InvaGen Receives FDA Approval for Generic of Pfizer’s Lyrica

InvaGen Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had approved its generic version of Pfizer’s Lyrica (pregabalin) for eight different dosages. InvaGen is a subsidiary of Mumbai, India-based Cipla Ltd., with offices in Hauppauge, New York.

The drug is approved for use for management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for partial-onset seizures in patients 17 years of age and older, fibromyalgia, and neuropathic pain associated with spinal cord injury.

Pfizer’s Lyrica brought in $5.4 billion for the 12-month period ending March 2019.

Pfizer’s Lyrica patent expired on December 30, 2018. Other generic drug companies, such as Mylan, Teva and Novartis Sandoz had received tentative approval for generic versions of pregabalin by the FDA, but the launches were postponed until mid-2019. This was the result of Pfizer receiving a six-month patent term extension from the FDA for pediatric exclusivity.

Pfizer has been aggressive in protecting Lyrica’s patents. It first lost exclusivity for epilepsy and anxiety in July 2014 in Europe. Another patent for neuropathic pain was set to expire in July 2017. The company challenged the expiration in the UK, “arguing that the generic pregabalin, which was set to launch for epilepsy and anxiety, would also be prescribed off-label by physicians, encroaching on the patented neuropathic pain use,” reported Pharmaceutical Technology in November 2018.

Pfizer filed a lawsuit against Actavis (Allergan) and Mylan. Those companies had launched a generic version of pregabalin with what was dubbed a “skinny label” that excluded pain. Pfizer also issued a warning letter to physicians not to prescribe generic pregabalin for neuropathic pain.

In September 2015 and October 2016, two courts ruled that generic drug manufacturers can avoid infringement if it “takes all reasonable steps within its power” to stop physicians from prescribing the generic version for still-covered indications. The UK Supreme Court on November 14, 2018, dismissed Pfizer’s last attempt to protect the brand and the secondary patent for neuropathic pain was held invalid.

But in the U.S., Pfizer won its court ruling blocking generic versions of Lyrica for its approved indications until December 2018, when U.S. patents expired. Then it filed for pediatric exclusivity in the U.S., and was granted the six-month extension.

Pharmaceutical Technology wrote, “As the brand has already been exposed to generic sales erosion in Europe, its sales have been declining since 2015. The UK Supreme Court decision is a blow for Pfizer since four out of five prescriptions for the drug were for pain. As such, this will result in a major drop in sales in the UK. Lyrica is still enjoying its last few months of patent protection in the U.S. However, once generics reach the market, Lyrica will see the most significant sales erosion from generics. Small molecule oral brands, such as Lyrica, can easily lose at least 50% of sales during the first full year of generic competition. With this in mind, GlobalData expects that global sales of Lyrica will drop from $5 billion in 2018 to $950 million in 2024.”

Many analysts believed that Pfizer would then work to make up for the loss of revenue from Lyrica by mergers and acquisitions. Which does seem to be at least part of the rationale for its $11.4 billion acquisition of Array BioPharma in June 2019. Array is an oncology company, which already had an approved combination of Braftovi (encorafenib) and Mektovi (binimetinib) for specific types of unresectable or metastatic melanoma.