3. Revlimid

Revlimid bottle
Revlimid generics could hit the scene as early as March 2022, though companies will only be able to sell limited volumes until early 2026. (BMS) (From Fraiser: Currently waiting for confirmation on a photo)

Revlimid
Company:
 Bristol Myers Squibb
2020 sales: $12.1 billion
Key patent expirations: 2025 to 2026

When it comes to Revlimid, Bristol Myers Squibb knows better than most when it will first have to sweat copycat competition—and from whom.

The drug’s future looked hazy when BMS inked its $74 billion Celgene buyout in early 2019. Since then, a series of settlements with generics makers and a big win at the U.S. Patent Office have dispelled some of that uncertainty.  

The drug, which is used to treat multiple myeloma, myelodysplastic syndromes and other diseases, had a stellar 2020, drumming up some $12.15 billion in sales. While it was eclipsed only by AbbVie’s immunology megablockbuster, Humira, and Merck & Co.’s immuno-oncology stalwart Keytruda, Revlimid’s time in the limelight is fading fast, with generic competitors set to enter the fray between 2025 and 2026, Moody’s analysts predict.

And to be clear, that launch window only covers the point at which generics can hit the scene unchecked. The first imitator, from India’s Natco Pharma, could roll out as early as March 2022, albeit in limited volumes, with several more generics cleared to launch with constraints sometime shortly after that.

RELATED: Bristol Myers Squibb can grow through Revlimid generics, execs insist, pointing to key launches

Celgene’s top-selling cancer med proved contentious when BMS unveiled its acquisition two years back. Investors were quick to point out Revlimid patent threats that could have amounted to a major sales blow.

The drug dodged a bullet just a few months later when the U.S. Patent and Trademark Office scrapped Dr. Reddy’s bid to invalidate three patents. By September 2020, BMS had settled with the Indian generics giant, allowing the company to start a “volume-limited” launch of its Revlimid offering sometime after March 2022.

Celgene has inked near-identical deals with Natco and New Jersey-based Alvogen. Natco has the green light to start selling “mid-single-digit percentages” of Revlimid’s total volume the month it could presumably launch, March 2022. That percentage is set to tick up over time to upward of one-third of Revlimid’s numbers.

For its part, Alvogen has already deployed a Revlimid mimic in some parts of Europe and inked a deal to sell generics up to single-digit percentages of Revlimid volumes in the U.S. during the same timeframe as Dr. Reddy’s.

RELATED: Celgene repeatedly raised Revlimid's price to hit aggressive sales targets, congressional probe finds

The settlement spree has bled into 2021 as well. In late June, Sun Pharma said it inked a patent settlement with Celgene, quieting disputes around the U.S. application for its Revlimid generic. The agreement allows Sun to produce and sell limited quantities of its copycat sometime after, you guessed it, March 2022—provided the drug wins out at the FDA.

For the four drugmakers—Natco, Alvogen, Dr. Reddy’s and Sun—all bets are off come January 31, 2026, when the companies are free to sell “unlimited quantities” of their generics.

Meanwhile, Revlimid owes its 2020 success story to price hikes, at least in part. The drug was first approved in 2005 and launched by Celgene at $215 per pill. In the ensuing years, more than 20 price bumps have seen the cost swell to more than $750 per pill, Congressional investigators said in September. Celgene charted those increases to meet its financial targets, the probe noted.

3. Revlimid