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Par Pharm Inc Company Profile

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

PAR PHARM INC has forty-three approved drugs.

There is one US patent protecting PAR PHARM INC drugs. There are nine tentative approvals on PAR PHARM INC drugs.

There are nine patent family members on PAR PHARM INC drugs in eight countries and forty-nine supplementary protection certificates in twelve countries.

Summary for Par Pharm Inc

International Patents:	9
US Patents:	1
Tradenames:	39
Ingredients:	39
NDAs:	43

Drugs and US Patents for Par Pharm Inc

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm Inc	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	207170-002	Jan 26, 2017		DISCN	No	No
Par Pharm Inc	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	090011-001	Mar 28, 2013		DISCN	No	No
Par Pharm Inc	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	200812-003	Nov 10, 2011		DISCN	No	No
Par Pharm Inc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	206159-001	May 31, 2019	AB	RX	No	No
Par Pharm Inc	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078783-002	Nov 13, 2009		DISCN	No	No
Par Pharm Inc	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	210027-001	Aug 20, 2019	AB	RX	No	No

Expired US Patents for Par Pharm Inc

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	5,294,636
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	6,143,775
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	4,859,692
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	5,583,152
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	5,482,963
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	5,612,367

Paragraph IV (Patent) Challenges for PAR PHARM INC drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	10 mg and 20 mg		2008-02-29

International Patents for Par Pharm Inc Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	1948613
Japan	2008538560
Mexico	2007013118
Japan	5378788
Canada	2605413
World Intellectual Property Organization (WIPO)	2006115626

Supplementary Protection Certificates for Par Pharm Inc Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	C300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0785926	08C0041	France		PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
0526708	0290017-3	Sweden		PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228

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