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Orange Book drug · Brand (NDA)

Korsuva

Difelikefalin Acetate

RLDNDA 214916 Vifor Intl
Approved
Aug 23, 2021
Strengths
1
Listed patents
12

What does the FDA Orange Book show for Korsuva?

Korsuva contains Difelikefalin Acetate and is the new drug FDA Orange Book record for NDA 214916. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 214916

New drug application identity from the Orange Book snapshot.

Application holder
Vifor (international) Inc

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
1

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
001EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)SOLUTIONINTRAVENOUSPrescriptionNone 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

Vifor (international) Inc

The Orange Book identifies this organization as the applicant responsible for NDA 214916.

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 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Nov 12, 2032. 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 214916 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Intravenous

Difelikefalin Acetate

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-214916

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 214916
RLDRS
Strength
EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    5 yr ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    in 28 d

  4. Patent 10017536 expires

    Listed drug substance patent expiration.

    in 1 yr 4 mo

  5. Patent 10138270 expires

    Listed method-of-use patent (U-3204) expiration.

    in 1 yr 4 mo

  6. Patent 10793596 expires

    Listed drug substance patent expiration.

    in 1 yr 4 mo

  7. Patent 7713937 expires

    Listed drug substance patent expiration.

    in 1 yr 4 mo

  8. Patent 7727963 expires

    Listed drug substance patent expiration.

    in 1 yr 4 mo

  9. Patent 8217007 expires

    Listed method-of-use patent (U-3204) expiration.

    in 1 yr 4 mo

  10. Patent 8236766 expires

    Listed method-of-use patent (U-3204) expiration.

    in 1 yr 4 mo

  11. Patent 8486894 expires

    Listed method-of-use patent (U-3204) expiration.

    in 1 yr 4 mo

  12. Patent 8536131 expires

    Listed drug substance patent expiration.

    in 1 yr 4 mo

  13. Patent 9334305 expires

    Listed method-of-use patent (U-3204) expiration.

    in 1 yr 4 mo

  14. Patent 9359399 expires

    Listed method-of-use patent (U-3204) expiration.

    in 1 yr 4 mo

  15. Patent 7402564 expires

    Listed drug substance patent expiration.

    in 6 yr 5 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033TodayExclusivity NCE: 2026-08-23Exclusivity NCEPatent 10017536: 2027-11-12Patent 10017536Patent 10138270: 2027-11-12Patent 10138270Patent 10793596: 2027-11-12Patent 10793596Patent 7713937: 2027-11-12Patent 7713937Patent 7727963: 2027-11-12Patent 7727963Patent 8217007: 2027-11-12Patent 8217007Patent 8236766: 2027-11-12Patent 8236766Patent 8486894: 2027-11-12Patent 8486894Patent 8536131: 2027-11-12Patent 8536131Patent 9334305: 2027-11-12Patent 9334305Patent 9359399: 2027-11-12Patent 9359399Patent 7402564: 2032-11-12Patent 7402564
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

DIFELIKEFALIN ACETATE

Strength

EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 214916

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NCENew chemical entity exclusivity (5 years)

    in 28 d

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10017536in 1 yr 4 mo
SubstanceU-3204
10138270in 1 yr 4 mo
U-3204
10793596in 1 yr 4 mo
SubstanceProductU-3204
7713937in 1 yr 4 mo
SubstanceProductU-3204
7727963in 1 yr 4 mo
SubstanceProductU-3204
8217007in 1 yr 4 mo
U-3204
8236766in 1 yr 4 mo
U-3204
8486894in 1 yr 4 mo
U-3204
8536131in 1 yr 4 mo
SubstanceProductU-3204
9334305in 1 yr 4 mo
U-3204
9359399in 1 yr 4 mo
U-3204
7402564in 6 yr 5 mo
SubstanceProductU-3204

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 Difelikefalin Acetate 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.

Korsuva: 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 214916 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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