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Orange Book drug · Brand (NDA)

Opsumit

Macitentan

RLDNDA 204410 Actelion
Approved
Oct 18, 2013
Strengths
1
Listed patents
10

What does the FDA Orange Book show for Opsumit?

Opsumit contains Macitentan and is the new drug FDA Orange Book record for NDA 204410. 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 204410

New drug application identity from the Orange Book snapshot.

Application holder
Actelion Pharmaceuticals US 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
AB

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

Listed patents
10

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
00110MGTABLETORALPrescriptionAB
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

Actelion Pharmaceuticals US Inc

The Orange Book identifies this organization as the applicant responsible for NDA 204410.

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

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

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

The latest future date recorded across those files is Oct 18, 2029. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

12 other ANDAs and 0 other NDAs found

12 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 204410 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-204410

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 204410
TE ABRLDRS
Strength
10MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr 11 mo ago

  2. Patent 7094781 expires

    Listed drug substance patent expiration.

    8 mo ago

  3. Patent 7094781*PED expires

    Listed listed patent expiration.

    2 mo ago

  4. Today

  5. Patent 10946015 expires

    Listed drug product patent expiration.

    in 2 mo

  6. Patent 10946015*PED expires

    Listed listed patent expiration.

    in 8 mo

  7. Patent 9265762 expires

    Listed drug product patent expiration.

    in 10 mo

  8. Patent 9265762*PED expires

    Listed listed patent expiration.

    in 1 yr 4 mo

  9. Exclusivity ends · M-187

    New use / labeling-change exclusivity (3 years)

    in 1 yr 7 mo

  10. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 2 yr 1 mo

  11. Patent 8367685 expires

    Listed drug product patent expiration.

    in 2 yr 3 mo

  12. Patent 8367685*PED expires

    Listed listed patent expiration.

    in 2 yr 9 mo

  13. Patent 8268847 expires

    Listed method-of-use patent (U-1446) expiration.

    in 2 yr 9 mo

  14. Patent 8268847*PED expires

    Listed listed patent expiration.

    in 3 yr 3 mo

Patent & exclusivity timeline

Protection horizon
202520262027202820292030TodayPatent 7094781: 2025-12-05Patent 7094781Patent 7094781*PED: 2026-06-05Patent 7094781*PEDPatent 10946015: 2026-09-11Patent 10946015Patent 10946015*PED: 2027-03-11Patent 10946015*PEDPatent 9265762: 2027-05-29Patent 9265762Patent 9265762*PED: 2027-11-29Patent 9265762*PEDExclusivity M-187: 2028-02-28Exclusivity M-187Exclusivity PED: 2028-08-28Exclusivity PEDPatent 8367685: 2028-10-04Patent 8367685Patent 8367685*PED: 2029-04-04Patent 8367685*PEDPatent 8268847: 2029-04-18Patent 8268847Patent 8268847*PED: 2029-10-18Patent 8268847*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

MACITENTAN

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 204410

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • M-187New use / labeling-change exclusivity (3 years)

    in 1 yr 7 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 2 yr 1 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
70947818 mo ago
SubstanceProduct
7094781*PED2 mo ago
10946015in 2 mo
ProductU-1445
10946015*PEDin 8 mo
9265762in 10 mo
ProductU-1820
9265762*PEDin 1 yr 4 mo
8367685in 2 yr 3 mo
ProductU-1445
8367685*PEDin 2 yr 9 mo
8268847in 2 yr 9 mo
U-1446
8268847*PEDin 3 yr 3 mo

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 Macitentan 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.

Opsumit: 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 204410 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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