JANUVIA^®

About JANUVIA^®

1. Marketed by Merck & Co
2. Dipeptidyl peptidase-4 (DPP-IV) inhibitor to treat type 2 diabetes

What to watch?

Will Merck settle with more generic filers? How many generic entrants will we see, and how quickly will prices erode for this top-selling drug?

Approvals

1. First U.S. approval date – October 16, 2006
2. First E.U. approval date – March 21, 2007

About JANUVIA^® in the market

1. In litigation in the United States, as of 2021
2. Blockbuster status due to its weight-neutral mechanism of action (MOA) and excellent safety and tolerability
3. According to the FDA, six ANDAs for generic versions of Januvia filed on the first day possible and eligibility for the 180-day generic drug exclusivity potentially shared by multiple companies
4. Eight tentative ANDA approvals and eight additional ANDA filings
5. According to Merck, with its sitagliptin patent settlement agreements, companies potentially able to bring their products to market in November 2026 or earlier under certain circumstances

U.S. market share analysis for competitors in the therapeutic area “Drugs used in diabetes”: prescription count

Source: Cortellis Generics Intelligence

U.S. market share analysis for competitors in the therapeutic area “Drugs used in diabetes”: dose units count

Source: Cortellis Generics Intelligence

Constraint date forecast:

1. U.S. 30-month stay expiries: 2022-2023
2. E.U. Supplementary protection certificate (SPC) expiries: 2022
3. Japan patent expiries: 2026

About Merck & Co

1. Main markets: oncology, vaccines, infectious diseases and cardiometabolic disorders
2. Additional products in their type 2 diabetes type II portfolio: STEGLUJAN® (ertugliflozin, sitagliptin phosphate), STEGLATRO® (ertugliflozin), SEGLUROMET® (ertugliflozin, metformin) and JANUMET® (sitagliptin, metformin) and its long- release version.
3. In April 2013, Merck & Co agreement to develop and commercialize Pfizer’s ertugliflozin, as well as ertugliflozin/metformin and ertugliflozin/sitagliptin combinations for type 2 diabetes worldwide, excluding Japan

Patient impact

Because DPP-IV inhibitors have excellent safety and tolerability profiles, physicians are willing to prescribe them as adjunctive therapy for a wide range of patients, including those with early-stage disease and elderly patients at risk of hypoglycemia.

They are also being increasingly used as a first-line option in patients who cannot tolerate metformin. However, cost is currently an issue, so physicians are frequently restricted to prescribing this drug class to patients who have already failed less-costly therapies such as metformin and the sulfonylureas.

Based on Cortellis data, API is excessively available, primarily from manufacturers in India and Mainland China.

Source: Cortellis Generics Intelligence

Source: Cortellis Generics Intelligence

Data current as of April 14, 2021