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	THIORIDAZINE HYDROCHLORIDE	thioridazine hydrochloride	TABLET;ORAL	088272-001	Apr 14, 1983		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Ani Pharms	BENAZEPRIL HYDROCHLORIDE	benazepril hydrochloride	TABLET;ORAL	076333-002	Feb 11, 2004	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Ani Pharms	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	203659-004	Apr 16, 2015	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	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,534,534*PED	⤷ Sign Up
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	5,534,534*PED	⤷ Sign Up
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-004	Jun 4, 1998	5,508,297	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Tablets	16 mg/12.5 mg and 32 mg/12.5 mg	➤ Subscribe	2008-06-25

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3141251	SPC/GB20/075	United Kingdom	⤷ Sign Up	PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS: POLYETHYLENE GLYCOL 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 20171016
1539166	CA 2013 00059	Denmark	⤷ Sign Up	PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
0303507	C970035	Netherlands	⤷ Sign Up	PRODUCT NAME: NARATRIPTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAA RDBAAR ZOUT OF SOLVAAT, IN HET BIJZONDER NARATRIPTAN-HYDROCHLOR IDE; NAT. REGISTRATION NO/DATE: RVG 21444 19970801; FIRST REGISTRATION: SE 13382 19970310
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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