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  • CREAM;TOPICAL - 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - 10MG/ML
  • SPRAY;TOPICAL - 0.147MG/GM
  • INJECTABLE;INJECTION - 40MG/ML
  • INJECTABLE;INJECTION - 80MG/ML
  • SPRAY, METERED;NASAL - 0.055MG/SPRAY
  • FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR - 32MG/VIAL
  • CREAM;TOPICAL - 0.025%
  • CREAM;TOPICAL - 0.1%
  • CREAM;TOPICAL - 0.5%
  • OINTMENT;TOPICAL - 0.025%
  • OINTMENT;TOPICAL - 0.1%
  • OINTMENT;TOPICAL - 0.5%

Details:

Triamcinolone Hexacetonide is a longest-acting corticosteroid for intra articular injection. The companies have agreed to a small upfront fee along with milestone payments at the time of FDA approval, at commercial product launch, and upon certain sales milestones.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Medexus Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement December 18, 2020

Details:

USFDA approved generic version of Triamcinolone Acetonide, a corticosteroid hormone receptor agonist ointment, which is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Dermatology Product Name: Triamcinolone Acetonide-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2020

Details:

USFDA approved generic version of Triamcinolone Acetonide Ointment which is a class of medications called corticosteroids. It is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Dermatology Product Name: Triamcinolone Acetonide-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 24, 2020

Details:

Harrow diversified its portfolio of branded pharmaceutical products by acquiring 5 ophthalmic products, Ilevro, Nevanac, Vigamox, Maxidex, and Triesence. Triamcinolone acetonide is a synthetic corticosteroid indicated for sympathetic ophthalmia, temporal arteritis and uveitis.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Rare Diseases and Disorders Product Name: Triesence

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Harrow

Deal Size: $130.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition November 29, 2023

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  • Development Update

Details:

KOURZEQ (triamcinolone acetonide dental paste USP, 0.1%) is an FDA-approved prescription medicine that is used to treat oral lesions, including canker sores in adults.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Immunology Product Name: Kourzeq

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 14, 2023

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Details:

Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use is a proprietary suspension of the corticosteroid triamcinolone acetonide for administration to the suprachoroidal space for the treatment of macular edema associated with uveitis.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 04, 2023

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Details:

Arcatus is a proprietary suspension of the corticosteroid triamcinolone acetonide for administration to the suprachoroidal space for the treatment of macular edema associated with uveitis and is referred as Xipere, approved in United States.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Arcatus

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Clearside Biomedical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 10, 2023

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Details:

Results with Xipere (triamcinolone acetonide) showed statistically significant reduction in tumor growth rate compared to each patient’s documented growth rate at study entry, and an 88.9% tumor control rate.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Bausch & Lomb Incorporated

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 04, 2022

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Details:

XIPERE® is a triamcinolone acetonide injectable suspension for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 06, 2022

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Details:

XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use, formerly known as CLS-TA, is a proprietary suspension of corticosteroid triamcinolone acetonide for administration to suprachoroidal space for treatment of macular edema associated with uveitis.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 05, 2022

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Details:

The commercialization of XIPERE® is an exciting step forward for the treatment of macular edema associated with uveitis, and also for increasing education and recognition of the suprachroidal space as a highly effective administration route for back-of-the-eye therapies.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Clearside Biomedical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 28, 2022

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Details:

The approved ANDA is therapeutically equivalent to the reference-listed drug product Nystatin and Triamcinolone Acetonide ointment, of strength 100,000 units/gram, used for the treatment of cutaneous candidiasis.


Lead Product(s): Nystatin,Triamcinolone Acetonide

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Aleor Dermaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 08, 2022

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Details:

Recent FDA approval of XIPERE™, first product approved for injection into the suprachoroidal space, and the first therapy approved for patients suffering from macular edema associated with uveitis.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 16, 2021

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Details:

XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 25, 2021

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Details:

This acquisition is a major milestone to build a robust offering of novel, non-opioid treatments to improve patient care along the neural pain pathway while simultaneously providing a complementary commercial asset in ZILRETTA for the treatment of OA knee pain.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Neurology Product Name: Zilretta

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Pacira BioSciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition October 11, 2021

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Details:

XIPERE, referred to as ARVN001 by Arctic Vision, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space (SCS®) using Clearside’s patented SCS Microinjector®.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Arctic Vision

Deal Size: Undisclosed Upfront Cash: $3.0 million

Deal Type: Licensing Agreement September 09, 2021

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Details:

Under the terms of the agreement, Harrow Health will have marketing rights for the U.S. and Canada, while Wakamoto Pharmaceuticals will retain MAQ-100 marketing rights in other countries. Wakamoto will supply Harrow with MAQ-100.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: MaQaid

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Harrow Health

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition August 18, 2021

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Details:

ARVN001 is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space (SCS®) through Clearside’s patented SCS Microinjector®.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Clearside Biomedical

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement August 15, 2021

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Details:

The virtual presentations will feature several of the company's prominent products from its pharmaceutical, surgical and vision care portfolios, including analyses on the company's investigational drug XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension).


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 29, 2021

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Details:

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram, of Taro Pharmaceuticals U.S.


Lead Product(s): Nystatin,Triamcinolone Acetonide

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 01, 2021

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Details:

Arctic Vision currently has three late-stage in-licensed products: ARVN001 for uveitic macular edema (UME), ARVN002 for pediatric progressive myopia and ARVN003 for presbyopia.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: ARVN001

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Loyal Valley Capital

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing March 10, 2021

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Details:

Clearside also announced that data from the Company’s Phase 2 clinical trial in diabetic macular edema (DME) was published in Ophthalmology Retina. The trial evaluated the investigational drug XIPERE™ used with intravitreally administered aflibercept in patients with DME.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Xipere

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 23, 2020

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Details:

Triamcinolone Hexacetonide Injectable Suspension 20 mg/mL (TH) has been approved for inclusion as a general benefit (open listing) on the List of Medications- Institutions administered by the Régie de l’assurance maladie du Québec (RAMQ), effective August 19, 2020.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2020

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Details:

TH is the longest acting corticosteroid for intra-articular injection, often lasting twice as long as comparator products.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 09, 2020

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Details:

Under the amended deal, Bausch + Lomb has now been granted exclusive options for the right to commercialize and develop XIPERE in Europe and the U.K, Australia, New Zealand, South America and Mexico.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Bausch + Lomb

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement April 28, 2020

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Details:

The data demonstrated that patients with noninfectious uveitis in the XIPERE study arm experienced clinically significant improvement in vision relative to the control arm.


Lead Product(s): Triamcinolone Acetonide

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 28, 2020

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