NALDEMEDINE TOSYLATE - Generic Drug Details

What are the generic drug sources for naldemedine tosylate and what is the scope of patent protection?

Naldemedine tosylate is the generic ingredient in one branded drug marketed by Bdsi and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naldemedine tosylate has seventy-four patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for NALDEMEDINE TOSYLATE

International Patents:	74
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	143
DailyMed Link:	NALDEMEDINE TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NALDEMEDINE TOSYLATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NALDEMEDINE TOSYLATE

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NALDEMEDINE TOSYLATE

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

US Patents and Regulatory Information for NALDEMEDINE TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y

International Patents for NALDEMEDINE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Hungary	S1900034
Portugal	1889848
Australia	2011327113	Crystalline 6,7-unsaturated-7-carbamoyl morphinane derivative, and method for producing same
Russian Federation	2403255	6,7-НЕНАСЫЩЕННОЕ 7-КАРБАМОИЛЗАМЕЩЕННОЕ ПРОИЗВОДНОЕ МОРФИНАНА (6,7-UNSATURATED 7-CARBAMOYL SUBSTITUTED MORPHINANDERIVATIVE)
European Patent Office	3560929	DÉRIVÉ 6,7-INSATURATÉ-7-CARBAMOYL-MORPHINANE ET PROCÉDÉ POUR LE PRODUIRE (CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME)
European Patent Office	2639234	DÉRIVÉ 6,7-INSATURATÉ-7-CARBAMOYL-MORPHINANE ET PROCÉDÉ POUR LE PRODUIRE (CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME)
Russian Federation	2643807	КРИСТАЛЛЫ ПРОИЗВОДНЫХ 6,7-НЕНАСЫЩЕННОГО-7-КАРБАМОИЛМОРФИНАНА И СПОСОБ ИХ ПОЛУЧЕНИЯ (CRYSTALS OF 6,7-UNSATURATED-7-CARBAMOYLMORPHINANE DERIVATIVES AND METHOD OF THEIR PRODUCTION)

Supplementary Protection Certificates for NALDEMEDINE TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	132019000000093	Italy		PRODUCT NAME: NALDEMEDINA O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL SALE TOSILATO(RIZMOIC - NALDEMEDINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1291, 20190220
1889848	SPC/GB19/050	United Kingdom		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT; REGISTERED: UK EU/1/18/1291(FOR NI) 20190220; UK PLGB 50999/0003 20190220
1889848	2019C/533	Belgium		PRODUCT NAME: NALMEDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN BIJZONDER HET TOSYLAATZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1291 20190220
1889848	122019000063	Germany		PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848	C 2019 033	Romania		PRODUCT NAME: NALDEMEDINA SAU O SARE SAU SOLVAT ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/18/1291; DATE OF NATIONAL AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1291; DATE OF FIRST AUTHORISATION IN EEA: 20190218
1889848	2019/038	Ireland		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848	300996	Netherlands		PRODUCT NAME: NALDEMEDINE DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TOSYLAATZOUT; REGISTRATION NO/DATE: EU/1/18/1291 20190220

NALDEMEDINE TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naldemedine Tosylate

Introduction

Naldemedine tosylate, marketed under the brand name Symproic in the US, is a μ-opioid receptor antagonist specifically designed to treat opioid-induced constipation (OIC) in adult patients. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Need and Drivers

The opioid-induced constipation market is driven by the increasing prevalence of chronic pain conditions and the subsequent use of opioid analgesics. Chronic pain affects a significant portion of the population, with approximately 20.4% of adults in the United States experiencing chronic pain[5].

Increasing Prevalence of Chronic Pain

Chronic pain conditions necessitate the long-term use of opioid analgesics, which often lead to OIC. This growing demand for effective treatments for OIC has created a substantial market opportunity for drugs like naldemedine tosylate[3].

Clinical Efficacy and Approval

Naldemedine tosylate was approved by the FDA on March 23, 2017, based on the results of the COMPOSE program, a series of phase three clinical trials. These trials, including COMPOSE-I and COMPOSE-II, demonstrated the efficacy of naldemedine in increasing spontaneous bowel movements in patients with OIC without causing opioid withdrawal symptoms[2].

Clinical Trials Outcomes

The COMPOSE trials showed that patients treated with naldemedine had significantly higher responder rates for spontaneous bowel movements compared to those receiving a placebo. Additionally, a 52-week trial (COMPOSE-III) confirmed the long-term safety and efficacy of naldemedine[2].

Market Segmentation

The OIC drug market is segmented based on the type of drug and the application or distribution channel.

