| Neurelis |
72252051005 |
Valtoco 10 MG Dose Nasal Liquid 10 MG/0.1ML 5 per box |
2025-03-17 |
1829.6800 |
None |
1 |
180000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Neurelis |
72252051510 |
Valtoco 15 MG Dose Nasal Liquid Therapy Pack 2 x 7.5 MG/0.1ML 5 per box |
2025-03-17 |
1829.6800 |
None |
1 |
180000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Neurelis |
72252052010 |
Valtoco 20 MG Dose Nasal Liquid Therapy Pack 2 x 10 MG/0.1ML 5 per box |
2025-03-17 |
1829.6800 |
None |
1 |
180000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Neurelis |
72252050505 |
Valtoco 5 MG Dose Nasal Liquid 5 MG/0.1ML 5 per box |
2025-03-17 |
1829.6800 |
None |
1 |
180000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Neurotech Pharmaceuticals, Inc. |
82958050101 |
ENCELTO (revakinagene taroretcel-lwey, 82958-501-01), a single-dose implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF for intravitreal surgical placement. Opaque semi-permeable capsule. |
2025-03-24 |
250000.0000 |
None |
1 |
165000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Novo |
00169208015 |
ALHEMO (concizumab-mtci) injection 150 mg/1.5 mL (100 mg/mL); 1.5 mL in 1 prefilled pen |
2025-02-19 |
25800.0000 |
At ALHEMO’s® launch on February 19, 2025, Novo Nordisk Inc. (NNI) intends to focus marketing efforts on pediatric and adult hematologists and their support staff primarily, who are likely to manage a significant population of patients that are likely to benefit from ALHEMO®. NNI also will market ALHEMO® for patients for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors., as per ALHEMO® label.
NNI educates health care professionals (HCPs) about ALHEMO® through in-office detailing visits, educational programs, promotion at large conferences and conventions, and web-based mediums. NNI does not provide any gifts to health care professionals as such activity is strictly prohibited by company policy. NNI distributes educational materials to health care professionals regarding ALHEMO® which may include medical journal articles about the drug. NNI also offers product information as well as product starter kits through HCPs for patient use.
Novo Nordisk considers a range of financial and non-financial factors when setting prices for its products, including ALHEMO®. Those factors include:
Ensuring patient access through discounts, rebates, and fees provided to payers and purchasers: These factors, include, among other things, class of trade discounts in the distribution channel, rebates demanded by payers to maintain formulary access.
Operating costs and investment in research and development: The nature of medicine development makes costs very high and revenues from product sales allow the company to perform research and development, and to innovate. For every medicine that is approved and launched, there are significant financial resources expended on the many other drug candidates that do not progress and ultimately come to market. The company uses revenues to cover its various operating costs, including costs associated with education, disease awareness activities, medical information support, sales and marketing activities, patient affordability initiatives, and operating costs associated with compliance with legal and regulatory requirements.
Additional detail on the methodology used to establish the price of ALHEMO®: In general, Novo Nordisk conducts market research across payers, patients, and health care professionals when developing pricing for new products. That research includes evaluation of the factors identified above. For instance, when assessing the value of innovation specific to ALHEMO®, Novo Nordisk used the clinical evidence and the acceptance of treatment to help derive an appropriate price point that will optimize access for patients. The company also considered the clinical and economic value proposition, formulary access drivers, barriers for adoption and adherence, product differentiation, market dynamics, and treatment pathways and clinical guidelines. Novo Nordisk carefully balanced these factors to establish a price for ALHEMO®, rather than determining price from a specific insight or model. The company is committed to ensuring broad, affordable, unrestricted patient access for ALHEMO®. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
The U.S. Food and Drug Administration (FDA) granted Priority Review designation for ALHEMO® (concizumab-mtci) injection for prophylactic treatment of patients with hemophilia A and B with inhibitors. Because of the unmet medical needs in this population, and based on the Phase 2 clinicial trial results, the FDA granted Breakthrough Therapy designation for ALHEMO® in hemophilia B with inhibitors.
