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Last Updated: November 14, 2024

Leo Pharm Company Profile


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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 INNOHEP tinzaparin sodium INJECTABLE;INJECTION 020484-001 Jul 14, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 AB RX Yes Yes 10,688,108 ⤷  Sign Up ⤷  Sign Up
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 PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002 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 Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As DOVONEX calcipotriene CREAM;TOPICAL 020554-001 Jul 22, 1996 5,763,426 ⤷  Sign Up
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 6,753,013 ⤷  Sign Up
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 4,866,048 ⤷  Sign Up
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 RE39706 ⤷  Sign Up
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 5,763,426 ⤷  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 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

Supplementary Protection Certificates for Leo Pharm Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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