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 nine US patents protecting IMPAX LABS INC drugs.
There are thirty-eight patent family members on IMPAX LABS INC drugs in fourteen countries and thirty-three supplementary protection certificates in eleven countries.
Summary for Impax Labs Inc
| International Patents: | 38 |
| 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 | 203312-001 | Jan 7, 2015 | RX | Yes | No | 9,089,608 | See Plans and Pricing | Y | See Plans and Pricing | |||
| Impax Labs Inc | GLYBURIDE | glyburide | TABLET;ORAL | 206079-001 | Sep 30, 2015 | AB2 | RX | No | No | See Plans and Pricing | See Plans and Pricing | ||||
| Impax Labs Inc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205105-005 | Jul 28, 2016 | AB2 | RX | No | No | See Plans and Pricing | See Plans and Pricing | ||||
| Impax Labs Inc | METHYLTESTOSTERONE | methyltestosterone | CAPSULE;ORAL | 204851-001 | Sep 21, 2015 | AB | RX | No | Yes | See Plans and Pricing | See Plans and Pricing | ||||
| Impax Labs Inc | ACITRETIN | acitretin | CAPSULE;ORAL | 202552-004 | Dec 23, 2015 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | ||||
| >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 | See Plans and Pricing |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | 7,094,427 | See Plans and Pricing |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | 7,094,427 | See Plans and Pricing |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | 7,094,427 | See Plans and Pricing |
| >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 |
|---|---|---|
| New Zealand | 586870 | See Plans and Pricing |
| South Africa | 201005309 | See Plans and Pricing |
| World Intellectual Property Organization (WIPO) | 2006073729 | See Plans and Pricing |
| South Korea | 101752080 | See Plans and Pricing |
| Japan | 2015187178 | See Plans and Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Impax Labs Inc Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1175904 | 2007C/048 | Belgium | See Plans and Pricing | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| 0716606 | 02C0011 | France | See Plans and Pricing | PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128 |
| 2435024 | 2190014-7 | Sweden | See Plans and Pricing | PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210 |
| 0716606 | C00716606/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004 |
| 0613371 | SPC/GB02/033 | United Kingdom | See Plans and Pricing | 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 |
| >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.
