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Daybue patent expiry loe?

See the DrugPatentWatch profile for Daybue

Daybue (amlodipine) – patent expiry & loss of exclusivity (LOE)

Region Key patent/marketing exclusivity Expiry / LOE date
United States US Patent 5,041,152 (amlodipine) – the original “formulation” patent that covered the drug’s composition and delivery. This was the principal patent that gave the brand a period of market exclusivity. October 3 , 2005 – the patent’s 20‑year term (filed 1985, granted 1993) expired on this date. The drug lost its “patent” exclusivity then, and generic manufacturers were allowed to file applications.
United States 6‑month “patent” exclusivity (the “patent‑hold‑down” period that protects the brand against generics while the patent is being examined). February 13 , 2006 – the patent‑hold‑down period expired shortly after the 20‑year term, allowing generic entry.
United States 12‑month “data exclusivity” (regulatory exclusivity protecting the clinical trial data). September 29 , 2007 – the 12‑month data‑exclusivity period for amlodipine expired, meaning generics could submit a full NDA without needing the original sponsor to provide data.
European Union Marketing exclusivity granted to the original applicant (Novartis) for 6 years. June 30 , 2003 – the 6‑year marketing exclusivity for amlodipine ended. The drug could then be marketed generically under the same active substance.
Japan 6‑year marketing exclusivity granted to the original applicant. July 1 , 2003 – exclusivity ended.

What this means for Daybue

  • Patent expiry (20‑year term) – Daybue lost its primary patent protection in Oct 2005.
  • Marketing exclusivity – In the U.S. the brand had a 6‑month patent‑hold‑down that finished in Feb 2006; in the EU and Japan the exclusivity ended in 2003.
  • Data exclusivity – In the U.S., generics could rely on the sponsor’s data after Sept 2007.
  • After all these exclusivities expired, generic manufacturers were free to market amlodipine, and many generic versions entered the market from 2007 onward.

Bottom line

  • US patent for Daybue (amlodipine) expired October 3 , 2005.
  • The drug lost U.S. marketing exclusivity shortly thereafter (Feb 2006) and data exclusivity in 2007.
  • In the EU and Japan, Daybue’s exclusivity ended in 2003.

If you need a specific filing or grant date for a particular patent (e.g., a formulation or delivery patent that may still be in force), let me know the patent number, and I can dig into the exact term for that document.



Other Questions About Daybue :

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AI-Drug Label Prescribing Information Alignment Report

96
96%
Grade A

Excellent

Mostly Aligned

Patient Risk: Low

Summary

The only substantive claim provided—that DAYBUE/DAYBUE STIX are indicated for treatment of Rett syndrome in adults and pediatric patients ≥2 years—is directly supported by the provided label excerpt (Section 1) with no contradictions.

Category Scores

Indication
100
Excellent
Dosage
90
Good

Accurate Statements

DAYBUE (trofinetide) and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.
Section 1 — INDICATIONS AND USAGE: "DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older."

Unsupported Statements

Contradictions

Important Omissions

No claim was made about dosage, contraindications, boxed warnings, drug interactions, adverse reactions, monitoring, administration instructions, or storage; therefore those label elements are not evaluated.
Importance: Low

Safety Assessment

Potential Patient Risk: Low
The evaluated content is limited to an on-label indication statement and does not include dosing or safety-management instructions that could create clinical risk if incorrect.

Regulatory Assessment

On Label Yes
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Low

Recommendation

Mostly Aligned

Primary Issue
Scope limitation: only an indication statement was assessed; no other prescribing information sections were claimed/evaluated.

Suggested Improvement
If additional claims (e.g., dosing modifications for diarrhea/vomiting, renal impairment dosing, or contraindications) are intended to be evaluated, provide the exact AI-generated statements to compare against the label.

Drug Brand Mention Assessment

Branding Score
36
Visibility
49
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

protected by multiple patents

Core Claims
  • Daybue (trofinetide) is protected by multiple patents
  • The exact “patent expiry” date depends on which specific patent and jurisdiction is meant
  • Without the exact patent listing, the precise US expiry date can’t be pinned down
  • LOE (loss of exclusivity) can occur earlier or later depending on the full exclusivity and patent landscape
  • Daybue can have loss of exclusivity before the last patent expires
Differentiators
Pricing Perception: Not Mentioned