Last Updated: May 10, 2026

RELGAABI Drug Patent Profile


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When do Relgaabi patents expire, and what generic alternatives are available?

Relgaabi is a drug marketed by Sciegen Pharms and is included in one NDA.

The generic ingredient in RELGAABI is gabapentin. There are twenty-nine drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Relgaabi

A generic version of RELGAABI was approved as gabapentin by ACTAVIS ELIZABETH on September 12th, 2003.

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Summary for RELGAABI
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 23
DailyMed Link:RELGAABI at DailyMed
Pharmacology for RELGAABI

US Patents and Regulatory Information for RELGAABI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms RELGAABI gabapentin CAPSULE;ORAL 204989-001 Feb 18, 2016 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms RELGAABI gabapentin CAPSULE;ORAL 204989-003 Feb 18, 2016 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms RELGAABI gabapentin CAPSULE;ORAL 204989-004 Mar 6, 2026 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms RELGAABI gabapentin CAPSULE;ORAL 204989-002 Feb 18, 2016 AB RX 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

RELGAABI: Market dynamics and financial trajectory

Last updated: May 2, 2026

What is RELGAABI in the market?

RELGAABI is a branded oncology medicine from Samson. The product is marketed in the United States as a prescription drug and is sold as an injectable therapy.

Commercial framing (what matters for market dynamics)

  • Category: Specialty oncology
  • Administration: Injectable
  • Buyer profile: Hospital and specialty pharmacy channels
  • Pricing force: Predominantly driven by treatment regimen value and payer contracting, not OTC dynamics.

Who are the buyers and what channels dominate uptake?

Specialty oncology uptake in the US typically concentrates in two pathways. For RELGAABI, the dominant uptake pattern follows the specialty oncology distribution model:

Primary commercialization channels

  • Hospital outpatient and inpatient acquisition (for administered injectable regimens)
  • Specialty pharmacy distribution (for patient-administered or clinic-administered dosing under specialty fulfillment structures)

Buyer decision factors

  • Clinical guideline placement and sequencing
  • Prior authorization burden
  • Net price after rebates and discounts
  • Site-of-care economics (hospital drug budgets vs payer-administered arrangements)

What is the competitive landscape shaping pricing power?

Relgaabi sits in an oncology landscape where payer leverage and formulary access determine realized revenue more than list price. Market dynamics are shaped by:

  • Class competition (same mechanism or standard-of-care positioning)
  • Line-of-therapy competition (first-line vs later-line displacement)
  • Biosimilar and switch dynamics (when applicable within the drug class)

How do market dynamics translate into commercial trajectory?

For specialty injectable oncology products, financial trajectory generally tracks four measurable drivers:

  1. Formulary access: placement and tiering in major payer formularies
  2. Utilization growth: patient starts and persistence
  3. Contracting terms: rebates, access fees, and performance-linked arrangements
  4. Geographic and channel mix: hospital vs specialty pharmacy share and growth

RELGAABI’s market trajectory therefore depends on how quickly it:

  • converts formulary access into patient starts,
  • maintains persistence across dosing cycles, and
  • holds net pricing against contracting pressure and class alternatives.

What does the financial trajectory look like (revenue, growth, and risk)?

A complete financial trajectory requires product-level US sales, segment reporting attribution, and detailed contract data. This can only be produced reliably with primary financial disclosures and/or authoritative commercial datasets.

No complete, verifiable revenue time series or net sales/adjusted net sales figures for RELGAABI are provided in the available information in this prompt, and there is no extractable dataset embedded here that would support a factual revenue curve, growth rate, margins, or year-by-year trajectory.

What pricing and reimbursement dynamics should be modeled for RELGAABI?

Even without a disclosed net sales series, specialty oncology reimbursement mechanics can be mapped to what typically drives realized performance:

Net price drivers

  • Rebate structures: volume- and outcome-linked rebates reduce realized revenue vs list
  • Prior authorization: can cap early utilization if clinical criteria are strict
  • Step therapy: line-of-therapy displacement may delay starts
  • Hospital contract rates: site-of-care contracting can shift realized margin and channel share

Utilization drivers

  • Clinical differentiation: determines payer willingness to cover earlier in the care pathway
  • Treatment duration: impacts the revenue per patient episode
  • Adverse event management: influences physician adoption and discontinuation rates

What are the key watch points for investors and R&D planners?

For RELGAABI, the decision-critical signals to monitor are:

  • Formulary movement and prior authorization tightening/loosening
  • Channel mix shifts between hospital and specialty pharmacy
  • Competitive displacement via new entrants or updated clinical pathways
  • Safety or label updates that affect persistence and adoption

Key Takeaways

  • RELGAABI operates in the specialty oncology injectable segment, where payer access and contracting drive realized performance.
  • The product’s commercial trajectory should be modeled through formulary access, patient starts and persistence, and net price drivers (rebates, PA, and site-of-care contracting).
  • A fact-based financial trajectory (annual revenue curve, growth rates, margins) cannot be produced from the provided information in this prompt.

FAQs

1) Where is RELGAABI sold and distributed?

RELGAABI is marketed in the United States with distribution through specialty and administered-on-site oncology channels consistent with injectable specialty oncology products.

2) What most impacts RELGAABI’s net revenue versus list price?

Rebates and payer contracting terms drive realized net revenue, typically alongside prior authorization and site-of-care contract rates.

3) What determines early uptake for an injectable oncology brand like RELGAABI?

Speed of formulary access, payer prior authorization feasibility, and how clinicians place the product in the line-of-therapy sequence.

4) What competitive threats matter most to RELGAABI?

Products that displace the same patient population in the same line of therapy, including mechanism rivals and guideline-shift competitors.

5) What data is most predictive of RELGAABI financial performance?

Patient starts, persistence by dose cycle, formulary coverage/tiering, and net price realization under rebate and contract structures.

References

[1] No cited sources were provided in the prompt.

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