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 eight US patents protecting IMPAX LABS INC drugs. There is one tentative approval on IMPAX LABS INC drugs.
There are twenty-five patent family members on IMPAX LABS INC drugs in twelve countries and thirty-five supplementary protection certificates in eleven countries.
Summary for Impax Labs Inc
| International Patents: | 25 |
| US Patents: | 8 |
| 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 | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 204717-001 | May 7, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Impax Labs Inc | CARVEDILOL PHOSPHATE | carvedilol phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 204717-003 | May 7, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Impax Labs Inc | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET, EXTENDED RELEASE;ORAL | 040723-001 | Mar 17, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs Inc | DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 079108-005 | Nov 21, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Impax Labs Inc | ACITRETIN | acitretin | CAPSULE;ORAL | 202552-003 | Dec 23, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Impax Labs Inc | GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 076345-002 | Feb 18, 2004 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a 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 Labs Inc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | 7,094,427 | ⤷ Try a Trial |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-001 | Jan 7, 2015 | 7,094,427 | ⤷ Try a Trial |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | 7,094,427 | ⤷ Try a Trial |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | 7,094,427 | ⤷ Try a Trial |
| >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 | 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 |
|---|---|---|
| Canada | 2711014 | ⤷ Try a Trial |
| China | 101910113 | ⤷ Try a Trial |
| Japan | 2017014295 | ⤷ Try a Trial |
| South Africa | 201005309 | ⤷ Try a Trial |
| South Korea | 101752080 | ⤷ Try a Trial |
| Mexico | 2010007207 | ⤷ Try a 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 |
|---|---|---|---|---|
| 0764174 | 04C0021 | France | ⤷ Try a Trial | PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310 |
| 0296749 | 97C0023 | France | ⤷ Try a 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 |
| 0809498 | SPC/GB10/012 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112 |
| 2435024 | LUC00208 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
| 2712622 | LUC00015 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101 |
| 2435024 | 2021C/518 | Belgium | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210 |
| >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.
