Since snag­ging a first ap­proval in prostate can­cer back in 2018, John­son & John­son has been work­ing to make Er­lea­da a block­buster fran­chise. Now that means fight­ing off a po­ten­tial gener­ic from Au­robindo.

A group of plain­tiffs, in­clud­ing J&J’s Janssen unit and the Sloan Ket­ter­ing In­sti­tute for Can­cer Re­search, filed a law­suit against Au­robindo on Thurs­day ac­cus­ing it of ap­ply­ing to mar­ket an Er­lea­da copy­cat be­fore five patents are up.

In the com­plaint, the plain­tiffs said Au­robindo sent a let­ter back in April in­form­ing them that the com­pa­ny had sub­mit­ted an ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA) for a gener­ic ver­sion of Er­lea­da. Ac­cord­ing to the de­fen­dants — Au­robindo and its units Eu­gia Phar­ma and Au­roMedics — the gener­ic doesn’t in­fringe on J&J’s patents be­cause it doesn’t con­tain crys­talline Form B of apa­lu­tamide, the ac­tive in­gre­di­ent in Er­lea­da.

The plain­tiffs claimed that they re­quest­ed more in­for­ma­tion re­gard­ing the AN­DA, but the de­fen­dants didn’t re­spond.

“By fail­ing to pro­vide in­for­ma­tion, De­fen­dants im­ped­ed Plain­tiffs’ abil­i­ty to eval­u­ate in­fringe­ment of the 663 Patent,” the com­plaint states.

How­ev­er, on in­for­ma­tion and be­lief, the plain­tiffs al­leged that Au­robindo’s gener­ic con­tains some amount of crys­talline Form B of apa­lu­tamide.

The plain­tiffs are look­ing for a rul­ing that Au­robindo has in­fringed on Er­lea­da’s patents through its AN­DA sub­mis­sion and that the man­u­fac­tur­ing or com­mer­cial­iza­tion of a gener­ic would al­so in­fringe up­on those patents.

Nei­ther J&J nor Au­rbindo re­spond­ed to a re­quest for com­ment.

Er­lea­da was first ap­proved for non-metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer back in 2018, months ahead of its PDU­FA date. At the time, Eval­u­ate Phar­ma pegged 2022 sales at $1.6 bil­lion, which is pos­si­ble con­sid­er­ing the drug raked in near­ly $1.3 bil­lion last year, up from $760 mil­lion the year be­fore. J&J lined Er­lea­da up as a suc­ces­sor to the best­selling Zyti­ga as gener­ic com­pe­ti­tion clos­es in.

In 2019, J&J ex­pand­ed Er­lea­da’s la­bel to in­clude pa­tients with metasta­t­ic cas­tra­tion-sen­si­tive prostate can­cer.

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.