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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-eight 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-three supplementary protection certificates in twelve countries.

Summary for Par Sterile Products

International Patents:	7
US Patents:	9
Tradenames:	26
Ingredients:	26
NDAs:	28
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	BREVITAL SODIUM	methohexital sodium	INJECTABLE;INJECTION	011559-004	Dec 21, 2012		DISCN	No	No
Par Sterile Products	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	208405-001	Apr 26, 2017	AP	RX	No	No
Par Sterile Products	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	077871-001	Jul 9, 2009		DISCN	No	No
Par Sterile Products	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	203972-001	Aug 18, 2014	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	CAPSULE;ORAL	017443-002	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	017443-003	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	Patent Number	Estimated Expiration
South Korea	20180034307
Canada	2978464
Japan	2018507915
China	107614017

Supplementary Protection Certificates for Par Sterile Products 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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629

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