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 | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | RX | Yes | No | 8,557,283 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | RX | Yes | No | 9,533,046 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Impax Labs Inc | MORPHINE SULFATE | morphine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 200411-005 | Apr 12, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs Inc | DOXYCYCLINE | doxycycline | CAPSULE;ORAL | 200065-001 | Feb 17, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Impax Labs Inc | BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 074253-001 | Mar 28, 2001 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Impax Labs Inc | PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 071972-001 | Apr 6, 1988 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Impax Labs Inc | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710-002 | Feb 6, 2008 | DISCN | 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 | 61.25 mg/245 mg | ➤ Subscribe | 2015-06-10 |
| ➤ 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 INC Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2009085306 | ⤷ Try a Trial |
| Australia | 2008343787 | ⤷ Try a Trial |
| Israel | 263053 | ⤷ Try a Trial |
| South Korea | 101569604 | ⤷ Try a Trial |
| Japan | 2015187178 | ⤷ Try a Trial |
| Japan | 2017014295 | ⤷ 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 |
|---|---|---|---|---|
| 2712622 | C02712622/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018 |
| 0613371 | SPC/GB02/033 | United Kingdom | ⤷ Try a 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 |
| 0716606 | 6/2002 | Austria | ⤷ Try a Trial | PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128 |
| 2712622 | 122017000006 | Germany | ⤷ Try a 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 |
| 0809498 | 10C0038 | France | ⤷ Try a Trial | PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026 |
| 0809498 | SPC/GB10/012 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112 |
| 3225249 | 300983 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513 |
| >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.
