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Last Updated: July 16, 2024

ANI PHARMS Company Profile


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Summary for ANI PHARMS
International Patents:29
US Patents:2
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 VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 RX Yes Yes 7,858,662 ⤷  Sign Up Y ⤷  Sign Up
Ani Pharms NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074439-002 Dec 10, 1996 DISCN No No ⤷  Sign Up ⤷  Sign Up
Ani Pharms PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 070705-001 Oct 1, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up
Ani Pharms PINDOLOL pindolol TABLET;ORAL 073609-001 Mar 29, 1993 AB RX No No ⤷  Sign Up ⤷  Sign Up
Ani Pharms DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 075432-002 Oct 18, 2000 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 021093-003 May 16, 2008 5,534,534*PED ⤷  Sign Up
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-002 Sep 5, 2000 5,534,534*PED ⤷  Sign Up
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-004 Jun 4, 1998 5,508,297 ⤷  Sign Up
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-001 Jun 4, 1998 5,703,110 ⤷  Sign Up
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-001 Sep 5, 2000 5,705,517*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 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

Supplementary Protection Certificates for ANI PHARMS Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1948158 1690020-1 Sweden ⤷  Sign Up 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
1077912 SZ 47/2007 Austria ⤷  Sign Up PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
0788511 SPC/GB08/036 United Kingdom ⤷  Sign Up PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1948158 93075 Luxembourg ⤷  Sign Up PRODUCT NAME: SACUBITRIL ET 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-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0443983 C00443983/03 Switzerland ⤷  Sign Up PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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