Orange Book drug · Brand (NDA)

Lonhala Magnair Kit

Glycopyrrolate

DiscontinuedRLDNDA 208437 Sumitomo Pharma Am

Approved

Dec 05, 2017

Strengths

Listed patents

What does the FDA Orange Book show for Lonhala Magnair Kit?

Lonhala Magnair Kit contains Glycopyrrolate and is the new drug FDA Orange Book record for NDA 208437. 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 208437
Application holder: Sumitomo Pharma America Inc
Product presentations: 1
Marketing categories: Discontinued
Reference roles: RLD
TE codes: None posted
Listed patents: 9
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	25MCG/ML	SOLUTIONINHALATION	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

Sumitomo Pharma America Inc

The Orange Book identifies this organization as the applicant responsible for NDA 208437.

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A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.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

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

The latest future date recorded across those files is Dec 07, 2036. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

59 other ANDAs and 8 other NDAs found

42 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 208437 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Inhalation

Glycopyrrolate

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-208437

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 208437

RLDDiscontinued

Strength: 25MCG/ML
Dosage form: SOLUTION
Route: INHALATION
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Dec 05, 2017
8 yr 9 mo ago
Today
Patent 11278683 expires
Listed drug product patent expiration.
Aug 16, 2026
in 21 d
Patent 9265900 expires
Listed drug product patent expiration.
Dec 07, 2028
in 2 yr 5 mo
Patent 10940110 expires
Listed drug product patent expiration.
Feb 26, 2029
in 2 yr 8 mo
Patent 9789270 expires
Listed drug product patent expiration.
Oct 30, 2030
in 4 yr 4 mo
Patent 9168556 expires
Listed drug product patent expiration.
Sep 01, 2032
in 6 yr 2 mo
Patent 9604018 expires
Listed drug product patent expiration.
May 16, 2033
in 6 yr 11 mo
Patent 10376661 expires
Listed drug product patent expiration.
Sep 14, 2035
in 9 yr 3 mo
Patent 10688518 expires
Listed drug product patent expiration.
Nov 12, 2036
in 10 yr 5 mo
Patent 10744277 expires
Listed drug product patent expiration.
Dec 07, 2036
in 10 yr 6 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

GLYCOPYRROLATE

Strength

25MCG/ML

Dosage form

SOLUTION

Route

INHALATION

TE code

Not listed

Application

NDA 208437

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
11278683	Aug 16, 2026	in 21 d	Product
9265900	Dec 07, 2028	in 2 yr 5 mo	Product
10940110	Feb 26, 2029	in 2 yr 8 mo	ProductU-1773
9789270	Oct 30, 2030	in 4 yr 4 mo	Product
9168556	Sep 01, 2032	in 6 yr 2 mo	Product
9604018	May 16, 2033	in 6 yr 11 mo	Product
10376661	Sep 14, 2035	in 9 yr 3 mo	Product
10688518	Nov 12, 2036	in 10 yr 5 mo	Product
10744277	Dec 07, 2036	in 10 yr 6 mo	ProductU-2941

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 Glycopyrrolate 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.