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Par Pharm Company Profile

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What is the competitive landscape for PAR PHARM, and when can generic versions of PAR PHARM drugs launch?

PAR PHARM has two hundred and sixteen approved drugs.

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

There are nine patent family members on PAR PHARM drugs in eight countries and one hundred and twenty-three supplementary protection certificates in twelve countries.

Summary for Par Pharm

International Patents:	9
US Patents:	1
Tradenames:	130
Ingredients:	127
NDAs:	216
Patent Litigation for Par Pharm:	See patent lawsuits for Par Pharm
PTAB Cases with Par Pharm as petitioner:	See PTAB cases with Par Pharm as petitioner

Drugs and US Patents for Par Pharm

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	077742-005	Nov 2, 2012	AB	RX	No	No
Par Pharm Inc	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078783-003	Sep 20, 2011	AB1	RX	No	No
Par Pharm	OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	078109-001	Oct 24, 2011	AB	RX	No	No
Par Pharm	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	088700-001	Sep 25, 1984		DISCN	No	No
Par Pharm	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	088702-001	Sep 25, 1984		DISCN	No	No
Par Pharm	CAPTOPRIL	captopril	TABLET;ORAL	074493-003	Feb 13, 1996		DISCN	No	No

Expired US Patents for Par Pharm

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	5,583,152
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-001	Approved Prior to Jan 1, 1982	4,105,776
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-005	Jan 17, 1985	5,238,924
Par Pharm Inc	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	5,583,152
Par Pharm	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996	4,724,231
Par Pharm	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995	4,258,027

Paragraph IV (Patent) Challenges for PAR PHARM drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	10 mg and 20 mg		2008-02-29
	Nasal Spray	500 mcg/spray		2017-04-28

International Patents for Par Pharm Drugs

Country	Patent Number	Estimated Expiration
South Korea	20080000660
Canada	2605413
Mexico	2007013118
European Patent Office	1948613
Australia	2006240490
China	101163679

Supplementary Protection Certificates for Par Pharm Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0806968	SPC/GB07/011	United Kingdom		PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
1948158	1690020-1	Sweden		PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006

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