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Last Updated: November 24, 2024

ANI PHARMS Company Profile


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Summary for ANI PHARMS
International Patents:29
US Patents:4
Tradenames:153
Ingredients:146
NDAs:242

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 TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076321-002 Sep 30, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up
Ani Pharms TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene TABLET;ORAL 073467-001 Jan 31, 1996 DISCN No No ⤷  Sign Up ⤷  Sign Up
Ani Pharms VANCOCIN HYDROCHLORIDE vancomycin hydrochloride FOR SOLUTION;ORAL 061667-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up
Ani Pharms KIONEX sodium polystyrene sulfonate POWDER;ORAL, RECTAL 040029-001 Feb 6, 1998 AA RX No No ⤷  Sign Up ⤷  Sign Up
Ani Pharms DEXCHLORPHENIRAMINE MALEATE dexchlorpheniramine maleate TABLET;ORAL 088682-001 Jan 17, 1986 DISCN No No ⤷  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

Expired US Patents for ANI PHARMS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-002 Sep 5, 2000 5,958,961 ⤷  Sign Up
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-004 Jun 4, 1998 5,705,517*PED ⤷  Sign Up
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-002 Sep 5, 2000 5,705,517*PED ⤷  Sign Up
Ani Pharms ARIMIDEX anastrozole TABLET;ORAL 020541-001 Dec 27, 1995 RE36617*PED ⤷  Sign Up
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-002 Sep 5, 2000 5,196,444*PED ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ANI PHARMS drugs
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

Supplementary Protection Certificates for ANI PHARMS Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1259550 08C0052 France ⤷  Sign Up PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
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
1948158 16C0018 France ⤷  Sign Up PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1534313 92923 Luxembourg ⤷  Sign Up 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
2932970 18C1043 France ⤷  Sign Up PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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