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LIDOPEN Drug Patent Profile
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When do Lidopen patents expire, and what generic alternatives are available?
Lidopen is a drug marketed by Meridian Medcl Techn and is included in one NDA.
The generic ingredient in LIDOPEN is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lidopen
A generic version of LIDOPEN was approved as lidocaine hydrochloride by PHARMOBEDIENT on November 18th, 1982.
US Patents and Regulatory Information for LIDOPEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Meridian Medcl Techn | LIDOPEN | lidocaine hydrochloride | INJECTABLE;INJECTION | 017549-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Investment Scenario and IP/Exclusivity Fundamentals for LIDOPEN (lidocaine)
Executive summary: LIDOPEN’s investment profile hinges on (1) FDA status and labeling scope for the specific LIDOPEN product, (2) whether the asset is protected primarily by composition-of-matter, formulation, and/or method-of-use patents, and (3) timing of key regulatory or exclusivity events that drive generic or 505(b)(2) entry risk. A complete, decision-grade fundamentals analysis requires mapping LIDOPEN to its exact active ingredient, route, dosage form, strengths, NDA/BLA/ANDA identifiers, and the corresponding Orange Book listings and dockets. With the currently provided input, those identifiers cannot be determined, so no complete and accurate patent-exclusivity calendar or investment risk assessment can be produced.
What exactly is LIDOPEN (lidocaine) and what drug product does it map to?
A fundamentals and investment case must begin with product identity: LIDOPEN can refer to different commercial presentations of lidocaine across topical, injectable, and other local anesthetic formats. The IP and competitive landscape are product-specific, because Orange Book protections attach to a specific FDA application and dosage form.
What active ingredient, route, and dosage form define the investment thesis?
- Active ingredient: lidocaine (molecule-level is not enough).
- Route and dosage form: topical gel/cream/solution, patch, injectable local anesthetic, or other delivery system.
- Strengths and labeling: dosing limits, indications, and use conditions change method-of-use exposure.
Which FDA application governs exclusivity and Orange Book risk?
Investment-grade assessment requires:
- NDA number (or ANDA reference for 505(b)(2))
- Label (indications and usage)
- Orange Book entries for that application
- Any listed patents tied to specific dosage forms (for example, topical strengths)
What patents protect LIDOPEN and how many are in the estate?
A defensible patent estate count requires the Orange Book patent list for the correct LIDOPEN NDA/product. The distribution of patent types drives both strength and design-around risk:
Composition vs formulation vs method-of-use
- Composition-of-matter patents: typically cover the active ingredient or core chemical structure. For lidocaine generics, true composition-of-matter coverage is often long expired, shifting attention to formulation and device/delivery systems.
- Formulation and delivery patents: excipients, particle size, penetration enhancers, controlled release matrices, and pH or stabilization systems.
- Method-of-use patents: dosing regimens, patient populations, pain models, or specific procedures.
How to quantify “how many patents” for diligence
Decision-grade counts usually separate:
- Listed Orange Book patents by type and claims scope
- Expiration by patent number
- Any unexpired terminal disclaimers that shorten protection
When does LIDOPEN lose exclusivity and patent protection?
A timing model for investment scenarios must include:
- Earliest expiration date among relevant listed patents
- Patent-by-patent lifetimes (including PTA/PTE effects if present)
- Any statutory exclusivity (3-year/5-year exclusivity where applicable)
- Orphan/other exclusivity programs if relevant (less common for lidocaine generics)
What does the exclusivity clock look like in a generic-entry model?
- Patent expiration: legal launch permission depends on the Orange Book list.
- Exclusivity expiration: gaps can allow another pathway only if exclusivity is done and patents are cleared or not infringed.
- Practical launch timing: 180-day exclusivity for the first ANDA filer after a successful Paragraph IV.
How to build a generic entry risk timeline
A correct timeline must be built from:
- Orange Book “patent expiration” dates
- FDA exclusivity codes and end dates
- Litigation or settlement-driven stay periods (if any)
What patent litigation affects LIDOPEN, including Paragraph IV challenges?
The investment risk changes materially if there are active or resolved ANDA/PIV challenges or 505(b)(2) disputes tied to the listed patents.
What to look for in dockets that change the investment case
- Paragraph IV notice dates
- Filed defendants (generic applicants)
- Asserted patents and claim theories
- Court outcomes or scheduled trial dates
- Settlement terms that shift launch dates
How settlement agreements typically drive revenue exposure
Where settlements exist, they often include:
- “Pay-for-delay” type restrictions on launch for a defined period
- Design-around obligations that affect formulation or dosage strength
- Licensing or distribution arrangements
A litigation-free status is not the same as low risk; the absence of published suits still leaves standard generic pathways.
What is the Orange Book status of LIDOPEN?
The Orange Book status must be checked at the application level and dosage form level.
What an Orange Book listing implies for investors
- Each listed patent blocks generic entry unless cleared.
- Patent expiration drives the outer boundary of launch.
- The presence of method-of-use patents can create infringement risk even after composition clearance.
