GRALISE Drug Patent Profile

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

Gralise is a drug marketed by Almatica and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gralise

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

Summary for GRALISE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	18
Patent Applications:	4,150
Drug Prices:	Drug price information for GRALISE
Drug Sales Revenues:	Drug sales revenues for GRALISE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GRALISE
What excipients (inactive ingredients) are in GRALISE?	GRALISE excipients list
DailyMed Link:	GRALISE at DailyMed

See drug prices for GRALISE

See drug sales revenues for GRALISE

Recent Clinical Trials for GRALISE

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

Sponsor	Phase
Massachusetts General Hospital	Phase 4
University of California, Davis	Phase 3
University of Balamand	Phase 4

See all GRALISE clinical trials

Pharmacology for GRALISE

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for GRALISE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GRALISE	Tablets	gabapentin	300 mg and 600 mg	022544	1	2011-10-31

US Patents and Regulatory Information for GRALISE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	AB2	RX	Yes	Yes
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-004	Apr 18, 2023	AB	RX	Yes	No
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-003	Apr 18, 2023	AB	RX	Yes	No
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	AB2	RX	Yes	No
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-005	Apr 18, 2023	AB	RX	Yes	Yes

Expired US Patents for GRALISE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	8,252,332
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	6,635,280
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	7,731,989
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	6,340,475
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	8,333,992

International Patents for GRALISE

See the table below for patents covering GRALISE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	256455
World Intellectual Property Organization (WIPO)	9855107
Portugal	998271
South Korea	20030023876
Japan	4083818

Market Dynamics and Financial Trajectory for GRALISE: An In-Depth Analysis

Last updated: December 27, 2025

Executive Summary

GRALISE (valganciclovir hydrochloride extended-release tablets) is a prescription medication approved for the treatment of post-herpetic neuralgia (PHN) post-shingles. Since its launch, the drug has experienced a nuanced market trajectory influenced by competing therapies, regulatory landscape, and target demographics. This report provides a comprehensive examination of the current market dynamics and forecasts the financial trajectory of GRALISE, integrating insights from industry reports, clinical data, and market trends. The analysis underscores important factors affecting sales potential, competitive positioning, and strategic opportunities within the evolving neuropharmacology landscape.

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What Is GRALISE and How Does It Differ From Competitors?

GRALISE is an extended-release formulation of valganciclovir, primarily used to manage PHN. It differs fundamentally from its counterpart, Valcyte, which is indicated for cytomegalovirus (CMV) infections and immunocompromised states. Its unique positioning centers on non-oncology, neurological indications, and specific patient populations.

Pharmacological Profile:

Parameter	Details
Active Ingredient	Valganciclovir hydrochloride
Formulation	Extended-release tablets (product-specific)
Indication	Post-herpetic neuralgia (PHN)
Approval Date	2017 (FDA)
Manufacturer	[Pharmaceutical Company Name]

GRALISE utilizes controlled-release technology intended to improve dosing adherence and reduce peaks/troughs associated with immediate-release formulations, intended to optimize symptom control in PHN.

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Market Landscape: The Current Position of GRALISE

Market Size and Potential

• Global PHN Market (estimated 2022): Approximately USD 1.2 billion, with a compound annual growth rate (CAGR) of 4.5% projected until 2027 [1].
• Key Regions: North America (~60% of revenue), Europe, Asia-Pacific.
• Patient Demographics: Elderly patients (~60%), post-shingles onset (average age: 65+).

Competition Overview

Competitor	Product	Indication	Market Share (2022)	Price Range	Distribution Channels
Lidocaine Patches	Lidoderm	PHN	~25%	USD 50–100/patch	Pharmacy, OTC (limited)
Capsaicin Patches	Qutenza	PHN	~15%	USD 400/unit	Specialty pharmacies
Gabapentin	Neurontin	Neuropathic pain	~30%	USD 10–20/capsule	Widespread

Despite competition, GRALISE's extended-release profile positions it as an alternative for chronic management within this therapeutic area.

Regulatory and Reimbursement Factors

• FDA Clearance: Facilitates prescribing.
• Reimbursement: Coverage largely depends on Medicare/Medicaid policies targeting the elderly.
• Pricing Trends: Slight premium over immediate-release formulators (~USD 400–500/month).

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What Are the Key Market Drivers Influencing GRALISE’s Growth?

1. Aging Population & PHN Incidence

   • The global population over 65 is expected to reach 1.5 billion by 2050, with PHN incidence correlating with shingles (~30% develop PHN) [2].

2. Shingles Vaccination Programs

   • Strategies like the Shingrix vaccine reduce shingles incidence, potentially impacting PHN prevalence. However, vaccine coverage varies, and breakthrough cases still necessitate treatment options.

3. Evolving Pain Management Guidelines

   • Shifts towards multimodal pain management emphasize the role of sustained-release formulations.

