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.

There are ten patent family members on PH HEALTH drugs in seven countries and four hundred and thirty-two supplementary protection certificates in eighteen countries.

Summary for Ph Health

International Patents:	10
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	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071422-002	Nov 9, 1987		DISCN	No	No
Ph Health	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	202842-002	Nov 30, 2016	AB	RX	No	No
Ph Health	DICLOFENAC POTASSIUM	diclofenac potassium	FOR SOLUTION;ORAL	202964-001	May 2, 2016	AB	RX	No	No
Ph Health	DIAZEPAM	diazepam	TABLET;ORAL	070228-001	Sep 26, 1985		DISCN	No	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	CAPSULE;ORAL	017443-002	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	017443-003	Approved Prior to Jan 1, 1982	3,415,821

Paragraph IV (Patent) Challenges for PH HEALTH drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for Ph Health Drugs

Country	Patent Number	Estimated Expiration
Canada	3093725
Canada	2978464
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
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
0861666	07C0006	France		PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1532149	92128	Luxembourg		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2498758	132020000000034	Italy		PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113

Similar Applicant Names

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

• Ph Health