Leo Pharma As Company Profile
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What is the competitive landscape for LEO PHARMA AS, and when can generic versions of LEO PHARMA AS drugs launch?
LEO PHARMA AS has ten approved drugs.
There are thirteen US patents protecting LEO PHARMA AS drugs.
There are one hundred and sixty-five patent family members on LEO PHARMA AS drugs in twenty-six countries and eight supplementary protection certificates in seven countries.
Summary for Leo Pharma As
| International Patents: | 165 |
| US Patents: | 13 |
| Tradenames: | 7 |
| Ingredients: | 6 |
| NDAs: | 10 |
| Drug Master File Entries: | 7 |
Drugs and US Patents for Leo Pharma As
| 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 | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | 8,435,498 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | 10,117,812 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | 10,716,799 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | 10,130,640*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | 10,660,908 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-001 | Dec 8, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 Pharma As
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | 6,534,070 | ⤷ Sign Up |
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | RE39706 | ⤷ Sign Up |
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | 8,900,554 | ⤷ Sign Up |
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | RE39706 | ⤷ Sign Up |
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | 6,787,529 | ⤷ Sign Up |
| Leo Pharma As | DOVONEX | calcipotriene | CREAM;TOPICAL | 020554-001 | Jul 22, 1996 | RE39706 | ⤷ Sign Up |
| Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-002 | Dec 8, 2000 | 5,385,907 | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for LEO PHARMA AS drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Topical Foam | 15% | ➤ Subscribe | 2017-09-14 |
| ➤ Subscribe | Gel | 0.05% | ➤ Subscribe | 2010-12-01 |
| ➤ Subscribe | Ointment | 0.03% | ➤ Subscribe | 2010-11-22 |
| ➤ Subscribe | Gel | 15% | ➤ Subscribe | 2012-07-27 |
| ➤ Subscribe | Topical Solution | 0.01% | ➤ Subscribe | 2006-05-19 |
| ➤ Subscribe | Ointment | 0.1% | ➤ Subscribe | 2010-09-09 |
| ➤ Subscribe | Ointment | 0.005%/0.064% | ➤ Subscribe | 2010-03-31 |
International Patents for Leo Pharma As Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | PA06006923 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007072216 | ⤷ Sign Up |
| South Africa | 200502171 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2011154004 | ⤷ Sign Up |
| Australia | 2011264198 | ⤷ Sign Up |
| Australia | 2005204347 | ⤷ Sign Up |
| European Patent Office | 2097065 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Leo Pharma As Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435024 | 21C1020 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
| 2435024 | SPC/GB21/029 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210 |
| 2435024 | LUC00208 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
| 2435024 | 301102 | Netherlands | ⤷ Sign Up | 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 |
| 2435024 | 2021C/518 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210 |
| 0613371 | SPC/GB02/033 | United Kingdom | ⤷ Sign Up | 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 | 2190014-7 | Sweden | ⤷ Sign Up | 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 |
| >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.
