| Carnegie Pharmaceuticals LLC |
80005016108 |
E.E.S. 400 ORAL TABLET 400 MG |
2025-02-14 |
365.2100 |
None |
1 |
2138 |
None |
None |
2024-11-11 |
None |
1 |
The acquisition price is inclusive of all EES products on this submission and other erythromycin products not launched yet. |
None |
None |
| Carnegie Pharmaceuticals LLC |
80005015218 |
E.E.S. GRANULES ORAL SUSPENSION RECONSTITUTED 200 MG/5ML 100ML |
2025-02-14 |
376.2200 |
None |
1 |
7968 |
None |
None |
2024-11-11 |
None |
1 |
The acquisition price is inclusive of all EES products on this submission and other erythromycin products not launched yet. |
None |
None |
| Carnegie Pharmaceuticals LLC |
80005015334 |
E.E.S. GRANULES ORAL SUSPENSION RECONSTITUTED 200 MG/5ML 200ML |
2025-02-14 |
661.6300 |
None |
1 |
3194 |
None |
None |
2024-11-11 |
None |
1 |
The acquisition price is inclusive of all EES products on this submission and other erythromycin products not launched yet. |
None |
None |
| Carnegie Pharmaceuticals LLC |
80005015518 |
ERYPED 400 ORAL SUSPENSION RECONSTITUTED 400 MG/5ML 30 TABLETS |
2025-02-14 |
661.6200 |
None |
1 |
5003 |
None |
None |
2024-11-11 |
None |
1 |
The acquisition price is inclusive of all EES products on this submission and other erythromycin products not launched yet. |
None |
None |
| Celltrion USA, Inc. |
72606002901 |
STEQEYMA 130MG/26ML (5mg/mL) Injectable; Subcutaneous Vial |
2025-02-22 |
303.6800 |
Celltrion has used two consultant groups to collect market intel on the market space. Additionally, public media was used to understand how the payers and providers would perceive the biosimilar competition of this class due to multiple Ustekinumab biosimilars that were approved around the same time. One main factor to consider is how the originator delayed the biosimilar competition. |
None |
24000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606002701 |
STEQEYMA 45MG/0.5ML Injectable; Subcutaneous Single-dose prefilled syringe with safety guard |
2025-02-22 |
2088.2100 |
Celltrion has used two consultant groups to collect market intel on the market space. Additionally, public media was used to understand how the payers and providers would perceive the biosimilar competition of this class due to multiple Ustekinumab biosimilars that were approved around the same time. One main factor to consider is how the originator delayed the biosimilar competition. |
None |
24000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606002801 |
STEQEYMA 90MG/ML Injectable; Subcutaneous Single-dose prefilled syringe with safety guard |
2025-02-22 |
4176.4300 |
Celltrion has used two consultant groups to collect market intel on the market space. Additionally, public media was used to understand how the payers and providers would perceive the biosimilar competition of this class due to multiple Ustekinumab biosimilars that were approved around the same time. One main factor to consider is how the originator delayed the biosimilar competition. |
None |
24000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Celltrion USA, Inc. |
72606004006 |
ADALIMUMAB-AATY STARTER PACK 80 mg/0.8 ml |
2025-04-09 |
1557.0000 |
Adalimumab-aaty is a low WAC biosimilar product in the adalimumab class in this package configuration (auto-injector) and has been granted approval for eight indications: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis and Hidradenitis Suppurativa. As part of the determination to launch the unbranded generic of Adalimumab-aaty, Celltrion conducted extensive market research utilizing data established in the US and abroad. Based on this information along with the market competitiveness as well as establishing a convenient delivery system which provides patients with one of only a few FDA-approved adalimumab generics that has a high-concentration, citrate-free formulation. This formulation can reduce injection discomfort for patients with chronic conditions like rheumatoid arthritis, thereby improving adherence to treatment. |
None |
398619 |
None |
None |
None |
None |
None |
None |
None |
None |
| Chartwell Rx LLC |
62135077423 |
Promethazine HCL Oral Solution 6.25mg/5mL 20 x 10mL UD |
2025-02-18 |
2011.4200 |
None |
1 |
81000000 |
None |
None |
2023-06-28 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135077424 |
Promethazine HCL Oral Solution 6.25mg/5mL 20 x 5mL UD |
2025-02-18 |
1905.7100 |
None |
1 |
81000000 |
None |
None |
2023-06-28 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135088523 |