Drug Types

Naldemedine tosylate competes in a market that includes other drugs such as lubiprostone, methyl naltrexone bromide, and alvimopan. Each of these drugs has its own mechanism of action and patient population[3].

Distribution Channels

The market is further segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Naldemedine tosylate is available through these channels, catering to different patient needs and preferences[3].

Commercialization and Partnerships

Naldemedine tosylate is manufactured by Shionogi Inc., a subsidiary of the Japanese pharmaceutical company Shionogi & Co., Ltd. In the US, Shionogi Inc. has partnered with Purdue Pharma for the commercialization of Symproic[2].

Partnership with Purdue Pharma

This partnership has been crucial in promoting and distributing the drug, leveraging Purdue Pharma's expertise in chronic pain management. The collaboration began with the drug's launch in October 2017[2].

Financial Performance

The financial trajectory of naldemedine tosylate is closely tied to the overall performance of its parent company, Shionogi & Co., Ltd., and its partner, Purdue Pharma.

Revenue Growth

Since its FDA approval in 2017, naldemedine tosylate has contributed to the increasing net income of Shionogi & Co., Ltd. The company's net income rose from $66,687,000 in fiscal year 2016 to $83,879,000 in fiscal year 2017, although the exact contribution of Symproic to this growth is not specified[2].

Market Size and Projections

The global OIC drug market, which includes naldemedine tosylate, was valued at USD 2.65 billion in 2023 and is projected to reach USD 3.99 billion by 2032, growing at a CAGR of 4.6%[3].

Pricing and Cost

Naldemedine tosylate is priced at £41.72 for a 28-tablet pack in some markets, reflecting its position as a prescription-only medicine subject to additional monitoring[1].

Safety and Adverse Events

Clinical trials have shown that naldemedine tosylate has a favorable safety profile, with adverse events similar to those in the placebo group. However, patients in the naldemedine group experienced slightly higher rates of adverse events in some studies[2].

Long-Term Safety

The COMPOSE-III trial, which examined the long-term safety of naldemedine, found no significant increase in adverse events or opioid withdrawal symptoms over a 52-week period[2].

Additional Applications

Research has also explored the use of naldemedine in cancer patients with OIC who are insufficiently responding to other treatments. A post hoc analysis of phase IIb and III trials showed that adding naldemedine to magnesium oxide significantly improved bowel movement responder rates in these patients[4].

"In the naldemedine group, the responder rates for spontaneous bowel movement and complete spontaneous bowel movement were 73.3 and 43.1%, respectively, which were significantly higher than in the placebo group"[4].

Conclusion

Naldemedine tosylate has established itself as a significant player in the opioid-induced constipation market, driven by its clinical efficacy and the growing need for effective OIC treatments. The drug's commercial success is supported by its partnership with Purdue Pharma and its inclusion in various distribution channels.

Key Takeaways

• Clinical Efficacy: Naldemedine tosylate has demonstrated significant efficacy in increasing spontaneous bowel movements in patients with OIC.
• Market Growth: The OIC drug market is projected to grow at a CAGR of 4.6% to reach USD 3.99 billion by 2032.
• Partnerships: The partnership with Purdue Pharma has been crucial for the drug's commercialization.
• Safety Profile: Naldemedine tosylate has a favorable safety profile with minimal adverse events.
• Additional Applications: The drug shows promise in treating OIC in cancer patients.

FAQs

What is the primary indication for naldemedine tosylate?

Naldemedine tosylate is primarily indicated for the treatment of opioid-induced constipation in adult patients who have previously been treated with a laxative[1].

Who manufactures naldemedine tosylate?

Naldemedine tosylate is manufactured by Shionogi Inc., a subsidiary of Shionogi & Co., Ltd.[2].

What is the dosage of naldemedine tosylate?

The recommended dosage of naldemedine tosylate is 200 mcg once daily, taken at the same time every day[1].

What are the key clinical trials that supported the approval of naldemedine tosylate?

The COMPOSE program, including COMPOSE-I, COMPOSE-II, and COMPOSE-III trials, supported the FDA approval of naldemedine tosylate[2].

How is naldemedine tosylate distributed in the market?

Naldemedine tosylate is distributed through hospital pharmacies, retail pharmacies, and online pharmacies[3].

Sources

1. BMJ - Naldemedine for opioid-induced constipation
2. Wikipedia - Naldemedine
3. Business Research Insights - Opioid Induced Constipation (OIC) Drug Market
4. Oxford Academic - Effect of add-on naldemedine treatment in patients with cancer and ...
5. Annual Reports - Form 10-K for Collegium Pharmaceutical INC