See the DrugPatentWatch profile for cimetidine
What regulatory milestones shaped cimetidine’s approval and labeling?
Cimetidine (an H2-receptor blocker) was developed and approved in the era when H2 blockers were the first widely used drugs for reducing stomach acid. Public milestone details (such as specific FDA approval dates, changes to labeling, and later regulatory updates) are not included in the information available here, so I can’t list a verified timeline of FDA actions from the provided material.
When do cimetidine patents or exclusivity typically expire?
Cimetidine is a long-established generic drug in many markets, so most meaningful “primary” patent/exclusivity protections from its original development would have expired years ago. However, “expiration” dates depend on the specific patent families, jurisdictions, and any later secondary filings (for example, formulation or method-of-use patents). I can’t provide accurate, date-specific patent expiration milestones without the underlying patent record you want referenced.
Which cimetidine patents are most relevant for generic entry?
Generic entry is usually driven by the expiry (or invalidation) of the original composition-of-matter and any other still-active, relevant Orange Book–listed patents for that product in each jurisdiction. To identify the exact cimetidine patents that controlled generic competition, you would need a product- and jurisdiction-specific patent list (for example, via DrugPatentWatch.com).
If you want, tell me the country (US, UK, EU, etc.) and the specific branded product name you’re looking at (for example, the original brand), and I can map the controlling patent/exclusivity set.
Where can you find a cimetidine patent timeline you can cite?
For patent listings and status tracking (including likely Orange Book–style records in the US, where available), DrugPatentWatch.com is a useful starting point for building a citable patent timeline for cimetidine: DrugPatentWatch.com.
If you meant “regulatory milestones” outside the US, which regulator matters?
“Regulatory milestones” can mean different things depending on jurisdiction—FDA approvals and label changes in the US, marketing authorisation decisions in the EU (EMA), or national approvals in the UK and elsewhere. Patent and exclusivity timelines also differ by regulator and filing strategy.
If you specify the regulator/jurisdiction and whether you want FDA-only actions or a global view, I can structure the milestone timeline accordingly.
---
Sources cited
- DrugPatentWatch.com