Table q1_q4_2020_prescription_drugs_wac

Table: q1_q4_2020_prescription_drugs_wac_increases , manufacturer_name like Z*

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 *

oshpd_id	manufacturer_name	date_reported	ndc_number	drug_product_description	wac_effective_date	wac_increase_amount	wac_after_increase	patent_expiration_date	drug_source_type	unit_sales_volume_in_us	unit_sales_volume_non_public_indicator	cost_increase_factors	cost_increase_factors_non_public_indicator	change_improvement_description	change_improvement_non_public_indicator	acquisition_date	company_acquired_from	acquisition_price	acquisition_price_non_public_indicator	acquisition_price_comment	wac_at_acquisition	wac_year_prior_to_acquisition	year_drug_introduced_to_market	wac_at_intro_to_market	supporting_documents	general_comments
Rx0000163	Zyla Life Sciences	03/31/2020	42211020329	Diclofenac 18 MG Capsule 90 EA	01/01/2020	64.35	714.35	04/23/2030	Innovator Multiple Source Drug	11374	None	None	1	None	1	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	383.05	350.14	2013	225.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 10/28/2013) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	42211020429	Diclofenac 35 MG Capsule 90 EA	01/01/2020	64.35	714.35	04/23/2030	Innovator Multiple Source Drug	82603	None	None	1	None	1	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	383.05	350.14	2013	225.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 10/28/2013) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	42211010111	Indomethacin Oral Suspension 25 mg per 5mL (237mL/Bottle)	01/01/2020	176.61	1960.57	None	Non-innovator Multiple Source Drug	4070	None	None	1	None	1	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	891.98	891.98	1985	232.17	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 4/2/2013) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	42211010243	Indomethacin Suppository 50mg per suppository (30 Suppository/Box)	01/01/2020	504.90	5604.90	None	Non-innovator Multiple Source Drug	12256	None	None	1	None	1	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 #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 4/2/2013) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	42211020623	Meloxicam 10 MG Capsule 30 EA	01/01/2020	77.70	862.57	03/31/2035	Innovator Multiple Source Drug	26446	None	None	1	None	1	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	784.87	717.43	2015	594.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 11/30/2015) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	42211020523	Meloxicam 5 MG Capsule 30 EA	01/01/2020	77.70	862.57	03/31/2035	Innovator Multiple Source Drug	5490	None	None	1	None	1	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	784.87	717.43	2015	594.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 11/30/2015) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	69344010101	Oral Suspension Indocin 25 mg per 5mL (237mL/Bottle)	01/01/2020	176.61	1960.57	None	Non-innovator Multiple Source Drug	4070	None	None	1	None	1	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	891.98	891.98	1985	232.17	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 4/2/2013) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively. Lastly, Zyla notes that this NDC represents the same product as 42211010111. Zyla changed the NDC of this product in the second half of 2019 from beginning with 42211 (Iroko labeler name) to 69344 (Zyla labeler name). Zyla only took one price increase on this product while under its new NDC; however, in an effort to be fully transparent, Zyla provided the same information for this NDC on the 5 year history as it provided for the 42211010111 NDC.
Rx0000163	Zyla Life Sciences	03/31/2020	69344011311	Oxaydo 5 mg/1 Tablet (100 per Bottle)	01/01/2020	72.70	807.04	03/16/2025	Innovator Multiple Source Drug	10966	None	None	1	None	1	01/07/2015	Acura Pharmaceuticals, Inc.	7500000	None	In addition to the upfront cash payment of $7.5M, Egalet US Inc. is also required to pay royalty of single-digit to double-digit percent based on sales thresholds. Upfront acquisition payment also does not include the following additional expenses associated with the purchase and ongoing maintenance of the product: - Significant sales milestone payments - Significant post-marketing requirement and development costs - Debt burden, maintenance and servicing costs to finance the original purchase - Second debt burden, maintenance and servicing costs, along with additional royalty payments on sales, associated with financing ongoing operations - Commercial infrastructure costs - Intellectual Property litigation and maintenance costs - Costs to comply with regulatory requirements - Co-payment assistance program utilization costs - Manufacturing costs	425.00	None	2011	425.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 9/11/2015) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	69344021311	Oxaydo 7.5mg/1 Tablet (100 per Bottle)	01/01/2020	108.93	1209.24	03/16/2025	Innovator Multiple Source Drug	4892	None	None	1	None	1	01/07/2015	Acura Pharmaceuticals, Inc.	7500000	None	In addition to the upfront cash payment of $7.5M, Egalet US Inc. is also required to pay royalty of single-digit to double-digit percent based on sales thresholds. Upfront acquisition payment also does not include the following additional expenses associated with the purchase and ongoing maintenance of the product: - Significant sales milestone payments - Significant post-marketing requirement and development costs - Debt burden, maintenance and servicing costs to finance the purchase - Second debt burden, maintenance and servicing costs, along with additional royalty payments on sales, associated with financing ongoing operations - Commercial infrastructure costs - Intellectual Property litigation and maintenance costs - Costs to comply with regulatory requirements - Co-payment assistance program utilization costs - Manufacturing costs	638.00	None	2011	638.