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Last Updated: July 17, 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 BLISOVI FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 201585-001 Nov 18, 2015 BX RX No No ⤷  Sign Up ⤷  Sign Up
Lupin Ltd LORAZEPAM lorazepam CONCENTRATE;ORAL 091407-001 Feb 19, 2013 AA RX No No ⤷  Sign Up ⤷  Sign Up
Lupin LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 209713-010 Jan 18, 2019 AB1,AB2,AB3 RX No No ⤷  Sign Up ⤷  Sign Up
Lupin Ltd JENCYCLA norethindrone TABLET;ORAL-28 091323-001 Mar 28, 2013 AB2 RX No No ⤷  Sign Up ⤷  Sign Up
Lupin RAMIPRIL ramipril CAPSULE;ORAL 077626-001 Jun 9, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up
>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 XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 8,765,153 ⤷  Sign Up
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 8,110,706 ⤷  Sign Up
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004 7,863,331 ⤷  Sign Up
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 7,145,036 ⤷  Sign Up
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 5,605,674 ⤷  Sign Up
>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
1534313 CR 2015 00072 Denmark ⤷  Sign Up PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1586316 11C0031 France ⤷  Sign Up PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
2137537 1490038-5 Sweden ⤷  Sign Up PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203
2957286 300962 Netherlands ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
1467728 C01467728/01 Switzerland ⤷  Sign Up PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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