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Mallinckrodt
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Harvard Business School

Last Updated: January 28, 2022

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Zyla Company Profile


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Summary for Zyla
International Patents:85
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 ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 RX Yes Yes 9,173,854 ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Zyla VIVLODEX meloxicam CAPSULE;ORAL 207233-002 Oct 22, 2015 DISCN Yes No 9,808,468 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Zyla ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-003 Jan 9, 2017 DISCN Yes No 9,044,402 ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 RX Yes No 8,409,616 ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 RX Yes No 7,510,726 ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 RX Yes No 7,201,920 ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
>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 SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 6,333,044 ⤷  Sign up for a Free Trial
Zyla SPRIX ketorolac tromethamine SPRAY, METERED;NASAL 022382-001 May 14, 2010 7,476,689 ⤷  Sign up for a Free Trial
>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 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

International Patents for Zyla Drugs

Country Patent Number Estimated Expiration
Eurasian Patent Organization 201171285 ⤷  Sign up for a Free Trial
Brazil PI1014272 ⤷  Sign up for a Free Trial
Hong Kong 1202061 ⤷  Sign up for a Free Trial
Mexico 2016016212 ⤷  Sign up for a Free Trial
Australia 2013206525 ⤷  Sign up for a Free Trial
Morocco 33295 ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Zyla Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 300784 Netherlands ⤷  Sign up for a Free 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 92923 Luxembourg ⤷  Sign up for a Free 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
1534313 122015000111 Germany ⤷  Sign up for a Free Trial PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313 CA 2015 00072 Denmark ⤷  Sign up for a Free Trial 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 C 2015 055 Romania ⤷  Sign up for a Free Trial PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
1534313 CR 2015 00072 Denmark ⤷  Sign up for a Free Trial PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 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:

Mallinckrodt
Express Scripts
Boehringer Ingelheim
AstraZeneca
Medtronic
Johnson and Johnson

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 verification 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.