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	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065190-002	Oct 18, 2004		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	071803-005	May 29, 1997		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	GLIPIZIDE	glipizide	TABLET;ORAL	074387-002	Mar 4, 1996		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Ani Pharms	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	076030-002	Oct 28, 2002		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	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	5,958,961	⤷ Try a Trial
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	7,538,133*PED	⤷ Try a Trial
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-004	Jun 4, 1998	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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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1077912	SPC/GB07/053	United Kingdom	⤷ Try a Trial	SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/053 GRANTED TO SCHWARZ PHARMA AG IN RESPECT OF THE PRODUCT FESOTERODINE AND ITS SALTS WITH PHYSIOLOGICALLY ACCEPTABLE ACIDS, INCLUDING FUMARIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6299 DATED 10 FEBRUARY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23 APRIL 2022.
1448186	29/2010	Austria	⤷ Try a Trial	PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908
2203431	1590018-6	Sweden	⤷ Try a Trial	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1856135	LUC00153	Luxembourg	⤷ Try a Trial	PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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