Lacosamide Oral Solution USP C-V 10mg/ml 20x10UD |
2025-02-26 |
1950.0000 |
None |
1 |
198000 |
None |
None |
2023-09-21 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135088524 |
Lacosamide Oral Solution USP C-V 10mg/ml 20x5UD |
2025-02-26 |
1925.0000 |
None |
1 |
198000 |
None |
None |
2023-09-21 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135094324 |
Memantine HCl Oral Solution 2MG/ML 20x5ML UD |
2025-03-24 |
1908.3300 |
None |
1 |
6900000 |
None |
None |
2022-09-22 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135080323 |
Acyclovir (Base) 200MG/5ML 20x20ML UD |
2025-03-26 |
1922.8300 |
None |
1 |
4000000 |
None |
None |
2023-08-04 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135080324 |
Acyclovir (Base) 200MG/5ML 20x5ML UD |
2025-03-26 |
1905.7100 |
None |
1 |
4000000 |
None |
None |
2023-08-04 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135018923 |
Albuterol (Sulfate) DAA Syrup Regular 2MG/5ML 20x20ML UD |
2025-04-07 |
1911.4200 |
None |
1 |
25000000 |
None |
None |
2020-11-25 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135018924 |
Albuterol (Sulfate) DAA Syrup Regular 2MG/5ML 20x5ML UD |
2025-04-07 |
1852.8500 |
None |
1 |
25000000 |
None |
None |
2020-11-25 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135070624 |
Lamivudine Oral Solution 10MG/ML 20x30ML UD |
2025-04-07 |
2000.0000 |
None |
1 |
2400000 |
None |
None |
2023-06-22 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135054024 |
Citalopram (Hydrobromide) 10MG/5ML 20x10ML UD |
2025-04-22 |
1911.4200 |
None |
1 |
21000000 |
None |
None |
2022-09-21 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135072924 |
Escitalopram Oxalate Oral Solution 5 MG/5ML 20x10ML UD |
2025-04-24 |
1975.0000 |
None |
1 |
68020000 |
None |
None |
2023-06-22 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135052024 |
Oxybutynin Chloride Solution 5 MG/5ML 20x5ML UD |
2025-04-24 |
1905.7100 |
None |
1 |
33000000 |
None |
None |
2022-03-24 |
None |
1 |
Chartwell acquired this ANDA file from the prior owner on the Acquisition Date stated in Section 10. ANDA was acquired as part of a bulk transaction for multiple ANDAs and no specific cost or value can be assigned to this particular ANDA. |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135096222 |
Phenobarbital Elixir 20MG/5ML 20x15ML UD |
2025-04-24 |
1985.4100 |
None |
1 |
3741100 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135096224 |
Phenobarbital Elixir 20MG/5ML 20x5ML UD |
2025-04-24 |
1895.1400 |
None |
1 |
3741100 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135096223 |
Phenobarbital Elixir 20MG/5ML 20x7.5ML UD |
2025-04-24 |
1942.7100 |
None |
1 |
3741100 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Chartwell Rx LLC |
62135043824 |
Tricitrates (Potassium Salt, Sodium Salt, Citric Acid) 550-500-334MG/5ML 20x5ML UD |
2025-04-30 |
1863.4200 |
None |
1 |
34010000 |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions: Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Chartwell believes is otherwise in the public domain or publicly available. Chartwell did not assume marketing functions from prior owner, and did not receive any historical data from the sellers of the ANDAs. |
None |
| Cintex Services LLC |
24470091740 |
ERGOTAMINE TARTRATE AND CAFFEINE (CAFFEINE; ERGOTAMINE TARTRATE) 100MG;1MG Oral Tablet, 40ct Bottle [Qty: 1] |
2025-03-27 |
980.0000 |
Cintex Services LLC determined the WAC by comparing it to the WAC pricing of other products currently available in the market for the same treatment. The WAC of Cintex Service's Ergotamine-Caffeine Oral Tablet 1-100 MG, 40ct bottle is priced 36.89% lower than branded comparator Ergomar NDC 70720-0120-20 marketed by Pangea Pharmaceuticals. Cintex Services LLC employs a tele-sales team to engage with neurology providers. Because the Cintex label already distributes a 100ct bottle of Ergotamine-Caffeine 1-100 MG Oral Tablets, there is an established market for this product. The 40-count bottle will enable pharmacies to dispense a single bottle, consistent with the approved indication and dosage for a one month supply. |
None |
39000000 |
None |
None |
None |
None |
None |
None |
US Patients Description: According to the National Institute of Neurological Disorders and Stroke (NINDS), an estimated 39 million Americans experience migraines each year. The American Academy of Neurology reported that 46% of patients were treated with prescription medicine. |
None |