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Orange Book product · Brand (NDA)

Akynzeo

Netupitant; Palonosetron Hydrochloride

Brand (NDA)NDA 205718RLD Helsinn Hlthcare
Approved
Oct 10, 2014
Application
Brand (NDA)
TE code
Not listed
Listed patents
12
Akynzeo (Netupitant; Palonosetron Hydrochloride) is Helsinn Hlthcare's brand-name drug, approved by the FDA under NDA 205718 in 2014. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 12 patents against it, the last expiring 2035.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 10, 2014

    11 yr 11 mo ago

  2. Today

  3. Patent 11559523 expires

    Listed drug product patent expiration.

    Nov 18, 2030

    in 4 yr 5 mo

  4. Patent 12042494 expires

    Listed drug product patent expiration.

    Nov 18, 2030

    in 4 yr 5 mo

  5. Patent 8623826 expires

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

    Nov 18, 2030

    in 4 yr 5 mo

  6. Patent 8951969 expires

    Listed drug product patent expiration.

    Nov 18, 2030

    in 4 yr 5 mo

  7. Patent 9186357 expires

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

    Nov 18, 2030

    in 4 yr 5 mo

  8. Patent 9943515 expires

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

    Nov 18, 2030

    in 4 yr 5 mo

  9. Patent 10828297 expires

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

    Dec 17, 2030

    in 4 yr 6 mo

  10. Patent 9271975 expires

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

    Sep 09, 2031

    in 5 yr 3 mo

  11. Patent 10233154 expires

    Listed drug substance patent expiration.

    Sep 25, 2035

    in 9 yr 4 mo

  12. Patent 10676440 expires

    Listed drug substance patent expiration.

    Sep 25, 2035

    in 9 yr 4 mo

  13. Patent 10961195 expires

    Listed drug substance patent expiration.

    Sep 25, 2035

    in 9 yr 4 mo

  14. Patent 9951016 expires

    Listed drug substance patent expiration.

    Sep 25, 2035

    in 9 yr 4 mo

Protection horizon

Patent & exclusivity timeline

20262027202820292030203120322033203420352036TodayPatent 11559523 — 2030-11-18Patent 11559523Patent 12042494 — 2030-11-18Patent 12042494Patent 8623826 — 2030-11-18Patent 8623826Patent 8951969 — 2030-11-18Patent 8951969Patent 9186357 — 2030-11-18Patent 9186357Patent 9943515 — 2030-11-18Patent 9943515Patent 10828297 — 2030-12-17Patent 10828297Patent 9271975 — 2031-09-09Patent 9271975Patent 10233154 — 2035-09-25Patent 10233154Patent 10676440 — 2035-09-25Patent 10676440Patent 10961195 — 2035-09-25Patent 10961195Patent 9951016 — 2035-09-25Patent 9951016
Patent expiryExclusivity endToday
FDA product record

Pharmaceutical detail

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

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Netupitant; Palonosetron Hydrochloride family
Orange Book patent file

Listed patents

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 5 mo
ProductU-3522
12042494Nov 18, 2030in 4 yr 5 mo
ProductU-3522
8623826Nov 18, 2030in 4 yr 5 mo
U-2293
8951969Nov 18, 2030in 4 yr 5 mo
Product
9186357Nov 18, 2030in 4 yr 5 mo
U-2293
9943515Nov 18, 2030in 4 yr 5 mo
U-2293
10828297Dec 17, 2030in 4 yr 6 mo
U-2293
9271975Sep 09, 2031in 5 yr 3 mo
U-2293
10233154Sep 25, 2035in 9 yr 4 mo
Substance
10676440Sep 25, 2035in 9 yr 4 mo
SubstanceProduct
10961195Sep 25, 2035in 9 yr 4 mo
SubstanceProduct
9951016Sep 25, 2035in 9 yr 4 mo
SubstanceProduct

Akynzeo — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Netupitant; Palonosetron Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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