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 | 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 |
International Patents for Zyla Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 2877161 | ⤷ Sign Up |
European Patent Office | 2402004 | ⤷ Sign Up |
European Patent Office | 2420225 | ⤷ Sign Up |
China | 106727424 | ⤷ Sign Up |
Eurasian Patent Organization | 201171285 | ⤷ Sign Up |
Japan | 6222924 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
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
Here is a list of applicants with similar names.