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Orange Book drug · Brand (NDA)

Akynzeo

Netupitant; Palonosetron Hydrochloride

RLDNDA 205718 Helsinn Hlthcare
Approved
Oct 10, 2014
Strengths
1
Listed patents
12
Applications
2

What does the FDA Orange Book show for Akynzeo?

Akynzeo contains Netupitant; Palonosetron Hydrochloride and appears in 2 FDA Orange Book applications. NDA 205718 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 205718

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Helsinn Healthcare Sa

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
12

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001300MG;EQ 0.5MG BASECAPSULEORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Helsinn Healthcare Sa

The Orange Book identifies this organization as the applicant responsible for NDA 205718.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

12 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Sep 25, 2035. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 205718 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Capsule · Oral

Netupitant; Palonosetron Hydrochloride

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-205718

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 205718
RLDRS
Strength
300MG;EQ 0.5MG BASE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr ago

  2. Today

  3. Patent 11559523 expires

    Listed drug product patent expiration.

    in 4 yr 5 mo

  4. Patent 12042494 expires

    Listed drug product patent expiration.

    in 4 yr 5 mo

  5. Patent 8623826 expires

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

    in 4 yr 5 mo

  6. Patent 8951969 expires

    Listed drug product patent expiration.

    in 4 yr 5 mo

  7. Patent 9186357 expires

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

    in 4 yr 5 mo

  8. Patent 9943515 expires

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

    in 4 yr 5 mo

  9. Patent 10828297 expires

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

    in 4 yr 6 mo

  10. Patent 9271975 expires

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

    in 5 yr 2 mo

  11. Patent 10233154 expires

    Listed drug substance patent expiration.

    in 9 yr 4 mo

  12. Patent 10676440 expires

    Listed drug substance patent expiration.

    in 9 yr 4 mo

  13. Patent 10961195 expires

    Listed drug substance patent expiration.

    in 9 yr 4 mo

  14. Patent 9951016 expires

    Listed drug substance patent expiration.

    in 9 yr 4 mo

Patent & exclusivity timeline

Protection horizon
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

Pharmaceutical detail

FDA product record

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

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11559523in 4 yr 5 mo
ProductU-3522
12042494in 4 yr 5 mo
ProductU-3522
8623826in 4 yr 5 mo
U-2293
8951969in 4 yr 5 mo
Product
9186357in 4 yr 5 mo
U-2293
9943515in 4 yr 5 mo
U-2293
10828297in 4 yr 6 mo
U-2293
9271975in 5 yr 2 mo
U-2293
10233154in 9 yr 4 mo
Substance
10676440in 9 yr 4 mo
SubstanceProduct
10961195in 9 yr 4 mo
SubstanceProduct
9951016in 9 yr 4 mo
SubstanceProduct

Other FDA applications for Akynzeo

1 additional filing

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Akynzeo, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 210493Helsinn HlthcareApr 19, 20182—Discontinued

Active-ingredient family

Brand + generics

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

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Akynzeo: frequently asked questions

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

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 205718 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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