Generics for Lyrica, expanded by 60% in 3 years

₩19.8 billion in the third quarter of 2017 → ₩32 billion in the third quarter of this year... Full-scale expansion after patent expiration

Sales of Lyrica is slow,counterattack with low-dose, sustained-release formulations, but the results are still ongoing

Lyrica

The market for Pregabalin, a pain treatment drug for peripheral neuropathy, has expanded rapidly over the past three years.

 

The amount of outpatient prescriptions from ₩19.8 billion in the third quarter of 2017 increased 61% to ₩32 billion in three years.

 

It is an analysis that the growth of generics after the expiration of the patent has greatly contributed to the market expansion.

 

Pfizer tried to defend generics by releasing new low-dose products and sustained-release formulations, but sales of the original 'Lyrica' are not as good as expected.

 

According to the drug market research institute UBIST on the 4th, the market size of Pregabalin in the third quarter of this year reached 32 billion.

 

It increased by 9% from ₩29.4 billion in the third quarter of last year.

 

It is rapidly expanding since the third quarter of 2017.

 

It is confirmed that it is 61% larger than 3 years ago, compared to ₩19.8 billion in the third quarter of 2017.

 

In particular, the prescription performance of generics increased significantly during this period.

 

Pregabalin's prescription performance increased more than 10 times from ₩1.5 billion in the third quarter of 2017 to ₩15.2 billion in the third quarter of this year.

 

On the other hand, Lyrica decreased 9% from ₩18.3 billion to ₩16.7 billion over the same period.

 

Looking at the quarterly results for the past three years, it appears that prescription performance has been stagnant with approximately ₩16 billion to ₩17 billion.

 

Quarterly prescription performance of Lyrica and generics (Pregabalin) (Unit: ₩100 million, Source: UBIST)

Lyrica's patent expiration is the reason why this generic market has expanded rapidly since three years ago.

 

The core of this patent was the indication (application patent).

 

A patent dispute between the original company and the generic company continued over whether generic products could be used for 'treatment of peripheral and central neuropathic pain in adults'.

 

In the dispute that reached the Supreme Court, Pfizer finally won.

 

Generic companies have been releasing products one after another since Lyrica's PMS expired in 2011, but they were unable to achieve satisfactory results due to failure to secure indications.

 

Then, in August 2017, the use patent expired.

 

The prescription performance of generics has grown rapidly from this period.

 

generics for Lyrica, which had produced ₩1 billion in prescriptions until the third quarter of 2017, jumped to ₩4 billion in the fourth quarter of that year.

 

The share of generics in the entire Pregabalin market has also increased from less than 10% to 20%.

 

From 2018, the prescription performance of generics has increased sharply.

 

The generic share in the Pregabalin market exceeded 30% in the second quarter of 2018 and 40% in the third quarter of 2019.

 

In the third quarter of this year, the market share increased to 48%.

 

It is expected that this trend will overtake the original prescription amount as early as in the fourth quarter of this year.

 

By product, HK inno.N's Kabalin’s sales amounted to ₩3 billion, Daewoong Bio's Lyribear amounted to ₩1.2 billion, Hanmi's Prebalin, and Gabaneuro amounted to ₩700 million, and Samjin's Neurocover-PG amounted to ₩600 million.

 

The market's explosive growth didn’t reduce the popularity of generics for Lyrica.

 

Domestic companies have obtained generic licenses until recently, three years after patent expiration.

 

This year 17 pharmaceutical companies have received new approvals for 41 products.

 

This accounts for 12% of the 338 generics.

 

Quarterly share of Lyrica & generics (unit: ₩100 million, data:UBIST)

Pfizer, the original company, came up with various strategies to prepare for competition with generic companies after Lyrica’s patent expiration.

 

In February 2018, it was granted a low-dose product, and in July 2018, it was granted a sustained-release formulation in line with the patent expiration.

 

However, it is observed that such a strategy is not very good yet.

 

Only in the fourth quarter of last year, sustained-release formulation achieved only ₩100 million.

 

In the third quarter of this year, only ₩160 million worth of prescriptions were prescribed.