Details for New Drug Application (NDA): 022108
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NDA 022108 describes APLENZIN, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug and three Paragraph IV challenges. Additional details are available on the APLENZIN profile page.
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.
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.
Summary for 022108
| Tradename: | APLENZIN |
| Applicant: | Bausch |
| Ingredient: | bupropion hydrobromide |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022108
Generic Entry Date for 022108*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 022108
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 022108
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108 | NDA | Bausch Health US, LLC | 0187-5810 | 0187-5810-07 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5810-07) |
| APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108 | NDA | Bausch Health US, LLC | 0187-5810 | 0187-5810-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5810-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 174MG | ||||
| Approval Date: | Apr 23, 2008 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 27, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 27, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 27, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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