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Last Updated: November 2, 2024

Zyla Company Profile


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Summary for Zyla
International Patents:68
US Patents:11
Tradenames:6
Ingredients:5
NDAs:8

Drugs and US Patents for Zyla

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 DISCN Yes No 9,173,854 ⤷  Sign Up Y ⤷  Sign Up
Zyla SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 RX Yes Yes ⤷  Sign Up ⤷  Sign Up
Zyla ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-003 Jan 9, 2017 DISCN Yes No 9,044,402 ⤷  Sign Up Y ⤷  Sign Up
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 DISCN Yes No 9,180,095 ⤷  Sign Up ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 DISCN Yes No 7,201,920 ⤷  Sign Up Y ⤷  Sign Up
Zyla Life Sciences INDOCIN indomethacin CAPSULE;ORAL 016059-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  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 Zyla

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 7,510,726 ⤷  Sign Up
Zyla INDOCIN SR indomethacin CAPSULE, EXTENDED RELEASE;ORAL 018185-001 Feb 23, 1982 4,173,626 ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 9,492,443 ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 7,981,439 ⤷  Sign Up
Zyla Life Sciences INDOCIN indomethacin SUPPOSITORY;RECTAL 017814-001 Aug 13, 1984 3,849,549 ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 9,492,443 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ZYLA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Nasal Spray 15.75 mg/spray ➤ Subscribe 2012-03-12
➤ Subscribe Capsules 18 mg and 35 mg ➤ Subscribe 2014-06-06
➤ Subscribe Extended-release Tablets 15 mg, 30 mg and 60 mg ➤ Subscribe 2017-12-29

Supplementary Protection Certificates for Zyla Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 CR 2015 00072 Denmark ⤷  Sign Up PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
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 76/2015 Austria ⤷  Sign Up 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 92923 Luxembourg ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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