OBREDON Drug Patent Profile
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When do Obredon patents expire, and what generic alternatives are available?
Obredon is a drug marketed by Sovereign Pharms and is included in one NDA. There are three patents protecting this drug.
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.
DrugPatentWatch® Generic Entry Outlook for Obredon
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 13, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for OBREDON
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Patent Applications: | 4 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in OBREDON? | OBREDON excipients list |
| DailyMed Link: | OBREDON at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OBREDON
Generic Entry Date for OBREDON*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;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 OBREDON
| Drug Class | Expectorant Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Anatomical Therapeutic Chemical (ATC) Classes for OBREDON
US Patents and Regulatory Information for OBREDON
OBREDON is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OBREDON is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting OBREDON
Immediate release oral guaifenesin solution
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Immediate release oral guaifenesin solution
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Immediate release oral guaifenesin solution
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sovereign Pharms | OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474-001 | Nov 14, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Sovereign Pharms | OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474-001 | Nov 14, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Sovereign Pharms | OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474-001 | Nov 14, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
