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Impax Company Profile
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.
Summary for Impax
| 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 | ALPRAZOLAM | alprazolam | TABLET, EXTENDED RELEASE;ORAL | 077968-002 | May 24, 2007 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | |||||
| Impax Pharms | MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 076449-003 | Dec 16, 2005 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Impax Labs Inc | METOCLOPRAMIDE HYDROCHLORIDE | metoclopramide hydrochloride | TABLET;ORAL | 071250-002 | Dec 28, 1995 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Impax Labs | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 085376-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | |||||
| Impax Labs | CHLORPHENIRAMINE MALEATE | chlorpheniramine maleate | TABLET;ORAL | 080809-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | |||||
| Impax Labs Inc | HYDROXYZINE PAMOATE | hydroxyzine pamoate | CAPSULE;ORAL | 040156-002 | Jul 15, 1996 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Impax Labs | CHLORDIAZEPOXIDE HYDROCHLORIDE | chlordiazepoxide hydrochloride | CAPSULE;ORAL | 086213-001 | Approved Prior to Jan 1, 1982 | 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 |
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 |
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 | Document Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2008103666 | ➤ Try a Free Trial |
| Australia | 2005314401 | ➤ Try a Free Trial |
| South Korea | 101451564 | ➤ Try a Free Trial |
| Russian Federation | 2431505 | ➤ Try a Free Trial |
| Israel | 206756 | ➤ Try a Free Trial |
| China | 101910113 | ➤ Try a Free Trial |
| Japan | 4980237 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Impax Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB11/015 | United Kingdom | ➤ Try a Free Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| C/GB08/040 | United Kingdom | ➤ Try a Free Trial | PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716 |
| C0011 | France | ➤ Try a Free Trial | PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128 |
| C0025 | Belgium | ➤ Try a Free Trial | PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215 |
| 00140 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225 |
| C0021 | France | ➤ Try a Free Trial | PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310 |
| 1506211/02 | Switzerland | ➤ Try a Free Trial | PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015 |
| 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.
