Ph Health Company Profile

What is the competitive landscape for PH HEALTH

PH HEALTH has two hundred and three approved drugs.

There are twenty-five US patents protecting PH HEALTH drugs. There is one tentative approval on PH HEALTH drugs.

Summary for Ph Health

US Patents:	25
Tradenames:	157
Ingredients:	144
NDAs:	203

Drugs and US Patents for Ph Health

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-003	Apr 21, 2023		RX	Yes	Yes	10,653,646		Y
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-005	Apr 21, 2021	AP	RX	Yes	Yes	9,974,827
Ph Health	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	090734-002	Jul 11, 2013		DISCN	No	No
Ph Health	GILDAGIA	ethinyl estradiol; norethindrone	TABLET;ORAL-28	078376-001	Nov 6, 2012		DISCN	No	No
Ph Health	LAMOTRIGINE	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	201791-004	Jan 18, 2013		DISCN	No	No
Ph Health	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	SOLUTION;ORAL	203573-001	Dec 18, 2014		DISCN	No	No
Ph Health	COLY-MYCIN M	colistimethate sodium	INJECTABLE;INJECTION	050108-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for Ph Health

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982	3,415,821
Ph Health	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	3,415,821
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982	3,415,821
Ph Health	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982	3,415,821

Paragraph IV (Patent) Challenges for PH HEALTH drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Injection	1 mg/mL ampules		2016-03-09
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	for Injection	200 mcg/vial		2015-05-01
	Injection	20 units/mL, 1 mL		2018-03-23

International Patents for Ph Health Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021150253
South Korea	20180034307
Canada	3093725
Canada	2978464
European Patent Office	3268045
World Intellectual Property Organization (WIPO)	2016149028
China	107614017

Supplementary Protection Certificates for Ph Health Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273658	2005C/001	Belgium		PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
2203431	1590018-6	Sweden		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
3347352	LUC00292	Luxembourg		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/22/1671 20220819
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
2330892	2016/064	Ireland		PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REGISTRATION NO/DATE: EU/1/15/1062 20151201
1506211	122014000071	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323

Similar Applicant Names

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

• Ph Health