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BEVESPI AEROSPHERE Drug Profile
Which patents cover Bevespi Aerosphere, and what generic alternatives are available?
Bevespi Aerosphere is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and twenty-nine patent family members in twenty-seven countries.
The generic ingredient in BEVESPI AEROSPHERE is formoterol fumarate; glycopyrrolate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; glycopyrrolate profile page.
Summary for BEVESPI AEROSPHERE
| International Patents: | 129 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BEVESPI AEROSPHERE |
| DailyMed Link: | BEVESPI AEROSPHERE at DailyMed |
Recent Clinical Trials for BEVESPI AEROSPHERE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bastiaan Driehuys | Phase 2/Phase 3 |
| Los Angeles Biomedical Research Institute | Phase 4 |
Pharmacology for BEVESPI AEROSPHERE
| Drug Class | Anticholinergic beta2-Adrenergic Agonist |
| Mechanism of Action | Cholinergic Antagonists Adrenergic beta2-Agonists |
Synonyms for BEVESPI AEROSPHERE
| Formoterol fumarate / Glycopyrrolate |
| Formoterol fumarate mixture with Glycopyrrolate |
| Glycopyrrolate / formoterol fumarate |
| Glycopyrrolate mixture with formoterol fumarate |
| S900007360 |
US Patents and Regulatory Information for BEVESPI AEROSPHERE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Pharms | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294-001 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Pharms | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294-001 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Pharms | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294-001 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Pharms | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294-001 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Pharms | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294-001 | Apr 25, 2016 | RX | Yes | Yes | Start Trial | Start Trial | 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 BEVESPI AEROSPHERE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2010138862 | Start Trial |
| Ukraine | 109529 | Start Trial |
| Australia | 2010253950 | Start Trial |
| European Patent Office | 3106149 | Start Trial |
| South Korea | 20180130602 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BEVESPI AEROSPHERE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435025 | 122019000068 | Germany | Start Trial | PRODUCT NAME: KOMBINATION VON GLYCOPYRROLAT, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON, UND FORMOTEROL, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
| 0613371 | SPC/GB02/033 | United Kingdom | Start Trial | PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515 |
| 2435025 | PA2019014 | Lithuania | Start Trial | PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
| 2435025 | 300995 | Netherlands | Start Trial | PRODUCT NAME: EEN COMBINATIE VAN GLYCOPYRROLAAT (MET INBEGRIP VAN ALLE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, ENANTIOMEREN OF ANDERE DERIVATEN DAARVAN) EN FORMOTEROL (MET INBEGRIP VAN ALLE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, ENANTIOMEREN OF ANDERE DERIVATEN DAARVAN); REGISTRATION NO/DATE: EU/ 1/18/1339 20181220 |
| 0613371 | 2002C/022 | Belgium | Start Trial | PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
