DrugPatentWatch Database Preview
CONTRAVE Drug Profile
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Which patents cover Contrave, and when can generic versions of Contrave launch?
Contrave is a drug marketed by Orexigen and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and thirty-seven patent family members in twenty-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.
Summary for CONTRAVE
| International Patents: | 137 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 7 |
| 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 |
| DailyMed Link: | CONTRAVE at DailyMed |
Generic Entry Opportunity Date for CONTRAVE
*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.
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 |
US Patents and Regulatory Information for CONTRAVE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orexigen | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Orexigen | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Orexigen | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Orexigen | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Orexigen | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for CONTRAVE
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 8 mg/90 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for CONTRAVE
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 |
|---|---|---|
| 9,457,005 | Compositions and methods for increasing insulin sensitivity | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for CONTRAVE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 5908008 | ➤ Sign Up |
| Portugal | 2316456 | ➤ Sign Up |
| Netherlands | 300918 | ➤ Sign Up |
| Israel | 198578 | ➤ Sign Up |
| Israel | 171519 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for CONTRAVE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2017 00062 | Denmark | ➤ Sign Up | 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 |
| 0918 | Netherlands | ➤ Sign Up | 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 |
| /2000 | Austria | ➤ Sign Up | PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201 |
| 2000 00018 | Denmark | ➤ Sign Up | PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201 |
| 2017000109 | Germany | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
