Table: q1_q4_2023_prescription_drugs_intro_to_market , manufacturer_name like K*

A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z  *

manufacturer_name ndc_number drug_product_description drug_category drug_category_source date_introduced_to_market wac_at_introduction marketing_pricing_plan_description marketing_pricing_plan_non_public_indicator estimated_number_of_patients breakthrough_therapy_indicator priority_review_indicator acquisition_date acquisition_price acquisition_price_non_public_indicator acquisition_price_comment general_comments supporting_documents
Kesin Pharma Corporation 81033006620 Metronidazole Oral Suspension 500mg/5mL - 200mL Bottle Brand FDA 2023-10-16 545.0000 LIKMEZ will be promoted by our commercial field team to healthcare professionals to educate them on our product. We will use various means of promotion including in-office visits, virtual meetings, ad campaigns, and digital marketing. Kesin conducted extensive market research and analysis, including the competitive landscape, product development expenses, and operational costs forecasted to reach our determination of the launch pricing. None 72000 None None None None None None None None
Krystal Biotech, Inc. 82194051002 Vyjuvek Gel 5x10^9 PFU/mL Brand FDA 2023-07-07 24250.0000 Marketing plans: HCP and Patient websites, HCP detailing, conferences/seminars, journal reprints. Pricing methodology: Krystal Biotech developed Vyjuvek based on a need to address a treatment for a rare genetic disease; dystrophic epidermolysis bullosa (“DEB”). DEB affects approximately 3,000 patients in the US and over time, in patients with DEB, repeated blistering and fibrosis can lead to squamous-cell carcinoma, life-threatening infections and limb deformities. Development of this drug product led to the FDA granting the following designations: Orphan Drug, Fast Track, Regenerative Medicine Advance Therapy, Rare Pediatric Disease Priority Review and Priority Review designations. Considerable efforts were expended in drug development and research, as Vyjuvek is the first and only treatment that addresses the genetic cause of DEB. Given the rarity of the condition Vyjuvek treats, Krystal Biotech employed methodologies based on research and development costs, as well as the value this product brings to the limited patient population that is affected by DEB. The clinical research costs (past and future), the cost of manufacturing, distribution to the marketplace including administrative requirements, patient availability and access were all contributing factors that shaped Krystal Biotech determination of Vyjuvek's pricing. None 1000 None 1 None None None None None None