Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
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Express Scripts

Last Updated: December 14, 2019

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Ani Pharms Inc Company Profile

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What is the competitive landscape for ANI PHARMS INC, and when can generic versions of ANI PHARMS INC drugs launch?

ANI PHARMS INC has two hundred and eighteen 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 sixty-four supplementary protection certificates in eleven countries.

Summary for Ani Pharms Inc
International Patents:14
US Patents:1
Tradenames:119
Ingredients:115
NDAs:218

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 PINDOLOL pindolol TABLET;ORAL 073609-002 Mar 29, 1993 AB RX No No   Start Trial   Start Trial
Ani Pharms Inc CHLORPROPAMIDE chlorpropamide TABLET;ORAL 088826-001 Sep 26, 1984 DISCN No No   Start Trial   Start Trial
Ani Pharms Inc MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 084657-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Ani Pharms Inc TIMOLOL MALEATE timolol maleate TABLET;ORAL 072918-001 Jul 31, 1991 DISCN No No   Start Trial   Start Trial
Ani Pharms Inc QUINAPRIL HYDROCHLORIDE quinapril hydrochloride TABLET;ORAL 075504-004 Aug 24, 2007 AB RX No No   Start Trial   Start Trial
Ani Pharms Inc ETODOLAC etodolac CAPSULE;ORAL 074844-001 Dec 23, 1997 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 020838-002 Jun 4, 1998 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 ARIMIDEX anastrozole TABLET;ORAL 020541-001 Dec 27, 1995 RE36617*PED   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-003 Jun 4, 1998 5,508,297   Start Trial
Ani Pharms Inc ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-003 May 16, 2008 5,534,534*PED   Start Trial
Ani Pharms Inc ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-001 Sep 5, 2000 5,705,517*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 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
➤ Subscribe Tablets 4 mg, 8 mg, 16 mg and 32 mg ➤ Subscribe 2006-12-22

Supplementary Protection Certificates for Ani Pharms Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0473687 SPC/GB98/030 United Kingdom   Start Trial PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0303507 C970035 Netherlands   Start Trial PRODUCT NAME: NARATRIPTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAA RDBAAR ZOUT OF SOLVAAT, IN HET BIJZONDER NARATRIPTAN-HYDROCHLOR IDE; NAT. REGISTRATION NO/DATE: RVG 21444 19970801; FIRST REGISTRATION: SE 13382 19970310
0303507 64/1997 Austria   Start Trial PRODUCT NAME: ''NARATRIPTAN'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATES EINSCHLIESSLICH DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-22059 19970731; FIRST REGISTRATION: SE 13382 19970310
0328535 96C0021 Belgium   Start Trial PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
0509752 C990041 Netherlands   Start Trial PRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306
0473687 99C0008 Belgium   Start Trial PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 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:

Harvard Business School
Baxter
Boehringer Ingelheim
Mallinckrodt
AstraZeneca
McKinsey

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 verifification 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.