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Last Updated: April 13, 2024

Impax Labs Company Profile


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Summary for Impax Labs
International Patents:25
US Patents:8
Tradenames:108
Ingredients:107
NDAs:141

Drugs and US Patents for Impax Labs

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs Inc RISEDRONATE SODIUM risedronate sodium TABLET, DELAYED RELEASE;ORAL 205066-001 Jun 29, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes 9,089,608 ⤷  Try a Trial Y ⤷  Try a Trial
Impax Labs TRICHLORMETHIAZIDE trichlormethiazide TABLET;ORAL 083967-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Impax Labs PREDNISONE prednisone TABLET;ORAL 080782-001 Approved Prior to Jan 1, 1982 DISCN 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 Impax Labs

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 7,094,427 ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 7,094,427 ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 7,094,427 ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 7,094,427 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for IMPAX LABS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe Extended-release Capsules 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg ➤ Subscribe 2015-06-24
➤ Subscribe Extended-release Capsules 61.25 mg/245 mg ➤ Subscribe 2015-06-10

Supplementary Protection Certificates for Impax Labs Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498758 2020C/509 Belgium ⤷  Try a Trial PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1539166 2013/055 Ireland ⤷  Try a Trial PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
2435024 2021C/518 Belgium ⤷  Try a Trial PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
0716606 02C0011 France ⤷  Try a Trial PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.