Details for New Drug Application (NDA): 200063
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NDA 200063 describes CONTRAVE, which is a drug marketed by Nalpropion and is included in one NDA. It is available from one supplier. There are twenty-two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CONTRAVE profile page.
The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. 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 hydrochloride; naltrexone hydrochloride profile page.
The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. 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 hydrochloride; naltrexone hydrochloride profile page.
Summary for 200063
| Tradename: | CONTRAVE |
| Applicant: | Nalpropion |
| Ingredient: | bupropion hydrochloride; naltrexone hydrochloride |
| Patents: | 22 |
Pharmacology for NDA: 200063
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors Opioid Antagonists |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 200063
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063 | NDA | Nalpropion Pharmaceuticals LLC | 51267-890 | 51267-890-07 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07) |
| CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063 | NDA | Nalpropion Pharmaceuticals LLC | 51267-890 | 51267-890-99 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 90MG;8MG | ||||
| Approval Date: | Sep 10, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 2, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Nov 8, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jun 5, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY | ||||||||
Expired US Patents for NDA 200063
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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