| Laurus Generics Inc. |
42385093412 |
Lopinavir and Ritonavir Tablets 200mg/50mg 120ct |
2022-12-09 |
884.7600 |
None |
1 |
25000 |
None |
None |
None |
None |
None |
None |
This product was not acquired. Product shipments to begin in the next two weeks. Estimated number of patients may change as the FDA is reviewing the efficacy of this drug for treatment in covid patients. |
None |
| Laurus Generics Inc. |
42385092499 |
Pirfenidone Tablets, 267mg (3) 90ct bottles in one carton |
2022-12-24 |
2680.2800 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
This product was not acquired. Laurus is the ANDA approval owner. The number of patients to be served is unknown at this time and is estimated. |
None |
| Laurus Generics Inc. |
42385092590 |
Pirfenidone Tablets, 534mg 90CT |
2022-12-24 |
2680.2800 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
This product was not acquired. Laurus is the ANDA approval owner. The number of patients to be served is unknown at this time and is estimated. |
None |
| Laurus Generics Inc. |
42385092690 |
Pirfenidone Tablets, 801mg 90CT |
2022-12-24 |
2680.2800 |
None |
1 |
5000 |
None |
None |
None |
None |
None |
None |
This product was not acquired. Laurus is the ANDA approval owner. The number of patients to be served is unknown at this time and is estimated. |
None |
| LEO Pharma Inc. |
50222034602 |
Adbry (tralokinumab-ldrm); 150 mg/mL solution injection in a single-dose prefilled syringe with needle guard; one carton containing 2 prefilled syringes |
2022-02-01 |
1674.4000 |
Adbry (tralokinumab-ldrm) will be marketed to appropriate healthcare professionals (HCPs) and adult patients in the U.S.* with moderate-to-severe atopic dermatitis who are candidates for the treatment. Generally, marketing activities that support the launch of a new treatment are designed to raise awareness and understanding among HCPs and patients about the approved indication, efficacy, and safety data contained within the treatment’s FDA-approved label.
Specific marketing materials and activities used in the launch of the drug in the U.S. include: marketing materials, sales materials, digital advertisements through mobile and web-based platforms, digital patient brochures, third-party media channels and paid search, product-specific websites (www.AdbryHCP.com and www.Adbry.com), social media ads, banner ads, videos and video banners, professional congresses (including exhibit booths), and product speaker programs.
LEO Pharma does not expect to launch any direct-to-consumer marketing advertisements on television in 2022.
Consistent with industry practice relating to biologics and other specialty medicines, LEO Pharma also offers (including through third party service providers) patient support programs that are intended to facilitate a patient’s access to his/her/their medication as prescribed by the patient’s doctor. LEO Pharma does not consider those programs to be marketing or promotional activities.
*Adbry is only marketed by LEO Pharma in the U.S.; however the drug is marketed and sold by affiliates of LEO Pharma in countries outside the U.S. under a different brand name in accordance with the laws and regulations of the corresponding jurisdiction.
With respect to pricing plans, LEO Pharma is guided by a commitment to help advance the standard of care for people with skin diseases. Pricing decisions are intended to balance the need to continue to innovate and help patients who may be facing limited treatment options, while facilitating access to products for eligible patients. When establishing the wholesale acquisition cost of Adbry, LEO Pharma considered a range of financial and non-financial factors. These factors included, without limitation, the unique clinical value that Adbry offers as the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms[1], [2], [3]; the safety and efficacy profile of the drug; availability and accessibility of alternative therapies for the approved indication; patient access considerations, including the introduction of the Adbry Advocate Program to support U.S. patients at diagnosis and throughout treatment with Adbry; preclinical and ongoing clinical trials for the drug; anticipated rebates, discounts and other fees to be negotiated with supply chain partners, including wholesalers, distributors, and payers; manufacturing and marketing costs; available and resourced competitive market data, including market pricing and sales data; past and ongoing investments in R&D (including resources, infrastructure and organization) to support and build on the existing product portfolio while developing new and innovative therapies via a robust product pipeline; and licensing fees and royalty payments to its licensor.
[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf
[2] Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
[3] Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Ra1 and IL-13Ra2. J Mol Biol. 2017; 429:208–19. |
None |
1 |
None |
None |
2016-06-30 |
115000000.0000 |
None |
LEO Pharma A/S, an affiliate of LEO Pharma Inc., entered into a license agreement with AstraZeneca on June 30, 2016 for the exclusive, global rights to tralokinumab in atopic dermatitis and any future dermatology indications. Per the terms of the agreement, the company was required to pay AstraZeneca an upfront payment of $115 million, plus up to $1 billion in commercially-related milestones and tiered percentage royalties on product sales. |
With respect to column 7 (Estimated Number of Patients), Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. [1] According to the National Eczema Association, approximately 16.5 million adults in the United States have AD, with nearly 6.6 million adults, or approximately 40%, affected by moderate or severe disease. [2], [3] LEO Pharma Inc. (LEO Pharma) does not know the specific number of patients who might meet the anticipated prescribing criteria for Adbry, or the volume of relevant patients who might be prescribed the product.
[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf
[2] National Eczema Association. (2022, March 1). Eczema Stats. https://nationaleczema.org/research/eczema-facts/
[3] Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590.
The wholesale acquisition cost (WAC) reflects the undiscounted list price to wholesalers without regard to prompt pay or other discounts, rebates, or other price reductions. The WAC may not represent actual costs to patients, payers and health systems and should not be considered a reflection of the actual transaction prices. The price paid by patients is often different than the WAC price, and most patients will not pay the WAC price. How much a patient will pay will depend on several factors, including the patient’s insurance coverage and any discount or other programs that the patient may be eligible to participate in.
