Par Sterile Products Company Profile

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-four approved drugs.

There are seventeen US patents protecting PAR STERILE PRODUCTS drugs.

There are seven patent family members on PAR STERILE PRODUCTS drugs in seven countries and fifty-five supplementary protection certificates in fourteen countries.

Summary for Par Sterile Products

International Patents:	7
US Patents:	17
Tradenames:	31
Ingredients:	31
NDAs:	34
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	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-004	Apr 15, 2020		RX	Yes	Yes	9,968,649
Par Sterile Products	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	214297-002	Jan 21, 2022	AB	RX	No	No
Par Sterile Products	KETALAR	ketamine hydrochloride	INJECTABLE;INJECTION	016812-003	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Par Sterile Products	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	208405-002	Apr 26, 2017	AP	RX	No	No
Par Sterile Products	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-003	Apr 15, 2020		RX	Yes	Yes	10,010,575

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	017443-002	Approved Prior to Jan 1, 1982	3,415,821
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	017443-003	Approved Prior to Jan 1, 1982	3,415,821

Paragraph IV (Patent) Challenges for PAR STERILE PRODUCTS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Injection	1 mg/mL, 50 mL vials		2011-12-16

International Patents for Par Sterile Products Drugs

Country	Patent Number	Estimated Expiration
China	107614017
Australia	2016233682
European Patent Office	3268045
South Korea	20180034307
Japan	2018507915

Supplementary Protection Certificates for Par Sterile Products Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0694547	C300071	Netherlands		PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
0770388	2009/012	Ireland		PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
2782584	122021000080	Germany		PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211

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