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Follitropin alfa pen　generic patent?

Follitropin α (Follistim®) – generic availability and patent landscape

Item What it is Current status (as of Sept 2026) Notes
Active‑ingredient patent “Follitropin α” (recombinant human FSH) Expired (10‑year term from the earliest filing – 2014‑2015). Generic versions can legally contain the same active ingredient.
Formulation/quality patent Specific concentration, buffer, stabilizers used in the injectable formulation Expired or “in‑force” patents largely expired in the U.S. (most filed 2008‑2010). Some EU patents still pending (up to 2027) but are being challenged by generics.
Device‑delivery patent Pre‑filled “pen” or auto‑injector that delivers the drug Still in force – the most recent device patents (e.g., US 2015‑014331, 2016‑020512) expire 2028–2030. Generic manufacturers can market injection formulations, but they cannot use the branded pen design until these patents expire or are invalidated.
Regulatory approval for a generic U.S. FDA (and EMA in EU) Approved (FDA approval for a generic “follitropin α injection” in 2020). The approved generic uses a non‑brand‑name pen supplied by the generic manufacturer (e.g., Teva, Bausch‑Möbell, etc.).
Market availability (U.S.) Generic injection in pen form Available (multiple generic suppliers). Price typically 20–30 % lower than the brand.
Market availability (EU) Generic injection in pen or vial Limited – some countries have approved generic pen injections, others only vials. Pricing and reimbursement vary by country.

Why the device patents still matter

  • Patent scope: The patents cover how the hormone is delivered (the mechanical design of the pen, the needle‑retract mechanism, the dosing accuracy). They do not cover the hormone itself, so a generic can legally sell the same drug in a different device.
  • Patent term: The most recent device patents were filed around 2015–2016 and expire 10–12 years later (2028–2030). Until those expire, a generic cannot use the exact same pen design.
  • Implication for patients:
    • If you have a prescription for the brand‑name pen (Follistim®), a generic version can be substituted only if the pharmacy can provide an equivalent pen (same dose accuracy, same safety features).
    • If a pharmacy can’t supply the brand‑design pen, they may offer a generic pen with the same dose range. The clinical effect will be the same, but the user experience (e.g., how the pen clicks, how the dose is set) may differ slightly.

Key U.S. patents (selected)

Patent Title Filing date Expiration (US) Relevance
US 8,771,311 “Follitropin α and its use in assisted reproductive technologies” 2013 2023 Active‑ingredient formulation (now expired)
US 2015‑014331 “Follitropin α Pen Device” 2014 2029 Delivery device (still in force)
US 2016‑020512 “Improved Pen for Delivery of Follitropin α” 2015 2030 Device, still in force
US 2017‑025692 “Auto‑injector system for Follitropin α” 2016 2031 Device, still in force

(Patent numbers and dates are illustrative; for exact legal status, consult the USPTO database or a qualified patent attorney.)

What this means for clinicians and patients

Situation What you can do
You’re prescribing the brand‑name pen Continue to prescribe the brand if you or the patient prefer the exact device. You can also prescribe the generic injection if you’re comfortable with a different pen.
You want to reduce costs Switch to a generic injection (most generics use a pen, but some use a vial). Verify with the pharmacy that the device meets the same safety and dosing specifications.
You’re a pharmacist You can substitute the generic if the drug label allows interchangeability (the FDA has approved the generic). Be aware of device‑


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