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Impax Labs Inc Company Profile
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What is the competitive landscape for IMPAX LABS INC, and when can generic versions of IMPAX LABS INC drugs launch?
IMPAX LABS INC has forty-nine approved drugs.
There are nine US patents protecting IMPAX LABS INC drugs. There is one tentative approval on IMPAX LABS INC drugs.
There are thirty-seven patent family members on IMPAX LABS INC drugs in fourteen countries and twenty-eight supplementary protection certificates in nine countries.
Summary for Impax Labs Inc
International Patents: | 37 |
US Patents: | 9 |
Tradenames: | 43 |
Ingredients: | 43 |
NDAs: | 49 |
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 | URSODIOL | ursodiol | TABLET;ORAL | 200826-001 | Dec 23, 2011 | DISCN | No | No | Start Trial | Start Trial | |||||
Impax Labs Inc | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710-001 | Feb 6, 2008 | AB | RX | No | No | Start Trial | Start Trial | ||||
Impax Labs Inc | MIRTAZAPINE | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 076901-003 | Jun 28, 2005 | DISCN | No | No | Start Trial | Start Trial | |||||
Impax Labs Inc | GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 076731-003 | Nov 19, 2004 | DISCN | No | No | Start Trial | Start Trial | |||||
Impax Labs Inc | NABUMETONE | nabumetone | TABLET;ORAL | 075189-001 | May 26, 2000 | DISCN | No | No | Start Trial | Start Trial | |||||
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | RX | Yes | No | 9,089,608 | Start Trial | Y | Start Trial | |||
Impax Labs Inc | LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 077756-001 | Apr 9, 2008 | AN | RX | No | No | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Paragraph IV (Patent) Challenges for IMPAX LABS INC drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Extended-release Capsules | 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg | ➤ Subscribe | 2015-06-24 |
➤ Subscribe | Extended-release Capsules | 61.25 mg/245 mg | ➤ Subscribe | 2015-06-10 |
International Patents for Impax Labs Inc Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2017014295 | Start Trial |
European Patent Office | 1507518 | Start Trial |
Israel | 164856 | Start Trial |
Australia | 2003247409 | Start Trial |
Canada | 2711014 | Start Trial |
Australia | 2008343787 | Start Trial |
European Patent Office | 2921170 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Impax Labs Inc Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0296749 | 97C0023 | France | Start Trial | PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D UN SEL D ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; NAT REG. NO/DATE: NL 21126 19961227; FIRST REG.: 12619/0106 19950811 |
0716606 | C300080 | Netherlands | Start Trial | PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128 |
1758590 | 300907 | Netherlands | Start Trial | PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT |
0613371 | SPC/GB02/033 | United Kingdom | Start Trial | 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 |
1175904 | 2007C/048 | Belgium | Start Trial | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
2712622 | 122017000006 | Germany | Start Trial | PRODUCT NAME: DESMOPRESSIN ODER DAS ACETAT DAVON; NAT. REGISTRATION NO/DATE: 94725.00.00 94726.00.00 20160901 FIRST REGISTRATION: BELGIEN BE497271 BE497280 20160504 |
0716606 | C00716606/01 | Switzerland | Start Trial | PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.