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ARMONAIR DIGIHALER Drug Profile
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Which patents cover Armonair Digihaler, and when can generic versions of Armonair Digihaler launch?
Armonair Digihaler is a drug marketed by Teva Pharm and is included in one NDA. There are twenty-one patents protecting this drug.
This drug has four hundred and eight patent family members in thirty-four countries.
The generic ingredient in ARMONAIR DIGIHALER is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
US ANDA Litigation and Generic Entry Outlook for Armonair Digihaler
A generic version of ARMONAIR DIGIHALER was approved as fluticasone propionate by ANDA REPOSITORY on May 14th, 2004.
Summary for ARMONAIR DIGIHALER
| International Patents: | 408 |
| US Patents: | 21 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARMONAIR DIGIHALER |
| DailyMed Link: | ARMONAIR DIGIHALER at DailyMed |
Pharmacology for ARMONAIR DIGIHALER
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for ARMONAIR DIGIHALER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-005 | Feb 20, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-005 | Feb 20, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-006 | Feb 20, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-006 | Feb 20, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-006 | Feb 20, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-006 | Feb 20, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-006 | Feb 20, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ARMONAIR DIGIHALER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20130103827 | Start Trial |
| Denmark | 2189176 | Start Trial |
| Japan | 2015231584 | Start Trial |
| Uruguay | 26796 | Start Trial |
| Australia | 8464301 | Start Trial |
| Hong Kong | 1219067 | Start Trial |
| Slovenia | 1294421 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ARMONAIR DIGIHALER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1519731 | 13C0067 | France | Start Trial | PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215 |
| 2506844 | LUC00077 | Luxembourg | Start Trial | PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117 |
| 1305329 | SPC/GB08/026 | United Kingdom | Start Trial | PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111 |
| 2506844 | 2018C/022 | Belgium | Start Trial | PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117 |
| 2506844 | 18C1022 | France | Start Trial | PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117 |
| 1305329 | 08C0014 | France | Start Trial | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
| 1519731 | 92269 | Luxembourg | Start Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
