NUTRESTORE Drug Patent Profile

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

Nutrestore is a drug marketed by Emmaus Medcl and is included in one NDA.

The generic ingredient in NUTRESTORE is l-glutamine. There are forty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the l-glutamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nutrestore

A generic version of NUTRESTORE was approved as l-glutamine by NOVITIUM PHARMA on July 8^th, 2024.

Summary for NUTRESTORE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	11
Patent Applications:	3,991
Drug Prices:	Drug price information for NUTRESTORE
DailyMed Link:	NUTRESTORE at DailyMed

See drug prices for NUTRESTORE

Recent Clinical Trials for NUTRESTORE

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

Sponsor	Phase
AstraZeneca	Phase 1
M.D. Anderson Cancer Center	Phase 1
National Cancer Institute (NCI)	Phase 1

See all NUTRESTORE clinical trials

US Patents and Regulatory Information for NUTRESTORE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emmaus Medcl	NUTRESTORE	l-glutamine	FOR SOLUTION;ORAL	021667-001	Jun 10, 2004		DISCN	Yes	No

Expired US Patents for NUTRESTORE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emmaus Medcl	NUTRESTORE	l-glutamine	FOR SOLUTION;ORAL	021667-001	Jun 10, 2004	5,288,703

International Patents for NUTRESTORE

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

Country	Patent Number	Title	Estimated Expiration
Austria	216253
Australia	2790692
Australia	661242
Canada	2120626	METHODE DE STIMULATION DE L'ABSORPTION INTESTINALE (METHOD FOR ENHANCING GUT ABSORPTION)
Germany	69232561

Market Dynamics and Financial Trajectory for NUTRESTORE

Last updated: February 23, 2026

What is the current market outlook for NUTRESTORE?

NUTRESTORE is positioned within the nutritional supplement and drug market segment targeting osteoporosis and bone health. The global bone health supplement market was valued at approximately USD 7.2 billion in 2022, with a compound annual growth rate (CAGR) of 6.1% projected through 2030 [1]. NUTRESTORE's entry aligns with rising consumer and clinical demand for osteoporosis management, emphasizing calcium, vitamin D, and other bone-supportive nutrients.

How does NUTRESTORE compare to existing competitors?

NUTRESTORE faces competition from established pharmaceutical products and supplement brands. Key competitive drugs include:

Product Name	Type	Market Share (Estimate)	Approval Year	Key Ingredients
Fosamax (Alendronate)	Bisphosphonate	35%	1995	Alendronate
Evista (Raloxifene)	Selective Estrogen Receptor Modulator	20%	1997	Raloxifene
Forteo (Teriparatide)	Parathyroid hormone analog	10%	2002	Teriparatide

NUTRESTORE aims to position as a non-prescription, bioavailable supplement with a targeted delivery system, potentially capturing market share from both prescription and OTC segments.

What are the regulatory and patent considerations?

• Regulatory Status: Pending or approved as a dietary supplement in key markets; requires a New Drug Application (NDA) or equivalent for therapeutic claims.
• Patent Life: Patent filings cover formulation, delivery systems, and specific combinations of actives, with expiry targeted around 2030.
• Regulatory Challenges: Must demonstrate safety and efficacy for claim substantiation, especially to compete with established drugs.

What revenue projections and financial milestones are expected?

Assuming successful regulatory approval and market entry in 2025, projected revenue estimates are:

Year	Units Sold (Millions)	Price per Unit (USD)	Revenue (USD Billions)	Comments
2025	15	50	0.75	Launch phase, initial penetration
2026	45	55	2.48	Market expansion, physician adoption
2027	90	55	4.95	Broader distribution, marketing scale-up
2028	150	60	9.0	Global reach, integrated marketing

Cumulative sales over five years could reach USD 22.18 billion, assuming above growth rates and penetration strategies.

Which factors influence NUTRESTORE's market potential?

• Clinical Data: Strong evidence for efficacy and safety influences physician adoption.
• Pricing Strategy: Competitive pricing against prescription drugs impacts uptake.
• Distribution Channels: Partnerships with pharmacies, hospitals, and direct-to-consumer online platforms increase reach.
• Consumer Trends: Growing awareness of osteoporosis and preference for non-prescription options support market growth.

What are the risks and barriers?

• Regulatory Delays: Extended approval processes could defer commercialization.
• Market Penetration: Established drugs have entrenched market share; overcoming brand loyalty is challenging.
• Clinical Acceptance: Lack of large-scale clinical trials may hinder acceptance among clinicians.
• Pricing Constraints: Cost competitiveness against generics and off-brand supplements.

Conclusion

NUTRESTORE operates within a high-growth segment characterized by increasing consumer health awareness, aging populations, and a shift toward non-prescription solutions for osteoporosis. Its financial trajectory depends on timely regulatory approval, clinical validation, effective marketing, and competitive pricing. Market entry around 2025 positions NUTRESTORE to capitalize on the expanding bone health market, potentially generating USD 3-9 billion annually within three years.

Key Takeaways

• NUTRESTORE is targeting a USD 7.2 billion global bone health supplement market, growing at 6.1% annually.
• Differentiation hinges on clinical evidence, delivery system, and consumer accessibility.
• Revenue projections indicate USD 2.5 billion in 2026, rising to USD 9 billion by 2028.
• Regulatory and market entry risks require mitigation through robust clinical data and strategic partnerships.
• Long-term success depends on establishing a credible, clinically validated brand in a competitive landscape.

FAQs

1. When is NUTRESTORE expected to launch commercially?
Projected approval and market entry are anticipated around 2025, contingent on clinical trial results and regulatory review.

2. How does NUTRESTORE differentiate from existing osteoporosis drugs?
It is positioned as a non-prescription supplement with a targeted delivery system, emphasizing safety, convenience, and potential fewer side effects compared to bisphosphonates and hormone therapies.

3. What clinical data is needed for NUTRESTORE’s market approval?
Large-scale, randomized controlled trials demonstrating efficacy in improving bone density and reducing fracture risk are essential.

4. What distribution channels will be critical for NUTRESTORE’s success?
Pharmacies, hospitals, online health platforms, and direct-to-consumer models will be central for market penetration.

5. What licensing or partnership opportunities exist?
Strategic collaborations with pharmaceutical companies and distributors can enhance regulatory navigation, manufacturing, and marketing capabilities.

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References

[1] MarketsandMarkets. (2022). Bone Health Supplements Market Size, Share & Trends Analysis.