ADASUVE Drug Patent Profile
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When do Adasuve patents expire, and when can generic versions of Adasuve launch?
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
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
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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: | 4,075 |
| 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 |
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 |
US Patents and Regulatory Information for ADASUVE
ADASUVE is protected by five US patents.
Patents protecting ADASUVE
Method and apparatus for vaporizing a compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method of forming an aerosol for inhalation delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Self-contained heating unit and drug-supply unit employing same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Self-contained heating unit and drug-supply unit employing same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Self-contained heating unit and drug-supply unit employing same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Japan | 2004531555 | ⤷ Sign Up | |
| Austria | 404173 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2004104490 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADASUVE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1389098 | 1390040-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220 |
| 1389098 | 473 | Finland | ⤷ Sign Up | |
| 1389098 | 2013C/054 | Belgium | ⤷ Sign Up | PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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