Competition in generic drug markets: international progress and room for improvement, 2010-2021

Presented at CAHSPR 2024, May 14-16, 2024, at the CDA Symposium 2024, Sept. 4-6, 2024, and at the 2024 CAPT Conference, October 21-22, 2024

Étienne Gaudette, Mina Tadrous, Shirin Rizzardo, and Kevin R. Pothier

Introduction

Objective: Generic drugs play a pivotal role in global drug utilization and are essential for population health. This research aimed to compare the generic drug markets of a group of industrialized countries with similar pharmaceutical regulatory environments and study how competition has evolved in recent years.

Approach: We used international sales data to study the generic markets of Australia, Belgium, Canada, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States. For each year from 2010 to 2021, we compiled and contrasted metrics related to the competitivity of small molecule generic drugs in these countries.

Data

Sales data: The IQVIA MIDAS^® database (all rights reserved) was the primary source used for the analysis. MIDAS data reflects the national retail and hospital sectors in Canada and internationally, including payers in all market segments (public, private, and out-of-pocket). Data were aggregated at fiscal years (Apr. to Mar.).

Definitions: Drugs were defined as unique arrangements of pharmaceutical ingredients and strengths. A drug was considered off-patent in a given year if at least one country recorded a sale of a generic version in the source data. Unit prices were computed as sales, valued at manufacturer ex-factory list prices, divided by units.

Results

Generic availability improved internationally since 2010, but competition remained limited

• The proportion of off-patent drugs for which generics were available grew in all countries except Japan (Figure 1).
• In 9 of 13 countries, fewer than 50% of drugs had at least 2 generic options in 2021, meaning that a majority of drugs did not feature competing generics.
• Generic availability and competing generics were generally higher in countries with larger populations, with exceptions.

Figure 1. Distribution of off-patent drugs by number of generic manufacturers, 2010 and 2021

In all countries, the markets for most drugs were dominated

• In 2021, at least 70% of off-patent drugs in all countries had markets where a single manufacturer accounted for over 50% of sales, except for the US (Figure 2.A).
• Of the four countries with the lowest rates of market dominance, three were those with the largest populations: the US, Germany, and Japan. Sweden, whose approach to generics was characterized by strict mandatory generic substitution combined with a unique auction-like system,^{Footnote 1} had the third lowest rate.
• Belgium, Norway and the UK had rates above 90%.
• Market dominance was also common for a group of high-use and clinically relevant generics, although trends for these were more heterogenous (Figure 2.B).

Figure 2. Proportion of off-patent drugs with a single manufacturer accounting for >50% of units sold, 2010-2021

Lower generic prices were found in countries with a smaller market size

• List prices in Sweden, Australia and the Netherlands were below the international median for over 66% of the high-use generic products analyzed (Table 1).
• Except for the US, countries with larger population sizes did not consistently show lower prices than other countries.
• Japan had the fewest products in common with the other countries and only three of these were priced below the median. It traditionally had a very modest take-up of generics and only started introducing policies to bolster utilization in recent years.^{Footnote 2}

