Is Armonair Respiclick still available?

Armonair Respiclick (NDA 208798) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Armonair Respiclick have a generic?

Yes. The Orange Book lists 24 approved generic (ANDA) applications sharing Armonair Respiclick's active ingredient (Fluticasone Propionate). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

When do Armonair Respiclick's patents expire?

The FDA Orange Book lists 4 patents against Armonair Respiclick, with the last listed patent expiring Feb 20, 2040. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Armonair Respiclick's FDA application number?

Armonair Respiclick is approved under NDA 208798, held by Teva Pharm.

Orange Book product · Brand (NDA)

Armonair Respiclick

Fluticasone Propionate

Brand (NDA)NDA 208798DiscontinuedRLD Teva Pharm

Approved

Jan 27, 2017

Application

Brand (NDA)

TE code

Not listed

Listed patents

Armonair Respiclick (Fluticasone Propionate) is Teva Pharm's brand-name drug, approved by the FDA under NDA 208798 in 2017. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 24 approved generics share this drug's active ingredient. The FDA Orange Book lists 4 patents against it, the last expiring 2040.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Jan 27, 2017
9 yr 7 mo ago
Today
Patent 10195375 expires
Listed drug product patent expiration.
Feb 14, 2031
in 4 yr 8 mo
Patent 10195375*PED expires
Listed listed patent expiration.
Aug 14, 2031
in 5 yr 2 mo
Patent 11969544 expires
Listed drug product patent expiration.
Aug 20, 2039
in 13 yr 4 mo
Patent 11969544*PED expires
Listed listed patent expiration.
Feb 20, 2040
in 13 yr 10 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

FLUTICASONE PROPIONATE

Strength

0.113MG/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 208798

Product number

002

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 208798

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Fluticasone Propionate family

Orange Book patent file

Listed patents

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10195375	Feb 14, 2031	in 4 yr 8 mo	Product
10195375*PED	Aug 14, 2031	in 5 yr 2 mo
11969544	Aug 20, 2039	in 13 yr 4 mo	Product
11969544*PED	Feb 20, 2040	in 13 yr 10 mo

Armonair Respiclick — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Fluticasone Propionate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo