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DOXYCYCLINE HYCLATE

ANDA

DOXYCYCLINE HYCLATE | A090134 | ACTAVIS ELIZABETH LLC

4 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Mayne Pharma International Pty Ltd. v. Actavis Elizabeth LLC et al 1:2017cv01614 4 patentsANDA 090134doxycycline hyclate	D. Del.	2017-11-09	Terminated 2019-01-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain9 active DMFs10 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

YANGZHOU LIBERTY PHARMACEUTICAL CO LTDDOXYCYCLINE HYCLATE

DMF 131741998

HOVIONE PHARMASCIENCE LTDDOXYCYCLINE HYCLATE

DMF 137141998

CHANGZHOU PHARMACEUTICAL FACTORYDOXYCYCLINE HYCLATE

DMF 137711998

GLAND PHARMA LTDDOXYCYCLINE HYCLATE USP

DMF 330932018

YANCHENG SUHAI PHARMACEUTICAL CO LTDDOXYCYCLINE HYCLATE

DMF 364912021

CHANGZHOU PHARMACEUTICAL FACTORYDOXYCYCLINE HYCLATE (ROUTE CODE: YDX)

DMF 407092024

MAITHRI DRUGS PRIVATE LTDDOXYCYCLINE HYCLATE USP

DMF 416892025

YANGZHOU LIBERTY PHARMACEUTICAL CO LTDDOXYCYCLINE HYCLATE (FOR USE IN THE MANUFACTURE OF PARENTERAL PREPARATIONS)

DMF 418042025

SHANDONG GUOBANG PHARMACEUTICAL CO LTDDOXYCYCLINE HYCLATE

DMF 425672025

HOUBA INCInactiveDOXYCYCLINE HYCLATE

DMF 132021998

PFIZER INCInactiveDOXYCYCLINE HYCLATE

DMF 133211998

PFIZER INCInactiveDOXYCYCLINE HYCLATE

DMF 133701998

PFIZER INCInactiveDOXYCYCLINE HYCLATE

DMF 134551998

PFIZER INCInactiveDOXYCYCLINE HYCLATE

DMF 134921998

HOVIONE FARMACIENCIA SAInactiveDOXYCYCLINE HYCLATE

DMF 136361998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveDOXYCYCLINE HYCLATE USP

DMF 137161998

YANCHENG SUHAI PHARMACEUTICAL CO LTDInactiveDOXYCYCLINE HYCLATE USP

DMF 161912002

KUNSHAN CHEMICALS AND PHARMACEUTICAL CO LTDInactiveDOXYCYCLINE HYCLATE USP

DMF 180042005

HUASHU PHARMACEUTICAL CORPInactiveDOXYCYCLINE HYCLATE

DMF 183142005

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 3, 2018	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — EQ 75MG BASE

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Dec 14, 2011

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Dec 14, 2011

#003 — EQ 50MG BASE

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: May 22, 2018

#004 — EQ 200MG BASE

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: May 22, 2018