Skip to content
Assyro AI
Orange Book drug · Brand (NDA)

Olysio

Simeprevir Sodium

DiscontinuedRLDNDA 205123 Janssen Prods
Approved
Nov 22, 2013
Strengths
1
Listed patents
8

What does the FDA Orange Book show for Olysio?

Olysio contains Simeprevir Sodium and is the new drug FDA Orange Book record for NDA 205123. 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 205123

New drug application identity from the Orange Book snapshot.

Application holder
Janssen Products LP

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
Discontinued

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

Reference roles
RLD

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
8

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
001EQ 150MG BASECAPSULEORALDiscontinuedNone 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

Janssen Products LP

The Orange Book identifies this organization as the applicant responsible for NDA 205123.

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 on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

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

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

The latest future date recorded across those files is Sep 05, 2029. 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 205123 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

Simeprevir Sodium

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

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-205123

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 205123
RLDDiscontinued
Strength
EQ 150MG BASE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr 10 mo ago

  2. Today

  3. Patent 8349869 expires

    Listed drug substance patent expiration.

    in 2 d

  4. Patent 8741926 expires

    Listed drug substance patent expiration.

    in 2 d

  5. Patent 8754106 expires

    Listed drug substance patent expiration.

    in 2 d

  6. Patent 9040562 expires

    Listed drug substance patent expiration.

    in 2 d

  7. Patent 9353103 expires

    Listed method-of-use patent (U-1467) expiration.

    in 2 d

  8. Patent 9623022 expires

    Listed method-of-use patent (U-1467) expiration.

    in 2 d

  9. Patent 9856265 expires

    Listed drug substance patent expiration.

    in 2 d

  10. Patent 8148399 expires

    Listed drug substance patent expiration.

    in 3 yr 2 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030TodayPatent 8349869: 2026-07-28Patent 8349869Patent 8741926: 2026-07-28Patent 8741926Patent 8754106: 2026-07-28Patent 8754106Patent 9040562: 2026-07-28Patent 9040562Patent 9353103: 2026-07-28Patent 9353103Patent 9623022: 2026-07-28Patent 9623022Patent 9856265: 2026-07-28Patent 9856265Patent 8148399: 2029-09-05Patent 8148399
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

SIMEPREVIR SODIUM

Strength

EQ 150MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 205123

Product number

001

Marketing status

Discontinued

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
8349869in 2 d
SubstanceProductU-1467
8741926in 2 d
SubstanceU-1467
8754106in 2 d
SubstanceU-1467
9040562in 2 d
SubstanceProductU-1467
9353103in 2 d
U-1467
9623022in 2 d
U-1467
9856265in 2 d
SubstanceProductU-1467
8148399in 3 yr 2 mo
SubstanceProductU-1467

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 Simeprevir Sodium 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.

Olysio: 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 205123 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo