| Rx0000163 |
Zyla Life Sciences |
06/30/2021 |
69344011311 |
OXAYDO (Oxycodone HCL Tablet) 5 MG 100 CT BOTTLE |
04/01/2021 |
79.90 |
886.94 |
03/16/2025 |
Single Source Drug |
3037 |
None |
Our pricing is guided by the value our products bring to patients and an understanding of the environment in which we operate. The following financial and nonfinancial factors, along with a narrative description and explanation of these factors, influenced our decisions to take a price action:
(1) Covering Operating Expenses. In order to maintain a commercial enterprise, our revenue, at a minimum, must cover operating expenses. We consider covering operating expenses in our decision around the pricing of our products.
(2) Recouping Development Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs, recoup the costs expended to develop our products. We consider covering development costs and expenses in our decision around the pricing of our products.
(3) Covering and Funding Acquisition Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs and developmental costs, cover the costs expended to acquire drug products. We consider covering acquisition costs in our decision around the pricing of our products.
(4) Supporting Investment in New Products. In order to maintain a commercial enterprise, we must invest money to develop and bring new products to market to help patients. We consider the costs to bring new products to market to meet unmet medical needs in our decisions around pricing our products.
(5) Supporting Investment in Existing Products. In order to maintain a commercial enterprise, we must invest money to improve our existing products to bring improved products to market to help patients. We consider the costs to improve our existing products in our decisions around the pricing of our products.
(6) Discounts and Rebates: We pay rebates and discounts to various stakeholders in the supply chain in connection with the sale of our products, including pharmacy benefits managers, health insurers and health plans, including government payors like California’s Medicaid program, as well as wholesalers and pharmacies. Collectively, these price concessions represent substantial dollars, and we consider them in our decisions around pricing our products.
(7) Inflation: We consider the rate of annual inflation in our decisions around pricing our products. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
This drug was not acquired in the past five years.
Comment re Year Introduced and WAC at Introduction: This product was acquired over 5 years ago, and despite utilizing reasonable efforts, certain historical data is unavailable to Assertio. The FDA Approval Date per the Orange Book is provided as Year Drug Introduced to Market (2011) and the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 9/11/2015) is provided as WAC at Introduction of $425.00. |
| Rx0000163 |
Zyla Life Sciences |
06/30/2021 |
69344021311 |
OXAYDO (Oxycodone HCL Tablet) 7.5 MG 100 CT BOTTLE |
04/01/2021 |
119.71 |
1328.95 |
03/16/2025 |
Single Source Drug |
7773 |
None |
Our pricing is guided by the value our products bring to patients and an understanding of the environment in which we operate. The following financial and nonfinancial factors, along with a narrative description and explanation of these factors, influenced our decisions to take a price action:
(1) Covering Operating Expenses. In order to maintain a commercial enterprise, our revenue, at a minimum, must cover operating expenses. We consider covering operating expenses in our decision around the pricing of our products.
(2) Recouping Development Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs, recoup the costs expended to develop our products. We consider covering development costs and expenses in our decision around the pricing of our products.
(3) Covering and Funding Acquisition Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs and developmental costs, cover the costs expended to acquire drug products. We consider covering acquisition costs in our decision around the pricing of our products.
(4) Supporting Investment in New Products. In order to maintain a commercial enterprise, we must invest money to develop and bring new products to market to help patients. We consider the costs to bring new products to market to meet unmet medical needs in our decisions around pricing our products.
(5) Supporting Investment in Existing Products. In order to maintain a commercial enterprise, we must invest money to improve our existing products to bring improved products to market to help patients. We consider the costs to improve our existing products in our decisions around the pricing of our products.
(6) Discounts and Rebates: We pay rebates and discounts to various stakeholders in the supply chain in connection with the sale of our products, including pharmacy benefits managers, health insurers and health plans, including government payors like California’s Medicaid program, as well as wholesalers and pharmacies. Collectively, these price concessions represent substantial dollars, and we consider them in our decisions around pricing our products.
(7) Inflation: We consider the rate of annual inflation in our decisions around pricing our products. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
This drug was not acquired in the past five years.
Comment re Year Introduced and WAC at Introduction: This product was acquired over 5 years ago, and despite utilizing reasonable efforts, certain historical data is unavailable to Assertio. The FDA Approval Date per the Orange Book is provided as Year Drug Introduced to Market (2011) and the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 9/11/2015) is provided as WAC at Introduction of $638.00. |
| Rx0000163 |
Zyla Life Sciences |
03/31/2021 |
69344014463 |
Sprix 15.75mg/1 Spray, Metered (1 Bottle) |
01/01/2021 |
27.49 |
420.19 |
None |
Innovator Multiple Source Drug |
None |
1 |
Our pricing is guided by the value our products bring to patients and an understanding of the environment in which we operate. The following financial and nonfinancial factors, along with a narrative description and explanation of these factors, influenced our decisions to take a price action:
(1) Covering Operating Expenses. In order to maintain a commercial enterprise, our revenue, at a minimum, must cover operating expenses. We consider covering operating expenses in our decision around the pricing of our products.
(2) Recouping Development Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs, recoup the costs expended to develop our products. We consider covering development costs and expenses in our decision around the pricing of our products.
(3) Covering and Funding Acquisition Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs and developmental costs, cover the costs expended to acquire drug products. We consider covering acquisition costs in our decision around the pricing of our products.
(4) Supporting Investment in New Products. In order to maintain a commercial enterprise, we must invest money to develop and bring new products to market to help patients. We consider the costs to bring new products to market to meet unmet medical needs in our decisions around pricing our products.
