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BEVESPI AEROSPHERE Drug Profile
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» See Plans and PricingWhen do Bevespi Aerosphere patents expire, 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 fifty patent family members in thirty 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
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 28, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for BEVESPI AEROSPHERE
| International Patents: | 150 |
| 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 |
Generic Entry Opportunity Date for BEVESPI AEROSPHERE
Generic Entry Date for BEVESPI AEROSPHERE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
AEROSOL, METERED;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
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 | 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 |
|---|---|---|
| Mexico | 350163 | Start Trial |
| Argentina | 076806 | Start Trial |
| Poland | 2435024 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BEVESPI AEROSPHERE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 132019000000087 | Italy | Start Trial | PRODUCT NAME: UNA COMBINAZIONE DI GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI) E FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI)(BEVESPI AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1339, 20181220 |
| 2435025 | 36/2019 | Austria | Start Trial | PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
