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Last Updated: March 28, 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 AZITHROMYCIN azithromycin TABLET;ORAL 065398-001 May 15, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin SESQUIENT fosphenytoin sodium SOLUTION;INTRAVENOUS 210864-002 Nov 5, 2020 DISCN Yes No 9,200,088 ⤷  Try a Trial Y ⤷  Try a Trial
Lupin Ltd IMIPRAMINE PAMOATE imipramine pamoate CAPSULE;ORAL 090444-002 Apr 16, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd FAYOSIM ethinyl estradiol; levonorgestrel TABLET;ORAL 205943-001 Mar 29, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Lupin CEFDINIR cefdinir FOR SUSPENSION;ORAL 065259-001 May 31, 2006 AB RX No 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 LUPIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-002 Nov 30, 2004 4,800,079 ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 6,068,833 ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 7,473,710 ⤷  Try a Trial
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 8,765,153 ⤷  Try a Trial
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 5,225,183 ⤷  Try a Trial
>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
1632232 300852 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
0513917 C980018 Netherlands ⤷  Try a Trial PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
1044189 SPC/GB08/034 United Kingdom ⤷  Try a Trial PRODUCT NAME: VARENICLINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE TARTRATE SALT; REGISTRATION NO/DATE: EU/1/06/360/001 - 010 20060928
2957286 CR 2018 00043 Denmark ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179/001-009 20170721
1586316 132011901975261 Italy ⤷  Try a Trial PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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