DrugPatentWatch Database Preview
ADASUVE Drug Profile
» See Plans and Pricing
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 eighteen patents protecting this drug.
This drug has two hundred and twenty-six patent family members in twenty 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 October 26, 2021. 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: | 226 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 32 |
| Clinical Trials: | 5 |
| Patent Applications: | 4,085 |
| 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 Generic Entry Opportunity 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 |
| Advocate Health Care | N/A |
| Teva Branded Pharmaceutical Products, R&D Inc. | Phase 1 |
US Patents and Regulatory Information for ADASUVE
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Alexza Pharms | ADASUVE | loxapine | POWDER;INHALATION | 022549-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | 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 |
International Patents for ADASUVE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1392258 | Start Trial |
| Japan | 2005503846 | Start Trial |
| Austria | 425784 | Start Trial |
| European Patent Office | 1506031 | Start Trial |
| Canada | 2462576 | Start Trial |
| European Patent Office | 1389098 | Start Trial |
| Mexico | PA05005609 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ADASUVE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1389098 | 300609 | Netherlands | Start Trial | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | C300609 | Netherlands | Start Trial | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | CR 2013 00046 | Denmark | Start Trial | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220 |
| 1389098 | C01389098/01 | Switzerland | Start Trial | PRODUCT NAME: LOXAPINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65461 13.12.2016 |
| 1389098 | 1390040-2 | Sweden | Start Trial | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220 |
| 1389098 | 2013C/054 | Belgium | Start Trial | PRODUCT NAME: ADASUVE-LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225 |
| 1389098 | 473 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
