiration.

    Dec 22, 2029

    in 3 yr 7 mo

  10. Patent 8357713 expires

    Listed drug product patent expiration.

    Dec 22, 2029

    in 3 yr 7 mo

  11. Patent 9216179 expires

    Listed method-of-use patent (U-1806) expiration.

    Aug 01, 2031

    in 5 yr 2 mo

  12. Patent 9956205 expires

    Listed method-of-use patent (U-2311) expiration.

    Dec 28, 2031

    in 5 yr 7 mo

  13. Patent 8546436 expires

    Listed drug substance patent expiration.

    Feb 29, 2032

    in 5 yr 9 mo

Pharmaceutical detail

Active ingredient

LESINURAD

Strength

200MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 207988

Product number

001

Marketing status

DISCN

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 (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10183012Nov 26, 2028in 2 yr 6 mo
U-2311
8283369Nov 26, 2028in 2 yr 6 mo
U-1804
8283369Nov 26, 2028in 2 yr 6 mo
U-1802
8546437Apr 29, 2029in 2 yr 11 mo
U-1803
8084483Aug 17, 2029in 3 yr 3 mo
U-1801
8357713Dec 22, 2029in 3 yr 7 mo
ProductU-1801
8357713Dec 22, 2029in 3 yr 7 mo
ProductU-1803
8357713Dec 22, 2029in 3 yr 7 mo
ProductU-1802
9216179Aug 01, 2031in 5 yr 2 mo
U-1806
9956205Dec 28, 2031in 5 yr 7 mo
U-2311
8546436Feb 29, 2032in 5 yr 9 mo
SubstanceProduct
Agent CTA Background

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