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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-seven approved drugs.

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

Summary for Par Sterile Products

US Patents:	8
Tradenames:	25
Ingredients:	25
NDAs:	27
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	009402-003	Approved Prior to Jan 1, 1982	AO	RX	Yes	Yes
Par Sterile Products	COLY-MYCIN M	colistimethate sodium	INJECTABLE;INJECTION	050108-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Par Sterile Products	BREVITAL SODIUM	methohexital sodium	INJECTABLE;INJECTION	011559-004	Dec 21, 2012		DISCN	No	No
Par Sterile Products	VASOSTRICT	vasopressin	SOLUTION;IV (INFUSION)	204485-002	Dec 17, 2016		RX	Yes	Yes	9,744,239
Par Sterile Products	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	204200-001	Dec 7, 2012	AP	RX	Yes	Yes	9,295,657
Par Sterile Products	VASOSTRICT	vasopressin	SOLUTION;IV (INFUSION)	204485-001	Apr 17, 2014		RX	Yes	Yes	9,750,785		Y
Par Sterile Products	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	INJECTABLE;INJECTION	206586-001	Jul 28, 2015	AP	RX	No	No

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	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
Par Sterile Products	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982	3,415,821

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

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016149028
Canada	2978464
European Patent Office	3268045
China	107614017
Australia	2016233682

Supplementary Protection Certificates for Par Sterile Products Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
C/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
156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
00221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
C/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.

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