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Last Updated: May 19, 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 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 205401-006 Jan 22, 2019 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 075882-001 Oct 28, 2002 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519-001 Dec 20, 2007 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms ACETOHEXAMIDE acetohexamide TABLET;ORAL 070870-001 Feb 9, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040435-001 Jun 20, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-003 Jun 4, 1998 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial
>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 VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 5,795,911 ⤷  Try a Trial
Ani Pharms BRETHINE terbutaline sulfate TABLET;ORAL 017849-001 Approved Prior to Jan 1, 1982 3,937,838 ⤷  Try a Trial
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-001 Jun 4, 1998 5,534,534*PED ⤷  Try a Trial
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-003 Jun 4, 1998 5,703,110 ⤷  Try a Trial
Ani Pharms LITHOBID lithium carbonate TABLET, EXTENDED RELEASE;ORAL 018027-001 Approved Prior to Jan 1, 1982 4,264,573 ⤷  Try a Trial
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-003 May 16, 2008 7,538,133*PED ⤷  Try a Trial
>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
0145340 99C0005 Belgium ⤷  Try a Trial PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0443983 C00443983/03 Switzerland ⤷  Try a Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
2203431 1590018-6 Sweden ⤷  Try a Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
0257344 SPC/GB98/043 United Kingdom ⤷  Try a Trial PRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512
0502314 SPC/GB02/037 United Kingdom ⤷  Try a Trial PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0306228 38/2000 Austria ⤷  Try a Trial PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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