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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School
Moodys
Daiichi Sankyo
McKesson
Mallinckrodt
McKinsey
Accenture
Healthtrust

Generated: April 22, 2018

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-seven drug master file entries for this compound. Eighty 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
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 050795
Ingredient-typeTetracyclines
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 N 51862-557-12
DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795 NDA Mayne Pharma Inc. 51862-557 N 51862-557-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 75MG BASE
Approval Date:May 6, 2005TE:ABRLD:Yes
Patent:➤ Sign UpPatent 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:➤ Sign UpPatent 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:➤ Sign UpPatent 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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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Army
Farmers Insurance
Cerilliant
Boehringer Ingelheim
UBS
Daiichi Sankyo
Chinese Patent Office
McKinsey

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