Leo Pharm Company Profile
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What is the competitive landscape for LEO PHARM, and when can generic versions of LEO PHARM drugs launch?
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 | 9,119,781*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 | 10,716,799 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | 9,566,286 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | 10,682,364 | ⤷ Sign Up | Y | ⤷ 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 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 | ⤷ Sign Up |
| Leo Pharma As | DOVONEX | calcipotriene | CREAM;TOPICAL | 020554-001 | Jul 22, 1996 | RE39706 | ⤷ Sign Up |
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | RE39706 | ⤷ Sign Up |
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | 8,900,554 | ⤷ Sign Up |
| >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
Supplementary Protection Certificates for Leo Pharm 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 |
| >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.
