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Last Updated: November 22, 2024

PADAGIS US Company Profile


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Summary for PADAGIS US
International Patents:22
US Patents:1
Tradenames:65
Ingredients:60
NDAs:88

Drugs and US Patents for PADAGIS US

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Padagis Us HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278-002 Apr 6, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up
Padagis Us POTASSIUM CHLORIDE potassium chloride TABLET, EXTENDED RELEASE;ORAL 205993-002 Nov 5, 2015 AB2 RX No No ⤷  Sign Up ⤷  Sign Up
Padagis Us CLINDETS clindamycin phosphate SWAB;TOPICAL 064136-001 Sep 30, 1996 AT RX No No ⤷  Sign Up ⤷  Sign Up
Padagis Us TRETINOIN tretinoin CREAM;TOPICAL 075264-001 Dec 24, 1998 AB RX No No ⤷  Sign Up ⤷  Sign Up
Padagis Us DESONIDE desonide OINTMENT;TOPICAL 017426-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up
Padagis Us BACITRACIN bacitracin OINTMENT;OPHTHALMIC 061212-001 Approved Prior to Jan 1, 1982 RX No 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 PADAGIS US

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Padagis Us EVAMIST estradiol SPRAY;TRANSDERMAL 022014-001 Jul 27, 2007 6,923,983 ⤷  Sign Up
Padagis Us EVAMIST estradiol SPRAY;TRANSDERMAL 022014-001 Jul 27, 2007 6,818,226 ⤷  Sign Up
Padagis Us ENTOCORT EC budesonide CAPSULE, DELAYED RELEASE;ORAL 021324-001 Oct 2, 2001 5,643,602*PED ⤷  Sign Up
Padagis Us BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997 4,551,148 ⤷  Sign Up
Padagis Us BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997 5,266,329 ⤷  Sign Up
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 5,993,856 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for PADAGIS US drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Vaginal Cream 2% ➤ Subscribe 2015-02-05
➤ Subscribe Enteric Coated Capsules 3 mg ➤ Subscribe 2008-02-01

Supplementary Protection Certificates for PADAGIS US Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2957286 300962 Netherlands ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
2957286 2018C/047 Belgium ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
1380301 2009C/007 Belgium ⤷  Sign Up PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
2782584 301153 Netherlands ⤷  Sign Up PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0733366 SPC/GB98/031 United Kingdom ⤷  Sign Up PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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