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Par Sterile Products Company Profile

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What is the competitive landscape for PAR STERILE PRODUCTS, and what generic alternatives to PAR STERILE PRODUCTS drugs are available?

PAR STERILE PRODUCTS has twenty-nine approved drugs.

There are nine US patents protecting PAR STERILE PRODUCTS drugs. There is one tentative approval on PAR STERILE PRODUCTS drugs.

There are seven patent family members on PAR STERILE PRODUCTS drugs in seven countries and forty-four supplementary protection certificates in thirteen countries.

Summary for Par Sterile Products

International Patents:	7
US Patents:	9
Tradenames:	27
Ingredients:	27
NDAs:	29
Patent Litigation for Par Sterile Products:	See patent lawsuits for Par Sterile Products

Drugs and US Patents for Par Sterile Products

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Sterile Products	DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Par Sterile Products	TREPROSTINIL	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	209382-002	Sep 24, 2019	AP	RX	No	No
Par Sterile Products	ETOMIDATE	etomidate	INJECTABLE;INJECTION	091297-001	Jun 20, 2012		DISCN	No	No
Par Sterile Products	PITOCIN	oxytocin	INJECTABLE;INJECTION	018261-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Par Sterile Products	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	INJECTABLE;INJECTION	206586-001	Jul 28, 2015	AP	RX	No	No
Par Sterile Products	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-001	Apr 17, 2014		RX	Yes	Yes	9,744,209
Par Sterile Products	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204640-001	Dec 18, 2013		RX	Yes	Yes	9,295,657

Expired US Patents for Par Sterile Products

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

Paragraph IV (Patent) Challenges for PAR STERILE PRODUCTS 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 Par Sterile Products Drugs

Country	Patent Number	Estimated Expiration
Australia	2016233682
World Intellectual Property Organization (WIPO)	2016149028
Japan	2018507915
European Patent Office	3268045
Canada	2978464
China	107614017
South Korea	20180034307

Supplementary Protection Certificates for Par Sterile Products Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0694547	03C0003	France		PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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

Similar Applicant Names

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

• Par Form
• Par Pharm
• Par Pharm Inc
• Par Sterile Products