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 nineteen 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: | 19 |
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: | 10,231,964 | Patent Expiration: | Jul 2, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY | ||||||||
| Patent: | 10,307,376 | 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: | 10,403,170 | 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 | 11,278,544 | ⤷ Get Started Free |
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | 8,815,889 | ⤷ Get Started Free |
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | 7,462,626 | ⤷ Get Started Free |
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | 7,375,111 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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