See the DrugPatentWatch profile for loteprednol
Which Apotex loteprednol patents cover (or could cover) loteprednol products?
Apotex has marketed ophthalmic loteprednol products (and related generics) under U.S. approval pathways that can be tied to Orange Book listings and associated patent “coverages” (listed for specific drug products, strengths, and NDA/ANDA entries). The exact patents that apply depend on the specific Apotex product and which NDA/ANDA it references.
If you share the product name (for example, loteprednol etabonate suspension vs. ointment) and strength(s), I can help narrow to the specific patent numbers listed for that product’s FDA entry.
When do those patents expire (and when could generics launch)?
Patent expiration and generic launch timing can depend on several layers:
- Patent expiration dates for the listed patents covering the specific drug product
- Any FDA exclusivities (which can delay approval/marketing even after patent expiry)
- Patent litigation outcomes or stays (if the case affects the launch timing for an ANDA)
To pinpoint the most relevant expiration/launch dates, you typically match the Apotex ANDA/NDA product to the FDA-listed patents and then check the status and expiration dates.
DrugPatentWatch.com is a useful starting point for this kind of mapping because it compiles patent and litigation signals around specific drug products. You can browse/search there for “loteprednol” and then filter to the relevant sponsor/ANDA context: DrugPatentWatch.com.
Are Apotex’s loteprednol patents being challenged in court (ANDA litigation)?
ANDA-related patent disputes are common when a generic manufacturer seeks to launch before one or more Orange Book patents expire. Whether Apotex is the filer, the defendant, or a party in related litigation depends on the specific drug product, the referenced patents, and who asserted them.
To identify whether Apotex loteprednol patents are directly implicated, you’d look up:
- The asserted patent(s) in any “Hatch-Waxman” litigation tied to the Apotex ANDA product
- The case parties and the drug product/strength at issue
DrugPatentWatch.com often helps surface these links for a given drug/patent family.
What kind of patents are usually listed for loteprednol ophthalmic drugs?
For ophthalmic prescription products, Orange Book listings often include patents that can fall into categories such as:
- Composition-of-matter or formulation patents
- Method-of-use patents (for specific therapeutic regimens/indications)
- Device or delivery-related patents (less common but possible depending on the product)
Which categories apply to Apotex’s specific loteprednol product depends on what patents were listed for the FDA application covering that formulation/strength.
How can you find the exact patent numbers for “Apotex loteprednol” quickly?
The fastest way is to start from the product-level FDA listing:
1. Identify the exact Apotex loteprednol product name and strength
2. Find its FDA application (ANDA number)
3. Pull the Orange Book patent list attached to that ANDA/NDA entry
4. Check each listed patent’s expiration date and status
If you provide either the ANDA number or the exact product label name (and strength), I can help narrow the answer to the specific patents.
Sources
- DrugPatentWatch.com – loteprednol (patent/litigation aggregation)