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Impax Company Profile
What is the competitive landscape for IMPAX, and what generic alternatives to IMPAX drugs are available?
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.
There are eighty patent family members on IMPAX drugs in eighteen countries and one hundred supplementary protection certificates in fourteen countries.
Summary for Impax
| International Patents: | 80 |
| US Patents: | 12 |
| Tradenames: | 120 |
| Ingredients: | 117 |
| 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 | MEPROBAMATE | meprobamate | TABLET;ORAL | 014322-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Impax Labs Inc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205105-001 | Jul 28, 2016 | AB2 | 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 | 076852-002 | Feb 16, 2016 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Impax Labs | PROBENECID AND COLCHICINE | colchicine; probenecid | TABLET;ORAL | 083720-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Impax Labs | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077415-002 | Dec 15, 2006 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Impax Labs Inc | LAMOTRIGINE | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 200828-004 | Jul 15, 2013 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Impax Labs Inc | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710-002 | Feb 6, 2008 | 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 | 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 |
| 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 | 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 |
International Patents for Impax Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 164856 | ➤ Sign Up |
| Taiwan | 200724182 | ➤ Sign Up |
| Japan | 2015187178 | ➤ Sign Up |
| Israel | 263053 | ➤ Sign Up |
| European Patent Office | 2234963 | ➤ Sign Up |
| South Korea | 101752080 | ➤ Sign Up |
| European Patent Office | 1904145 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for Impax Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0764174 | SPC/GB04/031 | United Kingdom | ➤ Sign Up | PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310 |
| 1261586 | 1290013-0 | Sweden | ➤ Sign Up | PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124 |
| 1506211 | 42/2014 | Austria | ➤ Sign Up | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121 |
| 1506211 | 92496 | Luxembourg | ➤ Sign Up | PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1 |
| 0454511 | 99C0009 | Belgium | ➤ Sign Up | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 |
| 1532149 | CA 2013 00001 | Denmark | ➤ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 |
| 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.
