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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-one 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:	37
Ingredients:	37
NDAs:	41

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	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	206159-004	May 31, 2019	AB	RX	No	No
Par Pharm Inc	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	CAPSULE;ORAL	207199-003	Mar 14, 2017	AB	RX	No	No
Par Pharm Inc	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	200812-003	Nov 10, 2011	AB	RX	No	No
Par Pharm Inc	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	205724-001	Dec 13, 2016	AB	RX	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	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	AB	RX	Yes	Yes

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	5,583,152
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	4,859,692
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	5,319,097
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	5,612,367
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	5,612,367
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	5,294,636

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
Mexico	2007013118
Australia	2006240490
South Korea	20080000660
Japan	2008538560
World Intellectual Property Organization (WIPO)	2006115626
China	101163679

Supplementary Protection Certificates for Par Pharm Inc Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
0481754	SPC/GB06/032	United Kingdom		PRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626
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
2236132	CA 2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1129088	2014/008	Ireland		PRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919

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