APLENZIN Drug Patent Profile
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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-two 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: | 52 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 20 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,646 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for APLENZIN |
| Drug Sales Revenues: | Drug sales revenues for APLENZIN |
| What excipients (inactive ingredients) are in APLENZIN? | APLENZIN excipients list |
| DailyMed Link: | APLENZIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
|---|---|
| Valeant Pharmaceuticals International, Inc. | Phase 4 |
| Bausch Health Americas, Inc. | Phase 4 |
| SRI International | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for APLENZIN
Paragraph IV (Patent) Challenges for APLENZIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| APLENZIN | Extended-release Tablets | bupropion hydrobromide | 522 mg | 022108 | 1 | 2009-12-24 |
| APLENZIN | Extended-release Tablets | bupropion hydrobromide | 174 mg | 022108 | 1 | 2009-09-28 |
| APLENZIN | Extended-release Tablets | bupropion hydrobromide | 348 mg | 022108 | 1 | 2009-09-24 |
US Patents and Regulatory Information for APLENZIN
APLENZIN is protected by eight US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of APLENZIN is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting APLENZIN
Modified release formulations of a bupropion salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations of a bupropion salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
Modified release formulations of a bupropion salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations of a bupropion salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Bupropion hydrobromide and therapeutic applications
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations of a bupropion salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modified release formulations of a bupropion salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Bupropion hydrobromide and therapeutic applications
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 APLENZIN
When does loss-of-exclusivity occur for APLENZIN?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 06261788
Estimated Expiration: ⤷ Try a Trial
Patent: 08285660
Estimated Expiration: ⤷ Try a Trial
Patent: 08320915
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 78626
Estimated Expiration: ⤷ Try a Trial
Patent: 55596
Estimated Expiration: ⤷ Try a Trial
Patent: 99588
Estimated Expiration: ⤷ Try a Trial
Patent: 00733
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1534808
Estimated Expiration: ⤷ Try a Trial
Patent: 1784266
Estimated Expiration: ⤷ Try a Trial
Patent: 1903016
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 51360
Estimated Expiration: ⤷ Try a Trial
Patent: 70385
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 09
Estimated Expiration: ⤷ Try a Trial
Patent: 259
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 077999
Estimated Expiration: ⤷ Try a Trial
Patent: 109923
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 96002
Estimated Expiration: ⤷ Try a Trial
Patent: 32124
Estimated Expiration: ⤷ Try a Trial
Patent: 85139
Estimated Expiration: ⤷ Try a Trial
Patent: 14650
Estimated Expiration: ⤷ Try a Trial
Patent: 74308
Estimated Expiration: ⤷ Try a Trial
Patent: 02621
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 42811
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5760
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 95615
Estimated Expiration: ⤷ Try a Trial
Patent: 08546841
Estimated Expiration: ⤷ Try a Trial
Patent: 10535740
Estimated Expiration: ⤷ Try a Trial
Patent: 11500865
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 10001449
Estimated Expiration: ⤷ Try a Trial
Patent: 10003872
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 1375
Estimated Expiration: ⤷ Try a Trial
Patent: 2925
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 1000015
Estimated Expiration: ⤷ Try a Trial
Patent: 1000044
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 08368
Estimated Expiration: ⤷ Try a Trial
Patent: 85942
Estimated Expiration: ⤷ Try a Trial
Patent: 85943
Estimated Expiration: ⤷ Try a Trial
Patent: 07147343
Estimated Expiration: ⤷ Try a Trial
Patent: 10107843
Estimated Expiration: ⤷ Try a Trial
Patent: 10116863
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 3695
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0711123
Estimated Expiration: ⤷ Try a Trial
Patent: 1000425
Estimated Expiration: ⤷ Try a Trial
Patent: 1003036
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1306635
Estimated Expiration: ⤷ Try a Trial
Patent: 080026098
Estimated Expiration: ⤷ Try a Trial
Patent: 100055402
Estimated Expiration: ⤷ Try a Trial
Patent: 100077182
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering APLENZIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2007147343 | ПРЕПАРАТЫ СОЛИ БУПРОПИОНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ | ⤷ Try a Trial |
| European Patent Office | 1896002 | FORMULATIONS A LIBERATION MODIFIEE D'UN SEL DE BUPROPION (MODIFIED-RELEASE FORMULATIONS OF A BUPROPION SALT) | ⤷ Try a Trial |
| Costa Rica | 11259 | BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPUETICAS | ⤷ Try a Trial |
| China | 101784266 | Bupropion hydrobromide and therapeutic applications | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2009019294 | ⤷ Try a Trial | |
| South Korea | 20100077182 | BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for APLENZIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | SPC/GB17/078 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330 |
| 2316456 | 17C1058 | France | ⤷ Try a Trial | PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
| 2316456 | 300918 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
| 0656775 | 28/2000 | Austria | ⤷ Try a Trial | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 |
| 2316456 | 1790064-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330 |
| 2316456 | 122017000109 | Germany | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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