IP Library Granted Patent US 12,128,137
Granted Patent B2
US 12,128,137 · App. 17/719,278 · Granted Oct 29, 2024

Topical compositions and methods for treating skin diseases

Inventors: Arturo Angel (Santa Rosa, CA); Radhakrishnan Pillai (Santa Rosa, CA)
Assignee: BAUSCH HEALTH IRELAND LIMITED
A61K9/107A61K9/0014A61K9/06A61K31/4436A61K47/06A61K47/14A61K47/32A61K47/34A61K47/44A61P17/00A61P17/10
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Quick Facts
Patent No.
US 12,128,137
App. No.
17/719,278
Granted
Oct 29, 2024
Kind
B2
Abstract

Topical pharmaceutical compositions include tazarotene or a pharmaceutically acceptable salt of tazarotenic acid and an oil-in-water emulsion vehicle that forms a lotion. The compositions are used to treat skin diseases, such as acne vulgaris.

Claims (21)

1. A method of treating acne vulgaris, the method comprising topically applying a pharmaceutical composition to an affected area of a body of a subject suffering from acne vulgaris, wherein the composition consists essentially of:

tazarotene or a pharmaceutically acceptable tazarotenic acid salt present in the composition at a concentration of about 0.045 percent by weight of the composition;

a liquid oil component; and

an aqueous component;

wherein said composition is an oil-in-water emulsion and is formulated as a lotion, and

wherein the tazarotene or tazarotenic acid salt is dissolved in the liquid oil component.

2. The method of claim 1 , wherein said aqueous component comprises water, a carbomer homopolymer, and a polymeric emulsifier; and wherein said oil component comprises a dicarboxylic acid ester, a monocarboxylic acid ester, or a combination thereof.

3. The method of claim 2 , wherein the oil component comprises a dicarboxylic acid ester.

4. The method of claim 2 , wherein the oil component further comprises mineral oil or light mineral oil.

5. The method of claim 4 , wherein the oil component comprises diethyl sebacate and light mineral oil.

6. The method of claim 4 , wherein the oil component of the emulsion consists of diethyl sebacate and mineral oil.

7. The method of claim 1 , wherein said applying is carried out once per day for at least eight weeks.

8. The method of claim 1 , wherein said applying is carried out once per day for at least twelve weeks.

9. The method of claim 1 , wherein said applying is carried out once per day for twelve weeks.

10. The method of claim 1 , wherein the composition has a pH of about 4 to about 6.

11. A pharmaceutical composition for treating acne vulgaris, the composition consisting essentially of:

tazarotene or a pharmaceutically acceptable tazarotenic acid salt present in the composition at a concentration of 0.045 percent by weight of the composition;

a liquid oil component; and

an aqueous component;

wherein said composition is an oil-in-water emulsion and is formulated as a lotion, and

wherein the tazarotene or tazarotenic acid salt is dissolved in the liquid oil component.

Assignments (12)
U.S. PATENT SECURITY AGREEMENT Recorded Nov 25, 2025
From: BAUSCH HEALTH IRELAND LIMITED
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 073715/0375 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
Reel/Frame 073654/0300 →
RELEASE OF SECURITY INTEREST Recorded Apr 8, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH IRELAND LIMITED (F/K/A/ VALEANT PHARMACEUTICALS IRELAND LIMITED); SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; HUMAX PHARMACEUTICAL S.A.; SOLTA MEDICAL IRELAND LIMITED; BAUSCH & LOMB MEXICO, S.A. DE C.V.; BAUSCH+LOMB OPS B.V.; BAUSCH HEALTH AMERICAS, INC.; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH HOLDCO LIMITED; BAUSCH HEALTH MAGYARORSZAG KFT (A/K/A BAUSCH HEALTH HUNGARY LLC); BAUSCH HEALTH POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA (F/K/A VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA); BAUSCH HEALTH US, LLC; BAUSCH HEALTH, CANADA INC. / SANTE BAUSCH, CANADA INC.; ICN POLFA RZESZOW SPOLKA AKCYJNA (A/K/A ICN POLFA RZESZOW S.A.); ORAPHARMA, INC.; PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA SPOLKA AKCYJNA (A/K/A PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S.A.); SOLTA MEDICAL DUTCH HOLDINGS B.V.; V-BAC HOLDING CORP.; VRX HOLDCO LLC; 1261229 B.C. LTD.; 1530065 B.C. LTD.
Reel/Frame 070778/0199 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Nov 4, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 062078/0276 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Nov 4, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061882/0708 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Oct 5, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061606/0468 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Oct 4, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061595/0066 →
SECURITY INTEREST Recorded Sep 16, 2022
From: BAUSCH HEALTH IRELAND LIMITED; SANTARUS, INC.; SOLTA MEDICAL IRELAND LIMITED
To: BARCLAYS BANK PLC
Reel/Frame 061122/0855 →
SECURITY INTEREST Recorded Sep 16, 2022
From: BAUSCH HEALTH IRELAND LIMITED; SANTARUS, INC.; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON
Reel/Frame 061122/0879 →
SECURITY INTEREST Recorded Jun 13, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON
Reel/Frame 060346/0705 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 27, 2022
From: BAUSCH HEALTH US, LLC
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 060038/0057 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2022
From: ANGEL, ARTURO; PILLAI, RADHAKRISHNAN
To: BAUSCH HEALTH US, LLC
Reel/Frame 059578/0579 →
Continuity (4)
Continuation 16179561 · Nov 2, 2018
Continuation In Part 15977088 · May 11, 2018
Provisional Application 62505421 · May 12, 2017
Related Publication 20220233439A1 · Jul 28, 2022