Orange Book drug · Brand (NDA)

Utibron Neohaler

Glycopyrrolate; Indacaterol Maleate

DiscontinuedRLDNDA 207930 Novartis

Approved

Oct 29, 2015

Strengths

Listed patents

What does the FDA Orange Book show for Utibron Neohaler?

Utibron Neohaler contains Glycopyrrolate; Indacaterol Maleate and is the new drug FDA Orange Book record for NDA 207930. 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 207930
Application holder: Novartis Pharmaceuticals Corp
Product presentations: 1
Marketing categories: Discontinued
Reference roles: RLD
TE codes: None posted
Listed patents: 2
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	15.6MCG/INH;27.5MCG/INH	POWDERINHALATION	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

Novartis Pharmaceuticals Corp

The Orange Book identifies this organization as the applicant responsible for NDA 207930.

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A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.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

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

The latest future date recorded across those files is Oct 20, 2028. 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 207930 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Powder · Inhalation

Glycopyrrolate; Indacaterol Maleate

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-207930

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 207930

RLDDiscontinued

Strength: 15.6MCG/INH;27.5MCG/INH
Dosage form: POWDER
Route: INHALATION
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Oct 29, 2015
10 yr 11 mo ago
Today
Patent 8479730 expires
Listed drug product patent expiration.
Oct 11, 2028
in 2 yr 3 mo
Patent 8182838 expires
Listed drug product patent expiration.
Oct 20, 2028
in 2 yr 3 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

GLYCOPYRROLATE; INDACATEROL MALEATE

Strength

15.6MCG/INH;27.5MCG/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 207930

Product number

001

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
8479730	Oct 11, 2028	in 2 yr 3 mo	Product
8182838	Oct 20, 2028	in 2 yr 3 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.

No other applications share this active ingredient.

View full Glycopyrrolate; Indacaterol Maleate 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.