Zyla Company Profile
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What is the competitive landscape for ZYLA, and when can generic versions of ZYLA drugs launch?
ZYLA has eight approved drugs.
There are eleven US patents protecting ZYLA drugs.
There are sixty-eight patent family members on ZYLA drugs in twenty-four countries and ten supplementary protection certificates in eight countries.
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 Life Sciences | INDOCIN | indomethacin | CAPSULE;ORAL | 016059-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Zyla | INDOCIN SR | indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 018185-001 | Feb 23, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Zyla | ZORVOLEX | diclofenac | CAPSULE;ORAL | 204592-002 | Oct 18, 2013 | DISCN | Yes | No | 8,679,544 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Zyla | ARYMO ER | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 208603-002 | Jan 9, 2017 | DISCN | Yes | No | 9,044,402 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Zyla | ZORVOLEX | diclofenac | CAPSULE;ORAL | 204592-002 | Oct 18, 2013 | DISCN | Yes | No | 9,173,854 | ⤷ Try a Trial | Y | ⤷ Try a 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 | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | 8,637,540 | ⤷ Try a Trial |
Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | 7,476,689 | ⤷ Try a Trial |
Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-002 | Jun 17, 2011 | 8,637,540 | ⤷ Try a Trial |
Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | 7,510,726 | ⤷ Try a Trial |
Zyla | INDOCIN SR | indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 018185-001 | Feb 23, 1982 | 4,173,626 | ⤷ Try a 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 | 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 |
International Patents for Zyla Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 6222924 | ⤷ Try a Trial |
China | 104684548 | ⤷ Try a Trial |
South Africa | 201108650 | ⤷ Try a Trial |
Canada | 2759123 | ⤷ Try a Trial |
South Korea | 101580656 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Zyla Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1685839 | 92292 | Luxembourg | ⤷ Try 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 | 122015000111 | Germany | ⤷ Try a Trial | PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
1534313 | 300784 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
1534313 | 2015/071 | Ireland | ⤷ Try 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 | C 2015 055 | Romania | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.