For the estimated patients per month requirement, Novo Nordisk utilizes product indication, targeted product profile, services, payer prior authorization requirements as well as the time factor to find the specialists managing undiagnosed patients and get them educated to estimate the number of patients who may be prescribed ALHEMO®. Novo Nordisk has estimated 2 patients per month or a total of 31 patients per year (approximately 25 HBwI patients and 6 HAwI patients) as the average number of patients who may be prescribed ALHEMO® each month in the United States. However, we note that the estimated prevalence of patients with hemophilia in the United States (US) is 33,000 between years 2012 and 2022 per the CDC. This includes both A and B subtypes. The prevalence of the two subtypes in hemophilia patients is approximately 20% have hemophilia B and 80% have hemophilia A. Overall, approximately 5% of each of these two cohorts will develop inhibitors. ALHEMO® is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. The indication for hemophilia B with inhibitors (HBwI) represents a significant unmet need for the prophylactic treatment of this disease. Since there are limited treatment options and given the small number of total patients affected with HBwI (approximately 1% of the total hemophilia population), we estimate a higher volume of HBwI patients in the US to receive ALHEMO® than HAwI patients, who may have other prophylactic medication treatment options available. Therefore, the estimated number of hemophilia patients who may be prescribed ALHEMO® is much less than the prevalence.
The full prescribing information for ALHEMO® is available at https://www.novo-pi.com/alhemo.pdf |
None |
| Novo |
00169208415 |
ALHEMO (concizumab-mtci) injection 60 mg/1.5 mL (40 mg/mL); 1.5 mL in 1 prefilled pen |
2025-02-19 |
10320.0000 |
At ALHEMO’s® launch on February 19, 2025, Novo Nordisk Inc. (NNI) intends to focus marketing efforts on pediatric and adult hematologists and their support staff primarily, who are likely to manage a significant population of patients that are likely to benefit from ALHEMO®. NNI also will market ALHEMO® for patients for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors., as per ALHEMO® label.
NNI educates health care professionals (HCPs) about ALHEMO® through in-office detailing visits, educational programs, promotion at large conferences and conventions, and web-based mediums. NNI does not provide any gifts to health care professionals as such activity is strictly prohibited by company policy. NNI distributes educational materials to health care professionals regarding ALHEMO® which may include medical journal articles about the drug. NNI also offers product information as well as product starter kits through HCPs for patient use.
Novo Nordisk considers a range of financial and non-financial factors when setting prices for its products, including ALHEMO®. Those factors include:
Ensuring patient access through discounts, rebates, and fees provided to payers and purchasers: These factors, include, among other things, class of trade discounts in the distribution channel, rebates demanded by payers to maintain formulary access.
Operating costs and investment in research and development: The nature of medicine development makes costs very high and revenues from product sales allow the company to perform research and development, and to innovate. For every medicine that is approved and launched, there are significant financial resources expended on the many other drug candidates that do not progress and ultimately come to market. The company uses revenues to cover its various operating costs, including costs associated with education, disease awareness activities, medical information support, sales and marketing activities, patient affordability initiatives, and operating costs associated with compliance with legal and regulatory requirements.
Additional detail on the methodology used to establish the price of ALHEMO®: In general, Novo Nordisk conducts market research across payers, patients, and health care professionals when developing pricing for new products. That research includes evaluation of the factors identified above. For instance, when assessing the value of innovation specific to ALHEMO®, Novo Nordisk used the clinical evidence and the acceptance of treatment to help derive an appropriate price point that will optimize access for patients. The company also considered the clinical and economic value proposition, formulary access drivers, barriers for adoption and adherence, product differentiation, market dynamics, and treatment pathways and clinical guidelines. Novo Nordisk carefully balanced these factors to establish a price for ALHEMO®, rather than determining price from a specific insight or model. The company is committed to ensuring broad, affordable, unrestricted patient access for ALHEMO®. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
The U.S. Food and Drug Administration (FDA) granted Priority Review designation for ALHEMO® (concizumab-mtci) injection for prophylactic treatment of patients with hemophilia A and B with inhibitors. Because of the unmet medical needs in this population, and based on the Phase 2 clinicial trial results, the FDA granted Breakthrough Therapy designation for ALHEMO® in hemophilia B with inhibitors.
