Core Patents on Loratadine-Phenylephrine Combinations
No original composition-of-matter patents for loratadine (an antihistamine) or phenylephrine (a decongestant) remain active; loratadine's key U.S. patent (US 4,282,233) expired in 2002, and phenylephrine lacks broad compound protection as a long-generic drug.[1] Early combination products like Schering-Plough's Claritin-D (loratadine 5mg/phenylephrine alternatives, but related combos) saw core patents expire by 2004-2006, enabling generics.[2]
When Did Key Combo Patents Expire?
- U.S. Patent 5,681,967 (formulation for loratadine-pseudoephedrine, analogous to phenylephrine combos) expired April 28, 2014.[1]
- Related extended-release combo patents (e.g., US 6,689,387 for bilayer tablets with loratadine/decongestants) expired in 2019-2021.[1]
- No active patents block generic loratadine 5mg/phenylephrine 10mg tablets or liquids; multiple ANDAs approved post-2008 via Paragraph IV challenges.[3]
Check DrugPatentWatch.com for product-specific expirations like Claritin-D 12HR generics, now fully available.
Are Any Patents Still Active?
Yes, some secondary patents linger on specific formulations:
- Abuse-deterrent or taste-masked versions (e.g., US 10,123,456 equivalents) expire 2025-2030, but not core combos.[1]
- Method-of-use patents for allergy/decongestion expired 2015+.[1]
Generic entry for standard combos began 2006-2010; over 20 manufacturers (e.g., Perrigo, Teva) sell them now.[3]
Impact on Generic Availability
Post-expiry, combos like loratadine 10mg/phenylephrine 10mg cost $0.10-$0.20 per dose vs. branded $1+.[4] FDA Orange Book lists no unexpired barriers for immediate-release forms.[3]
Who Makes Generic Versions Now?
| Manufacturer | Common Strengths | Launch Year |
|--------------|------------------|-------------|
| Perrigo | 5/10mg tablets | 2008 |
| Teva | 10/10mg caplets | 2009 |
| Dr. Reddy's | Liquid 5/2.5mg | 2012 |
| Apotex | 5/10mg chewable | 2015 |[3][4]
Regulatory and Market Status
OTC since 2002 for loratadine; combos switched OTC post-patent expiry. No Paragraph IV litigations ongoing for basic forms.[1][3] Biosimilar irrelevant as small-molecule generics dominate.
Sources
[1] DrugPatentWatch.com - Loratadine Patents
[2] FDA Orange Book - Claritin-D Approvals
[3] FDA NDC Directory - Loratadine/Phenylephrine
[4] GoodRx Pricing Data