ANI PHARMS Company Profile

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ANI PHARMS has two hundred and forty-two approved drugs.

There are two US patents protecting ANI PHARMS drugs. There is one tentative approval on ANI PHARMS drugs.

There are twenty-nine patent family members on ANI PHARMS drugs in twenty countries and one hundred and seventy supplementary protection certificates in sixteen countries.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	086032-001	Jan 7, 1988		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	075897-001	Jan 25, 2001		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	077979-003	Feb 28, 2007		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	ACETOHEXAMIDE	acetohexamide	TABLET;ORAL	070870-002	Feb 9, 1987		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	075110-001	Jun 18, 1998		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	6,500,454	⤷ Try a Trial
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	5,196,444*PED	⤷ Try a Trial
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-004	Jun 4, 1998	5,703,110	⤷ Try a Trial
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	5,712,251	⤷ Try a Trial
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,705,517*PED	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Country	Patent Number	Estimated Expiration
Mexico	PA04004532	⤷ Try a Trial
China	1589141	⤷ Try a Trial
Australia	2002356673	⤷ Try a Trial
Spain	2569395	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	03043628	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	CR 2019 00001	Denmark	⤷ Try a Trial	PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
1758590	LUC00029	Luxembourg	⤷ Try a Trial	PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
0186405	SPC/GB00/021	United Kingdom	⤷ Try a Trial	PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
0281459	9890035-0 98910359	Sweden	⤷ Try a Trial	PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
1713823	1490064-1	Sweden	⤷ Try a Trial	PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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