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Impax Labs Inc Company Profile
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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 | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | RX | Yes | No | 9,533,046 | Start Trial | Y | Start Trial | |||
| Impax Labs Inc | MORPHINE SULFATE | morphine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 200411-006 | Apr 12, 2016 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Impax Labs Inc | LAMOTRIGINE | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 200828-003 | Jul 15, 2013 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Impax Labs Inc | LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 077756-003 | Apr 9, 2008 | AN | RX | 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 | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 040646-001 | Mar 30, 2007 | AB | 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 | 6328205 | Start Trial |
| Spain | 2606463 | Start Trial |
| European Patent Office | 1507518 | Start Trial |
| Japan | 2015187178 | Start Trial |
| Canada | 2711014 | Start Trial |
| Japan | 2017014295 | 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 | 09C0055 | France | Start Trial | PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D’UN SEL D’ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; REGISTRATION NO/DATE IN FRANCE: NL 21126 DU 19961227; REGISTRATION NO/DATE AT EEC: 12619/0106 DU 19950811 |
| 1746976 | LUC00026 | Luxembourg | Start 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 |
| 0716606 | C300428 | Netherlands | Start Trial | PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610 |
| 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 |
| 1175904 | 2007C/048 | Belgium | Start Trial | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| 3225249 | 2019C/520 | Belgium | Start Trial | PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
