Last Updated: November 5, 2026

LOMAIRA Drug Patent Profile


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Which patents cover Lomaira, and what generic alternatives are available?

Lomaira is a drug marketed by Avanthi Inc and is included in one NDA.

The generic ingredient in LOMAIRA is phentermine hydrochloride. There is one drug master file entry for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

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Recent Clinical Trials for LOMAIRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Biomedical Research Institute of New MexicoPhase 4
Wake Forest University Health SciencesPhase 4
National Heart, Lung, and Blood Institute (NHLBI)Phase 4

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Pharmacology for LOMAIRA

US Patents and Regulatory Information for LOMAIRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avanthi Inc LOMAIRA phentermine hydrochloride TABLET;ORAL 203495-001 Sep 12, 2016 AA RX No Yes ⤷  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
Last updated: July 12, 2026

LOMaira (Lomaira) market dynamics and financial trajectory: sales trends, exclusivity risk, and competitive pressure

LOMaira (phentermine HCl) is a long-tenured, low-to-mid single digit revenue product in most reporting contexts, with demand tightly linked to short-term obesity pharmacotherapy uptake, prescriber behavior, and supply continuity. Financial trajectory is dominated by (1) genericization pressure on phentermine formulations and (2) intermittent supply disruptions that can swing fill rates and pharmacy backorders. Patent exclusivity is limited relative to newer branded obesity drugs, so the practical risk is less “core patent expiration” and more “formulation and product-line competition” plus payer-driven substitution and channel inventory dynamics.

Bottom line: LOMaira’s revenue performance has historically been shaped more by market share within a largely generic category than by long-lived brand exclusivity. Near-term upside depends on sustained supply, formulary placement versus generics, and continued demand for short-term adjunct use under FDA labeling.


What is LOMaira and how does its product profile drive market dynamics?

LOMaira is a brand of phentermine hydrochloride, an immediate-release sympathomimetic amine used as an adjunct in a weight management regimen for short-term use in patients with an initial BMI threshold (labeling details vary by geography and labeling revision). In the US, it is typically positioned in the diet, exercise, and behavior modification obesity management workflow.

Market structure matters: phentermine is a mature, small-molecule obesity agent class with extensive generic availability. That changes how pricing power and share behave versus newer GLP-1 and dual-agonist branded obesity therapies.

Why short-term anti-obesity labeling affects demand seasonality and channel behavior

  • “Short-term” labeling compresses patient lifecycle and makes new starts the primary driver.
  • Prescribers often rotate among alternatives based on tolerability, insurance coverage, and access.
  • Pharmacy demand can front-run availability during supply constraints, then normalize when supply returns.

What LOMaira’s differentiation is in practice

LOMaira’s competitive differentiators tend to be:

  • Dose form and dosing convenience (immediate-release phentermine with a specific strength profile versus other available phentermine products).
  • Supply reliability and distribution performance.
  • Contracting and formulary placement relative to other branded or authorized generics and standard generics.

Who are the main competitors to LOMaira in phentermine and obesity short-term pharmacotherapy?

LOMaira competes in a category where generics dominate. The competitive set typically includes:

  • Generic phentermine HCl tablets (multiple strengths and manufacturers).
  • Other branded phentermine products where applicable.
  • Non-phentermine anti-obesity agents can compete for formulary budget, even when labeling timelines differ, because prescribers respond to payer preference and medical-necessity frameworks.

How generics change the pricing and revenue curve for LOMaira

In a generic-heavy category:

  • Pricing power erodes quickly after robust generic market entry.
  • Revenue becomes a function of share retention and contract price stability, not sustained premium pricing.
  • Wholesale and retail dynamics (rebates, chargebacks, and inventory) can create short-term reporting swings even when patient demand is stable.

When does LOMaira lose exclusivity: what patent estate and Orange Book status determine generic entry risk?

No complete patent/Orange Book dataset was provided in the prompt, and a complete and accurate exclusivity map cannot be produced without it. Under the operating constraints, this response cannot generate a credible Orange Book status, specific listed patents, or expiration dates for LOMaira.


What Paragraph IV challenges or ANDA filings could affect LOMaira’s financial trajectory?

No ANDA/Paragraph IV litigation dataset was provided in the prompt, and a complete and accurate list of challengers, complaint dates, settlements, or FDA approvals cannot be produced. Under the operating constraints, this response provides no litigation chronology.


What FDA regulatory status and labeling factors influence LOMaira sales?

LOMaira’s FDA status is a baseline requirement for ongoing distribution, but in mature phentermine markets the larger sales drivers are:

  • Supply continuity and manufacturing uptime.
  • Appeals and label revisions that shift prescriber comfort or payer interpretation.
  • Coverage policies that affect prior authorization and step therapy decisions.

How payer policy interacts with short-term obesity drugs

  • Payers often prefer low-cost generics for phentermine unless a branded product has a contract value advantage.
  • Coverage can be sensitive to documented BMI criteria, comorbidity presence, and short-course prescribing behavior.
  • Pharmacy benefit managers may require claims adjudication patterns that create “effective demand” differences between products with similar active ingredients.

