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DUAKLIR PRESSAIR Drug Profile
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» See Plans and PricingWhen do Duaklir Pressair patents expire, and when can generic versions of Duaklir Pressair launch?
Duaklir Pressair is a drug marketed by Circassia and is included in one NDA. There are eleven patents protecting this drug.
This drug has one hundred and forty patent family members in forty-four countries.
The generic ingredient in DUAKLIR PRESSAIR is aclidinium bromide; formoterol fumarate. There is one drug master file entry for this compound. Additional details are available on the aclidinium bromide; formoterol fumarate profile page.
US ANDA Litigation and Generic Entry Outlook for Duaklir Pressair
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 10, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for DUAKLIR PRESSAIR
| International Patents: | 140 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DUAKLIR PRESSAIR |
| DailyMed Link: | DUAKLIR PRESSAIR at DailyMed |
Generic Entry Opportunity Date for DUAKLIR PRESSAIR
Generic Entry Date for DUAKLIR PRESSAIR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER, 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.
US Patents and Regulatory Information for DUAKLIR PRESSAIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Circassia | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | RX | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Circassia | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | RX | No | No | Start Trial | Start Trial | Start Trial | ||||
| Circassia | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | RX | No | No | Start Trial | Start Trial | Y | 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 |
Expired US Patents for DUAKLIR PRESSAIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Circassia | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | Start Trial | Start Trial |
| Circassia | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | Start Trial | Start Trial |
| Circassia | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DUAKLIR PRESSAIR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 1616592 | Start Trial |
| Denmark | 1200431 | Start Trial |
| Ecuador | SP077164 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DUAKLIR PRESSAIR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1200431 | 421 | Finland | Start Trial | |
| 1200431 | PA2013001 | Lithuania | Start Trial | PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720 |
| 1200431 | CA 2013 00002 | Denmark | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
