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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: October 15, 2019

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Lupin Company Profile

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Summary for Lupin

Drugs and US Patents for Lupin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209285-001 Oct 23, 2017 AB1 RX No No   See Pricing   See Pricing
Lupin Ltd MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090051-002 Apr 10, 2015 AB RX No No   See Pricing   See Pricing
Lupin Ltd CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210548-003 Jun 28, 2019 AB RX No No   See Pricing   See Pricing
Lupin Ltd VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078946-004 Mar 21, 2013 AB RX No No   See Pricing   See Pricing
Lupin TOPIRAMATE topiramate TABLET;ORAL 078410-004 Sep 11, 2013 AB RX No No   See Pricing   See Pricing
Lupin Ltd PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 204134-002 Jan 20, 2017 AB RX No No   See Pricing   See Pricing
>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 Lupin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lupin Atlantis ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004 4,800,079   See Pricing
Lupin Atlantis ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-001 Nov 30, 2004 4,800,079   See Pricing
Lupin Atlantis ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-002 Nov 30, 2004 4,800,079   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for LUPIN drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe for Oral Suspension 500 mg/5 mL ➤ Subscribe 2014-07-22

Supplementary Protection Certificates for Lupin Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1109558 2008/034 Ireland   See Pricing PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
0253310 SZ 16/1996 Austria   See Pricing PRODUCT NAME: LOSARTAN-KALIUM
1506211 122014000070 Germany   See Pricing PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1467728 93074 Luxembourg   See Pricing PRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123
0268956 1999C0030 Belgium   See Pricing PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
0434450 1999C0033 Belgium   See Pricing PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
>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:

McKesson
Colorcon
Medtronic
Baxter
Johnson and Johnson
Moodys

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