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Last Updated: November 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050795

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NDA 050795 describes DORYX MPC, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DORYX MPC profile page.

The generic ingredient in DORYX MPC is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 050795
Tradename:DORYX MPC
Applicant:Mayne Pharma
Ingredient:doxycycline hyclate
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 050795
Suppliers and Packaging for NDA: 050795
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795 NDA Mayne Pharma Inc. 51862-557 51862-557-00 1 BOTTLE in 1 CARTON (51862-557-00) > 6 TABLET, DELAYED RELEASE in 1 BOTTLE
DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795 NDA Mayne Pharma Inc. 51862-557 51862-557-00 1 BOTTLE in 1 CARTON (51862-557-00) > 6 TABLET, DELAYED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 050795
Tradename Dosage Ingredient NDA Submissiondate
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2017-09-28
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2017-09-28
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-11-05
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-11-05
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-07-01
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-07-01
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2008-12-19
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2008-12-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 75MG BASE
Approval Date:May 6, 2005TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 15, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
Patent:  Start TrialPatent Expiration:Feb 3, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 100MG BASE
Approval Date:May 6, 2005TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 15, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET

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