Zyla Company Profile

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ZYLA has eight approved drugs.

There are nine US patents protecting ZYLA drugs.

There are fifty-five patent family members on ZYLA drugs in twenty-three countries and ten supplementary protection certificates in eight countries.

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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	204592-001	Oct 18, 2013		DISCN	Yes	No	9,186,328	⤷ Start Trial				⤷ Start Trial
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No	8,679,544	⤷ Start Trial	Y			⤷ Start Trial
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No	9,017,721	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	7,981,439	⤷ Start Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	9,492,443	⤷ Start Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	8,637,540	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	CA 2015 00072	Denmark	⤷ Start 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	2015/071	Ireland	⤷ Start 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	300784	Netherlands	⤷ Start 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

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