(5) Supporting Investment in Existing Products. In order to maintain a commercial enterprise, we must invest money to improve our existing products to bring improved products to market to help patients. We consider the costs to improve our existing products in our decisions around the pricing of our products.
(6) Discounts and Rebates: We pay rebates and discounts to various stakeholders in the supply chain in connection with the sale of our products, including pharmacy benefits managers, health insurers and health plans, including government payors like California’s Medicaid program, as well as wholesalers and pharmacies. Collectively, these price concessions represent substantial dollars, and we consider them in our decisions around pricing our products.
(7) Inflation: We consider the rate of annual inflation in our decisions around pricing our products. |
None |
None - see statement on cost increase factors |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
This drug was not acquired in the past five years.
Comment on data element #8: While this is an active NDC in the compendia, we did not have any sales of the single unit NDC. We attempted to put 0 in this field but the validation failed so based on guidance from CA we are indicating non-public in data element #9. There were no US Sales of this NDC in 2020. |
| Rx0000163 |
Zyla Life Sciences |
03/31/2021 |
69344014443 |
Sprix 15.75mg/1 Spray, Metered (5 Bottles per Carton) |
01/01/2021 |
137.45 |
2100.97 |
None |
Innovator Multiple Source Drug |
36312 |
None |
Our pricing is guided by the value our products bring to patients and an understanding of the environment in which we operate. The following financial and nonfinancial factors, along with a narrative description and explanation of these factors, influenced our decisions to take a price action:
(1) Covering Operating Expenses. In order to maintain a commercial enterprise, our revenue, at a minimum, must cover operating expenses. We consider covering operating expenses in our decision around the pricing of our products.
(2) Recouping Development Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs, recoup the costs expended to develop our products. We consider covering development costs and expenses in our decision around the pricing of our products.
(3) Covering and Funding Acquisition Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs and developmental costs, cover the costs expended to acquire drug products. We consider covering acquisition costs in our decision around the pricing of our products.
(4) Supporting Investment in New Products. In order to maintain a commercial enterprise, we must invest money to develop and bring new products to market to help patients. We consider the costs to bring new products to market to meet unmet medical needs in our decisions around pricing our products.
(5) Supporting Investment in Existing Products. In order to maintain a commercial enterprise, we must invest money to improve our existing products to bring improved products to market to help patients. We consider the costs to improve our existing products in our decisions around the pricing of our products.
(6) Discounts and Rebates: We pay rebates and discounts to various stakeholders in the supply chain in connection with the sale of our products, including pharmacy benefits managers, health insurers and health plans, including government payors like California’s Medicaid program, as well as wholesalers and pharmacies. Collectively, these price concessions represent substantial dollars, and we consider them in our decisions around pricing our products.
(7) Inflation: We consider the rate of annual inflation in our decisions around pricing our products. |
None |
None - see statement on cost increase factors |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
This drug was not acquired in the past five years. |
| Rx0000163 |
Zyla Life Sciences |
03/31/2021 |
69344010233 |
Suppository Indocin 50mg per suppository (30 Suppository/Box) |
01/01/2021 |
554.89 |
6159.79 |
None |
Non-innovator Multiple Source Drug |
12432 |
None |
Our pricing is guided by the value our products bring to patients and an understanding of the environment in which we operate. The following financial and nonfinancial factors, along with a narrative description and explanation of these factors, influenced our decisions to take a price action:
(1) Covering Operating Expenses. In order to maintain a commercial enterprise, our revenue, at a minimum, must cover operating expenses. We consider covering operating expenses in our decision around the pricing of our products.
(2) Recouping Development Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs, recoup the costs expended to develop our products. We consider covering development costs and expenses in our decision around the pricing of our products.
(3) Covering and Funding Acquisition Costs. In order to maintain a commercial enterprise, our revenue, must, in addition to covering operating costs and developmental costs, cover the costs expended to acquire drug products. We consider covering acquisition costs in our decision around the pricing of our products.
(4) Supporting Investment in New Products. In order to maintain a commercial enterprise, we must invest money to develop and bring new products to market to help patients. We consider the costs to bring new products to market to meet unmet medical needs in our decisions around pricing our products.
(5) Supporting Investment in Existing Products. In order to maintain a commercial enterprise, we must invest money to improve our existing products to bring improved products to market to help patients. We consider the costs to improve our existing products in our decisions around the pricing of our products.
(6) Discounts and Rebates: We pay rebates and discounts to various stakeholders in the supply chain in connection with the sale of our products, including pharmacy benefits managers, health insurers and health plans, including government payors like California’s Medicaid program, as well as wholesalers and pharmacies. Collectively, these price concessions represent substantial dollars, and we consider them in our decisions around pricing our products.
(7) Inflation: We consider the rate of annual inflation in our decisions around pricing our products. |
None |
None - see statement on cost increase factors |
None |
01/31/2019 |
Iroko Pharmaceuticals, Inc. |
87000000 |
None |
What Zyla US Inc. has provided in Field #16 is an estimate of a portion of the purchase price of the product acquired from Iroko. This does not include the following additional costs totaling approximately $125M:
- Significant ongoing royalty payments on net sales
- Additional debt burden of $55M and royalty payments associated with this debt
- Cost of acquired inventory
- Bankruptcy restructuring costs in connection with acquisition
- Assumption of additional liabilities in connection with acquisition
- Post-marketing and development costs
- Commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Co-payment assistance program utilization costs
- Significant increase in manufacturing costs |
2550.00 |
2550.00 |
1984 |
309.62 |
None |
Comment on data elements #21 and #22: Zyla utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Zyla is unable to access WAC pricing for this product when introduced to the market. Therefore: Zyla provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #21 and Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 4/2/2013) for #22. |