ADASUVE Drug Patent Profile
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Which patents cover Adasuve, and what generic alternatives are available?
Adasuve is a drug marketed by Alexza Pharms and is included in one NDA. There are five patents protecting this drug.
This drug has two hundred and twenty-seven patent family members in twenty-one countries.
The generic ingredient in ADASUVE is loxapine. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the loxapine profile page.
DrugPatentWatch® Generic Entry Outlook for Adasuve
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 20, 2024. This may change due to patent challenges or generic licensing.
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 ADASUVE
International Patents: | 227 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 13 |
Patent Applications: | 5,118 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ADASUVE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADASUVE |
What excipients (inactive ingredients) are in ADASUVE? | ADASUVE excipients list |
DailyMed Link: | ADASUVE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ADASUVE
Generic Entry Date for ADASUVE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;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 ADASUVE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Lee's Pharmaceutical Limited | Phase 3 |
University of Arkansas | Phase 4 |
Mount Sinai Hospital, Chicago | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ADASUVE
US Patents and Regulatory Information for ADASUVE
ADASUVE is protected by five US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ADASUVE is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ADASUVE
Method and apparatus for vaporizing a compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of forming an aerosol for inhalation delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Self-contained heating unit and drug-supply unit employing same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Self-contained heating unit and drug-supply unit employing same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Self-contained heating unit and drug-supply unit employing same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 ADASUVE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ADASUVE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Ferrer Internacional S.A. | Adasuve | loxapine | EMEA/H/C/002400 Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms. |
Authorised | no | no | no | 2013-02-20 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ADASUVE
See the table below for patents covering ADASUVE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 100496458 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 02094235 | ⤷ Try a Trial | |
Japan | 4601619 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADASUVE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1389098 | C300609 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 |
1389098 | 473 | Finland | ⤷ Try a Trial | |
1389098 | 300609 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |