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Last Updated: April 19, 2024

PADAGIS US Company Profile


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Summary for PADAGIS US
International Patents:22
US Patents:1
Tradenames:64
Ingredients:59
NDAs:87

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 TRETINOIN tretinoin CREAM;TOPICAL 075264-001 Dec 24, 1998 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Padagis Us HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 204658-001 Apr 29, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Padagis Us FLAVOXATE HYDROCHLORIDE flavoxate hydrochloride TABLET;ORAL 076831-001 Dec 16, 2004 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Padagis Us BACITRACIN bacitracin OINTMENT;OPHTHALMIC 061212-001 Approved Prior to Jan 1, 1982 RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Padagis Us CICLOPIROX ciclopirox SOLUTION;TOPICAL 077623-001 Sep 18, 2007 AT RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Padagis Us DIHYDROERGOTAMINE MESYLATE dihydroergotamine mesylate INJECTABLE;INJECTION 040475-001 Apr 28, 2003 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
>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 BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997 4,078,071 ⤷  Try a Trial
Padagis Us BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997 4,551,148 ⤷  Try a Trial
Padagis Us BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997 5,266,329 ⤷  Try a Trial
Padagis Us ENTOCORT EC budesonide CAPSULE, DELAYED RELEASE;ORAL 021324-001 Oct 2, 2001 5,643,602*PED ⤷  Try a Trial
Padagis Us EVAMIST estradiol SPRAY;TRANSDERMAL 022014-001 Jul 27, 2007 6,818,226 ⤷  Try a Trial
Padagis Us CENTANY mupirocin OINTMENT;TOPICAL 050788-001 Dec 4, 2002 6,013,657 ⤷  Try a Trial
>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
3043773 21C1057 France ⤷  Try a Trial PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
0733366 SPC/GB98/031 United Kingdom ⤷  Try a Trial 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
0617614 11/2001 Austria ⤷  Try a Trial PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
2782584 122021000080 Germany ⤷  Try a Trial PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
2782584 301153 Netherlands ⤷  Try a Trial 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
2782584 132021000000197 Italy ⤷  Try a Trial PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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