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 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:	151
Clinical Trials:	18
Patent Applications:	4,482
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	022544-002	Jan 28, 2011	AB2	RX	Yes	No
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-003	Apr 18, 2023		RX	Yes	No
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-004	Apr 18, 2023		RX	Yes	No
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-005	Apr 18, 2023		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	022544-002	Jan 28, 2011
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011

International Patents for GRALISE

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

Country	Patent Number	Title	Estimated Expiration
Australia	3989301
Canada	2575555
Japan	2016166239	膨潤性の制御放出経口剤形の胃における滞留性を増強するための錠剤の形状 (TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM)
Japan	4083818
Japan	2009522294
Mexico	PA04003793	MEZCLAS OPTIMAS DE POLIMEROS PARA TABLETAS RETENTIVAS GASTRICAS. (OPTIMAL POLYMER MIXTURES FOR GASTRIC RETENTIVE TABLETS.)
World Intellectual Property Organization (WIPO)	03035040

Market Dynamics and Financial Trajectory for GRALISE

Introduction

GRALISE, a formulation of gabapentin, is a significant player in the pharmaceutical market, particularly in the treatment of post-herpetic neuralgia (PHN) and other neuropathic pain conditions. Here, we delve into the market dynamics and financial trajectory of GRALISE.

Market Size and Growth

The gabapentin market, which includes GRALISE, was valued at USD 2.2 billion in 2022 and is projected to grow to USD 3.7 billion by 2032, with a compound annual growth rate (CAGR) of 5.90% during the forecast period[1].

Application and Market Segmentation

GRALISE falls under the neuropathic pain segment of the gabapentin market. This segment is anticipated to experience the quickest CAGR during the forecast period due to the increasing prevalence of neuropathic pain and the rising acceptance of therapies[1].

Regional Market Insights

• North America: This region held the largest market revenue share for gabapentin in 2022, driven by the high incidence of neurological diseases and persistent pain. The U.S. market, in particular, dominates this region, with Canada being the fastest-growing market[1].
• Asia-Pacific: This region is expected to grow at the fastest CAGR from 2023 to 2032, fueled by growing awareness of gabapentin's advantages over opioids and increasing healthcare spending in countries like India and China[1].

Product Approval and Market Impact

GRALISE, a once-daily gabapentin extended-release tablet, was approved by the Ministry of Food and Drug Safety of Korea (MFDS) in 2023. This approval marks the first sustained release formulation of gabapentin in Korea for PHN, offering enhanced convenience to patients compared to conventional immediate-release forms[4].

Competitive Landscape

The competitive landscape for gabapentin, including GRALISE, is influenced by several factors:

• Innovation: Drug formulation innovations, such as the extended-release formulation of GRALISE, play a crucial role in market competition.
• Marketing Strategies: Effective marketing strategies by pharmaceutical companies can significantly impact market share.
• Generic Competition: The presence of generic players, especially in emerging markets, affects the pricing and availability of branded products like GRALISE[1].

Financial Performance

• Revenue: While specific financial data for GRALISE alone is not readily available, the overall gabapentin market provides context. For instance, the gabapentin market in Korea was approximately USD 40 million in 2022[4].
• Market Exclusivity: GRALISE benefits from market exclusivity, particularly through orphan drug designations. However, this exclusivity can be a double-edged sword, as it can protect against competition but also faces scrutiny for potential abuse. For example, Depomed Inc., the manufacturer of GRALISE, successfully sued the FDA to secure market exclusivity for GRALISE, despite the FDA's initial denial[3].

Orphan Drug Designations and Market Exclusivity

The Orphan Drug Act grants seven years of market exclusivity for drugs approved for rare diseases. This exclusivity can be a potent pricing tool, allowing drugmakers to charge high prices by shielding their medicines from competition. GRALISE, approved for PHN, a condition following shingles, benefits from this exclusivity, which is crucial for its financial performance[3].

Challenges and Opportunities

• Competition from Generics: The expiration of market exclusivity periods can lead to the entry of generic competitors, which can significantly impact the revenue of branded products like GRALISE.
• Regulatory Scrutiny: There is ongoing scrutiny regarding the use of orphan drug designations to extend market exclusivity. Regulatory changes or increased oversight could affect the financial trajectory of GRALISE[3].
• Market Expansion: The approval of GRALISE in new regions, such as Korea, presents opportunities for growth and expansion. The novel formulation of GRALISE offers enhanced convenience, which can drive patient preference and market share[4].

Key Takeaways

• Market Growth: The gabapentin market, including GRALISE, is expected to grow significantly due to increasing prevalence of neuropathic pain and other neurological conditions.
• Regional Dynamics: North America and Asia-Pacific are key regions for GRALISE, with the latter expected to show rapid growth.
• Competitive Edge: Innovation in drug formulation and effective marketing strategies are crucial for maintaining a competitive edge.
• Regulatory Impact: Market exclusivity through orphan drug designations is a significant factor in the financial performance of GRALISE but is subject to regulatory scrutiny.

FAQs

Q: What is the projected growth rate of the gabapentin market, which includes GRALISE? A: The gabapentin market is projected to grow at a CAGR of 5.90% from 2023 to 2032[1].

Q: Which region dominates the gabapentin market, including GRALISE? A: North America holds the largest market revenue share for gabapentin, with the U.S. being the dominant market within this region[1].

Q: What is the significance of the orphan drug designation for GRALISE? A: The orphan drug designation grants GRALISE seven years of market exclusivity, protecting it from competition and allowing higher pricing[3].

Q: How does the approval of GRALISE in new regions impact its market? A: The approval of GRALISE in new regions, such as Korea, offers opportunities for growth and expansion by providing a novel and convenient treatment option for patients[4].

Q: What are the potential challenges for GRALISE in the future? A: GRALISE faces challenges from generic competition upon the expiration of market exclusivity and regulatory scrutiny over the use of orphan drug designations[3].