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Last Updated: January 24, 2020

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BEVESPI AEROSPHERE Drug Profile

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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 thirty-one patent family members in twenty-eight 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.

US ANDA Litigation and Generic Entry Outlook for Bevespi Aerosphere

Bevespi Aerosphere was eligible for patent challenges on December 31, 1968.

Indicators of Generic Entry

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Drug patent expirations by year for BEVESPI AEROSPHERE
Drug Prices for BEVESPI AEROSPHERE

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Recent Clinical Trials for BEVESPI AEROSPHERE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bastiaan DriehuysPhase 2/Phase 3
Los Angeles Biomedical Research InstitutePhase 4

See all BEVESPI AEROSPHERE clinical trials

Pharmacology for BEVESPI AEROSPHERE
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 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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for BEVESPI AEROSPHERE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 300995 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER GLYCOPYRRONIUYM BROMIDE, EN FORMOTEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER FORMOTEROL FUMARAAT DIHYDRAAT; 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
2435025 2019C/532 Belgium   Start Trial PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435025 CA 2019 00032 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Harvard Business School
Express Scripts
Baxter
Merck

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