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Serving leading biopharmaceutical companies globally:

McKesson
US Army
Teva
Cerilliant
Deloitte
Fish and Richardson
Boehringer Ingelheim
Cantor Fitzgerald
Accenture
Mallinckrodt

Generated: January 23, 2018

DrugPatentWatch Database Preview

ACULAR LS Drug Profile

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Which patents cover Acular Ls, and when can generic versions of Acular Ls launch?

Acular Ls is a drug marketed by Allergan and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in three countries.

The generic ingredient in ACULAR LS is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

US Patents and Regulatory Information for ACULAR LS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for ACULAR LS
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Ophthalmic Solution 0.40% ➤ Subscribe 1/28/2005

Supplementary Protection Certificates for ACULAR LS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0784 Netherlands ➤ Subscribe 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
923 Luxembourg ➤ Subscribe 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
/2015 Austria ➤ Subscribe 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
2015000111 Germany ➤ Subscribe 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
2015 00072 Denmark ➤ Subscribe 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
C0090 France ➤ Subscribe 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

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Federal Trade Commission
Daiichi Sankyo
Deloitte
US Department of Justice
McKesson
Moodys
Boehringer Ingelheim
Fuji

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 verifification 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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