For the estimated patients per month requirement, Novo Nordisk utilizes product indication, targeted product profile, services, payer prior authorization requirements as well as the time factor to find the specialists managing undiagnosed patients and get them educated to estimate the number of patients who may be prescribed ALHEMO®. Novo Nordisk has estimated 2 patients per month or a total of 31 patients per year (approximately 25 HBwI patients and 6 HAwI patients) as the average number of patients who may be prescribed ALHEMO® each month in the United States. However, we note that the estimated prevalence of patients with hemophilia in the United States (US) is 33,000 between years 2012 and 2022 per the CDC. This includes both A and B subtypes. The prevalence of the two subtypes in hemophilia patients is approximately 20% have hemophilia B and 80% have hemophilia A. Overall, approximately 5% of each of these two cohorts will develop inhibitors. ALHEMO® is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. The indication for hemophilia B with inhibitors (HBwI) represents a significant unmet need for the prophylactic treatment of this disease. Since there are limited treatment options and given the small number of total patients affected with HBwI (approximately 1% of the total hemophilia population), we estimate a higher volume of HBwI patients in the US to receive ALHEMO® than HAwI patients, who may have other prophylactic medication treatment options available. Therefore, the estimated number of hemophilia patients who may be prescribed ALHEMO® is much less than the prevalence.
The full prescribing information for ALHEMO® is available at https://www.novo-pi.com/alhemo.pdf |
None |
| Novo |
00169208103 |
ALHEMO (concizumab-mtci) injection 300 mg/3 mL (100 mg/mL); 3 mL in 1 prefilled pen |
2025-03-24 |
51600.0000 |
At ALHEMO’s® launch on February 19, 2025, Novo Nordisk Inc. (NNI) intends to focus marketing efforts on pediatric and adult hematologists and their support staff primarily, who are likely to manage a significant population of patients that are likely to benefit from ALHEMO®. NNI also will market ALHEMO® for patients for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors., as per ALHEMO® label.
NNI educates health care professionals (HCPs) about ALHEMO® through in-office detailing visits, educational programs, promotion at large conferences and conventions, and web-based mediums. NNI does not provide any gifts to health care professionals as such activity is strictly prohibited by company policy. NNI distributes educational materials to health care professionals regarding ALHEMO® which may include medical journal articles about the drug. NNI also offers product information as well as product starter kits through HCPs for patient use.
Novo Nordisk considers a range of financial and non-financial factors when setting prices for its products, including ALHEMO®. Those factors include:
Ensuring patient access through discounts, rebates, and fees provided to payers and purchasers: These factors, include, among other things, class of trade discounts in the distribution channel, rebates demanded by payers to maintain formulary access.
Operating costs and investment in research and development: The nature of medicine development makes costs very high and revenues from product sales allow the company to perform research and development, and to innovate. For every medicine that is approved and launched, there are significant financial resources expended on the many other drug candidates that do not progress and ultimately come to market. The company uses revenues to cover its various operating costs, including costs associated with education, disease awareness activities, medical information support, sales and marketing activities, patient affordability initiatives, and operating costs associated with compliance with legal and regulatory requirements.
Additional detail on the methodology used to establish the price of ALHEMO®: In general, Novo Nordisk conducts market research across payers, patients, and health care professionals when developing pricing for new products. That research includes evaluation of the factors identified above. For instance, when assessing the value of innovation specific to ALHEMO®, Novo Nordisk used the clinical evidence and the acceptance of treatment to help derive an appropriate price point that will optimize access for patients. The company also considered the clinical and economic value proposition, formulary access drivers, barriers for adoption and adherence, product differentiation, market dynamics, and treatment pathways and clinical guidelines. Novo Nordisk carefully balanced these factors to establish a price for ALHEMO®, rather than determining price from a specific insight or model. The company is committed to ensuring broad, affordable, unrestricted patient access for ALHEMO®. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
The U.S. Food and Drug Administration (FDA) granted Priority Review designation for ALHEMO® (concizumab-mtci) injection for prophylactic treatment of patients with hemophilia A and B with inhibitors. Because of the unmet medical needs in this population, and based on the Phase 2 clinicial trial results, the FDA granted Breakthrough Therapy designation for ALHEMO® in hemophilia B with inhibitors.
