Ani Pharms Company Profile

What is the competitive landscape for ANI PHARMS

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

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

Summary for Ani Pharms

US Patents:	6
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	FENOPROFEN CALCIUM	fenoprofen calcium	TABLET;ORAL	072274-001	May 2, 1988		DISCN	No	No
Ani Pharms	IBUPROFEN	ibuprofen	TABLET;ORAL	072903-001	Dec 19, 1991		DISCN	No	No
Ani Pharms	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	077725-003	Jul 31, 2006		DISCN	No	No
Ani Pharms	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	203490-006	Jul 13, 2016		DISCN	No	No
Ani Pharms	PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; propranolol hydrochloride	TABLET;ORAL	070705-001	Oct 1, 1986		DISCN	No	No
Ani Pharms	ETODOLAC	etodolac	CAPSULE;ORAL	074840-001	Aug 29, 1997		DISCN	No	No

Expired US Patents for Ani Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	5,795,911
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982	3,937,838
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-001	Approved Prior to Jan 1, 1982	4,011,258
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-004	Jun 4, 1998	5,508,297
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	6,500,454
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,958,961

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
Israel	161625
South Korea	20050044344
Mexico	PA04004532
Canada	2466720
China	1589141
Japan	4495459

Supplementary Protection Certificates for Ani Pharms Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	SPC/GB18/031	United Kingdom		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
3209302	202340008	Slovenia		PRODUCT NAME: COMBINATION OF FOSLEVODOPA OR ITS PHARMACEUTICALLY ACCEPTABLE SALT AND FOSCARBIDOPA OR ITS PHARMACEUTICALLY ACCEPTABLE SALT; NATIONAL AUTHORISATION NUMBER: H/05/00514/002; DATE OF NATIONAL AUTHORISATION: 20221215; AUTHORITY FOR NATIONAL AUTHORISATION: SI; FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 141371; DATE OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 20220825; AUTHORITY OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: AT
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
1448186	29/2010	Austria		PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908
0392059	SPC/GB02/046	United Kingdom		PRODUCT NAME: MEMANTINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/219/001 20020515; UK EU/1/02/219/002 20020515; UK EU/1/02/219/003 20020515; UK EU/1/02/219/004 20020515; UK EU/1/02/219/005 20020515; UK EU/1/02/219/006 20020515
1948158	1690020-1	Sweden		PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123

Similar Applicant Names

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

• Ani Pharms