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Last Updated: July 6, 2020

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Ani Pharms Inc Company Profile


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What is the competitive landscape for ANI PHARMS INC, and what generic alternatives to ANI PHARMS INC drugs are available?

ANI PHARMS INC has two hundred and twenty-seven approved drugs.

There is one US patent protecting ANI PHARMS INC drugs.

There are fourteen patent family members on ANI PHARMS INC drugs in eleven countries and eighty-two supplementary protection certificates in twelve countries.

Summary for Ani Pharms Inc
International Patents:14
US Patents:1
Tradenames:129
Ingredients:125
NDAs:227

Drugs and US Patents for Ani Pharms Inc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms Inc INDAPAMIDE indapamide TABLET;ORAL 074299-001 Jul 27, 1995 AB RX No No   Start Trial   Start Trial
Ani Pharms Inc ROSIGLITAZONE MALEATE rosiglitazone maleate TABLET;ORAL 076747-003 Jan 25, 2013 DISCN No No   Start Trial   Start Trial
Ani Pharms Inc DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 075432-004 Oct 18, 2000 DISCN No No   Start Trial   Start Trial
Ani Pharms Inc THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride TABLET;ORAL 088270-001 Apr 14, 1983 DISCN No No   Start Trial   Start Trial
Ani Pharms Inc AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 085031-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Ani Pharms Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076284-001 Jul 3, 2002 DISCN No No   Start Trial   Start Trial
Ani Pharms Inc PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 070704-001 Oct 1, 1986 DISCN No No   Start Trial   Start 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 Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-003 Jun 4, 1998 5,534,534*PED   Start Trial
Ani Pharms Inc ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-002 Sep 5, 2000 7,538,133*PED   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-002 Jun 4, 1998 5,703,110   Start Trial
Ani Pharms Inc BRETHINE terbutaline sulfate TABLET;ORAL 017849-002 Approved Prior to Jan 1, 1982 3,937,838   Start Trial
Ani Pharms Inc CASODEX bicalutamide TABLET;ORAL 020498-001 Oct 4, 1995 5,712,251   Start Trial
Ani Pharms Inc ARIMIDEX anastrozole TABLET;ORAL 020541-001 Dec 27, 1995 4,935,437   Start Trial
Ani Pharms Inc CASODEX bicalutamide TABLET;ORAL 020498-001 Oct 4, 1995 4,636,505*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ANI PHARMS INC 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 Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539166 13C0062 France   Start Trial PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
0473687 C980045 Netherlands   Start Trial PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
0306228 C300034 Netherlands   Start Trial PRODUCT NAME: ROSIGLITAZONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT, IN HET BIJZONDER ROSIGLITAZONE MALEAAT; REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711
1539166 SPC/GB13/070 United Kingdom   Start Trial PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. Q; REGISTERED: UK EU/1/13/833 20130626
0281459 C990002 Netherlands   Start Trial PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715
0281459 98C0036 France   Start Trial PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
0473687 3/1999 Austria   Start Trial PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
Harvard Business School
McKesson
McKinsey
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.