As Bristol Myers Squibb looks to guard Celgene’s top-selling cancer drug Revlimid from copycat competition, the company has inked a series of deals to welcome generic challengers in waves. India’s Sun Pharmaceutical is the latest to get in on the action.
Sun Pharma on Tuesday said it inked a patent settlement with Celgene, snapped up by BMS for $74 billion in late 2019, to resolve a patent dispute around the U.S. application for its Revlimid generic.
Under the deal, Celgene will bless Sun with a license to manufacture and sell limited quantities of its copycat sometime after March 2022, provided Sun’s med passes muster at the FDA. Starting January 31, 2026, Sun will be able to sell an “unlimited quantity” of its generic in the U.S.
The settlement details, including the specific date of Sun’s 2022 rollout and the amount it will be able to sell, are confidential, the company noted in a statement.
The move follows a similar deal with Dr. Reddy’s Laboratories, which settled with BMS in September to start a “volume-limited” launch of its own Revlimid generic during the same post-March 2022 timeframe. Like Sun, Dr. Reddy’s deal tees up the company to sell the drug without restriction beginning in early 2026.
Celgene has also forged near-identical pacts with India’s Natco Pharma and New Jersey’s Alvogen. For its part, Natco in March 2022 could start selling “mid-single-digit percentages” of Revlimid’s total volume that month, with the figure set to gradually climb up to one-third of Revlimid’s numbers.
Alvogen, which has already rolled out a Revlimid copycat in some parts of Europe, has also been cleared to sell generics up to single-digit percentages of Revlimid volumes sometime after March 2022. It will be open season for both companies starting on January 31, 2026.
Revlimid’s patent cliff was a big concern for investors when BMS and Celgene unveiled their megamerger in early 2019, but the companies won some relief in February of that year when the U.S. Patent and Trademark Office scrapped Dr. Reddy’s bid to invalidate three Revlimid patents.
The move positioned BMS to strike a favorable settlement with the Indian generics giant, Credit Suisse Analyst Vamil Divan wrote to clients at the time.
Meanwhile, Revlimid has continued to turn out blockbuster revenues, landing the no. 3 spot on Fierce Pharma’s list of the top 20 drugs by worldwide sales in 2020. The drug pulled in a whopping $12.15 billion for the year, edged out of the gold and silver positions by AbbVie’s top-seller Humira and Merck’s immuno-oncology superstar Keytruda, respectively.
Some of the momentum comes courtesy of price hikes. The drug launched in 2005 at $215 per pill, but after more than 20 price increases, the drug now runs for more than $750 per pill, Congressional investigators said in September. Their probe noted that while many drugmakers cite expensive, risky research as fuel for price increases, Celgene was motivated by the need to meet financial targets.