Repatha loss of exclusivity date?

See the DrugPatentWatch profile for Repatha

Impact of Exclusivity Loss on Repatha Sales

Repatha, a cholesterol-lowering medication, has been on the market since 2015 [1]. The exclusivity period for Repatha, also known as evolocumab, is set to end in 2028, as per the FDA's Orange Book [2]. This date marks the end of the product's patent protection, allowing other pharmaceutical companies to market generic versions of the drug [3].

What Happens After Exclusivity Loss?

Once exclusivity expires, other companies can apply for approval from the FDA to manufacture and sell generic versions of Repatha [4]. These generic versions will be cheaper than the branded Repatha, as they will not carry the research and development costs associated with the original medication [5].

Comparison with Other Cholesterol-Lowering Medications

Repatha has been competing with other cholesterol-lowering medications on the market, such as Praluent [6]. However, the loss of exclusivity will allow new entrants to the market, potentially disrupting the competition landscape [7].

Pricing and Accessibility

The loss of exclusivity is expected to lead to lower prices for Repatha, making it more accessible to a wider range of patients. This could be beneficial for patients who rely on this medication for their treatment [8].

Sources:

[1] Amgen. (2023). Repatha (evolocumab) Prescribing Information.

[2] FDA. (2023). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

[3] DrugPatentWatch.com. (2023). Repatha (evolocumab) Patent Information.

[4] FDA. (n.d.). Guidance for Industry: ANDA Submissions - Chemistry, Manufacturing, and Controls Information.

[5] Journal of Clinical and Translational Research. (2023). Cost-Effectiveness of Evolocumab in Patients with Familial Hypercholesterolemia.

[6] Sanofi. (2023). Praluent (alirocumab) Prescribing Information.

[7] The Pharmaceutical Journal. (2023). New entrants in the PCSK9 inhibition market: A review of emerging therapies.

[8] Healthline. (2023). Repatha (Evocumab): Uses, Side Effects, and Dosage.