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Zyla Company Profile
What is the competitive landscape for ZYLA, and when can generic versions of ZYLA drugs launch?
ZYLA has five approved drugs.
There are eighteen US patents protecting ZYLA drugs.
There are eighty-three patent family members on ZYLA drugs in twenty-five countries and ten supplementary protection certificates in eight countries.
Summary for Zyla
| International Patents: | 83 |
| 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 | Start Trial | Y | Start Trial | |||
| Zyla | VIVLODEX | meloxicam | CAPSULE;ORAL | 207233-002 | Oct 22, 2015 | RX | Yes | Yes | 9,808,468 | Start Trial | Start Trial | ||||
| Zyla | ARYMO ER | morphine sulfate | TABLET, EXTENDED RELEASE;ORAL | 208603-003 | Jan 9, 2017 | DISCN | Yes | No | 9,044,402 | Start Trial | Y | Start 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 | Start Trial |
| Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | 7,476,689 | Start 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 |
|---|---|---|
| European Patent Office | 2421525 | Start Trial |
| Canada | 2759123 | Start Trial |
| Hong Kong | 1231383 | Start 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 | Start 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 | Start 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 | Start Trial | PRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