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 9/11/2015) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	69344014463	Sprix 15.75mg/1 Spray, Metered (1 Bottle)	01/01/2020	35.38	392.70	None	Innovator Multiple Source Drug	None	1	None	1	None	1	01/08/2015	Luitpold Pharmaceuticals, Inc.	7000000	None	In addition to the upfront cash payment of $7M, Egalet US Inc. is also required to pay a fixed, single-digit royalty on net sales. Upfront acquisition payment also does not include the following additional expenses associated with the purchase and ongoing maintenance of the product: - Transition services - Debt burden, maintenance and servicing costs to finance the purchase - Second debt burden, maintenance and servicing costs, along with additional royalty payments on sales, associated with financing ongoing operations commercial infrastructure costs - Intellectual Property litigation and maintenance costs - Costs to comply with regulatory requirements - Co-payment assistance program utilization costs - Component and manufacturing costs	282.60	None	2010	282.60	None	Comment on #8: This NDC, which is the single vial configuration of Sprix, was approved in the NDA as a marketable item; however, this has never been commercialized either by Zyla or by Luitpold, previously. There were zero sales of this NDC in 2019. The system would not allow Zyla to input "0" as a value. Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 9/15/2015) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	69344014443	Sprix 15.75mg/1 Spray, Metered (5 Bottles per Carton)	01/01/2020	176.88	1963.52	None	Innovator Multiple Source Drug	70680	None	None	1	None	1	01/08/2015	Luitpold Pharmaceuticals, Inc.	7000000	None	In addition to the upfront cash payment of $7M, Egalet US Inc. is also required to pay a fixed, single-digit royalty on net sales. Upfront acquisition payment also does not include the following additional expenses associated with the purchase and ongoing maintenance of the product: - Transition services - Debt burden, maintenance and servicing costs to finance the purchase - Second debt burden, maintenance and servicing costs, along with additional royalty payments on sales, associated with financing ongoing operations commercial infrastructure costs - Intellectual Property litigation and maintenance costs - Costs to comply with regulatory requirements - Co-payment assistance program utilization costs - Component and manufacturing costs	1413.00	None	2010	1413.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 9/15/2015) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively.
Rx0000163	Zyla Life Sciences	03/31/2020	69344010233	Suppository Indocin 50mg per suppository (30 Suppository/Box)	01/01/2020	504.90	5604.90	None	Non-innovator Multiple Source Drug	12256	None	None	1	None	1	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 #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 4/2/2013) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively. Lastly, Zyla notes that this NDC represents the same product as 42211010243. Zyla changed the NDC of this product in the second half of 2019 from beginning with 42211 (Iroko labeler name) to 69344 (Zyla labeler name). Zyla only took one price increase on this product while under its new NDC; however, in an effort to be fully transparent, Zyla provided the same information for this NDC on the 5 year history as it provided for the 42211010243 NDC.
Rx0000163	Zyla Life Sciences	03/31/2020	69344020623	Vivlodex 10 MG Capsule 30 EA	01/01/2020	77.70	862.57	03/31/2035	Innovator Multiple Source Drug	26446	None	None	1	None	1	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	784.87	717.43	2015	594.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 11/30/2015) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively. Lastly, Zyla notes that this NDC represents the same product as 42211020623. Zyla changed the NDC of this product in the second half of 2019 from beginning with 42211 (Iroko labeler name) to 69344 (Zyla labeler name). Zyla only took one price increase on this product while under its new NDC; however, in an effort to be fully transparent, Zyla provided the same information for this NDC on the 5 year history as it provided for the 42211020623 NDC.
Rx0000163	Zyla Life Sciences	03/31/2020	69344020523	Vivlodex 5 MG Capsule 30 EA	01/01/2020	77.70	862.57	03/31/2035	Innovator Multiple Source Drug	5490	None	None	1	None	1	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	784.87	717.43	2015	594.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 11/30/2015) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively. Lastly, Zyla notes that this NDC represents the same product as 42211020523. Zyla changed the NDC of this product in the second half of 2019 from beginning with 42211 (Iroko labeler name) to 69344 (Zyla labeler name). Zyla only took one price increase on this product while under its new NDC; however, in an effort to be fully transparent, Zyla provided the same information for this NDC on the 5 year history as it provided for the 42211020523 NDC.
Rx0000163	Zyla Life Sciences	03/31/2020	69344020329	Zorvolex 18 MG Capsule 90 EA	01/01/2020	64.35	714.35	04/23/2030	Innovator Multiple Source Drug	11374	None	None	1	None	1	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: - 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	383.05	350.14	2013	225.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 10/28/2013) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively. Lastly, Zyla notes that this NDC represents the same product as 42211020329. Zyla changed the NDC of this product in the second half of 2019 from beginning with 42211 (Iroko labeler name) to 69344 (Zyla labeler name). Zyla only took one price increase on this product while under its new NDC; however, in an effort to be fully transparent, Zyla provided the same information for this NDC on the 5 year history as it provided for the 42211020329 NDC.
Rx0000163	Zyla Life Sciences	03/31/2020	69344020429	Zorvolex 35 MG Capsule 90 EA	01/01/2020	64.35	714.35	04/23/2030	Innovator Multiple Source Drug	82603	None	None	1	None	1	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	383.05	350.14	2013	225.00	None	Comment on #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 - Zyla provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 10/28/2013) for #22 General Comment on report: Zyla Life Sciences US Inc. is not a profitable company; it has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2019, December 31, 2018 and 2017, Zyla reported a net loss of approximately $46.6 million, $95.5 million and $69.4 million, respectively. Lastly, Zyla notes that this NDC represents the same product as 42211020429. Zyla changed the NDC of this product in the second half of 2019 from beginning with 42211 (Iroko labeler name) to 69344 (Zyla labeler name). Zyla only took one price increase on this product while under its new NDC; however, in an effort to be fully transparent, Zyla provided the same information for this NDC on the 5 year history as it provided for the 42211020429 NDC.