Which listed patents are most important for entry blocking
Not all patents have equal weight. Investors focus on:
- The patent(s) with the latest expiration among the “primary” set
- Patents covering the most broadly used strength(s) or dosage form(s)
- Patents with claims that are hard to design around without changing product performance
What formulations are protected by LIDOPEN patents?
For lidocaine, the commercial advantage often comes from formulation and delivery performance rather than chemical novelty.
What formulation IP usually matters
- Penetration enhancer systems and skin tissue transfer behavior
- Controlled release matrices and release kinetics
- Stabilizers that control degradation (pH, antioxidants, buffers)
- Packaging and device-related delivery (if the product uses a proprietary system)
How formulation patents create manufacturing/IP barriers
- Generic applicants may need bioequivalence only if the formulation is accepted as equivalent, but formulation patents can still block.
- Design-around may require different excipients or release profiles, potentially triggering new bio studies and new regulatory complexity.
How strong is the patent estate for LIDOPEN?
Strength depends on:
- Claim scope coverage relative to competitor design parameters
- Likelihood of invalidity based on prior art for formulation or method-of-use claims
- Litigation history and whether earlier validity challenges occurred
Patent quality metrics investors use
- Independent claim breadth and number of claim construction hot spots
- Prior art density (especially for formulation enhancements and delivery systems)
- Terminal disclaimers and prosecution history that narrow claims
What generic entry risks exist for LIDOPEN?
Generic risk scenarios differ by regulatory pathway and product category.
Scenario 1: Full ANDA with Paragraph IV vs compliant ANDA
- Full ANDA requires bioequivalence and may still be blocked by Orange Book patents.
- Paragraph IV changes the timeline if the applicant seeks an early launch through legal clearance.
Scenario 2: 505(b)(2) pathway risk
If LIDOPEN is not an ordinary AB-rated generic target, competitors may use 505(b)(2) to rely on reference data for some aspects while introducing changes that may or may not avoid infringement.
Scenario 3: 180-day exclusivity impact
If a challenger becomes the first Paragraph IV filer, 180-day exclusivity can increase near-term competitive pressure even if later patents exist.
How does LIDOPEN compare with competing lidocaine products?
Competition for lidocaine often centers on:
- Equivalent indications (for example, topical pain conditions or procedural anesthesia)
- Delivery performance (onset speed and duration)
- Safety profile and tolerability under labeled conditions
- Pricing and payer coverage
What investors should benchmark against
- FDA approval dates and labeling breadth of key rivals
- Patent and exclusivity status of top-selling competitors
- Launch strategies for generic/local anesthetic alternatives
What is the revenue exposure tied to LIDOPEN’s exclusivity and patent calendar?
Revenue exposure is a function of:
- Proportion of sales from the protected strength(s)/dosage form(s)
- Share of the market that depends on the protected method-of-use claims
- Likelihood and timing of generic substitution after patent expiry
What a revenue cliff model requires
A complete model must input:
- Expected market penetration of generics at expiry
- Pricing impact and rebate dynamics
- Payer policies for local anesthetics after generic entry
Without the exact FDA product mapping and Orange Book schedule, no defensible revenue-exposure calendar can be produced.
What manufacturing/IP barriers exist for LIDOPEN?
For formulation-heavy assets, practical barriers include:
- Proprietary manufacturing process steps that could be protected by process patents
- Proprietary excipient sourcing
- Controls and specifications that are required for performance and shelf life
- Regulatory dependency on process validation
Process patent exposure and design-around risk
- If process patents exist, generic manufacturers may need to change manufacturing flow or in-process parameters.
- Process IP can also create litigation leverage even when composition claims are weak.
Key Takeaways
- LIDOPEN’s investment fundamentals depend on the exact FDA application and Orange Book listing for the specific LIDOPEN product presentation.
- A complete investment scenario requires: patent estate mapping, exclusivity timeline, litigation/Paragraph IV status, and a product-level generic risk model.
- With only “LIDOPEN (lidocaine)” as input and no NDA/BLA/ANDA identifier or Orange Book listings, no accurate patent-expiration or entry-risk calendar can be built.
FAQs
-
How do I determine the relevant Orange Book patents for a lidocaine product called LIDOPEN?
You must start from the exact FDA application for the specific dosage form and strength, then pull all Orange Book patent listings tied to that application. -
What patent types most often protect topical lidocaine brands after chemical exclusivity ends?
Formulation, delivery system, and method-of-use patents often dominate the post-chemical novelty protection period. -
How do Paragraph IV challenges change the generic entry timetable for a lidocaine NDA?
They can accelerate legal clearance and trigger first-filer 180-day exclusivity, shifting launch timing even if other patents remain. -
What is the biggest driver of revenue risk for a lidocaine localized anesthetic asset?
The expiration date and strength of the latest-blocking listed patents for the product’s primary commercial strengths. -
When do settlements with ANDA filers matter most for investors in LIDOPEN?
Settlements matter when they impose defined launch-date restrictions or include licenses that alter the market entry pathway.
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA Exclusivity Information. U.S. Food and Drug Administration.
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