Impax Labs Company Profile
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What is the competitive landscape for IMPAX LABS, and what generic alternatives to IMPAX LABS drugs are available?
IMPAX LABS has one hundred and forty-one approved drugs.
There are eight US patents protecting IMPAX LABS drugs. There are four tentative approvals on IMPAX LABS drugs.
There are twenty-five patent family members on IMPAX LABS drugs in twelve countries and one hundred and thirty-seven supplementary protection certificates in sixteen countries.
Summary for Impax Labs
| International Patents: | 25 |
| US Patents: | 8 |
| Tradenames: | 108 |
| Ingredients: | 107 |
| NDAs: | 141 |
Drugs and US Patents for Impax Labs
| 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 | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | 9,089,607 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Impax Labs Inc | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 090505-002 | Dec 28, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs Inc | NABUMETONE | nabumetone | TABLET;ORAL | 075189-001 | May 26, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs Inc | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710-005 | Feb 6, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs | BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 076711-001 | Dec 3, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs | PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | TABLET;ORAL | 040502-002 | Jun 28, 2022 | 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
| 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 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 Labs Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 586870 | ⤷ Try a Trial |
| Japan | 2011507956 | ⤷ Try a Trial |
| Japan | 2015187178 | ⤷ Try a Trial |
| South Korea | 101752080 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2009085306 | ⤷ Try a Trial |
| South Korea | 101451564 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Impax Labs Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 2316456 | SPC/GB17/078 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330 |
| 2316456 | C 2017 047 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326 |
| 2316456 | 300918 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
| 2498758 | 132020000000034 | Italy | ⤷ Try a Trial | PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113 |
| 1602370 | 09C0020 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028 |
| >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.
