Table: q1_q4_2020_prescription_drugs_intro_to_market , manufacturer_name like C*

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 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
CASPER PHARMA, LLC 70199002114 HELIDAC THERAPY CHEW/TAB/CAP 224 2020-06-24 966.0000 Casper Pharma engages in strategic marketing to create awareness and understanding with healthcare providers and pharmacies about the approved indication, efficacy and safety data contained within the drug's FDA approved label. We employ a comparative pricing model as compared to other H-Pylori therapies in the market. Our mission is to ensure a favorable patient cost benefit while also providing broad patient and market access. None 59000 None None 2017-07-18 0.0000 1 Trade Secret Additional Comments Relative to Estimated Number of Patients: 1. Per the attached Product Insert for HELIDAC, this therapy is indicated for treatment of H-Pylori & Duodenal Ulcers. 2. Out of total US population of ~340 Million, H-Pylori prevalence pool is ~35% which is about ~119 Million people. Source for estimates https://publichealth.arizona.edu/outreach/health-literacy-awareness/hpylori/prevalence#:~:text=pylori%20prevalence%20is%2060%20percent,those%20older%20than%2060%20years. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107911/ 3. Although there is wide prevalence of H-Pylori, only ~10% of the prevalent pool are symptomatic. There are high chances of misdiagnosis based on symptoms alone and often acid suppressants or OTCs are prescribed for prevention of ulcers. 4. Our source of the market data is the industry standard, IQVIA data. During the time period Dec 2018 to Nov 2019, there have been a total of 59,534 patients diagnosed and undergoing treatment for H Pylori, with a total of 61,748 prescriptions filled with a drug from the same therapeutic class. 5. Despite high incidence and wide prevalence, the treatment choice is limited by wide spread resistance to some of the drugs and also the availability of other multi drug regimens and OTCs. None
Celltrion USA, Inc. 72606055902 Busulfan Injection 60 mg/10 mL 2020-02-04 1496.0100 N/A - generic product None 33000 1 None None None None None Celltrion USA has confirmed that they are responsible for setting the WAC. Also, there are or may be other manufacturers selling these products under a different labeler code. None
Chiesi USA 10122010401 FERRIPROX tablets twice-a-day 1000mg 2020-07-02 8590.1500 None 1 650 None None None None None None Acquired while in development; Approved while owned by Chiesi USA. None
Cipla USA, Inc. 69097096453 Vigabatrin Powd Pack 500 MG, 50 Each, Unit-Dose, Box 2020-04-30 1337.0600 None 1 7500000 None 1 None None None None Product was not acquired None
Cipla USA, Inc. 69097082037 Plazomicin Sulfate IV Soln 500 MG/10ML (50 MG/ML) (Base Eq), 10 ML, Unit-Dose, Vial 2020-05-01 315.0000 None 1 20 None None None None None None Estimated number of patients is considered a trade secret and non-public information. This information is not generally known or disclosed publicly and is of a highly sensitive and competitive nature that are confidential and proprietary trade secrets. Cipla provides this information solely for purposes of compliance with applicable reporting requirements mandated by state law. Any authorized disclosure of this sensitive information would be against Cipla’s express objection and a misappropriation of Cipla’s trade secrets. None
Cipla USA, Inc. 69097082096 Plazomicin Sulfate IV Soln 500 MG/10ML (50 MG/ML) (Base Eq), 10 ML, Unit-Dose, Vial Qty 10 2020-05-01 3150.0000 None 1 20 None None None None None None Estimated number of patients is considered a trade secret and non-public information. This information is not generally known or disclosed publicly and is of a highly sensitive and competitive nature that are confidential and proprietary trade secrets. Cipla provides this information solely for purposes of compliance with applicable reporting requirements mandated by state law. Any authorized disclosure of this sensitive information would be against Cipla’s express objection and a misappropriation of Cipla’s trade secrets. None
Cipla USA, Inc. 69097050327 Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL 2020-05-23 3426.8400 None 1 1700 None None None None None None Drug was not acquired. Estimated number of patients is 1,700 per month None
Cipla USA, Inc. 69097066434 Icatibant Acetate Subcutaneous Solution 30 MG/3ML 2020-07-20 5083.2600 None 1 10000 None None None None None None Product not acquired None
Cipla USA, Inc. 69097032303 Dimethyl Fumarate Oral Capsule Delayed Release 240 MG 2020-09-25 2607.1600 None 1 1000000 None None None None None None Drug not acquired None
Cipla USA, Inc. 69097055203 Dimethyl Fumarate Starter Pack Oral Miscellaneous 120 & 240 MG 2020-09-25 2607.1600 None 1 1000000 None None None None None None Drug not acquired None
Cipla USA, Inc. 69097066468 Icatibant Acetate Subcutaneous Solution 30 MG/3ML 3x3ml 2020-11-03 15249.7800 None 1 10000 None None None None None None Product was not acquired None