Table 1. International price rankings for high-use generics*, 2021

Ingredient (strength, formulation)	Country rank (1=lowest price)
	SWE	AUS	NLD	USA	BEL	ESP	DEU	GBR	NOR	ITA	FRA	CAN	JPN
% of country's prices below the international median (excluding blanks)	84%	75%	69%	59%	52%	52%	46%	45%	41%	31%	25%	24%	13%
Allopurinol (100MG, AAA Tablets)	1a	3a	9c	11c	4a	5a	2a	10c	8c	6a	7b	13c	12c
Amitriptyline (25MG, ABC FILM-CTD Tabs)	5a	4a	6b	9c	1a		8c	2a	3a		7c	11c	10c
Atorvastatin (20MG, ABC FILM-CTD Tabs)	1a	2a	3a	5a	8c	10c	4a	12c	6a	9c	7b	11c	13c
Carbidopa:levodopa (50MG+200MG, BAA RET.Tablets)	5a	8c	7c	6c		3a	9c	4a		2a	1a	10c
Citalopram (20MG, ABC FILM-CTD Tabs)	1a	5a	3a	2a	12c	9c	7c	4a	6a	10c	11c	8c
Clonazepam (500Y, AAA Tablets)	7c	8c	6a	3a	9c	1a	11c	12c	2a	5a		4a	10c
Clopidogrel (75MG, ABC FILM-CTD Tabs)	6a	4a	3a	2a	5a	12c	7b	1a	8c	11c	10c	9c	13c
Doxycycline (100MG, AAA Tablets)	6c	2a	10c	8c	4a		1a		7c	5a	3a	9c
Escitalopram (10MG, ABC FILM-CTD Tabs)	6a	5a	4a	1a	8c	10c	7b	3a	2a	11c	9c	12c	13c
Finasteride (5MG, ABC FILM-CTD Tabs)	1a	12c	4a	3a	11c	5a	9c	2a	6a	8c	10c	7c
Fluoxetine (20MG, ACA Capsules)	4a	6a	5a	2a	8c	3a	7c	1a	11c	10c	9c	12c
Fluticasone (50Y/DOSE, QGP N.TOP M-D LIQ)	6a		1a	3a	2a	7c	8c	9c	5a	12c	4a	11c	10c
Furosemide (40MG, AAA Tablets)	2a	1a	7c	5a	9c	11c	4a	6a	8c		10c	3a	12c
Gabapentin (300MG, ACA Capsules)	2a	6a	5a	1a	8c	3a	10c	9c	7c	12c	11c	4a
Hydrochlorothiazide (25MG, AAA Tablets)	5a	11c	4a	1a		12c	7c	3a	9c	10c	8c	2a	6a
Hydromorphone (10MG/1ML, FMA Ampoules INJ.)	3a	2a	5b	7c			8c	6c	4a			1a	9c
Hydroxychloroquine (200MG, ABC FILM-CTD Tabs)			3a	7c		6c	4a	2a		1a		5c	8c
Isotretinoin (20MG, ACA Capsules)	1a	3a	2a	12c	4a	5a	6a	8c	10c	7c	9c	11c
Latanoprost (50Y/1ML, NGB Drops eye)	3a	2a	4a	5a	1a	6a	11c	12c	8c	10c	7b	13c	9c
Levothyroxine sodium (50Y, AAA Tablets)	8c	11c	3a	13c	2a	1a	4a	9c	10c	6a	5a	7b	12c
Lorazepam (1MG, AAA Tablets)	5a	12c	9c	7b	6a	1a	8c	10c	13c	11c	2a	3a	4a
Metformin (500MG, ABC FILM-CTD Tabs)	1a	6a	7c	2a	5a		3a	10c	8c	9c	11c	4a	12c
Methylphenidate (10MG, BCA Retard Caps)	8c	6a	10c	12c	4a	1a	2a	11c	5a	3a	7c	9c
Metoprolol (100MG, AAA Tablets)		3a	5a	1a	8c	4a	2a	9c		6c	7c	10c
Mometasone (50Y/DOSE, QGP N.TOP M-D LIQ)	1a	9c	4a	13c	2a	8c	6a	7b	3a	12c	5a	10c	11c
Pantoprazole (40MG, ABD ENTERIC-CT Tab)	3a	1a	2a	4a	10c	12c	6a	5a	7c	11c	9c	8c
Propranolol (40MG, AAA Tablets)		1a	7c	9c	2a	4a	8c	6b	11c	5a	3a	10c
Quetiapine (50MG, BBC FILM-C Tab RET)	5a	2a	4a	9c	12c	6a	1a	13c	3a	10	8c	7b	11c
Ramipril (5MG, AAA Tablets)	2a	3a	4a		10c	8c	1a	9c	5a	7c	6c
Rosuvastatin (10MG, ABC FILM-CTD Tabs)	1a	5a	4a	6a	7b	13c	2a	3a	8c	9c	12c	10c	11c
Salbutamol (100Y/DOSE, RHQ CFC-FREE MDI)	4a		6a	12c	1a	3a	8c	2a	11c	5a	7c	9c	10c
Sertraline (50MG, ABC FILM-CTD Tabs)	1a	4a	2a	3a	10c	7c	8c	6a	11c	9c	5a		12c
Sumatriptan (50MG, ABC FILM-CTD Tabs)	1a	7b	2a	4a	6a	12c	9c	5a	3a	8c	10c	13c	11c
Valaciclovir (500MG, ABC FILM-CTD Tabs)	3a	4a	2a	1a	5a	9c	12c	13c	8c	10c	7b	6a	11c
Vancomycin (1G, FQD INF DRY Bottle)	10c	2a	8c	1a	9c	5a	3a		11c	6a	7c	12c	4a

^a Lower than the int'l median
^b Int'l median
^c Higher than the int'l median

Data source: MIDAS^® database, 2010-2021, IQVIA (all rights reserved).
*This group of drugs was assembled with the aim of offering a collection of clinically meaningful markets, as assessed by a pharmacist in the team, with enough buyers and time since the end of patent protection for competition to emerge and stabilize. The group accounted for 15.3% of all generic sales in the basket of countries in 2021.

Conclusions

While increases were found in the number of competing generics in most countries investigated, important cross-country differences remained, and most off-patent drugs were dominated by a single company in all countries in 2021. Larger populations were associated with lower rates of market dominance, but not with lower prices. Other factors such as the policy environment also appeared to play an important role. Policy efforts to further strengthen generic markets could have benefits for supply chain resiliency and access to medicines.

Limitations

Patent protection timelines may differ by country and authorized generics may record sales before a drug is off-patent. List prices were used for price comparisons and rankings of confidential discounted prices may differ from those shown.

Disclaimer

Although based in part on data provided by the Canadian Institute for Health Information (CIHI) or under license by IQVIA™, the statements, findings, conclusions, views and opinions expressed in this report are exclusively those of the PMPRB.