ACULAR PRESERVATIVE FREE Drug Patent Profile
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When do Acular Preservative Free patents expire, and what generic alternatives are available?
Acular Preservative Free is a drug marketed by Allergan and is included in one NDA.
The generic ingredient in ACULAR PRESERVATIVE FREE is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Acular Preservative Free
A generic version of ACULAR PRESERVATIVE FREE was approved as ketorolac tromethamine by MYLAN on May 16th, 1997.
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Summary for ACULAR PRESERVATIVE FREE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,893 |
| DailyMed Link: | ACULAR PRESERVATIVE FREE at DailyMed |
Recent Clinical Trials for ACULAR PRESERVATIVE FREE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundação Altino Ventura | Phase 2/Phase 3 |
US Patents and Regulatory Information for ACULAR PRESERVATIVE FREE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | ACULAR PRESERVATIVE FREE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 020811-001 | Nov 3, 1997 | DISCN | No | No | ⤷ 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 |
Expired US Patents for ACULAR PRESERVATIVE FREE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | ACULAR PRESERVATIVE FREE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 020811-001 | Nov 3, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACULAR PRESERVATIVE FREE
See the table below for patents covering ACULAR PRESERVATIVE FREE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | H047324 | ⤷ Sign Up | |
| Australia | 1265183 | ⤷ Sign Up | |
| Italy | 1162842 | COMPOSIZIONE FARMACEUTICA TOPICA PER USO OFTALMICO E SUA APPLICAZIONE | ⤷ Sign Up |
| New Zealand | 203639 | TOPICAL OPHTHALMIC COMPOSITIONS CONTAINING CERTAIN 5-AROYL-1,2-DIHYDRO-3H-PYRROLO(1,2-A)PYRROL-1-YLCARBOXYLIC ACID DERIVATIVES | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACULAR PRESERVATIVE FREE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1534313 | 2015/071 | Ireland | ⤷ Sign Up | 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 | CA 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 |
| 1534313 | 122015000111 | Germany | ⤷ Sign Up | PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| 1534313 | 300784 | Netherlands | ⤷ Sign Up | PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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