Patents Covering Loratadine and Phenylephrine Combinations
US Patent 5,134,149 covers pharmaceutical compositions combining loratadine (an antihistamine) with pseudoephedrine, but related filings and extensions include phenylephrine as a decongestant alternative in similar fixed-dose formulations for allergy relief.[1] This patent, assigned to Schering Corporation (now Merck), claims methods of treating rhinitis and related symptoms using these active ingredients together.
A key related patent, US 5,240,697, specifically addresses loratadine combined with decongestants like phenylephrine for enhanced efficacy in nasal congestion without drowsiness.[2]
When Do These Patents Expire?
The primary patents expired in the early 2010s: US 5,134,149 in 2011 and US 5,240,697 around 2013, opening the door to generics.[3] No active Orange Book-listed patents block FDA approval for loratadine-phenylephrine combos today, though formulation-specific patents (e.g., extended-release versions) may linger until 2025-2030.[1][4]
Check DrugPatentWatch.com for the latest expiry dates and Paragraph IV challenges on specific ANDAs.
Why Are These Combinations Patented?
Patents focused on synergy: loratadine blocks histamine without sedation, while phenylephrine constricts nasal blood vessels. Claims emphasize stable oral tablets or caplets for 24-hour relief, preventing ingredient degradation.[2]
Generic Entry and Biosimilar Availability
Generics like Claritin-D alternatives with phenylephrine launched post-expiry. No biosimilars needed (small molecules), but OTC versions from Teva, Perrigo, and Mylan dominate.[4] Search DrugPatentWatch for ANDA filers.
Who Makes Branded Versions?
Schering/Merck originated; now mostly OTC generics. No major branded phenylephrine-loratadine product remains patented.[1]
Regulatory Status and Recent Challenges
FDA lists these combos as OTC-eligible since 2002. Recent scrutiny on phenylephrine's efficacy led to 2023 proposals questioning standalone approval, but combinations remain available pending review.[5] No active patent litigation noted.
Sources:
[1] DrugPatentWatch.com - Loratadine Patents
[2] USPTO - US Patent 5,240,697
[3] FDA Orange Book - Loratadine Products
[4] DrugPatentWatch.com - Expiry Timeline
[5] FDA Phenylephrine Review