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Orange Book product · Brand (NDA)

Armonair Digihaler

Fluticasone Propionate

Brand (NDA)NDA 208798DiscontinuedRLD Teva Pharm
Approved
Feb 20, 2020
Application
Brand (NDA)
TE code
Not listed
Listed patents
10
Armonair Digihaler (Fluticasone Propionate) is Teva Pharm's brand-name drug, approved by the FDA under NDA 208798 in 2020. 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 Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 24 approved generics share this drug's active ingredient.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 10 patents against it, the last expiring 2041.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 20, 2020

    6 yr 6 mo ago

  2. Today

  3. Patent 10195375 expires

    Listed drug product patent expiration.

    Feb 14, 2031

    in 4 yr 8 mo

  4. Patent 10195375*PED expires

    Listed listed patent expiration.

    Aug 14, 2031

    in 5 yr 2 mo

  5. Patent 10918816 expires

    Listed drug product patent expiration.

    Dec 14, 2035

    in 9 yr 7 mo

  6. Patent 10918816*PED expires

    Listed listed patent expiration.

    Jun 14, 2036

    in 10 yr 1 mo

  7. Patent 11969544 expires

    Listed drug product patent expiration.

    Aug 20, 2039

    in 13 yr 4 mo

  8. Patent 11344685 expires

    Listed drug product patent expiration.

    Sep 26, 2039

    in 13 yr 5 mo

  9. Patent 11969544*PED expires

    Listed listed patent expiration.

    Feb 20, 2040

    in 13 yr 10 mo

  10. Patent 11344685*PED expires

    Listed listed patent expiration.

    Mar 26, 2040

    in 13 yr 11 mo

  11. Patent 11173259 expires

    Listed drug product patent expiration.

    Jul 06, 2040

    in 14 yr 2 mo

  12. Patent 11173259*PED expires

    Listed listed patent expiration.

    Jan 06, 2041

    in 14 yr 8 mo

Protection horizon

Patent & exclusivity timeline

202620282030203220342036203820402042TodayPatent 10195375 — 2031-02-14Patent 10195375Patent 10195375*PED — 2031-08-14Patent 10195375*PEDPatent 10918816 — 2035-12-14Patent 10918816Patent 10918816*PED — 2036-06-14Patent 10918816*PEDPatent 11969544 — 2039-08-20Patent 11969544Patent 11344685 — 2039-09-26Patent 11344685Patent 11969544*PED — 2040-02-20Patent 11969544*PEDPatent 11344685*PED — 2040-03-26Patent 11344685*PEDPatent 11173259 — 2040-07-06Patent 11173259Patent 11173259*PED — 2041-01-06Patent 11173259*PED
Patent expiryExclusivity endToday
FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

FLUTICASONE PROPIONATE

Strength

0.055MG/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 208798

Product number

004

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10195375Feb 14, 2031in 4 yr 8 mo
Product
10195375*PEDAug 14, 2031in 5 yr 2 mo
10918816Dec 14, 2035in 9 yr 7 mo
Product
10918816*PEDJun 14, 2036in 10 yr 1 mo
11969544Aug 20, 2039in 13 yr 4 mo
Product
11344685Sep 26, 2039in 13 yr 5 mo
Product
11969544*PEDFeb 20, 2040in 13 yr 10 mo
11344685*PEDMar 26, 2040in 13 yr 11 mo
11173259Jul 06, 2040in 14 yr 2 mo
Product
11173259*PEDJan 06, 2041in 14 yr 8 mo

Armonair Digihaler — 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.

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