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Last Updated: March 22, 2023

Impax Labs Company Profile


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Summary for Impax Labs
International Patents:38
US Patents:9
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 METHYLTESTOSTERONE methyltestosterone TABLET;BUCCAL, SUBLINGUAL 084287-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing
Impax Labs Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 079108-002 Aug 5, 2015 AB RX No No See Plans and Pricing See Plans and Pricing
Impax Labs Inc GUANFACINE HYDROCHLORIDE guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 202238-002 Oct 20, 2015 DISCN No No See Plans and Pricing See Plans and Pricing
Impax Labs Inc EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065331-001 Aug 9, 2007 AP RX No No See Plans and Pricing See Plans and Pricing
Impax Labs PROPOXYPHENE HYDROCHLORIDE propoxyphene hydrochloride CAPSULE;ORAL 083317-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing
Impax Labs Inc URSODIOL ursodiol TABLET;ORAL 200826-002 Dec 23, 2011 DISCN No No See Plans and Pricing See Plans and Pricing
Impax Labs HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 083607-002 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 7,094,427 See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 7,094,427 See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 7,094,427 See Plans and Pricing
>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 Extended-release Capsules 61.25 mg/245 mg ➤ Subscribe 2015-06-10
➤ 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

Supplementary Protection Certificates for Impax Labs Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 PA2014026,C1506211 Lithuania See Plans and Pricing PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1532149 CA 2013 00001 Denmark See Plans and Pricing PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
2316456 2017/059 Ireland See Plans and Pricing PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 SPC/GB17/078 United Kingdom See Plans and Pricing PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
2498758 PA2020003 Lithuania See Plans and Pricing PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
2498758 301040 Netherlands See Plans and Pricing PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
1506211 CA 2014 00037 Denmark See Plans and Pricing PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Harvard Business School
McKesson
Johnson and Johnson
Moodys

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