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Promethazine paten?

See the DrugPatentWatch profile for Promethazine

Promethazine is a first‑generation, non‑selective antihistamine that was first synthesized in the late 1950s and introduced to the market in the early 1960s. Because it has been on the market for more than six decades, all of the original patents that covered its discovery, synthesis, and primary therapeutic indications have long since expired. Here’s a quick rundown of the patent landscape for Promethazine:

Period Key Patent Information What the Patent Covered Current Status
1959–1964 US Patent 3,498,470 (Bayer AG) Chemical synthesis of 4‑(dimethylamino)‑5‑hydroxy‑2‑phenyl‑2‑propoxy‑phenyl‑ethyl‑amine (promethazine) and its basic salt forms Expired 1984
1960s European patents (e.g., EP 1 223 425) Manufacturing process, salt forms, and use as an antihistamine/antiemetic Expired
1970s–1990s Various formulation patents (e.g., extended‑release oral suspensions) Novel excipient combinations, taste‑masking, and pediatric formulations Most expired; a handful of formulation patents may still be active in specific jurisdictions
2000s–present Patents on “promethazine‑containing drug delivery systems” (e.g., transdermal patches, nasal sprays) New dosage forms, combination therapies (e.g., with lidocaine or other agents) Some still pending or expiring within the next 5–10 years
2020s Patent applications for “promethazine‑based therapeutics for specific conditions” (e.g., anti‑cancer adjuncts, novel CNS indications) Potentially new indications or delivery technologies Under review or pending

What does “patent expired” mean for Promethazine?

  • Generic Availability: Because all foundational patents have lapsed, generic manufacturers can produce and sell promethazine under the name “promethazine hydrochloride” (the common salt form used in most oral solutions and tablets).
  • Formulation Patents: Some newer formulation patents (e.g., a once‑daily extended‑release formulation or a pediatric oral suspension with a proprietary taste‑masking excipient) may still be in force in particular markets. Those patents only restrict the specific formulation, not the core drug substance itself.
  • Combination Patents: If a new therapeutic use involves a combination of promethazine with another drug (e.g., a cough suppressant plus a decongestant), a combination patent could still be in play, but the core antihistamine remains free for generic use.

Where to look if you need the detailed patent history

Resource What you’ll find How to use it
USPTO Patent Full‑Text and Image Database (PatFT) Full‑text US patents, citations, legal status Search by “promethazine” or “Bayer”
European Patent Office (EPO) Espacenet European patents, filing dates, legal status Search for “promethazine” and filter by “status”
WIPO PATENTSCOPE International Patent Cooperation Treaty (PCT) applications Search for “promethazine” and review “Legal Status” column
Google Patents Aggregated patent view, often easier navigation Use keyword search; look for “patent expiry” notes
PatentWatch (subscription) Alerts on new patents, litigation, and expirations Good for ongoing monitoring

Quick FAQ

Question Short answer
Is promethazine still under a single global patent? No. The original patents expired decades ago. Some formulation or combination patents may still exist locally.
Can a company still file a new patent for promethazine? Yes, for new formulations, novel delivery methods, or new therapeutic indications. The core chemical structure is already in the public domain.
Does a new patent affect the generic price? It can for the specific formulation covered by that patent, but generic manufacturers can still produce the base drug.
What about “patent thicket” concerns? For promethazine, the main patents are largely expired, so the thicket is thin. Any remaining active patents usually relate to delivery systems, not the drug itself.

Bottom line:
Promethazine as a drug compound is in the public domain; its original patents have long expired. Current patent activity mainly revolves around novel formulations or specific therapeutic indications rather than the core antihistamine itself. If you’re looking into a particular formulation or a new indication, check the USPTO or EPO databases with the specific details you need.



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