For the estimated patients per month requirement, Novo Nordisk utilizes product indication, targeted product profile, services, payer prior authorization requirements as well as the time factor to find the specialists managing undiagnosed patients and get them educated to estimate the number of patients who may be prescribed ALHEMO®. Novo Nordisk has estimated 2 patients per month or a total of 31 patients per year (approximately 25 HBwI patients and 6 HAwI patients) as the average number of patients who may be prescribed ALHEMO® each month in the United States. However, we note that the estimated prevalence of patients with hemophilia in the United States (US) is 33,000 between years 2012 and 2022 per the CDC. This includes both A and B subtypes. The prevalence of the two subtypes in hemophilia patients is approximately 20% have hemophilia B and 80% have hemophilia A. Overall, approximately 5% of each of these two cohorts will develop inhibitors. ALHEMO® is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. The indication for hemophilia B with inhibitors (HBwI) represents a significant unmet need for the prophylactic treatment of this disease. Since there are limited treatment options and given the small number of total patients affected with HBwI (approximately 1% of the total hemophilia population), we estimate a higher volume of HBwI patients in the US to receive ALHEMO® than HAwI patients, who may have other prophylactic medication treatment options available. Therefore, the estimated number of hemophilia patients who may be prescribed ALHEMO® is much less than the prevalence.
The full prescribing information for ALHEMO® is available at https://www.novo-pi.com/alhemo.pdf |
None |
| Nuvaila US, LLC |
84612039901 |
AMJEVITA 20mg/0.2ml PREFILLED SYRINGE 1 Count |
2025-01-01 |
599.5000 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
4000000 |
None |
None |
2024-07-08 |
None |
1 |
Amjevita is manufactured pursuant to a private label distribution agreement executed on July 8, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). |
None |
| Nuvaila US, LLC |
84612048202 |
AMJEVITA 40mg/0.4ml AUTOINJECTOR 2 Count |
2025-01-01 |
1199.0000 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
4000000 |
None |
None |
2024-07-08 |
None |
1 |
Amjevita is manufactured pursuant to a private label distribution agreement executed on July 8, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). |
None |
| Nuvaila US, LLC |
84612047902 |
AMJEVITA 40mg/0.4ml PREFILLED SYRINGE 2 Count |
2025-01-01 |
1199.0000 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
4000000 |
None |
None |
2024-07-08 |
None |
1 |
Amjevita is manufactured pursuant to a private label distribution agreement executed on July 8, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). |
None |
| Nuvaila US, LLC |
84612048102 |
AMJEVITA 80mg/0.8ml AUTOINJECTOR 2 Count |
2025-01-01 |
2398.0000 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
4000000 |
None |
None |
2024-07-08 |
None |
1 |
Amjevita is manufactured pursuant to a private label distribution agreement executed on July 8, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (AMJEVITA). |
None |
| Nuvaila US, LLC |
84612006601 |
WEZLANA 130mg/26ml SINGLE DOSE VIAL 1 Count |
2025-01-01 |
1417.1600 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612007601 |
WEZLANA 45mg/0.5ml PREFILLED SYRINGE 1 Count |
2025-01-01 |
2784.2900 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612087601 |
WEZLANA 45mg/0.5ml PREFILLED SYRINGE 1 Count Standard |
2025-01-01 |
13782.2200 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612005501 |
WEZLANA 45mg/0.5ml SINGLE DOSE VIAL 1 Count |
2025-01-01 |
2784.2900 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612085501 |
WEZLANA 45mg/0.5ml SINGLE DOSE VIAL 1 Count Standard |
2025-01-01 |
13782.2200 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612008901 |
WEZLANA 90mg/ml PREFILLED SYRINGE 1 Count |
2025-01-01 |
5568.5700 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |
| Nuvaila US, LLC |
84612088901 |
WEZLANA 90mg/ml PREFILLED SYRINGE 1 Count Standard |
2025-01-01 |
27564.4200 |
Nuvaila’s marketing strategy will include a digital presence without direct marketing to prescribers or consumers. Nuvaila will maintain a global website as the primary information hub, provide a Co-pay program, and will create other compliant materials for use with PBMS, GPOs, distributors and pharmacies.
The prices of Nuvaila’s products reflect Nuvaila’s mission to provide lower-cost therapeutic alternatives for patients, the competitive landscape, and the price of the reference product. Additionally, Wezlana is offered at both a standard list price and low list price for certain formulations in alignment with the competitive landscape.
Nuvaila's marketing and pricing is for the United States only. Nuvaila does not distribute the product internationally. |
None |
3750000 |
None |
None |
2024-07-29 |
None |
1 |
Wezlana is manufactured pursuant to a private label distribution agreement executed on July 29, 2024. The terms of the agreement are considered trade secrets and/or not otherwise in the public domain or publicly available. |
Estimated patients in the United States with a condition that may be prescribed the drug annually. An estimate is provided for the product family (WEZLANA). |
None |