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Generated: June 29, 2017
Which patents cover Aplenzin, and when can generic versions of Aplenzin launch?
Aplenzin is a drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this drug and three Paragraph IV challenges.| Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 3 |
| Bulk Api Vendors: see list | 37 |
| Clinical Trials: see list | 1 |
| Patent Applications: see list | 46 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | APLENZIN at DailyMed |
| Drug Class | Aminoketone |
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | 7,572,935 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | 7,572,935 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | 7,569,610 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | 7,662,407 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | 7,585,897 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| bupropion hydrobromide | Extended-release Tablets | 522 mg | Aplenzin | 12/24/2009 |
| bupropion hydrobromide | Extended-release Tablets | 174 mg | Aplenzin | 9/28/2009 |
| bupropion hydrobromide | Extended-release Tablets | 348 mg | Aplenzin | 9/24/2009 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,579,380 | Modified release formulations of a bupropion salt | ► Subscribe | |||||||||||||||||||||||||||
| 7,884,136 | Modified-release formulations of a bupropion salt | ► Subscribe | |||||||||||||||||||||||||||
| 7,553,992 | Modified release formulations of a bupropion salt | ► Subscribe | |||||||||||||||||||||||||||
| 7,569,611 | Modified release formulations of a bupropion salt | ► Subscribe | |||||||||||||||||||||||||||
| 8,354,453 | Bupropion hydrobromide and therapeutic applications | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ecuador | SP077999 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2010535740 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 185760 | ► Subscribe | |||||||||||||||||||||||||||
| Ecuador | SP109923 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2007002597 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2000 00018 | Denmark | ► Subscribe | PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201 | ||||||||||||||||||||||||||
| /2000 | Austria | ► Subscribe | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 | ||||||||||||||||||||||||||
| C/GB00/019 | United Kingdom | ► Subscribe | PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607 | ||||||||||||||||||||||||||
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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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