LEO Pharma provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681. In providing this report, LEO Pharma does not waive, but expressly reserves, any and all rights, claims or legal challenges with respect to Cal. Health & Safety Code § 127681, and related legislation, and any implementing regulations thereto, LEO Pharma’s interpretation thereof and/or the application thereof to LEO Pharma and/or any other entity affiliated with LEO Pharma. |
None |
| LEO Pharma Inc. |
50222034604 |
Adbry (tralokinumab-ldrm); 150 mg/mL solution injection in a single-dose prefilled syringe with needle guard; two cartons (multipack) containing 4 prefilled syringes |
2022-02-01 |
3348.8000 |
Adbry (tralokinumab-ldrm) will be marketed to appropriate healthcare professionals (HCPs) and adult patients in the U.S.* with moderate-to-severe atopic dermatitis who are candidates for the treatment. Generally, marketing activities that support the launch of a new treatment are designed to raise awareness and understanding among HCPs and patients about the approved indication, efficacy, and safety data contained within the treatment’s FDA-approved label.
Specific marketing materials and activities used in the launch of the drug in the U.S. include: marketing materials, sales materials, digital advertisements through mobile and web-based platforms, digital patient brochures, third-party media channels and paid search, product-specific websites (www.AdbryHCP.com and www.Adbry.com), social media ads, banner ads, videos and video banners, professional congresses (including exhibit booths), and product speaker programs.
LEO Pharma does not expect to launch any direct-to-consumer marketing advertisements on television in 2022.
Consistent with industry practice relating to biologics and other specialty medicines, LEO Pharma also offers (including through third party service providers) patient support programs that are intended to facilitate a patient’s access to his/her/their medication as prescribed by the patient’s doctor. LEO Pharma does not consider those programs to be marketing or promotional activities.
*Adbry is only marketed by LEO Pharma in the U.S.; however the drug is marketed and sold by affiliates of LEO Pharma in countries outside the U.S. under a different brand name in accordance with the laws and regulations of the corresponding jurisdiction.
With respect to pricing plans, LEO Pharma is guided by a commitment to help advance the standard of care for people with skin diseases. Pricing decisions are intended to balance the need to continue to innovate and help patients who may be facing limited treatment options, while facilitating access to products for eligible patients. When establishing the wholesale acquisition cost of Adbry, LEO Pharma considered a range of financial and non-financial factors. These factors included, without limitation, the unique clinical value that Adbry offers as the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms[1], [2], [3]; the safety and efficacy profile of the drug; availability and accessibility of alternative therapies for the approved indication; patient access considerations, including the introduction of the Adbry Advocate Program to support U.S. patients at diagnosis and throughout treatment with Adbry; preclinical and ongoing clinical trials for the drug; anticipated rebates, discounts and other fees to be negotiated with supply chain partners, including wholesalers, distributors, and payers; manufacturing and marketing costs; available and resourced competitive market data, including market pricing and sales data; past and ongoing investments in R&D (including resources, infrastructure and organization) to support and build on the existing product portfolio while developing new and innovative therapies via a robust product pipeline; and licensing fees and royalty payments to its licensor.
[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf
[2] Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
[3] Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Ra1 and IL-13Ra2. J Mol Biol. 2017; 429:208–19. |
None |
1 |
None |
None |
2016-06-30 |
115000000.0000 |
None |
LEO Pharma A/S, an affiliate of LEO Pharma Inc., entered into a license agreement with AstraZeneca on June 30, 2016 for the exclusive, global rights to tralokinumab in atopic dermatitis and any future dermatology indications. Per the terms of the agreement, the company was required to pay AstraZeneca an upfront payment of $115 million, plus up to $1 billion in commercially-related milestones and tiered percentage royalties on product sales. |
With respect to column 7 (Estimated Number of Patients), Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. [1] According to the National Eczema Association, approximately 16.5 million adults in the United States have AD, with nearly 6.6 million adults, or approximately 40%, affected by moderate or severe disease. [2], [3] LEO Pharma Inc. (LEO Pharma) does not know the specific number of patients who might meet the anticipated prescribing criteria for Adbry, or the volume of relevant patients who might be prescribed the product.
[1] LEO Pharma Inc. (2022). Adbry (tralokinumab-ldrm): Prescribing Information. Retrieved from: https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf
[2] National Eczema Association. (2022, March 1). Eczema Stats. https://nationaleczema.org/research/eczema-facts/
[3] Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590.
The wholesale acquisition cost (WAC) reflects the undiscounted list price to wholesalers without regard to prompt pay or other discounts, rebates, or other price reductions. The WAC may not represent actual costs to patients, payers and health systems and should not be considered a reflection of the actual transaction prices. The price paid by patients is often different than the WAC price, and most patients will not pay the WAC price. How much a patient will pay will depend on several factors, including the patient’s insurance coverage and any discount or other programs that the patient may be eligible to participate in.
LEO Pharma provides this report consistent with its good faith understanding and interpretation of Cal. Health & Safety Code § 127681. In providing this report, LEO Pharma does not waive, but expressly reserves, any and all rights, claims or legal challenges with respect to Cal. Health & Safety Code § 127681, and related legislation, and any implementing regulations thereto, LEO Pharma’s interpretation thereof and/or the application thereof to LEO Pharma and/or any other entity affiliated with LEO Pharma. |
None |
| Lifestar Pharma LLC |
70756061756 |
Tobramycin Inhalation Solution, USP 300mg/4ml |
2022-09-22 |
2350.0000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
Not Acquired |
None |