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Last Updated: October 16, 2019

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Zyla Company Profile

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Summary for Zyla
International Patents:83
US Patents:18
Tradenames:5
Ingredients:5
NDAs:5

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 ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-003 Jan 9, 2017 DISCN Yes No 9,549,899   Request a Trial Y   Request a Trial
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 RX No No 8,637,540   Request a Trial Y   Request a Trial
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 RX Yes No 9,180,096   Request a Trial Y   Request a Trial
Zyla ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-002 Jan 9, 2017 DISCN Yes No 9,044,402   Request a Trial Y   Request a Trial
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 RX No No 7,981,439   Request a Trial Y   Request a Trial
Zyla VIVLODEX meloxicam CAPSULE;ORAL 207233-001 Oct 22, 2015 RX Yes No 9,649,318   Request a Trial Y   Request a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for ZYLA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe Capsules 5 mg and 10 mg ➤ Subscribe 2017-01-09
➤ Subscribe Nasal Spray 15.75 mg/spray ➤ Subscribe 2012-03-12

Supplementary Protection Certificates for Zyla Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 15C0090 France   Request a Trial 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
1685839 92292 Luxembourg   Request a Trial PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
1534313 300784 Netherlands   Request a Trial 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
1534313 2015/071 Ireland   Request a Trial 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 CR 2015 00072 Denmark   Request a Trial PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313 92923 Luxembourg   Request a Trial 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
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Boehringer Ingelheim
Johnson and Johnson
Express Scripts
Dow

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