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OMIDRIA Drug Profile
Which patents cover Omidria, and what generic alternatives are available?
Omidria is a drug marketed by Omeros and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-three patent family members in thirty-three 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: | 63 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OMIDRIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OMIDRIA |
| DailyMed Link: | OMIDRIA at DailyMed |
Recent Clinical Trials for OMIDRIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Omeros Corporation | Phase 4 |
| Wake Forest University Health Sciences | Phase 4 |
| Milton S. Hershey Medical Center | Phase 4 |
Recent Litigation for OMIDRIA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Omeros Corporation v. Lupin Ltd. | 2017-06-22 |
| OMEROS CORPORATION v. LUPIN LTD | 2017-06-22 |
| Omeros Corporation v. Sandoz Inc. | 2017-06-21 |
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 |
Synonyms for OMIDRIA
| Ketorolac / phenylephrine |
| Ketorolac mixture with phenylephrine |
| OMS 302 |
| OMS302 |
| Phenylephrine and ketorolac injection |
| S900006490 |
US Patents and Regulatory Information for OMIDRIA
Paragraph IV (Patent) Challenges for OMIDRIA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 1%/0.3% | ➤ Subscribe | Start Trial |
International Patents for OMIDRIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1534313 | Start Trial |
| Japan | 2018009033 | Start Trial |
| Japan | 2015535250 | Start Trial |
| Ukraine | 114650 | Start Trial |
| China | 101327325 | Start Trial |
| Costa Rica | 20150233 | Start Trial |
| Australia | 2013201465 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OMIDRIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1534313 | CR 2015 00072 | Denmark | Start Trial | PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 |
| 1534313 | 300784 | Netherlands | Start Trial | 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 |
| 1534313 | 2015/071 | Ireland | Start Trial | PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| 1534313 | 92923 | Luxembourg | Start Trial | PRODUCT NAME: UNE 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; FIRST REGISTRATION: 20150730 |
| 1534313 | 264 5031-2015 | Slovakia | Start Trial | PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
| 1534313 | 122015000111 | Germany | Start Trial | PRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| 1534313 | 15C0090 | France | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
