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 four approved drugs.
There are fifteen 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.
Summary for Zyla
| International Patents: | 68 |
| US Patents: | 15 |
| Tradenames: | 4 |
| Ingredients: | 4 |
| NDAs: | 4 |
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 | 9,044,402 | See Plans and Pricing | Y | See Plans and Pricing | |||
| Zyla | ARYMO ER | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 208603-001 | Jan 9, 2017 | DISCN | Yes | No | 9,044,402 | See Plans and Pricing | Y | See Plans and Pricing | |||
| Zyla | OXAYDO | oxycodone hydrochloride | TABLET;ORAL | 202080-002 | Jun 17, 2011 | RX | Yes | No | 7,981,439 | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 | See Plans and Pricing |
| Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | 7,476,689 | See Plans and Pricing |
| >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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2010121327 | See Plans and Pricing |
| China | 104684548 | See Plans and Pricing |
| African Regional IP Organization (ARIPO) | 3774 | See Plans and Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Zyla Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1534313 | 2015/071 | Ireland | See Plans and Pricing | 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 |
| 1685839 | 92292 | Luxembourg | See Plans and Pricing | 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 | CR 2015 00072 | Denmark | See Plans and Pricing | 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.
Here is a list of applicants with similar names.
