What patents cover Vabomere, and who owns them?
Vabomere (meropenem-vaborbactam) is an FDA-approved antibiotic product combining meropenem with the beta-lactamase inhibitor vaborbactam. Patent coverage typically comes from a mix of product/formulation patents and method-of-use and process patents tied to:
- the fixed-dose combination itself (meropenem + vaborbactam),
- the composition/formulation of the individual components or their combined dosage form,
- and related manufacturing or dosing approaches.
The exact patent set (and their remaining life) depends on what filings and assignments are listed in the FDA’s Orange Book for Vabomere and the relevant patent numbers assigned to the product.
When do Vabomere patents expire?
Patent expiration dates are not one single date. The practical “end of exclusivity” depends on multiple time points, including:
- the expiration of the latest listed patent(s) in the FDA Orange Book,
- any patent term adjustments (or extensions),
- and any periods of regulatory exclusivity that may run independently of patent term.
To give accurate dates, you typically need the current Orange Book patent list for Vabomere (including each patent’s expiration date and whether it is eligible for extension/adjustment).
Can generic or biosimilar versions of Vabomere enter before the patents expire?
For drug products like Vabomere, the main market-authorization pathway for a lower-cost alternative is generally an abbreviated route for generics (not biosimilars). Whether a generic can launch depends on:
- whether it is legally allowed under the “patent certification” framework using the Orange Book-listed patents,
- and which patents block approval versus those that have already expired.
If you want, share the specific “Vabomere” label you mean (strengths) or the patent numbers you’ve found, and I can help interpret what those patents are likely covering and how they affect launch timing.
How do Orange Book patents work for Vabomere challenges?
Generic applicants reference the FDA Orange Book and certify against listed patents (for example, whether a patent is expired, expires on a specific date, or is not infringed or invalid). This matters because:
- the first-to-file generic may get exclusivity before other applicants (depending on facts),
- litigation can trigger stay periods,
- and the “trigger” for a permitted launch typically tracks the relevant patent certifications and any resulting court outcomes.
Why patent coverage can differ from launch timing (formulations, new strengths, or new indications)
Even if one patent expires, other patents can keep a product protected. Common reasons include:
- new strengths or formulations filed later than the original product,
- method-of-use patents tied to specific dosing regimens or treatment settings,
- and continuation filings that add later-expiring claims.
So the “last patent standing” is what usually governs when generic competition becomes easier.
What I need to answer with exact patent numbers and dates
To list Vabomere patents precisely (numbers, owners/assignees, expiration dates, and which are Orange Book–listed), I need at least one of the following:
- the patent numbers you’re asking about, or
- the FDA Orange Book entry details you’re using (you can paste the Orange Book table), or
- the strength(s) (e.g., dosing presentation) and the applicant/label holder shown on the Orange Book.
If you paste the Orange Book patent listing text (or a link), I can extract and organize the Vabomere patent set with expiration timelines and what each patent likely covers.
Sources
None provided in your prompt.