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	PRAZOSIN HYDROCHLORIDE	prazosin hydrochloride	CAPSULE;ORAL	072577-001	May 16, 1989		DISCN	No	No
Ani Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208607-003	Jul 14, 2017		DISCN	No	No
Ani Pharms	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	085031-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	AB	RX	Yes	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

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
Portugal	1448186
Hong Kong	1131048
Cyprus	1108882

Supplementary Protection Certificates for Ani Pharms Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	2018/031	Ireland		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0486666	C980001	Netherlands		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
3209302	2023C/510	Belgium		PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: BE660571 20220901
2666774	202040029	Slovenia		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF SODIUM SALT; NATIONAL AUTHORISATION NUMBER: EU/1/19/1420; DATE OF NATIONAL AUTHORISATION: 20200213; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Similar Applicant Names

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

• Ani Pharms