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

Esbriet

Pirfenidone

RLDNDA 022535 Legacy Pharma
Approved
Oct 15, 2014
Strengths
1
Listed patents
19
Applications
2

What does the FDA Orange Book show for Esbriet?

Esbriet contains Pirfenidone and appears in 2 FDA Orange Book applications. NDA 022535 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 022535

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Legacy Pharma 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
19

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
001267MGCAPSULEORALPrescriptionAB
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

Legacy Pharma Inc

The Orange Book identifies this organization as the applicant responsible for NDA 022535.

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

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

The latest future date recorded across those files is Aug 30, 2033. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

23 other ANDAs and 0 other NDAs found

20 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 022535 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-022535

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 022535
TE ABRLDRS
Strength
267MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr 11 mo ago

  2. Today

  3. Patent 7767225 expires

    Listed drug product patent expiration.

    in 2 mo

  4. Patent 7988994 expires

    Listed drug product patent expiration.

    in 2 mo

  5. Patent 8753679 expires

    Listed drug product patent expiration.

    in 2 mo

  6. Patent 7696236 expires

    Listed method-of-use patent (U-1601) expiration.

    in 1 yr 5 mo

  7. Patent 7767700 expires

    Listed method-of-use patent (U-1601) expiration.

    in 1 yr 5 mo

  8. Patent 8420674 expires

    Listed drug product patent expiration.

    in 1 yr 5 mo

  9. Patent 8383150 expires

    Listed drug product patent expiration.

    in 1 yr 10 mo

  10. Patent 7566729 expires

    Listed method-of-use patent (U-1600) expiration.

    in 2 yr 9 mo

  11. Patent 7635707 expires

    Listed method-of-use patent (U-1609) expiration.

    in 2 yr 9 mo

  12. Patent 8592462 expires

    Listed method-of-use patent (U-1609) expiration.

    in 2 yr 9 mo

  13. Patent 8609701 expires

    Listed method-of-use patent (U-1610) expiration.

    in 2 yr 9 mo

  14. Patent 7816383 expires

    Listed method-of-use patent (U-1603) expiration.

    in 3 yr 6 mo

  15. Patent 7910610 expires

    Listed method-of-use patent (U-1604) expiration.

    in 3 yr 6 mo

  16. Patent 8013002 expires

    Listed method-of-use patent (U-1603) expiration.

    in 3 yr 6 mo

  17. Patent 8084475 expires

    Listed method-of-use patent (U-1605) expiration.

    in 3 yr 6 mo

  18. Patent 8318780 expires

    Listed method-of-use patent (U-1606) expiration.

    in 3 yr 6 mo

  19. Patent 8648098 expires

    Listed method-of-use patent (U-1611) expiration.

    in 3 yr 6 mo

  20. Patent 8754109 expires

    Listed method-of-use patent (U-1612) expiration.

    in 3 yr 6 mo

  21. Patent 8778947 expires

    Listed method-of-use patent (U-1613) expiration.

    in 7 yr 2 mo

Patent & exclusivity timeline

Protection horizon
202620272028202920302031203220332034TodayPatent 7767225: 2026-09-22Patent 7767225Patent 7988994: 2026-09-22Patent 7988994Patent 8753679: 2026-09-22Patent 8753679Patent 7696236: 2027-12-18Patent 7696236Patent 7767700: 2027-12-18Patent 7767700Patent 8420674: 2027-12-18Patent 8420674Patent 8383150: 2028-05-10Patent 8383150Patent 7566729: 2029-04-22Patent 7566729Patent 7635707: 2029-04-22Patent 7635707Patent 8592462: 2029-04-22Patent 8592462Patent 8609701: 2029-04-22Patent 8609701Patent 7816383: 2030-01-08Patent 7816383Patent 7910610: 2030-01-08Patent 7910610Patent 8013002: 2030-01-08Patent 8013002Patent 8084475: 2030-01-08Patent 8084475Patent 8318780: 2030-01-08Patent 8318780Patent 8648098: 2030-01-08Patent 8648098Patent 8754109: 2030-01-08Patent 8754109Patent 8778947: 2033-08-30Patent 8778947
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

PIRFENIDONE

Strength

267MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

NDA 022535

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7767225in 2 mo
ProductU-1602
7988994in 2 mo
ProductU-1602
8753679in 2 mo
ProductU-1602
7696236in 1 yr 5 mo
U-1601
7767700in 1 yr 5 mo
U-1601
8420674in 1 yr 5 mo
ProductU-1608
8383150in 1 yr 10 mo
ProductU-2361
7566729in 2 yr 9 mo
U-1600
7635707in 2 yr 9 mo
U-1609
8592462in 2 yr 9 mo
U-1609
8609701in 2 yr 9 mo
U-1610
7816383in 3 yr 6 mo
U-1603
7910610in 3 yr 6 mo
U-1604
8013002in 3 yr 6 mo
U-1603
8084475in 3 yr 6 mo
U-1605
8318780in 3 yr 6 mo
U-1606
8648098in 3 yr 6 mo
U-1611
8754109in 3 yr 6 mo
U-1612
8778947in 7 yr 2 mo
U-1613

Other FDA applications for Esbriet

1 additional filing

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Esbriet, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 208780Legacy PharmaJan 11, 20173ABPrescription

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 Pirfenidone 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.

Esbriet: 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 022535 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