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Serving leading biopharmaceutical companies globally:

Express Scripts
Chubb
Cantor Fitzgerald
Covington
Cerilliant
Teva
Merck
Citi
US Department of Justice
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Ketorolac tromethamine - Generic Drug Details

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What are the generic drug sources for ketorolac tromethamine and what is the scope of ketorolac tromethamine freedom to operate?

Ketorolac tromethamine
is the generic ingredient in eight branded drugs marketed by Amphastar Pharm, Apotex Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Cycle Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, Sun Pharma Global, West-ward Pharms Int, Wockhardt, Roche Palo, Allergan, Akorn, Alcon Pharms Ltd, Egalet Us Inc, Mylan, Pliva, Teva, Watson Labs, and Omeros, and is included in forty-seven NDAs. There are nineteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ketorolac tromethamine has sixty-nine patent family members in twenty-three countries and six supplementary protection certificates in six countries.

There are eighteen drug master file entries for ketorolac tromethamine. Fifty-four suppliers are listed for this compound.
Summary for ketorolac tromethamine
Medical Subject Heading (MeSH) Categories for ketorolac tromethamine

US Patents and Regulatory Information for ketorolac tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427-001 Jul 22, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Alcon Pharms Ltd KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 078721-001 Nov 5, 2009 AT RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Baxter Hlthcare Corp KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075631-002 Jun 29, 2001 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gland Pharma Ltd KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 076722-001 Jul 27, 2004 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 074761-001 May 16, 1997 AB RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva KETOROLAC TROMETHAMINE ketorolac tromethamine TABLET;ORAL 074754-001 May 16, 1997 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Omeros OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bedford KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075230-002 Oct 25, 1999 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 AT RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ 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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Expired US Patents for ketorolac tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ➤ Subscribe ➤ Subscribe
Roche Palo TORADOL ketorolac tromethamine TABLET;ORAL 019645-001 Dec 20, 1991 ➤ Subscribe ➤ Subscribe
Allergan ACULAR PRESERVATIVE FREE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 020811-001 Nov 3, 1997 ➤ Subscribe ➤ Subscribe
Egalet Us Inc SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 ➤ Subscribe ➤ Subscribe
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ➤ Subscribe ➤ Subscribe
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 ➤ Subscribe ➤ Subscribe
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ketorolac tromethamine

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
7,267,827 Therapeutic compositions for intranasal administration which include KETOROLAC ➤ Subscribe
7,476,689 Therapeutic compositions for intranasal administration which include KETOROLAC ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ketorolac tromethamine

Supplementary Protection Certificates for ketorolac tromethamine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Medtronic
Cantor Fitzgerald
AstraZeneca
Dow
Queensland Health
Baxter
Daiichi Sankyo
McKesson

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