Ani Pharms Company Profile

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What is the competitive landscape for ANI PHARMS

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

There are seven US patents protecting ANI PHARMS drugs. There is one tentative approval on ANI PHARMS drugs.

Summary for Ani Pharms

US Patents:	7
Tradenames:	158
Ingredients:	151
NDAs:	248

Drugs and US Patents for Ani Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	GUANABENZ ACETATE	guanabenz acetate	TABLET;ORAL	074267-001	Jun 1, 1994		DISCN	No	No
Ani Pharms	CORTENEMA	hydrocortisone	ENEMA;RECTAL	016199-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Ani Pharms	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	074439-001	Dec 10, 1996		DISCN	No	No
Ani Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	077144-002	Aug 16, 2005		DISCN	No	No
Ani Pharms	INDAPAMIDE	indapamide	TABLET;ORAL	074498-002	Feb 12, 1998		DISCN	No	No

Expired US Patents for Ani Pharms

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
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-001	Approved Prior to Jan 1, 1982	3,937,838
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,721,263
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	5,703,110
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	5,712,251

Paragraph IV (Patent) Challenges for ANI PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	for Injection	200 mcg/vial		2015-05-01
	Tablets	16 mg/12.5 mg and 32 mg/12.5 mg		2008-06-25
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Tablets	4 mg, 8 mg, 16 mg and 32 mg		2006-12-22
	Tablets	32 mg/25 mg		2009-03-06

International Patents for Ani Pharms Drugs

Country	Patent Number	Estimated Expiration
South Korea	100956369
Germany	122009000073
Argentina	037526
Hong Kong	1131048
Spain	2319626

Supplementary Protection Certificates for Ani Pharms Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	2012/008	Ireland		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
1109558	SPC/GB08/058	United Kingdom		PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/08/462/001 20080714; UK EU/1/08/462/002 20080714; UK EU/1/08/462/003 20080714; UK EU/1/08/462/004 20080714; UK EU/1/08/462/005 20080714; UK EU/1/08/462/006 20080714
1109558	09C0001	France		PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
3209302	11/2023	Austria		PRODUCT NAME: KOMBINATION VON FOSLEVODOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON UND FOSCARBIDOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON; REGISTRATION NO/DATE: 141371 20220826
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730

Similar Applicant Names

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

• Ani Pharms