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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Cerilliant
Dow
Argus Health
Fuji
Colorcon
Daiichi Sankyo
Federal Trade Commission
Express Scripts

Generated: September 20, 2018

DrugPatentWatch Database Preview

Impax Company Profile

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

IMPAX has one hundred and fifty-one approved drugs.

There are twelve US patents protecting IMPAX drugs. There are four tentative approvals on IMPAX drugs.

Drugs and US Patents for Impax

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 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
Impax Labs TRICHLORMETHIAZIDE trichlormethiazide TABLET;ORAL 083967-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 RX Yes No 7,094,427 ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Impax Labs Inc MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 200411-002 Apr 12, 2016 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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Expired US Patents for Impax

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-003 Nov 25, 2009 5,665,071 ➤ Try a Free Trial
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-004 Nov 25, 2009 5,665,071 ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for IMPAX 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

Non-Orange Book US Patents for Impax

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,927,303 Medicine injection devices and methods ➤ Try a Free Trial
8,187,224 Methods performed by medicine injection apparatuses ➤ Try a Free Trial
7,931,618 Apparatuses and methods for injecting medicines to a desired depth ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for Impax Drugs

Supplementary Protection Certificates for Impax Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0907 Netherlands ➤ Try a Free Trial PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT
C/GB98/043 United Kingdom ➤ Try a Free Trial PRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512
C0021 France ➤ Try a Free Trial PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310
C/GB12/058 United Kingdom ➤ Try a Free Trial PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
C/GB02/037 United Kingdom ➤ Try a Free Trial PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
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.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
AstraZeneca
Harvard Business School
Healthtrust
Chubb
Cantor Fitzgerald
Chinese Patent Office
Baxter
Julphar

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