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SPRIX Drug Profile

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Sprix is a drug marketed by Egalet Us Inc and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in eight countries.

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

Summary for Tradename: SPRIX

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details

Clinical Trials for: SPRIX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Egalet Us Inc
SPRIX
ketorolac tromethamine
SPRAY, METERED;NASAL022382-001May 14, 2010RXYes6,333,044Dec 25, 2018Y
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Expired Patents for Tradename: SPRIX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Egalet Us Inc
SPRIX
ketorolac tromethamine
SPRAY, METERED;NASAL022382-001May 14, 20107,476,689<disabled>
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Paragraph IV activity for: SPRIX

Drugname Dosage Strength RLD Submissiondate
ketorolac tromethamineNasal Spray15.75 mg/spraySprix3/12/2012

Non-Orange Book Patents for Tradename: SPRIX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,267,827Therapeutic compositions for intranasal administration which include KETOROLAC<disabled in preview>
7,476,689Therapeutic compositions for intranasal administration which include KETOROLAC<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: SPRIX

Country Document Number Estimated Expiration
Japan3586735<disabled in preview>
Greece3019012<disabled in preview>
Italy1250691<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SPRIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
923Luxembourg<disabled>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
0784Netherlands<disabled>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
C0090France<disabled>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
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