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	AMINOCAPROIC ACID	aminocaproic acid	TABLET;ORAL	211629-001	Dec 14, 2020	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Ani Pharms	REGLAN	metoclopramide hydrochloride	TABLET;ORAL	017854-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Ani Pharms	PANDEL	hydrocortisone probutate	CREAM;TOPICAL	020453-001	Feb 28, 1997		RX	Yes	Yes		⤷ 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
>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
0509752	49/1999	Austria	⤷ Sign Up	PRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306
2203431	2015/009	Ireland	⤷ Sign Up	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
0473687	99C0008	Belgium	⤷ Sign Up	PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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