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DORYX

NDA

DOXYCYCLINE HYCLATE | N050795 | MAYNE PHARMA INTERNATIONAL PTY LTD

8 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Feb. 3, 2028

Oct. 23, 2034

Dec. 23, 2034

Oct. 23, 2034

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Doryx Mpc (2023)

Total Spending

$146K

Total Claims

167

Beneficiaries

101

Avg Cost/Unit

$17.98

Spending Trend

$63K(2019)→$64K(2020)→$44K(2021)→$37K(2022)→$146K(2023)

YoY Change:+36.2%

5yr CAGR:+9.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

17 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -37	View Letter (PDF)
Oct 15, 2024	SUPPL -36	View Letter (PDF)
Jul 26, 2022	SUPPL -30	View Letter (PDF)
Feb 13, 2020	SUPPL -28	View Letter (PDF)
Feb 8, 2018	SUPPL -26	View Letter (PDF)
Jun 5, 2017	SUPPL -24	View Letter (PDF)
May 24, 2016	SUPPL -22	View Letter (PDF)
May 20, 2016	SUPPL -21	View Letter (PDF)
Apr 1, 2016	SUPPL -19	View Letter (PDF)
Jun 10, 2015	SUPPL -18	View Letter (PDF)
Mar 6, 2015	SUPPL -20	View Letter (PDF)
Apr 16, 2013	SUPPL -10	View Letter (PDF)
Mar 24, 2011	SUPPL -13	View Letter (PDF)
Jun 24, 2008	SUPPL -5	View Letter (PDF)
Jan 9, 2008	SUPPL -3	View Letter (PDF)
Dec 28, 2006	SUPPL -2	View Letter (PDF)
May 17, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

Sort:

#001 — EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: May 6, 2005

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8715724	Feb 3, 2028	—	—	Yes	—	—

#002 — EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: May 6, 2005

#003 — EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Jun 20, 2008

#004 — EQ 80MG BASE

RLD

1 patent0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Apr 11, 2013

#005 — EQ 200MG BASE

RLD

1 patent0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Apr 11, 2013

#006 — EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Dec 19, 2014

#007 — EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

4 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: May 20, 2016

#008 — EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

4 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: May 20, 2016