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Last Updated: May 8, 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 LISINOPRIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; lisinopril TABLET;ORAL 077912-003 Sep 27, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 208818-001 Sep 27, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 216075-001 Nov 16, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd DAYSEE ethinyl estradiol; levonorgestrel TABLET;ORAL 091467-001 Apr 10, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200797-004 Jun 3, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE;ORAL 209294-003 Nov 21, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd AZITHROMYCIN azithromycin TABLET;ORAL 065398-001 May 15, 2015 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 BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 6,589,508 ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 8,110,706 ⤷  Try a Trial
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 5,760,090 ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 7,462,645 ⤷  Try a Trial
Lupin XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 5,439,670 ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 6,667,344 ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 5,795,564 ⤷  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 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
➤ Subscribe Inhalation Solution Eq. 0.015 mg base/2 mL ➤ Subscribe 2009-10-01

Supplementary Protection Certificates for Lupin Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 C300080 Netherlands ⤷  Try a Trial PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128
1663240 132016000129162 Italy ⤷  Try a Trial PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME UN SALE FARMACEUTICAMENTE ACCETTABILE DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, EMTRICITABINA, E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623
2487166 PA2016038 Lithuania ⤷  Try a Trial PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
0434450 SPC/GB99/032 United Kingdom ⤷  Try a Trial PRODUCT NAME: ABACAVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE INCLUDING ABACAVIR SULPHATE; REGISTERED: CH CH 55048 001 19990628; CH CH 55049 002 19990628; UK EU/1/99/112/001 19990708; UK EU/1/99/112/002 19990708
2487162 PA2016040 Lithuania ⤷  Try a Trial PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
1948158 PA2016017 Lithuania ⤷  Try a Trial PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
2957286 SPC/GB19/003 United Kingdom ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 20170721
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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