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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Express Scripts
AstraZeneca
Moodys
Merck

Last Updated: June 27, 2022

Leo Pharma As Company Profile


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Summary for Leo Pharma As
International Patents:165
US Patents:16
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 ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes 10,660,908 See Plans and Pricing Y See Plans and Pricing
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 AB RX Yes Yes See Plans and Pricing See Plans and Pricing
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 AB RX Yes Yes 8,435,498 See Plans and Pricing See Plans and Pricing
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes 10,682,364 See Plans and Pricing Y 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 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 See Plans and Pricing
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 6,730,288 See Plans and Pricing
Leo Pharma As DOVONEX calcipotriene CREAM;TOPICAL 020554-001 Jul 22, 1996 5,763,426 See Plans and Pricing
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 6,753,013 See Plans and Pricing
>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 Ointment 0.005%/0.064% ➤ Subscribe 2010-03-31
➤ 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

Supplementary Protection Certificates for Leo Pharma As Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 LUC00208 Luxembourg See Plans and Pricing 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 132021000000095 Italy See Plans and Pricing 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 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
2435024 2021C/518 Belgium See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

Merck
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AstraZeneca
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