SEARLE AND MYLAN ARE FIRST GENERIC HALOPERIDOL TABLET MARKETERS

SEARLE AND MYLAN ARE FIRST GENERIC HALOPERIDOL TABLET MARKETERS after receiving FDA approval on June 10. While a few companies have already received approval for and begun marketing haloperidol oral solution (including Bay Labs, Barre-National, and National Pharmaceutical Manufacturing), Searle and Mylan are the first competitors to CmNeil's Haldol tablets. Both Searle and Mylan received approval to market .5, 1, 2, and 5 mg tablets. Searle additionally received approval for 10 mg tablets, 20 mg tablets (which cannot be marketed until Sept. 24 under exclusivity provisions of the ANDA/Patent Restoration law), and oral concentrate (2 mg/ml) in 120 ml bottles. In a June 11 release announcing the approval, Mylan said that "current annual sales of Haldol are approximately $60 mil. and Mylan expects to ship $3 mil. worth of haloperidol within the next 45 days." Mylan said its product, which it began shipping to customers June 11, is priced 30-to-50% below Haldol. For Searle, the U.S. approval will complement its overseas haloperidol marketing effort. In a June 10 release on the approval, Searle maintains that it "is the number one marketer of haloperidol in 64 countries, with nine manufacturing sites worldwide." Noting that Searle "has manufactured and distributed this anti-psychotic drug outside the U.S. . . for more than a quarter century," Searle VP David Bethune said in the release that the company is "taking advantage of our international experience in producing and marketing haloperidol by now making it available to pharmacists and patients in this country." Searle's haloperidol tablets, with the exception of the 20 mg strength, and oral solution became available to the trade June 11. Searle is offering a special introductory haloperidol deal to whslrs. for one week. Prices for 100 tabs are: $12.60 for the .5 mg, $18.65 for 1 mg tab; $25.70 for 2 mg tabs; $42 for 5 mg tabs; and $54.09 for 10 mg tabs. The introductory price for the 2 mg/ml solution is $19.65 for a 120 ml bottle. Following the introductory offer, regular prices for the products, respectively, will be: $14; $20.72; $28.56; $46.67; $60.10; and $32.75. The one-week special deal price cuts approximately 10% off Searle's regular price for the tablet products and 40% off for the oral solution. Searle's regular prices to whslrs. are approximately 20% below average whsle. prices for McNeil's Haldol prices, according to Redbook figures.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By 

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By 

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

More from Pink Sheet

US FDA’s Top Cell and Gene Therapy Regulators Forced Out

 

Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.

First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide Authority

 

As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.

Not Over Yet: Eisai And Lilly To Appeal England’s ‘Flawed’ Refusal To Fund Leqembi And Kisunla

 

Eisai and Lilly explain why they disagree with today’s conclusion by the health technology assessment institute, NICE, that the benefits of their respective drugs for Alzheimer’s disease are too small to justify the additional cost to the National Health Service.