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Last Updated: May 31, 2020

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Impax Labs Inc Company Profile


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What is the competitive landscape for IMPAX LABS INC, and when can generic versions of IMPAX LABS INC drugs launch?

IMPAX LABS INC has forty-nine approved drugs.

There are nine US patents protecting IMPAX LABS INC drugs. There is one tentative approval on IMPAX LABS INC drugs.

There are thirty-seven patent family members on IMPAX LABS INC drugs in fourteen countries and twenty-eight supplementary protection certificates in nine countries.

Summary for Impax Labs Inc
International Patents:37
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 203312-002 Jan 7, 2015 RX Yes No 9,533,046   Start Trial Y   Start Trial
Impax Labs Inc MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 200411-006 Apr 12, 2016 AB RX No No   Start Trial   Start Trial
Impax Labs Inc LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 200828-003 Jul 15, 2013 AB RX No No   Start Trial   Start Trial
Impax Labs Inc LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 077756-003 Apr 9, 2008 AN RX No No   Start Trial   Start Trial
Impax Labs Inc ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 075710-001 Feb 6, 2008 AB RX No No   Start Trial   Start Trial
Impax Labs Inc HYDROCORTISONE hydrocortisone TABLET;ORAL 040646-001 Mar 30, 2007 AB RX No No   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for IMPAX LABS INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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 Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296749 09C0055 France   Start Trial PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D’UN SEL D’ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; REGISTRATION NO/DATE IN FRANCE: NL 21126 DU 19961227; REGISTRATION NO/DATE AT EEC: 12619/0106 DU 19950811
1746976 LUC00026 Luxembourg   Start Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
0716606 C300428 Netherlands   Start Trial PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0296749 97C0023 France   Start Trial PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D UN SEL D ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; NAT REG. NO/DATE: NL 21126 19961227; FIRST REG.: 12619/0106 19950811
1175904 2007C/048 Belgium   Start Trial PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
3225249 2019C/520 Belgium   Start Trial PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513
>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

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.