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Orange Book drug · Brand (NDA)

Samsca

Tolvaptan

RLDNDA 022275 3 strengths Otsuka
Approved
May 19, 2009
Strengths
3
Listed patents
2

What does the FDA Orange Book show for Samsca?

Samsca contains Tolvaptan and is the new drug FDA Orange Book record for NDA 022275. The application has 3 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 022275

New drug application identity from the Orange Book snapshot.

Application holder
Otsuka Pharmaceutical Co Ltd

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

Product presentations
3

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
AB1

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

Listed patents
2

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
00115MGTABLETORALPrescriptionAB1
RLD
00230MGTABLETORALPrescriptionAB1
RLDRS
00360MGTABLETORALDiscontinuedNone 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

Otsuka Pharmaceutical Co Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 022275.

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: 2 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

TE code AB1 across rated presentations

FDA considers products with the same AB1 code therapeutically equivalent within the same active ingredient, dosage form, route, and strength heading. A different numbered AB code is a different equivalence group. 1 presentation in the application has no posted TE code.

Patent & exclusivity record

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

The latest future date recorded across those files is Apr 07, 2030. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

8 other ANDAs and 1 other NDA found

8 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 022275 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-022275

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

3 approved presentations · NDA 022275
TE AB1RLD
Strength
15MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    17 yr 5 mo ago

  2. Today

  3. Patent 8501730 expires

    Listed drug substance patent expiration.

    in 1 mo

  4. Patent 10905694 expires

    Listed drug product patent expiration.

    in 3 yr 9 mo

Patent & exclusivity timeline

Protection horizon
202620272028202920302031TodayPatent 8501730: 2026-09-01Patent 8501730Patent 10905694: 2030-04-07Patent 10905694
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

TOLVAPTAN

Strength

15MG

Dosage form

TABLET

Route

ORAL

TE code

AB1

Application

NDA 022275

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8501730in 1 mo
Substance
10905694in 3 yr 9 mo
Product

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.

View full Tolvaptan 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.

Samsca: 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 022275 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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