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Last Updated: May 19, 2024

Lupin Ltd Company Profile


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Drugs and US Patents for Lupin Ltd

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206028-002 Sep 28, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd TELMISARTAN AND AMLODIPINE amlodipine besylate; telmisartan TABLET;ORAL 201586-004 Jan 8, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd FEBUXOSTAT febuxostat TABLET;ORAL 205406-002 Jan 17, 2024 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd MELOXICAM meloxicam CAPSULE;ORAL 209487-001 Jun 1, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd GABAPENTIN gabapentin TABLET;ORAL 209306-002 Aug 24, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 090692-002 Jun 29, 2011 AB2 RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd LEFLUNOMIDE leflunomide TABLET;ORAL 211863-002 Feb 4, 2020 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
Paragraph IV (Patent) Challenges for LUPIN LTD drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Oral Suspension 500 mg/5 mL ➤ Subscribe 2014-07-22
➤ 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 Ltd Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 C300164 Netherlands ⤷  Try a Trial PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
2316456 C 2017 047 Romania ⤷  Try a Trial PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
1948158 300810 Netherlands ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIUM (3-((LS,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1948158 1690020-1 Sweden ⤷  Try a Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
1467728 132016000051059 Italy ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUSI LORO SALI FARMACEUTICAMENTE ACCETTABILI(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058 - C(2015)8288, 20151123
2236132 CA 2015 00004 Denmark ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
0162036 C300028 Netherlands ⤷  Try a Trial PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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