IMPAX LABS INC Company Profile
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What is the competitive landscape for IMPAX LABS INC, and what generic alternatives to IMPAX LABS INC drugs are available?
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 | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202238-002 | Oct 20, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs Inc | URSODIOL | ursodiol | TABLET;ORAL | 200826-002 | Dec 23, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs Inc | DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 079108-002 | Aug 5, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Impax Labs Inc | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710-001 | Feb 6, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs Inc | EMVERM | mebendazole | TABLET, CHEWABLE;ORAL | 073580-001 | Jan 4, 1995 | RX | No | Yes | ⤷ 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 | 203312-001 | 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 |
| 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 | 203312-002 | 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 |
|---|---|---|
| Israel | 248520 | ⤷ Try a Trial |
| South Korea | 20130113533 | ⤷ Try a Trial |
| South Korea | 20100099731 | ⤷ Try a Trial |
| South Korea | 20150133854 | ⤷ Try a Trial |
| New Zealand | 586870 | ⤷ 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 |
|---|---|---|---|---|
| 0716606 | C300080 | Netherlands | ⤷ Try a 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 |
| 2435024 | 301102 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
| 1746976 | LUC00026 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018 |
| 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 |
| 1175904 | 2007C/048 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| >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.
