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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Army
QuintilesIMS
UBS
Accenture
Baxter
Merck
Covington
Queensland Health

Generated: October 16, 2018

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Impax Labs Company Profile

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What is the competitive landscape for IMPAX LABS, and what generic alternatives to IMPAX LABS drugs are available?

IMPAX LABS has one hundred and forty-three approved drugs.

There are nine US patents protecting IMPAX LABS drugs. There are three tentative approvals on IMPAX LABS drugs.

Summary for Impax Labs
US Patents:9
Tradenames:110
Ingredients:109
NDAs:143

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 OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 079087-005 Jun 14, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No 8,557,283 ➤ Try a Free Trial Y ➤ Try a Free Trial
Impax Labs Inc DESMOPRESSIN ACETATE desmopressin acetate TABLET;ORAL 077122-002 Jan 25, 2006 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs PREDNISONE prednisone TABLET;ORAL 080782-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Impax Labs METHYLTESTOSTERONE methyltestosterone TABLET;BUCCAL, SUBLINGUAL 084287-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ 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 DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065094-001 Mar 22, 2004 DISCN 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 drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe Extended-release Capsules 61.25 mg/245 mg ➤ Subscribe 2015-06-10

International Patents for Impax Labs Drugs

Country Document Number Estimated Expiration
Israel 248520 ➤ Try a Free Trial
Mexico 2010007207 ➤ Try a Free Trial
Japan 2005528430 ➤ Try a Free Trial
Japan 2017014295 ➤ Try a Free Trial
Australia 2003247409 ➤ Try a Free Trial
New Zealand 602302 ➤ Try a Free Trial
South Korea 101569604 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for Impax Labs Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2000 00018 Denmark ➤ Try a Free Trial PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
2014026,C1506211 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
/2000 Austria ➤ Try a Free Trial PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
C0062 France ➤ Try a Free Trial PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
2012022 Lithuania ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
9 5017-2014 Slovakia ➤ Try a Free Trial PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
2017 00030 Denmark ➤ Try a Free 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)...; REG. NO/DATE: EU/1 /16/1130 20161018
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
QuintilesIMS
Harvard Business School
Express Scripts
Chubb
Medtronic
Argus Health
McKinsey
Cerilliant

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