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Last Updated: December 15, 2024

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 SILODOSIN silodosin CAPSULE;ORAL 206541-002 Dec 3, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe
Lupin Ltd REPAGLINIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; repaglinide TABLET;ORAL 200624-001 Jul 15, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe
Lupin Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 204203-004 May 17, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe
>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 ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004 4,800,079 ⤷  Subscribe
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-002 Nov 30, 2004 4,800,079 ⤷  Subscribe
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 5,760,090 ⤷  Subscribe
>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 Inhalation Solution Eq. 0.015 mg base/2 mL ➤ Subscribe 2009-10-01
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe for Oral Suspension 500 mg/5 mL ➤ Subscribe 2014-07-22
➤ 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 Injection 250 mcg/0.5 mL, 1 mL PFS ➤ Subscribe 2012-03-30

Supplementary Protection Certificates for Lupin Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2207786 LUC00326 Luxembourg ⤷  Subscribe PRODUCT NAME: COMPOSITION COMPRENANT: DE LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; ET DE LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230913
2435024 132021000000095 Italy ⤷  Subscribe PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435025 36/2019 Austria ⤷  Subscribe PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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