SHARON FAITH LEVY
Medical Practice in Philadelphia, PA

2011026, Oct 27, 2011

Jul 18, 2011

13/184579

Michael T. Nordsiek - Wayne PA, US
Sharon F. Levy - Philadelphia PA, US
James H. Lee - Devon PA, US
James H. Kulp - West Chester PA, US
Kodumudi S. Balaji - Lansdale PA, US
Tze-Chiang Meng - Lino Lakes MN, US
Jason J. Wu - Wayne PA, US
Valyn S. Bahm - Phoenixville PA, US
Robert Babilon - Boyertown PA, US

Graceway Pharmaceuticals, LLC. - Bristol TN

A61K 31/4745, A61P 17/00, A61P 35/00

514293

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat actinic keratosis are also disclosed and described.

2011031, Dec 29, 2011

Jun 24, 2011

13/168796

Michael T. Nordsiek - Wayne PA, US
Sharon F. Levy - Philadelphia PA, US
James Hurn-Joung Lee - St. Paul MN, US
James H. Kulp - West Chester PA, US
Tze-Chiang Meng - Lino Lakes MN, US
Jason J. Wu - Wayne PA, US
Robert Babilon - Boyertown PA, US
Kodumudi S. Balaji - Lansdale PA, US
Valyn S. Bahm - Phoenixville PA, US

A61M 37/00

604 22

The present invention is directed to the use of complementary or combination lesion-directed therapy, such as cryosurgery, and field-directed therapy, such as low dose imiquimod topical therapy with short durations, in combination to treat actinic keratosis (“AK”). In carrying out the present invention, the lesion-directed and field-directed therapies may be applied sequentially or concomitantly, in accordance with the present invention. The novel complementary or combination AK therapy contemplated by the present invention: (1) significantly improves clearance of cryosurgery-treated Aks; (2) treats subclinical AK lesions; (3) treats those visible AK lesions in excess of that cryosurgery can actually treat in a single treatment due to, e.g., patient tolerance, provider treatment limits and/or cryosurgery cost to the patient; and (4) enhances sustained clearance overall, as compared to mono AK lesion-directed therapy.

2011002, Jan 27, 2011

Dec 11, 2009

12/636613

Michael T. Nordsiek - Berwyn PA, US
Sharon F. Levy - Philadelphia PA, US
James H. Lee - Devon PA, US
James H. Kulp - West Chester PA, US
Kodumudi S. Balaji - Downingtown PA, US
Tze-Chiang Meng - Lino Lakes MN, US
Jason J. Wu - Wayne PA, US
Valyn J. Bahm - Phoenixville PA, US
Robert Babilon - Boyertown PA, US

Graceway Pharmaceuticals, LLC - Bristol TN

A61K 31/4745, A61P 17/12

514293

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat actinic keratosis are also disclosed and described.

2012028, Nov 15, 2012

Jul 26, 2012

13/559473

Michael T. NORDSIEK - Wayne PA, US
Sharon F. LEVY - Philadelphia PA, US
James H. LEE - Devon PA, US
James H. KULP - West Chester PA, US
Kodumudi S. BALAJI - Lansdale PA, US
Tze-Chiang MENG - Lino Lakes MN, US
Jason J. WU - Wayne PA, US
Valyn S. BAHM - Phoenixville PA, US
Robert BABILON - Boyertown PA, US

MEDICIS PHARMACEUTICAL CORPORATION - Scottsdale AZ

A61K 31/4745, A61P 17/12, A61P 15/00

514293

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5 c]quinolin-4-amine, i.e., imiquimod, to treat genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available for Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat genital/perianal warts are also disclosed and described.

2011020, Aug 25, 2011

Apr 30, 2010

12/771076

Michael T. Nordsiek - Berwyn PA, US
Sharon F. Levy - Philadelphia PA, US
James H. Lee - Devon PA, US
James H. Kulp - West Chester PA, US
Kodumudi S. Balaji - Downingtown PA, US
Tze-Chiang Meng - Lino Lakes MN, US
Jason J. Wu - Wayne PA, US
Valyn S. Bahm - Phoenixville PA, US
Robert Babilon - Boyertown PA, US

Graceway Pharmaceuticals, LLC. - Bristol TN

A61K 31/4745, A61P 17/12

514293

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5 c]quinolin-4-amine, i.e., imiquimod, to treat genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat genital/perianal warts are also disclosed and described.

2012032, Dec 27, 2012

Jun 26, 2012

13/533913

Michael T. Nordsiek - Berwyn PA, US
Sharon F. Levy - Philadelphia PA, US
James H. Lee - Devon PA, US
James H. Kulp - West Chester PA, US
Kodumudi S. Balaji - Downingtown PA, US
Tze-Chiang Meng - Lino Lakes MN, US
Jason J. Wu - Wayne PA, US
Valyn S. Bahm - Phoenixville PA, US
Robert Babilon - Boyertown PA, US

Medicis Pharmaceutical Corporation - Scottsdae AZ

A61K 31/4745, A61P 17/12

514293

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat genital/perianal warts are also disclosed and described.

2011025, Oct 20, 2011

Jul 8, 2011

13/179315

Michael T. Nordsiek - Wayne PA, US
Sharon F. Levy - Philadelphia PA, US
James H. Lee - Devon PA, US
James H. Kulp - West Chester PA, US
Kodumudi S. Balaji - Lansdale PA, US
Tze-Chiang Meng - Lino Lakes MN, US
Jason J. Wu - Wayne PA, US
Valyn S. Bahm - Phoenixville PA, US
Robert Babilon - Boyertown PA, US

A61K 31/437, A61P 17/12

514293

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat actinic keratosis are also disclosed and described.

2012032, Dec 27, 2012

Jul 26, 2012

13/559444

Michael T. NORDSIEK - Wayne PA, US
Sharon F. LEVY - Philadelphia PA, US
James H. LEE - Devon PA, US
James H. KULP - West Chester PA, US
Kodumudi S. BALAJI - Lansdale PA, US
Tze-Chiang MENG - Lino Lakes MN, US
Jason J. WU - Wayne PA, US
Valyn S. BAHM - Phoenixville PA, US
Robert BABILON - Boyertown PA, US

MEDICIS PHARMACEUTICAL CORPORATION - Scottsdale AZ

A61K 31/437, A61P 17/12

514293

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5c]quinolin-4-amine, i.e., imiquimod, to treat genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available for Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat genital/perianal warts are also disclosed and described.

2002000, Jan 24, 2002

Dec 20, 2000

09/741585

Raymond Tobey - Radnor PA, US
Sharon Levy - Philadelphia PA, US

A61K009/16, A61K009/50

424/497000

A composition and method of treatment of dermatological disorders using 5-fluorouracil at levels below about 1.0%. The disorders to be treated include actinic keratosis, non-malignant lesions of the skin and psoriasis.