Orange Book drug · Brand (NDA)

Antara (micronized)

Fenofibrate

RLDNDA 021695 5 strengths Lupin

Approved

Nov 30, 2004

Strengths

Listed patents

What does the FDA Orange Book show for Antara (micronized)?

Antara (micronized) contains Fenofibrate and is the new drug FDA Orange Book record for NDA 021695. The application has 5 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 021695
Application holder: Lupin Inc
Product presentations: 5
Marketing categories: Prescription and Discontinued
Reference roles: RLD / RS
TE codes: AB
Listed patents: 1
Exclusivity records: 0

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

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.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
001	43MG	CAPSULEORAL	Prescription	AB	RLD
002	87MG	CAPSULEORAL	Discontinued	None posted	None posted
003	130MG	CAPSULEORAL	Prescription	AB	RLDRS
004	30MG	CAPSULEORAL	Discontinued	None posted	RLD
005	90MG	CAPSULEORAL	Discontinued	None 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

Lupin Inc

The Orange Book identifies this organization as the applicant responsible for NDA 021695.

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 3 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 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. 3 presentations in the application have no posted TE code.

Patent & exclusivity record

1 listed patent expiration and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is May 31, 2033. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

48 other ANDAs and 6 other NDAs found

37 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 021695 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

Fenofibrate

20 applications

Product rows: 59
Active applications: 13
Active with AB row: 12

Lipofen · NDA 021612 Lipidil · NDA 019304 Fenofibrate (micronized) · ANDA 211407 Fenofibrate (micronized) · ANDA 212232 Fenofibrate (micronized) · ANDA 213842 Fenofibrate (micronized) · ANDA 207564

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-021695

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

5 approved presentations · NDA 021695

TE ABRLD

Strength: 43MG
Dosage form: CAPSULE
Route: ORAL
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Nov 30, 2004
22 yr ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

FENOFIBRATE

Strength

43MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 021695

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

RLDDiscontinued

Strength: 90MG
Dosage form: CAPSULE
Route: ORAL
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Oct 18, 2013
12 yr 11 mo ago
Today
Patent 9314447 expires
Listed drug product patent expiration.
May 31, 2033
in 6 yr 11 mo
Patent 9314447 expires
Listed drug product patent expiration.
May 31, 2033
in 6 yr 11 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

FENOFIBRATE

Strength

90MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 021695

Product number

005

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9314447	May 31, 2033	in 6 yr 11 mo	ProductU-1447
9314447	May 31, 2033	in 6 yr 11 mo	ProductU-1448

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 Fenofibrate 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.