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-two approved drugs.
There are nineteen US patents protecting IMPAX drugs. There are five tentative approvals on IMPAX drugs.
There are fifty-six patent family members on IMPAX drugs in fourteen countries and one hundred and thirty-seven supplementary protection certificates in sixteen countries.
Summary for Impax
| International Patents: | 56 |
| US Patents: | 19 |
| Tradenames: | 119 |
| Ingredients: | 115 |
| NDAs: | 152 |
| 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 Inc | PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 071976-001 | Apr 6, 1988 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs Inc | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090024-002 | Feb 3, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Impax Labs Inc | BUDESONIDE | budesonide | SUSPENSION;INHALATION | 078404-002 | Jul 31, 2012 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Pharms | MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 076449-001 | May 27, 2004 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 076852-005 | Feb 16, 2016 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax | CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186-004 | Aug 7, 2024 | RX | Yes | Yes | 10,292,935 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Impax Labs Inc | LAMOTRIGINE | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 200828-001 | Jul 15, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-001 | Jan 7, 2015 | 7,094,427 | ⤷ Sign Up |
| Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-003 | Nov 25, 2009 | 5,665,071 | ⤷ Sign Up |
| Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-004 | Nov 25, 2009 | 5,665,071 | ⤷ Sign Up |
| Impax | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | 7,094,427 | ⤷ Sign Up |
| Impax | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | 7,094,427 | ⤷ Sign Up |
| Impax | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | 7,094,427 | ⤷ Sign Up |
| >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 | 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 |
| ➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
International Patents for Impax Drugs
Supplementary Protection Certificates for Impax Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 2316456 | 1790064-8 | Sweden | ⤷ Sign Up | 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; REG. NO/DATE: EU/1/14/988 20150330 |
| 2435024 | SPC/GB21/029 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210 |
| 0236940 | 97C0053 | Belgium | ⤷ Sign Up | PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072 |
| 3225249 | 300983 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513 |
| 2498758 | 2020C/509 | Belgium | ⤷ Sign Up | PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113 |
| 1412357 | DO 77; 5006-2008 | Slovakia | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
| >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.
Here is a list of applicants with similar names.
