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 eight US patents protecting IMPAX drugs. There are five tentative approvals on IMPAX drugs.
There are twenty-five patent family members on IMPAX drugs in twelve countries and one hundred and thirty-seven supplementary protection certificates in sixteen countries.
Summary for Impax
| International Patents: | 25 |
| US Patents: | 8 |
| Tradenames: | 119 |
| Ingredients: | 116 |
| 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 | MEPROBAMATE | meprobamate | TABLET;ORAL | 014322-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Impax Labs | AMINOPHYLLINE | aminophylline | TABLET, DELAYED RELEASE;ORAL | 084575-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Impax Labs Inc | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 090505-002 | Dec 28, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Impax | SEVELAMER CARBONATE | sevelamer carbonate | FOR SUSPENSION;ORAL | 211316-002 | Nov 20, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs | RILUZOLE | riluzole | TABLET;ORAL | 076173-001 | Jan 29, 2003 | 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 Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | 7,094,427 | ⤷ Sign Up |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | 7,094,427 | ⤷ Sign Up |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-001 | Jan 7, 2015 | 7,094,427 | ⤷ Sign Up |
| Impax Labs Inc | 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 | 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
Supplementary Protection Certificates for Impax Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2498758 | CA 2020 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113 |
| 0236684 | C300140 | Netherlands | ⤷ Sign Up | 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 |
| 0613371 | SPC/GB02/033 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515 |
| 1602370 | 2009/010 | Ireland | ⤷ Sign Up | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028 |
| 2498758 | 2090013-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113 |
| >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.
