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 | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | 9,265,725 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | 9,211,259 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Leo Pharma As | ENSTILAR | betamethasone dipropionate; calcipotriene | AEROSOL, FOAM;TOPICAL | 207589-001 | Oct 16, 2015 | AB | RX | Yes | Yes | 10,688,108 | ⤷ Subscribe | ⤷ Subscribe | |||
| Leo Pharma As | DOVONEX | calcipotriene | OINTMENT;TOPICAL | 020273-001 | Dec 29, 1993 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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 | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-001 | Dec 8, 2000 | 5,665,727 | ⤷ Subscribe |
| Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-001 | Dec 8, 2000 | 5,385,907 | ⤷ Subscribe |
| Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-002 | Dec 8, 2000 | 5,385,907 | ⤷ Subscribe |
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | OINTMENT;TOPICAL | 021852-001 | Jan 9, 2006 | 6,753,013 | ⤷ Subscribe |
| >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 | 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 |
| ➤ Subscribe | Gel | 15% | ➤ Subscribe | 2012-07-27 |
| ➤ Subscribe | Gel | 0.05% | ➤ Subscribe | 2010-12-01 |
| ➤ Subscribe | Ointment | 0.03% | ➤ Subscribe | 2010-11-22 |
International Patents for Leo Pharm Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 6258402 | ⤷ Subscribe |
| Mexico | PA05004278 | ⤷ Subscribe |
| World Intellectual Property Organization (WIPO) | 2008152444 | ⤷ Subscribe |
| Australia | 2006313443 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Leo Pharm Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435024 | 2021C/518 | Belgium | ⤷ Subscribe | 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 |
| 2435024 | 132021000000095 | Italy | ⤷ Subscribe | 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 | ⤷ Subscribe | 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 | ⤷ Subscribe | 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.
