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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 thirty approved drugs.

There are seventeen 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-five supplementary protection certificates in thirteen countries.

Summary for Par Sterile Products

International Patents:	7
US Patents:	17
Tradenames:	28
Ingredients:	28
NDAs:	30
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	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Par Sterile Products	TREPROSTINIL	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	209382-004	Sep 24, 2019	AP	RX	No	No
Par Sterile Products	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	077871-001	Jul 9, 2009		DISCN	No	No
Par Sterile Products	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	208405-001	Apr 26, 2017	AP	RX	No	No
Par Sterile Products	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	076394-001	Apr 25, 2003		DISCN	No	No
Par Sterile Products	CORPHEDRA	ephedrine sulfate	SOLUTION;INTRAVENOUS	208943-001	Jan 27, 2017	AP	RX	No	No
Par Sterile Products	KETALAR	ketamine hydrochloride	INJECTABLE;INJECTION	016812-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

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

Supplementary Protection Certificates for Par Sterile Products Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
0281713	96C0031	Belgium		PRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103
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
0770388	9/2009	Austria		PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103

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