DrugPatentWatch Database Preview
OMIDRIA Drug Profile
Which patents cover Omidria, and what generic alternatives are available?
This drug has fifty-seven patent family members in thirty-one countries.
The generic ingredient in OMIDRIA is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for OMIDRIA
| International Patents: | 57 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | OMIDRIA at DailyMed |
Pharmacology for OMIDRIA
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | alpha-1 Adrenergic Agonist Nonsteroidal Anti-inflammatory Drug Cyclooxygenase Inhibitor |
| Mechanism of Action | Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for OMIDRIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Omeros | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Omeros | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Omeros | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Omeros | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for OMIDRIA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 1%/0.3% | ➤ Subscribe | 2015-05-29 |
Non-Orange Book US Patents for OMIDRIA
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 |
|---|---|---|
| 9,585,895 | Ophthalmologic irrigation solutions and method | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for OMIDRIA
Supplementary Protection Certificates for OMIDRIA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 4 5031-2015 | Slovakia | ➤ Sign Up | PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
| 2015 00072 | Denmark | ➤ Sign Up | PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 |
| 0784 | Netherlands | ➤ Sign Up | PRODUCT NAME: EEN OCULAIRE OPLOSSING WELKE FENYLEFRINE BEVAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ALSMEDE KETOROLAC, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
| C0090 | France | ➤ Sign Up | PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
