Details for New Drug Application (NDA): 205474
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NDA 205474 describes OBREDON, which is a drug marketed by Sovereign Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the OBREDON profile page.
The generic ingredient in OBREDON is guaifenesin; hydrocodone bitartrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.
The generic ingredient in OBREDON is guaifenesin; hydrocodone bitartrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.
Summary for 205474
| Tradename: | OBREDON |
| Applicant: | Sovereign Pharms |
| Ingredient: | guaifenesin; hydrocodone bitartrate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205474
*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: 205474
| Mechanism of Action | Opioid Agonists |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Suppliers and Packaging for NDA: 205474
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474 | NDA | Sovereign Pharmaceuticals, LLC | 58716-433 | 58716-433-04 | 118 mL in 1 BOTTLE (58716-433-04) |
| OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474 | NDA | Sovereign Pharmaceuticals, LLC | 58716-433 | 58716-433-16 | 473 mL in 1 BOTTLE (58716-433-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 200MG/5ML;2.5MG/5ML | ||||
| Approval Date: | Nov 14, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 13, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4 | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 13, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4 | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 13, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4 | ||||||||
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