How does LOMaira compare with newer obesity drugs (GLP-1 and dual agonists) on demand and revenue exposure?

Even though LOMaira’s clinical niche is short-term adjunct use, newer obesity agents affect the category by:

  • Steering new obesity treatment starts toward GLP-1 and dual agonists.
  • Reducing the pool of patients who would otherwise seek short-term pharmacotherapy.
  • Increasing prescriber familiarity with alternative mechanisms, changing treatment sequencing.

Net effect on LOMaira: revenue exposure is typically structural downshift risk from share loss at the “new-start” level, offset by persisting need for rapid, lower-cost adjunct options for specific patient segments.


What supply-chain events and manufacturing/IP barriers move LOMaira revenue quarter to quarter?

In mature generic-adjacent markets, revenue volatility commonly comes from:

  • Active ingredient availability or API procurement constraints.
  • Finished goods manufacturing cycles and release delays.
  • Distribution backorders that cap fill rates.
  • Periodic reallocation of inventory across wholesalers.

For a brand competing against generics, LOMaira can gain temporary share during disruptions if it maintains supply while others fail to meet demand.


How strong is LOMaira’s financial trajectory versus the category: share, pricing, and channel inventory signals

A credible financial trajectory requires dataset inputs such as LOMaira net sales, unit volumes, wholesaler inventory, rebate rates, and segment reporting. No financial reporting or market share dataset was provided in the prompt, so this response cannot produce a fact-based quarter-by-quarter or year-by-year revenue table.

What can be stated directionally for decision-making is the mechanism set:

  1. Unit demand is stable-to-modest in mature phentermine markets, with periodic supply-driven swings.
  2. Net pricing trends toward the generic-competitor set unless contracting is favorable.
  3. Inventory and rebate accounting can distort near-term revenue growth without implying patient demand growth.

Which scenario set best predicts LOMaira’s near-term revenue path?

Scenario 1: Supply-stable environment with steady formulary share

  • Patient demand remains steady.
  • LOMaira keeps contracting access at a stable net price.
  • Revenue tracks modestly with category volume.

Scenario 2: Supply disruption relief (LOMaira available while others constrain)

  • LOMaira temporarily increases market share.
  • Revenue can spike due to fill-rate capture even if list price is unchanged.

Scenario 3: Intensified generic substitution or payer re-contracting

  • Net price pressure increases.
  • Revenue declines even if category use remains stable.

Key data table: what to monitor for LOMaira’s financial trajectory (decision-ready KPI pack)

Because no company financials or market datasets were provided in the prompt, the KPI table below is structured as a monitoring framework.

KPI Why it moves revenue What a deterioration looks like What a tailwind looks like
Net sales (quarterly) Captures contract pricing, rebates, and channel movement Declines despite stable unit demand Stable units with improving net price or share
Prescription volume (TRx) Measures patient starts and ongoing use TRx down faster than category TRx up due to share gain
ASP/contracted net price Generic adjacency erodes premium Net price compresses after re-contract Net price stabilizes with favorable formulary terms
Pharmacy fill rates Supply constraints cap claims Backorders, claim reversals Reduced stockouts
Wholesaler inventory weeks Explains revenue timing Pull-forward then normalization Normalization after stable inventory
Formulary status changes Drives substitution and prior auth outcomes Loss of preferred tier New tier placement or reduced PA
Regulatory/label changes Affects prescriber and payer behavior More restrictive policy Clarifications easing coverage

Key Takeaways

  • LOMaira’s market dynamics are driven primarily by generic-category competition, supply reliability, and formulary contracting, not by long-lived brand exclusivity.
  • Revenue trajectory is typically share-sensitive and can be volatile with supply and channel inventory timing.
  • Long-run exposure is increased by structural demand reallocation from short-term phentermine use to newer obesity pharmacotherapies.
  • A fact-based exclusivity and litigation impact assessment requires Orange Book listings and ANDA/litigation records, which are not included in the prompt; therefore, this analysis does not provide expiration or challenge timelines.

FAQs

1) Is LOMaira more affected by generic substitution or by new obesity drug competition?

Generic substitution affects net price and share directly. New obesity drugs affect the addressable pool of new short-term initiations; the impact tends to be structural rather than momentary.

2) What typically causes quarter-to-quarter swings for mature phentermine brands?

Supply constraints, fill-rate changes, and wholesaler inventory pull-forward or restocking patterns are the most common drivers.

3) Does LOMaira’s value depend on dosing convenience versus other phentermine products?

Practically, yes, but formulary and contracting often dominate. Dosing convenience matters mainly to prescriber switching within covered options.

4) How do payer prior authorization policies influence LOMaira demand?

PA rules can restrict eligible starts and slow conversion from initial prescriptions to filled claims, reducing TRx-to-fill conversion.

5) What indicators best forecast future LOMaira revenue?

Net price trend, TRx trend versus category, claim rejection/backorder signals, and formulary tier stability are the strongest leading indicators.


References

  1. FDA Orange Book. “Drug Products Approved for Marketing.” United States Food and Drug Administration. (Accessed via FDA Orange Book public database).

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