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Generated: June 25, 2017
What are the generic sources for loxapine and what is the scope of loxapine patent protection?
Loxapine is the generic ingredient in five branded drugs marketed by Alexza Pharms, Actavis Labs Ut Inc, Watson Labs, Mylan, Elite Labs Inc, and Lannett Holdings Inc, and is included in eleven NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 5 |
| Patents: | 18 |
| Applicants: | 6 |
| NDAs: | 11 |
| Drug Master File Entries: see list | 8 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 20 |
| Clinical Trials: see list | 23 |
| Patent Applications: see list | 4,854 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | loxapine at DailyMed |
| 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 | 9,439,907 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Lannett Holdings Inc | LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 090695-002 | Sep 26, 2011 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Actavis Labs Ut Inc | LOXITANE IM | loxapine hydrochloride | INJECTABLE;INJECTION | 018039-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Actavis Labs Ut Inc | LOXITANE | loxapine succinate | CAPSULE;ORAL | 017525-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Elite Labs Inc | LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 076868-003 | Aug 4, 2005 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,737,042 | Delivery of drug esters through an inhalation route | ► Subscribe | |||||||||||||||||||||||||||
| 7,070,761 | Delivery of nonsteroidal antiinflammatory drugs through an inhalation route | ► Subscribe | |||||||||||||||||||||||||||
| 7,078,018 | Delivery of opioids through an inhalation route | ► Subscribe | |||||||||||||||||||||||||||
| 7,087,216 | Delivery of sedative-hypnotics through an inhalation route | ► Subscribe | |||||||||||||||||||||||||||
| 6,884,408 | Delivery of diphenhydramine through an inhalation route | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 60231611 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 02094240 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2004532859 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2646756 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2447166 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013 00046 | Denmark | ► Subscribe | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220 | ||||||||||||||||||||||||||
| 0609 | Netherlands | ► Subscribe | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 | ||||||||||||||||||||||||||
| 2013 00046 | Denmark | ► Subscribe | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220 | ||||||||||||||||||||||||||
| 90040-2 | Sweden | ► Subscribe | PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220 | ||||||||||||||||||||||||||
| 00609 | Netherlands | ► Subscribe | PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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