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 thirteen US patents protecting IMPAX drugs. There are five tentative approvals on IMPAX drugs.
There are eighty-one patent family members on IMPAX drugs in eighteen countries and one hundred and thirty-four supplementary protection certificates in sixteen countries.
Summary for Impax
International Patents: | 81 |
US Patents: | 13 |
Tradenames: | 119 |
Ingredients: | 116 |
NDAs: | 151 |
Patent Litigation for Impax: | See patent lawsuits for Impax |
PTAB Cases with Impax as petitioner: | See PTAB cases with Impax as petitioner |
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 | SULFISOXAZOLE | sulfisoxazole | TABLET;ORAL | 080109-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | |||||
Impax Labs | RESERPINE | reserpine | TABLET;ORAL | 009627-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | |||||
Impax Labs | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079087-005 | Jun 14, 2010 | RX | No | No | See Plans and Pricing | See Plans and Pricing | |||||
Impax Labs Inc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205105-001 | Jul 28, 2016 | AB2 | RX | No | No | See Plans and Pricing | See Plans and Pricing | ||||
Impax Labs | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 065005-001 | Mar 23, 1999 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | ||||
Impax Labs Inc | BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 074253-001 | Mar 28, 2001 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | ||||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | 7,094,427 | See Plans and Pricing |
Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-003 | Nov 25, 2009 | 5,665,071 | See Plans and Pricing |
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-001 | Jan 7, 2015 | 7,094,427 | See Plans and Pricing |
Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-004 | Nov 25, 2009 | 5,665,071 | See Plans and Pricing |
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | 7,094,427 | See Plans and Pricing |
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | 7,094,427 | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for IMPAX 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 Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 5783725 | See Plans and Pricing |
Taiwan | 200724182 | See Plans and Pricing |
San Marino | P200700023 | See Plans and Pricing |
South Africa | 200704515 | See Plans and Pricing |
Spain | 2804348 | See Plans and Pricing |
Mexico | 2007006251 | See Plans and Pricing |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Impax Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0984957 | 2012/048 | Ireland | See Plans and Pricing | PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812 |
1506211 | 122014000071 | Germany | See Plans and Pricing | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1411900 | 2011/016 | Ireland | See Plans and Pricing | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 |
1506211 | 122014000070 | Germany | See Plans and Pricing | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
2316456 | 2017/059 | Ireland | See Plans and Pricing | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
1539166 | 2013/055 | Ireland | See Plans and Pricing | PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.