DrugPatentWatch Database Preview
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 Inc | RISEDRONATE SODIUM | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 205066-001 | Jun 29, 2018 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Impax Labs | TRICHLORMETHIAZIDE | trichlormethiazide | TABLET;ORAL | 083967-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | |||||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | |||||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | RX | Yes | No | 7,094,427 | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Impax Labs Inc | MORPHINE SULFATE | morphine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 200411-002 | Apr 12, 2016 | AB | RX | 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 |
Non-Orange Book US Patents for Impax
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,927,303 | Medicine injection devices and methods | ➤ Try a Free Trial |
| 8,187,224 | Methods performed by medicine injection apparatuses | ➤ Try a Free Trial |
| 7,931,618 | Apparatuses and methods for injecting medicines to a desired depth | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Impax Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Canada | 2711014 | ➤ Try a Free Trial |
| World Intellectual Property Organization (WIPO) | 03101432 | ➤ Try a Free Trial |
| Spain | 2606463 | ➤ Try a Free Trial |
| Russian Federation | 2007125259 | ➤ Try a Free Trial |
| World Intellectual Property Organization (WIPO) | 2007008257 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Impax Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0907 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT |
| C/GB98/043 | United Kingdom | ➤ Try a Free Trial | PRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512 |
| C0021 | France | ➤ Try a Free Trial | PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310 |
| C/GB12/058 | United Kingdom | ➤ Try a Free Trial | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
| C/GB02/037 | United Kingdom | ➤ Try a Free Trial | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
| 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.
