OMIDRIA Drug Patent Profile
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Which patents cover Omidria, and when can generic versions of Omidria launch?
Omidria is a drug marketed by Rayner Surgical and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-five patent family members in thirty-nine countries.
The generic ingredient in OMIDRIA is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Omidria
A generic version of OMIDRIA was approved as ketorolac tromethamine; phenylephrine hydrochloride by LUPIN LTD on July 1st, 2019.
Summary for OMIDRIA
| International Patents: | 85 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 5 |
| Patent Applications: | 19 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OMIDRIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OMIDRIA |
| What excipients (inactive ingredients) are in OMIDRIA? | OMIDRIA excipients list |
| DailyMed Link: | OMIDRIA at DailyMed |
Recent Clinical Trials for OMIDRIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Luigi Rondas | Phase 3 |
| European Society of Cataract and Refractive Surgeons | Phase 3 |
| University of Florida | Phase 4 |
Pharmacology for OMIDRIA
Anatomical Therapeutic Chemical (ATC) Classes for OMIDRIA
Paragraph IV (Patent) Challenges for OMIDRIA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OMIDRIA | Injection | ketorolac tromethamine; phenylephrine hydrochloride | 1%/0.3% | 205388 | 1 | 2015-05-29 |
US Patents and Regulatory Information for OMIDRIA
OMIDRIA is protected by seven US patents.
Patents protecting OMIDRIA
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ophthalmologic irrigation solutions and method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
Expired US Patents for OMIDRIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OMIDRIA
See the table below for patents covering OMIDRIA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2493581 | SOLUTIONS ET PROCEDE D'IRRIGATION OPHTALMOLOGIQUE (OPHTHALMOLOGIC IRRIGATION SOLUTIONS AND METHOD) | ⤷ Try a Trial |
| Peru | 20150958 | SOLUCIONES MIDRIATICAS Y ANTIINFLAMATORIAS INYECTABLES, ESTABLES Y LIBRES DE CONSERVANTES | ⤷ Try a Trial |
| Hong Kong | 1213434 | 穩定的不含防腐劑的瞳孔散大劑和用於注射的抗炎溶液 (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION) | ⤷ Try a Trial |
| South Africa | 201502684 | STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION | ⤷ Try a Trial |
| New Zealand | 628398 | Stable preservative-free mydriatic and anti-inflammatory solutions for injection | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OMIDRIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1534313 | 264 5031-2015 | Slovakia | ⤷ Try a 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 | CA 2015 00072 | Denmark | ⤷ Try a 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 |
| 1534313 | 76/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730 |
| 1534313 | 1590074-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: EN KOMBINATION INNEFATTANDE FENYLEFRIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV OCH KETOROLAK ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/15/1018 20150730 |
| 1534313 | 2015/071 | Ireland | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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