Zyla Company Profile

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.

Summary for Zyla

International Patents:	68
US Patents:	11
Tradenames:	6
Ingredients:	5
NDAs:	8

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	9,180,096		Y
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-003	Jan 9, 2017		DISCN	Yes	No	9,044,402		Y
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No	8,679,544		Y
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No	9,017,721		Y
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010		RX	Yes	Yes

Expired US Patents for Zyla

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	8,409,616
Zyla	INDOCIN SR	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	018185-001	Feb 23, 1982	4,173,626
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	3,849,549
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	7,510,726
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	7,981,439

Paragraph IV (Patent) Challenges for ZYLA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Nasal Spray	15.75 mg/spray		2012-03-12
	Capsules	18 mg and 35 mg		2014-06-06
	Extended-release Tablets	15 mg, 30 mg and 60 mg		2017-12-29

International Patents for Zyla Drugs

Country	Patent Number	Estimated Expiration
Australia	2013285988
Eurasian Patent Organization	201590165
World Intellectual Property Organization (WIPO)	2010121327
China	106727424
Mexico	2011011222

Supplementary Protection Certificates for Zyla Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		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	76/2015	Austria		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	2015/071	Ireland		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		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	C 2015 055	Romania		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

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Zyla
• Zyla Life Sciences