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AIRDUO DIGIHALER Drug Profile
» See Plans and Pricing
Which patents cover Airduo Digihaler, and when can generic versions of Airduo Digihaler launch?
Airduo Digihaler is a drug marketed by Teva Pharm and is included in one NDA. There are twenty-four patents protecting this drug.
This drug has four hundred and forty-six patent family members in thirty-six countries.
The generic ingredient in AIRDUO DIGIHALER is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
US ANDA Litigation and Generic Entry Outlook for Airduo Digihaler
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for AIRDUO DIGIHALER
| International Patents: | 446 |
| US Patents: | 24 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AIRDUO DIGIHALER |
| DailyMed Link: | AIRDUO DIGIHALER at DailyMed |
Pharmacology for AIRDUO DIGIHALER
| Drug Class | beta2-Adrenergic Agonist Corticosteroid |
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for AIRDUO 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 | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | Jul 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | Jul 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | RX | Yes | No | 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 AIRDUO DIGIHALER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 201307990 | Start Trial |
| Denmark | 0966309 | Start Trial |
| Japan | 6543620 | Start Trial |
| Japan | 6403287 | Start Trial |
| Cyprus | 1113531 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AIRDUO DIGIHALER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 |
| 1519731 | 92269 | Luxembourg | Start Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 2506844 | 132018000000341 | Italy | Start Trial | PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
