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Orange Book drug · Brand (NDA)

Veltassa

Patiromer Sorbitex Calcium

RLDNDA 205739 4 strengths Vifor Pharma
Approved
Oct 21, 2015
Strengths
4
Listed patents
7

What does the FDA Orange Book show for Veltassa?

Veltassa contains Patiromer Sorbitex Calcium and is the new drug FDA Orange Book record for NDA 205739. The application has 4 presentations 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 205739

New drug application identity from the Orange Book snapshot.

Application holder
Vifor Pharma Inc

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

Product presentations
4

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

Marketing categories
Prescription and Discontinued

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
7

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

Exclusivity records
2

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 8.4GM BASE/PACKETPOWDERORALPrescriptionNone posted
RLD
002EQ 16.8GM BASE/PACKETPOWDERORALPrescriptionNone posted
RLDRS
003EQ 25.2GM BASE/PACKETPOWDERORALDiscontinuedNone posted
RLD
004EQ 1GM BASE/PACKETPOWDERORALPrescriptionNone posted
RLD

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 Pharma Inc

The Orange Book identifies this organization as the applicant responsible for NDA 205739.

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

Status varies by presentation: 3 prescription and 1 on the Discontinued Drug Product List

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

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

7 listed patent expirations and 2 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Oct 08, 2033. 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 205739 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Powder · Oral

Patiromer Sorbitex Calcium

1 application
Product rows
4
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-205739

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.

Strengths & dosage forms

4 approved presentations · NDA 205739
RLD
Strength
EQ 8.4GM BASE/PACKET
Dosage form
POWDER
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    10 yr 11 mo ago

  2. Today

  3. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    in 2 mo

  4. Patent 8216560 expires

    Listed method-of-use patent (U-1766) expiration.

    in 8 mo

  5. Patent 8282913 expires

    Listed drug product patent expiration.

    in 10 mo

  6. Patent 8147873 expires

    Listed drug product patent expiration.

    in 1 yr 11 mo

  7. Patent 8337824 expires

    Listed drug substance patent expiration.

    in 3 yr 11 mo

  8. Patent 11123363 expires

    Listed method-of-use patent (U-1766) expiration.

    in 7 yr 4 mo

  9. Patent 9492476 expires

    Listed method-of-use patent (U-1766) expiration.

    in 7 yr 4 mo

  10. Patent 9925212 expires

    Listed method-of-use patent (U-1766) expiration.

    in 7 yr 4 mo

Patent & exclusivity timeline

Protection horizon
202620272028202920302031203220332034TodayExclusivity NPP: 2026-10-02Exclusivity NPPPatent 8216560: 2027-03-14Patent 8216560Patent 8282913: 2027-05-29Patent 8282913Patent 8147873: 2028-06-20Patent 8147873Patent 8337824: 2030-05-29Patent 8337824Patent 11123363: 2033-10-08Patent 11123363Patent 9492476: 2033-10-08Patent 9492476Patent 9925212: 2033-10-08Patent 9925212
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

PATIROMER SORBITEX CALCIUM

Strength

EQ 8.4GM BASE/PACKET

Dosage form

POWDER

Route

ORAL

TE code

Not listed

Application

NDA 205739

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • NPPNew patient population exclusivity (3 years)

    in 2 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8216560in 8 mo
U-1766
8282913in 10 mo
Product
8147873in 1 yr 11 mo
Product
8337824in 3 yr 11 mo
SubstanceU-1766
11123363in 7 yr 4 mo
U-1766
9492476in 7 yr 4 mo
U-1766
9925212in 7 yr 4 mo
U-1766

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 Patiromer Sorbitex Calcium 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.

Veltassa: 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 205739 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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