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Ani Pharms Inc Company Profile

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

ANI PHARMS INC has two hundred and twenty-seven approved drugs.

There is one US patent protecting ANI PHARMS INC drugs.

There are fourteen patent family members on ANI PHARMS INC drugs in eleven countries and eighty-two supplementary protection certificates in twelve countries.

Summary for Ani Pharms Inc

International Patents:	14
US Patents:	1
Tradenames:	129
Ingredients:	125
NDAs:	227

Drugs and US Patents for Ani Pharms Inc

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms Inc	INDAPAMIDE	indapamide	TABLET;ORAL	074299-001	Jul 27, 1995	AB	RX	No	No
Ani Pharms Inc	ROSIGLITAZONE MALEATE	rosiglitazone maleate	TABLET;ORAL	076747-003	Jan 25, 2013		DISCN	No	No
Ani Pharms Inc	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	075432-004	Oct 18, 2000		DISCN	No	No
Ani Pharms Inc	THIORIDAZINE HYDROCHLORIDE	thioridazine hydrochloride	TABLET;ORAL	088270-001	Apr 14, 1983		DISCN	No	No
Ani Pharms Inc	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	085031-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Ani Pharms Inc	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	076284-001	Jul 3, 2002		DISCN	No	No
Ani Pharms Inc	PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; propranolol hydrochloride	TABLET;ORAL	070704-001	Oct 1, 1986		DISCN	No	No

Expired US Patents for Ani Pharms Inc

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms Inc	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	5,534,534*PED
Ani Pharms Inc	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	7,538,133*PED
Ani Pharms Inc	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998	5,703,110
Ani Pharms Inc	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982	3,937,838
Ani Pharms Inc	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	5,712,251
Ani Pharms Inc	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995	4,935,437
Ani Pharms Inc	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	4,636,505*PED

Paragraph IV (Patent) Challenges for ANI PHARMS INC drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	4 mg, 8 mg, 16 mg and 32 mg		2006-12-22
	Tablets	32 mg/25 mg		2009-03-06
	Tablets	16 mg/12.5 mg and 32 mg/12.5 mg		2008-06-25

International Patents for Ani Pharms Inc Drugs

Country	Patent Number	Estimated Expiration
Norway	20041740
Norway	335070
Japan	4369752
South Korea	101090719
Germany	60233668
World Intellectual Property Organization (WIPO)	03028708
South Korea	20040084890

Supplementary Protection Certificates for Ani Pharms Inc Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	13C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
0473687	C980045	Netherlands		PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
0306228	C300034	Netherlands		PRODUCT NAME: ROSIGLITAZONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT, IN HET BIJZONDER ROSIGLITAZONE MALEAAT; REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711
1539166	SPC/GB13/070	United Kingdom		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. Q; REGISTERED: UK EU/1/13/833 20130626
0281459	C990002	Netherlands		PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715
0281459	98C0036	France		PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
0473687	3/1999	Austria		PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Ani Pharms
• Ani Pharms Inc