Assyro AI

Orange Book product · Brand (NDA)

AKYNZEO

NETUPITANT; PALONOSETRON HYDROCHLORIDE

Brand (NDA)NDA 205718RX HELSINN HLTHCARE

At a glance

Oct 10, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

12

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 10, 2014

    11 yr 10 mo ago

  2. Today

  3. Patent 11559523 expires

    Listed drug product patent expiration.

    Nov 18, 2030

    in 4 yr 6 mo

  4. Patent 12042494 expires

    Listed drug product patent expiration.

    Nov 18, 2030

    in 4 yr 6 mo

  5. Patent 8623826 expires

    Listed method-of-use patent (U-2293) expiration.

    Nov 18, 2030

    in 4 yr 6 mo

  6. Patent 8951969 expires

    Listed drug product patent expiration.

    Nov 18, 2030

    in 4 yr 6 mo

  7. Patent 9186357 expires

    Listed method-of-use patent (U-2293) expiration.

    Nov 18, 2030

    in 4 yr 6 mo

  8. Patent 9943515 expires

    Listed method-of-use patent (U-2293) expiration.

    Nov 18, 2030

    in 4 yr 6 mo

  9. Patent 10828297 expires

    Listed method-of-use patent (U-2293) expiration.

    Dec 17, 2030

    in 4 yr 7 mo

  10. Patent 9271975 expires

    Listed method-of-use patent (U-2293) expiration.

    Sep 09, 2031

    in 5 yr 4 mo

  11. Patent 10233154 expires

    Listed drug substance patent expiration.

    Sep 25, 2035

    in 9 yr 5 mo

  12. Patent 10676440 expires

    Listed drug substance patent expiration.

    Sep 25, 2035

    in 9 yr 5 mo

  13. Patent 10961195 expires

    Listed drug substance patent expiration.

    Sep 25, 2035

    in 9 yr 5 mo

  14. Patent 9951016 expires

    Listed drug substance patent expiration.

    Sep 25, 2035

    in 9 yr 5 mo

Pharmaceutical detail

Active ingredient

NETUPITANT; PALONOSETRON HYDROCHLORIDE

Strength

300MG;EQ 0.5MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 205718

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 (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11559523Nov 18, 2030in 4 yr 6 mo
ProductU-3522
12042494Nov 18, 2030in 4 yr 6 mo
ProductU-3522
8623826Nov 18, 2030in 4 yr 6 mo
U-2293
8951969Nov 18, 2030in 4 yr 6 mo
Product
9186357Nov 18, 2030in 4 yr 6 mo
U-2293
9943515Nov 18, 2030in 4 yr 6 mo
U-2293
10828297Dec 17, 2030in 4 yr 7 mo
U-2293
9271975Sep 09, 2031in 5 yr 4 mo
U-2293
10233154Sep 25, 2035in 9 yr 5 mo
Substance
10676440Sep 25, 2035in 9 yr 5 mo
SubstanceProduct
10961195Sep 25, 2035in 9 yr 5 mo
SubstanceProduct
9951016Sep 25, 2035in 9 yr 5 mo
SubstanceProduct
Agent CTA Background

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