DrugPatentWatch Database Preview
CONTRAVE Drug Profile
» See Plans and Pricing
Which patents cover Contrave, and what generic alternatives are available?
Contrave is a drug marketed by Nalpropion and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eighty-four patent family members in thirty-four countries.
The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride; naltrexone hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Contrave
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 20, 2024. 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 CONTRAVE
| International Patents: | 184 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 17 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CONTRAVE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CONTRAVE |
| What excipients (inactive ingredients) are in CONTRAVE? | CONTRAVE excipients list |
| DailyMed Link: | CONTRAVE at DailyMed |
Generic Entry Opportunity Date for CONTRAVE
Generic Entry Date for CONTRAVE*:
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 CONTRAVE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bausch Health, Canada Inc. | Phase 4 |
| St. Joseph's Healthcare Hamilton | Phase 4 |
| The Cleveland Clinic | Phase 4 |
Pharmacology for CONTRAVE
| Drug Class | Opioid Antagonist Aminoketone |
| Mechanism of Action | Opioid Antagonists Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Paragraph IV (Patent) Challenges for CONTRAVE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CONTRAVE | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrochloride; naltrexone hydrochloride | 200063 | 2015-03-12 |
US Patents and Regulatory Information for CONTRAVE
International Patents for CONTRAVE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2089005 | Start Trial |
| Taiwan | 200509928 | Start Trial |
| Luxembourg | C00054 | Start Trial |
| South Korea | 101654176 | Start Trial |
| Costa Rica | 20160313 | Start Trial |
| Japan | 2010508997 | Start Trial |
| European Patent Office | 1870096 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CONTRAVE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 122017000109 | Germany | Start 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 |
| 2316456 | 65/2017 | Austria | Start Trial | PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330 |
| 2316456 | CA 2017 00062 | Denmark | Start Trial | 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 |
| 2316456 | 2017/059 | Ireland | Start 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; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
| 2316456 | 1790064-8 | Sweden | Start 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 | C20170044 00252 | Estonia | Start Trial | PRODUCT NAME: NALTREKSOON/BUPROPIOON;REG NO/DATE: EU/1/14/988 30.03.2015 |
| 0656775 | 28/2000 | Austria | Start Trial | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
