Zyla Company Profile

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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.

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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	204592-002	Oct 18, 2013		DISCN	Yes	No	8,679,544	⤷ Try a Trial	Y			⤷ Try a Trial
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-003	Jan 9, 2017		DISCN	Yes	No	9,549,899	⤷ Try a Trial	Y			⤷ Try a Trial
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No	9,173,854	⤷ Try a Trial	Y			⤷ 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

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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	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	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	8,637,540	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	76/2015	Austria	⤷ Try a Trial	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	CR 2015 00072	Denmark	⤷ Try a Trial	PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Here is a list of applicants with similar names.