IP Library Patent Application 16822831
Patent Application
App. No. 16/822,831

TOPICAL COMPOSITIONS AND METHODS FOR TREATING ACNE VULGARIS

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Patent No.
US None
App. No.
16/822,831
Abstract

Topical pharmaceutical compositions comprise a combination of retinoid and an antibacterial agent. In particular, a topical composition comprises tretinoin and benzoyl peroxide. Such compositions are used for treating acne vulgaris.

Claims (20)

1 . A method of treating acne vulgaris, comprising: administering topically a therapeutically effective amount of a composition comprising tretinoin at a concentration of about 0.01-0.1 weight percent and benzoyl peroxide at a concentration of about 1-5 weight percent, to an affected area, at a frequency and for a period of time sufficient to treat said acne vulgaris; wherein said concentrations are based on weight percent of the composition, and said tretinoin and benzoyl peroxide are present together in the composition.

2 . The method of claim 1 ; wherein the tretinoin concentration is about 0.04-0.06 weight percent, and the benzoyl peroxide concentration is about 2-3 weight percent.

3 . The method of claim 1 ; wherein the tretinoin concentration is about 0.05 weight percent, and the benzoyl peroxide concentration is about 2.5 weight percent.

4 . The method of claim 1 ; wherein said administering is carried out 1 or 2 times daily for 1-24 weeks.

5 . The method of claim 3 ; wherein said administering is carried out once daily for 12 weeks.

6 . The method of claim 3 ; wherein said administering is carried out once daily for 24 weeks.

7 . The method of claim 3 ; wherein said composition is an admixture of a first composition comprising tretinoin and a second composition comprising benzoyl peroxide.

8 . The method of claim 7 ; wherein said first composition and said second composition are admixed substantially immediately prior to said administering.

9 . A topical pharmaceutical composition for treating acne vulgaris, comprising: tretinoin at a concentration of about 0.01-0.1 weight percent of the composition and benzoyl peroxide at a concentration of about 1-5 weight percent of the composition.

10 . The composition of claim 9 ; wherein the tretinoin concentration is about 0.04-0.06 weight percent of the composition, and the benzoyl peroxide concentration is about 2-3 weight percent of the composition.

11 . The composition of claim 9 ; wherein the tretinoin concentration is about 0.05 weight percent of the composition, and the benzoyl peroxide concentration is about 2.5 weight percent of the composition

12 . The composition of claim 9 ; wherein the composition is a gel.

13 . The composition of claim 12 ; wherein said gel is an aqueous gel.

14 . The composition of claim 9 ; wherein said composition comprises an admixture of a first amount of a first composition comprising tretinoin and a second mount of a second composition comprising benzoyl peroxide; wherein a tretinoin concentration of said first composition and a benzoyl peroxide concentration of said second composition are sufficient to provide tretinoin at about 0.05 weight percent and benzoyl peroxide at about 2.5 weight percent of said admixture.

15 . The composition of claim 14 ; wherein weights of said first amount and said second amount are approximately equal.

16 . The composition of claim 9 ; wherein said composition comprises an admixture of a first composition comprising tretinoin at a concentration of about 0.1 weight percent, and a second composition comprising benzoyl peroxide at a concentration of about 5 weight percent.

17 . The composition of claim 16 ; wherein the tretinoin of the composition is stable at 32 degrees C., for about 24 hours.

18 . The composition of claim 16 ; wherein the tretinoin of the composition is stable at 32 degrees C., for about 24 hours under room light condition.

19 . The composition of claim 16 ; wherein the tretinoin of the composition is stable at room condition for about 24 hours.

20 . The composition of claim 16 ; wherein more than 95 percent of the tretinoin of the composition remains after 24 hours at 32 degrees C. under room light.

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 (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 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 (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 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 →
SECURITY INTEREST Recorded Oct 5, 2021
From: BAUSCH & LOMB IRELAND LIMITED; BAUSCH HEALTH COMPANIES INC.; DR. GERHARD MANN CHEM.-PHARM. FABRIK GMBH; TECHNOLAS PERFECT VISION GMBH
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 057821/0800 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 30, 2021
From: PILLAI, RADHAKRISHNAN; BHATT, VARSHA D.
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 056725/0806 →
SECURITY INTEREST Recorded May 6, 2020
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, LTD; SALIX PHARMACEUTICALS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 052589/0884 →
SECURITY INTEREST Recorded May 6, 2020
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, LTD; SALIX PHARMACEUTICALS, INC.; SOLTA MEDICAL, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 052589/0813 →