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Last Updated: April 26, 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 BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 074253-002 Mar 28, 2001 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Impax Labs OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 079087-007 Jun 14, 2010 RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No 9,089,608 ⤷  Try a Trial Y ⤷  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 203312-004 Jan 7, 2015 7,094,427 ⤷  Try a Trial
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
>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
0480717 98C0025 Belgium ⤷  Try a Trial PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0809498 SPC/GB10/012 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
1412357 50/2008 Austria ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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