ANI PHARMS Company Profile

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

There are four 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	TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073392-001	Jan 24, 1992		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
Ani Pharms	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	077725-001	Jul 31, 2006		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
Ani Pharms	THIORIDAZINE HYDROCHLORIDE	thioridazine hydrochloride	TABLET;ORAL	088194-001	Apr 14, 1983		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
Ani Pharms	METOLAZONE	metolazone	TABLET;ORAL	075543-002	Mar 1, 2004		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
Ani Pharms	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	073587-001	Jun 29, 1995		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-001	Approved Prior to Jan 1, 1982		DISCN	No	No	12,102,662	⤷ Subscribe				⤷ Subscribe
>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	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	1,712,251	⤷ Subscribe
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,196,444*PED	⤷ Subscribe
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,721,263	⤷ Subscribe
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	7,538,133*PED	⤷ Subscribe
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	4,472,382	⤷ Subscribe
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-001	Approved Prior to Jan 1, 1982	3,937,838	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	32 mg/25 mg	➤ Subscribe	2009-03-06
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	13C0055	France	⤷ Subscribe	PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1856135	CA 2020 00018	Denmark	⤷ Subscribe	PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
1874117	2014/032	Ireland	⤷ Subscribe	PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
0281459	9890035-0 98910359	Sweden	⤷ Subscribe	PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
1441735	SPC/GB08/020	United Kingdom	⤷ Subscribe	PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
0463756	300048	Netherlands	⤷ Subscribe	PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NATL. REGISTRATION: RVG 21079 RVG 21080 19970925; FIRST REGISTRATION: PL 12619/0116 19970307
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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