DrugPatentWatch Database Preview
OMIDRIA Drug Profile
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
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-four 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.
US ANDA Litigation and Generic Entry Outlook for Omidria
Omidria was eligible for patent challenges on December 31st, 1968.
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Summary for OMIDRIA
| International Patents: | 64 |
| 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 |
|---|---|
| Wake Forest University Health Sciences | Phase 4 |
| Omeros Corporation | 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
Synonyms for OMIDRIA
| Ketorolac / phenylephrine |
| Ketorolac mixture with phenylephrine |
| OMS 302 |
| OMS302 |
| Phenylephrine and ketorolac injection |
| S900006490 |
Paragraph IV (Patent) Challenges for OMIDRIA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OMIDRIA | SOLUTION;IRRIGATION | ketorolac tromethamine; phenylephrine hydrochloride | 205388 | 2015-05-29 |
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 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Omeros | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Omeros | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for OMIDRIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Argentina | 093115 | Start Trial |
| Morocco | 38096 | Start Trial |
| Mexico | 2015005089 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OMIDRIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1534313 | C20150054 00179 | Estonia | Start Trial | PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015 |
| 1534313 | CA 2015 00072 | Denmark | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
