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	TETRACYCLINE HYDROCHLORIDE	tetracycline hydrochloride	CAPSULE;ORAL	061471-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Ani Pharms	RISPERIDONE	risperidone	SOLUTION;ORAL	076440-001	Jan 30, 2009		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Ani Pharms	CHLORPROPAMIDE	chlorpropamide	TABLET;ORAL	088918-001	Oct 16, 1984		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Ani Pharms	DIPYRIDAMOLE	dipyridamole	TABLET;ORAL	086944-001	Feb 25, 1992		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Ani Pharms	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074859-001	Jul 9, 1998		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Ani Pharms	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	212779-001	Jan 14, 2020	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
>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	PANDEL	hydrocortisone probutate	CREAM;TOPICAL	020453-001	Feb 28, 1997	4,794,106	⤷ Sign Up
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	5,712,251	⤷ Sign Up
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,534,534*PED	⤷ Sign Up
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	5,534,534*PED	⤷ Sign Up
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998	5,508,297	⤷ Sign Up
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998	5,703,110	⤷ Sign Up
>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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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	2018/031	Ireland	⤷ Sign Up	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0486666	C980001	Netherlands	⤷ Sign Up	PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 21079, RVG 21080 19970925; FIRST REGISTRATION: GB PL 12619/0116 19970307
0637297	01C0027	France	⤷ Sign Up	PRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329
1448186	140 5025-2012	Slovakia	⤷ Sign Up	PRODUCT NAME: PURIFIKOVANY SUCHY EXTRAKT ZO ZELENEHO CAJU (CAMELLIA SINENSIS (L.) O. KUNTZE) A IZOPROPYLMYRISTAT; NAT. REGISTRATION NO/DATE: 46/0306/12-S 20120716; FIRST REGISTRATION: DE 73486.00.00 20090831
1718641	SPC/GB12/028	United Kingdom	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
1874117	SPC/GB14/041	United Kingdom	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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