Viewing data from:

SOLODYN

NDA

MINOCYCLINE HYDROCHLORIDE | N050808 | BAUSCH HEALTH US LLC

8 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Expiring < 1yr (3)Active (1)Today

2027

2028

2029

2030

2031

2032

Today

Apr. 2, 2027

Apr. 2, 2027

Mar. 7, 2027

Nov. 17, 2031

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
Medicis Pharmaceutical Corporation v. Zydus Pharmaceuticals USA Inc. et al 1:2012cv00707 3 patentsANDA 203553minocycline HCl extended release	D. Del.	2012-06-04	Terminated 2012-12-28	—

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 Solodyn (2023)

Total Spending

$4K

Total Claims

Beneficiaries

Avg Cost/Unit

$2.32

Spending Trend

$206K(2019)→$8K(2020)→$3K(2021)→$5K(2022)→$4K(2023)

YoY Change:+2.2%

5yr CAGR:-50.6%

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

API Supply Chain9 active DMFs7 inactive

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

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE

DMF 137381998

CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SAMINOCYCLINE HYDROCHLORIDE

DMF 137581998

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE)

DMF 148022000

IDT AUSTRALIA LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 150142000

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 260502012

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE MICRONIZED

DMF 290032015

ZHEJIANG MEDICINE CO LTDMINOCYCLINE HYDROCHLORIDE

DMF 326642018

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE) MICRONIZED

DMF 332792018

ZHEJIANG CHANGHAI PHARMACEUTICALS CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 359392022

PARKE DAVIS AND COInactiveMINOCYCLINE HYDROCHLORIDE CAP

DMF 24081975

FINE CHEMICALS CORPInactiveMINOCYCLINE HYDROCHLORIDE

DMF 71991987

LEDERLE LABORATORIESInactiveMINOCYCLINE HYDROCHLORIDE

DMF 134041998

NIPPON KAYAKU CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137481998

KYOWA HAKKO KOGYO CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137551998

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMINOCYCLINE HYDROCHLORIDE USP

DMF 151712000

HOVIONE FARMACIENCIA SAInactiveMINOCYCLINE

DMF 342172019

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -28	View Letter (PDF)
Mar 19, 2025	SUPPL -27	View Letter (PDF)
Mar 19, 2025	SUPPL -24	View Letter (PDF)
Oct 22, 2013	SUPPL -23	View Letter (PDF)
Apr 21, 2011	SUPPL -15	View Letter (PDF)
Mar 25, 2011	SUPPL -14	View Letter (PDF)
Jan 5, 2010	SUPPL -11	View Letter (PDF)
Jul 31, 2009	SUPPL -7	View Letter (PDF)
May 16, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

Sort:

#001 — EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 8, 2006

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7919483	Mar 7, 2027	—	—	—		—

#002 — EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

3 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 8, 2006

#003 — EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 8, 2006

#004 — EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 23, 2009

#005 — EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 23, 2009

#006 — EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 27, 2010

#007 — EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 27, 2010

#008 — EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 27, 2010