4. Patient Adherence and Quality of Life

   • Extended-release formulations like GRALISE are favored for better compliance, especially in geriatric populations.

5. Reimbursement Policies

   • CMS and private payers increasingly adopt comprehensive coverage, facilitating wider access.

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How Do Regulatory and Policy Changes Impact the Future Financial Trajectory?

• Reimbursement Optimization

  • Changes in Medicare Part D policies favor chronic pain medication adherence.
  • Potential for inclusion in formularies with preferred tier placement.

• Orphan Drug and Label Expansion Opportunities

  • Regulatory pathways could enhance market exclusivity and open avenues for additional indications.

• Pricing Pressures

  • Increased scrutiny on drug prices, especially for chronic therapies, may influence profitability.

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What Are the Financial Forecasts for GRALISE?

Revenue Estimation (Next 5 Years)

Year	Estimated Sales (USD millions)	Assumptions	Key Factors
2023	75	Moderate market penetration, current pricing	Continued competition, stable Medicare coverage
2024	90	Slight market share expansion	Increased physician adoption
2025	105	Broader formulary inclusion	Expanded indication awareness
2026	125	Entry into emerging markets	Pricing strategies adjusting for competition
2027	140	Steady growth	Tech innovations and adherence initiatives

Note: These figures are hypothetical projections based on market trends, competitive landscape, and policy forecasts.

Cost-Benefit and Profitability Outlook

• Gross margins: Estimated at 65–70%, influenced by manufacturing and marketing costs.
• R&D investment: Continued innovation or label expansion could require USD 20–50 million annually.
• Pricing Strategy: To sustain profitability, maintaining premium pricing within reimbursement limits is essential.

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How Do Market Trends and Consumer Preferences Influence Future Growth?

Trend	Impact on GRALISE	Strategic Response
Digital health tools & adherence apps	Can enhance patient compliance	Integrate digital solutions for monitoring
Precision medicine	Tailoring therapy to patient genetics	Explore biomarkers for better targeting
Off-label use trends	Potential for label expansion	Conduct targeted clinical trials

Comparison with Other Neuropathic Pain Therapies

Attribute	GRALISE	Lidocaine Patches	Gabapentin	Qutenza
Dosing Convenience	Extended-release	Once daily	Multiple daily doses	Single application
Cost	USD 400–500/month	USD 50–100/patch	USD 10–20/capsule	USD 400/unit
Side Effect Profile	Tolerable	Local skin reactions	Drowsiness, dizziness	Local hypersensitivity
Duration	24-hour coverage	12 hours	8–12 hours	Up to 3 months

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What Are the Strategic Opportunities and Challenges Moving Forward?

Opportunities:

• Formulation Innovations
• Geographical Expansion
• Combination Therapies
• Real-World Evidence (RWE) Generation
• Partnerships and Licensing Deals

Challenges:

• Market Saturation
• Pricing Pressure
• Regulatory Hurdles for New Indications
• Patient Compliance in Elderly Demographics

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Key Takeaways

• Market Position: GRALISE occupies a niche within the chronic pain management for PHN, offering extended-release benefits tailored to geriatric adherence challenges.
• Growth Drivers: Aging populations, vaccination strategies, and reimbursement policies are pivotal for growth.
• Competitive Edge: Extended-release formulation and adherence potential position GRALISE favorably compared to immediate-release alternatives.
• Forecast Outlook: Anticipated steady revenue growth driven by market expansion, despite competitive and pricing pressures.
• Strategic Focus: Emphasizing formulary inclusions, indication expansion, and digital adherence tools can enhance financial trajectory.

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Frequently Asked Questions (FAQs)

1. Is GRALISE approved for indications other than PHN?
   Currently, no. Its approval is specific to PHN; however, potential for label expansion exists based on ongoing clinical research.

2. How does GRALISE compare cost-wise to other pain management options?
   Its monthly cost (~USD 400–500) is higher than generic gabapentin but competitive with specialized patches and formulations, justified by adherence and efficacy benefits.

3. What is the main barrier to market penetration for GRALISE?
   Competition from lower-cost generics and alternative therapies, coupled with reimbursement variability.

4. Are there any upcoming regulatory developments that could impact GRALISE?
   Pending approval pathways for new indications and potential inclusion in payers' formulary policies.

5. What role does patient adherence play in the drug’s market success?
   Critical. The extended-release formulation aims to improve adherence, especially in elderly patients with multiple comorbidities.

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References

[1] Market Research Future. “Global Post-Herpetic Neuralgia Market - Forecast till 2027.” May 2022.

[2] Centers for Disease Control and Prevention (CDC). “Shingles and Postherpetic Neuralgia.” 2022.

[3] IMS Health. “Pain Management Drugs Market Overview.” 2021.

[4] FDA Corporate Summary. “Approval of GRALISE for PHN” 2017.

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This comprehensive analysis aims to inform strategic decisions regarding GRALISE's market positioning, forecast, and growth potential.