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OBREDON Drug Profile
When do Obredon patents expire, and when can generic versions of Obredon launch?
The generic ingredient in OBREDON is guaifenesin; hydrocodone bitartrate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.
Summary for OBREDON
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | OBREDON at DailyMed |
Pharmacology for OBREDON
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
US Patents and Regulatory Information for OBREDON
| 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 Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Non-Orange Book US Patents for OBREDON
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,808,431 | Immediate release oral guaifenesin solution | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
