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 | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-001 | Jun 17, 2011 | DISCN | Yes | No | 7,201,920 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Zyla | ZORVOLEX | diclofenac | CAPSULE;ORAL | 204592-002 | Oct 18, 2013 | DISCN | Yes | No | 9,180,096 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Zyla | ZORVOLEX | diclofenac | CAPSULE;ORAL | 204592-001 | Oct 18, 2013 | DISCN | Yes | No | 9,180,095 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Zyla Life Sciences | INDOCIN | indomethacin | CAPSULE;ORAL | 016059-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ 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 Life Sciences | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | 3,849,549 | ⤷ 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 | 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 | Nasal Spray | 15.75 mg/spray | ➤ Subscribe | 2012-03-12 |
International Patents for Zyla Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
China | 106420667 | ⤷ Try a Trial |
Japan | 6154846 | ⤷ Try a Trial |
South Korea | 20150059167 | ⤷ Try a Trial |
Australia | 2010200979 | ⤷ 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 |
---|---|---|---|---|
1534313 | 92923 | Luxembourg | ⤷ Try 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 |
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 |
1534313 | CA 2015 00072 | Denmark | ⤷ Try a 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.