Vyleesi Patent Expiration and Generic Bremelanotide Timeline

What the Vyleesi record establishes

Vyleesi is the FDA-approved bremelanotide product, approved under NDA 210557 on June 21, 2019; the current holder is Cosette Pharmaceuticals, originally AMAG [1][2]. The label directs 1.75 mg subcutaneously into the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. The label says not to take more than one dose within 24 hours and does not recommend more than eight doses per month [1]. The approved use is premenopausal women with acquired, generalized hypoactive sexual desire disorder [1].

Vyleesi is an NDA product, and the generic pathway for such drugs is the ANDA pathway [3][7]. Patent and generic status sit outside the prescribing information, in the Orange Book entry for NDA 210557 and in FDA's ANDA records [3][7].

Compounded PT-141 is not Vyleesi. Vyleesi is the FDA-approved bremelanotide product; PT-141 products sold as compounded or research-use peptides are not FDA-approved drugs, and compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [1][6].

Why the approval date is not a patent date

Patent terms are set by statute: 20 years from the U.S. filing date [4]. FDA exclusivity is separate. FDA lists five years for new chemical entity exclusivity, seven years for orphan drug exclusivity and six months added for pediatric exclusivity, and patents and exclusivity may or may not run at the same time [4].

The Orange Book lists patents and exclusivity for approved drug products [3]. For Vyleesi the entry to check is NDA 210557 [1][3].

A generic applicant can challenge a listed patent through a Paragraph IV certification, which states that the patent is invalid, unenforceable or would not be infringed [7]. If the brand sponsor or patent holder files an infringement suit within 45 days, FDA approval is generally postponed for 30 months unless the patent expires or is judged invalid or not infringed before that time [7]. The first substantially complete ANDA with a Paragraph IV certification can be eligible for 180-day exclusivity [7].

How FDA exclusivity periods work

FDA's standard periods are five years for a new chemical entity, seven years for an orphan drug and six months added for pediatric exclusivity [4]. The Orange Book records any patent and exclusivity entries for NDA 210557 [3][5].

What determines a generic-entry date

A generic-entry date turns on when the listed patents expire or are held invalid or not infringed, whether a Paragraph IV suit and a 30-month stay follow, when any FDA exclusivity ends, and review of a substantially complete ANDA; the first filer may earn 180-day exclusivity [4][7]. None of this is in the prescribing information [1].