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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Fish and Richardson
US Department of Justice
Covington
US Army
QuintilesIMS

Generated: March 22, 2019

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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-five patent family members on IMPAX LABS INC drugs in fourteen countries and twenty-two supplementary protection certificates in nine countries.

Summary for Impax Labs Inc
International Patents:35
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 203312-003 Jan 7, 2015 RX Yes No 8,454,998 ➤ Try a Free Trial Y ➤ Try a Free Trial
Impax Labs Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076345-003 Feb 18, 2004 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 RX Yes No 9,901,640 ➤ Try a Free Trial Y ➤ Try a Free Trial
Impax Labs Inc METHYLTESTOSTERONE methyltestosterone CAPSULE;ORAL 204851-001 Sep 21, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 203184-001 Sep 15, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc RISEDRONATE SODIUM risedronate sodium TABLET, DELAYED RELEASE;ORAL 205066-001 Jun 29, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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
2712622 122017000006 Germany ➤ Try a Free Trial PRODUCT NAME: DESMOPRESSIN ODER DAS ACETAT DAVON; NAT. REGISTRATION NO/DATE: 94725.00.00 94726.00.00 20160901 FIRST REGISTRATION: BELGIEN BE497271 BE497280 20160504
0809498 SPC/GB10/012 United Kingdom ➤ Try a Free Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
2712622 LUC00015 Luxembourg ➤ Try a Free Trial PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101
0716606 6/2002 Austria ➤ Try a Free Trial PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
0716606 SPC/GB02/011 United Kingdom ➤ Try a Free Trial PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
0613371 SPC/GB02/033 United Kingdom ➤ Try a Free Trial 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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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Federal Trade Commission
Accenture
Argus Health
Johnson and Johnson
Farmers Insurance

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 verifification 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.