LEO PHARM Company Profile
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What is the competitive landscape for LEO PHARM, and what generic alternatives to LEO PHARM drugs are available?
LEO PHARM has twelve approved drugs.
There are thirteen US patents protecting LEO PHARM drugs.
There are one hundred and sixty-five patent family members on LEO PHARM drugs in twenty-six countries and eight supplementary protection certificates in seven countries.
Summary for LEO PHARM
International Patents: | 165 |
US Patents: | 13 |
Tradenames: | 8 |
Ingredients: | 7 |
NDAs: | 12 |
Drug Master File Entries: | 2 |
Patent Litigation for LEO PHARM: | See patent lawsuits for LEO PHARM |
Drugs and US Patents for LEO PHARM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | 10,130,640*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-002 | Dec 8, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-001 | Dec 8, 2000 | AB | RX | Yes | 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 LEO PHARM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | 6,787,529 | ⤷ Try a Trial |
Leo Pharm | DOVONEX | calcipotriene | SOLUTION;TOPICAL | 020611-001 | Mar 3, 1997 | RE39706 | ⤷ Try a Trial |
Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | 5,763,426 | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for LEO PHARM drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Gel | 15% | ➤ Subscribe | 2012-07-27 |
➤ Subscribe | Gel | 0.05% | ➤ Subscribe | 2010-12-01 |
➤ Subscribe | Ointment | 0.03% | ➤ Subscribe | 2010-11-22 |
➤ Subscribe | Topical Solution | 0.01% | ➤ Subscribe | 2006-05-19 |
➤ Subscribe | Topical Foam | 15% | ➤ Subscribe | 2017-09-14 |
➤ Subscribe | Ointment | 0.1% | ➤ Subscribe | 2010-09-09 |
➤ Subscribe | Ointment | 0.005%/0.064% | ➤ Subscribe | 2010-03-31 |
International Patents for LEO PHARM Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2008539222 | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2009007785 | ⤷ Try a Trial |
Australia | 2006201878 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LEO PHARM Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435024 | 132021000000095 | Italy | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210 |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.