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Last Updated: March 26, 2023

Impax Labs Inc Company Profile


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Summary for Impax Labs Inc
International Patents:38
US Patents:9
Tradenames:43
Ingredients:43
NDAs:49

Drugs and US Patents for Impax Labs Inc

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 RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 RX Yes No 9,089,608 See Plans and Pricing Y See Plans and Pricing
Impax Labs Inc GLYBURIDE glyburide TABLET;ORAL 206079-001 Sep 30, 2015 AB2 RX No No See Plans and Pricing See Plans and Pricing
Impax Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205105-005 Jul 28, 2016 AB2 RX No No See Plans and Pricing See Plans and Pricing
Impax Labs Inc METHYLTESTOSTERONE methyltestosterone CAPSULE;ORAL 204851-001 Sep 21, 2015 AB RX No Yes See Plans and Pricing See Plans and Pricing
Impax Labs Inc ACITRETIN acitretin CAPSULE;ORAL 202552-004 Dec 23, 2015 AB RX 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 Inc

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 INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Capsules 61.25 mg/245 mg ➤ Subscribe 2015-06-10
➤ 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 Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 2007C/048 Belgium See Plans and Pricing PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
0716606 02C0011 France See Plans and Pricing PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
2435024 2190014-7 Sweden See Plans and Pricing PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
0716606 C00716606/01 Switzerland See Plans and Pricing PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
0613371 SPC/GB02/033 United Kingdom See Plans and Pricing 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
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:

Colorcon
Baxter
Moodys
McKinsey
Boehringer Ingelheim
Merck

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