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Impax Labs Inc Company Profile
What is the competitive landscape for IMPAX LABS INC, and when can generic versions of IMPAX LABS INC drugs launch?
There are twelve US patents protecting IMPAX LABS INC drugs. There is one tentative approval on IMPAX LABS INC drugs.
There are seventy-eight patent family members on IMPAX LABS INC drugs in eighteen countries and eighteen supplementary protection certificates in seven countries.
Summary for Impax Labs Inc
| International Patents: | 78 |
| US Patents: | 12 |
| Tradenames: | 46 |
| Ingredients: | 44 |
| NDAs: | 53 |
Drugs and US Patents for Impax Labs Inc
| 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 | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | RX | Yes | No | 8,377,474 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Impax Labs Inc | MORPHINE SULFATE | morphine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 200411-003 | Apr 12, 2016 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Impax Labs Inc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205105-005 | Jul 28, 2016 | AB2 | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Impax Labs Inc | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 040646-003 | Mar 30, 2007 | 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 Labs Inc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Impax Labs Inc | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-003 | Nov 25, 2009 | 5,665,071 | ➤ Sign Up |
| Impax Labs Inc | 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 LABS INC drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 61.25 mg/245 mg | ➤ Subscribe | 2015-06-10 |
| ➤ 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 Labs Inc
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 |
|---|---|---|
| 8,187,224 | Methods performed by medicine injection apparatuses | ➤ Sign Up |
| 7,927,303 | Medicine injection devices and methods | ➤ Sign Up |
| 7,931,618 | Apparatuses and methods for injecting medicines to a desired depth | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Impax Labs Inc Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Norway | 20073488 | ➤ Sign Up |
| Japan | 5783725 | ➤ Sign Up |
| New Zealand | 602302 | ➤ Sign Up |
| South Korea | 20130113533 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Impax Labs Inc Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0907 | Netherlands | ➤ Sign Up | PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT |
| C0040 | France | ➤ Sign Up | PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402 |
| 0716606/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004 |
| C/GB96/004 | United Kingdom | ➤ Sign Up | PRODUCT NAME: ANASTROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT; REGISTRATION NO/DATE: UK 12619/0106 19950811 |
| 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.
