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
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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Questions you can ask:
- What is the 5 year forecast for ADASUVE?
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- What is Average Wholesale Price for ADASUVE?
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: | 4,084 |
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
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Method of forming an aerosol for inhalation delivery
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Self-contained heating unit and drug-supply unit employing same
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Patent Expiration: ⤷ Sign Up
Self-contained heating unit and drug-supply unit employing same
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Self-contained heating unit and drug-supply unit employing same
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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 | |||
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 |
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 | 2005503846 | ⤷ Sign Up | |
Mexico | PA05005609 | TRATAMIENTO DE DOLOR DE CABEZA CON ANTIPSICOTICOS SUMINISTRADOS POR INHALACION. (TREATMENT OF HEADACHE WITH ANTIPSYCHOTICS DELIVERED BY INHALATION.) | ⤷ Sign Up |
European Patent Office | 1392261 | ADMINISTRATION DE MEDICAMENTS ANTI-INFLAMMATOIRES NON STEROIDIENS VIA UNE VOIE PULMONAIRE (DELIVERY OF NONSTEROIDAL ANTIINFLAMMATORY DRUGS THROUGH AN INHALATION ROUTE) | ⤷ Sign Up |
Japan | 2010270138 | DELIVERY OF ANTIPSYCHOTICS THROUGH PREDETERMINED INHALATION ROUTE | ⤷ Sign Up |
Slovenia | 2052753 | ⤷ Sign Up | |
European Patent Office | 2052753 | Procédé de vaporisation d'un composé (Method for vaporizing a compound) | ⤷ 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 | C300609 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 |
1389098 | 2013C/054 | Belgium | ⤷ Sign Up | PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225 |
1389098 | SPC/GB13/055 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220 |
1389098 | 300609 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 |
1389098 | 132013902184784 | Italy | ⤷ Sign Up | PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220 |
1389098 | CR 2013 00046 | Denmark | ⤷ Sign Up | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |