DrugPatentWatch Database Preview
APLENZIN Drug Profile
» See Plans and Pricing
When do Aplenzin patents expire, and what generic alternatives are available?
Aplenzin is a drug marketed by Bausch and is included in one NDA. There are eight patents protecting this drug and three Paragraph IV challenges.
This drug has fifty-three patent family members in eighteen countries.
The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupropion hydrobromide profile page.
DrugPatentWatch® Generic Entry Outlook for Aplenzin
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 27, 2026. This may change due to patent challenges or generic licensing.
There are three Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
There is one tentative approval for the generic drug (bupropion hydrobromide), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for APLENZIN
| International Patents: | 53 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 1 |
| Patent Applications: | 54 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for APLENZIN |
| What excipients (inactive ingredients) are in APLENZIN? | APLENZIN excipients list |
| DailyMed Link: | APLENZIN at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for APLENZIN
Generic Entry Date for APLENZIN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*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 APLENZIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| SRI International | Phase 4 |
| Johns Hopkins University | Phase 4 |
| University of Bristol | Phase 4 |
Pharmacology for APLENZIN
| Drug Class | Aminoketone |
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Paragraph IV (Patent) Challenges for APLENZIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| APLENZIN | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrobromide | 022108 | 2009-12-24 |
| APLENZIN | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrobromide | 022108 | 2009-09-28 |
| APLENZIN | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrobromide | 022108 | 2009-09-24 |
US Patents and Regulatory Information for APLENZIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| >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 APLENZIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 185760 | Get Started for $10 |
| Ecuador | SP077999 | Get Started for $10 |
| Mexico | 2010001449 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for APLENZIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 122017000109 | Germany | Get Started for $10 | PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
| 2316456 | 132017000142109 | Italy | Get Started for $10 | PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330 |
| 2316456 | CR 2017 00062 | Denmark | Get Started for $10 | PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
