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Last Updated: July 16, 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 PIPERAZINE CITRATE piperazine citrate TABLET;ORAL 080874-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up
Impax Labs BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077415-002 Dec 15, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc ISOSORBIDE DINITRATE isosorbide dinitrate TABLET, EXTENDED RELEASE;ORAL 040723-001 Mar 17, 2008 DISCN 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 Impax Labs

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 7,094,427 ⤷  Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 7,094,427 ⤷  Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 7,094,427 ⤷  Sign Up
>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 CA 2020 00017 Denmark ⤷  Sign Up PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
0236684 C300140 Netherlands ⤷  Sign Up PRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225
0613371 SPC/GB02/033 United Kingdom ⤷  Sign Up PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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