➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
Baxter
McKesson
Moodys
Mallinckrodt
McKinsey

Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050795


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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-four 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 51862-557-12 120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-557-12)
DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795 NDA Mayne Pharma Inc. 51862-557 51862-557-12 120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-557-12)
Paragraph IV (Patent) Challenges for 050795
Tradename Dosage Ingredient NDA Submissiondate
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2017-09-28
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2017-09-28
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-11-05
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-11-05
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-07-01
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-07-01
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2008-12-19
DORYX MPC 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Express Scripts
Mallinckrodt
Johnson and Johnson
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.