MULTRYS Drug Patent Profile

When do Multrys patents expire, and when can generic versions of Multrys launch?

Multrys is a drug marketed by Am Regent and is included in one NDA. There are five patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in MULTRYS is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. One supplier is listed for this compound. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Multrys

Multrys was eligible for patent challenges on April 30, 2023.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for MULTRYS

International Patents:	6
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for MULTRYS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MULTRYS
What excipients (inactive ingredients) are in MULTRYS?	MULTRYS excipients list
DailyMed Link:	MULTRYS at DailyMed

See drug prices for MULTRYS

Pharmacology for MULTRYS

Drug Class	Copper Absorption Inhibitor Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity
Physiological Effect	Decreased Copper Ion Absorption

US Patents and Regulatory Information for MULTRYS

MULTRYS is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes			Y
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes			Y

International Patents for MULTRYS

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

Country	Patent Number	Title	Estimated Expiration
Australia	2021300384	Trace element compositions, methods of making and use
Canada	3186578	COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
China	116096423	微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application)
European Patent Office	4175615	COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
South Korea	20230058047	미량 원소 조성물, 그 제조 및 사용 방법
World Intellectual Property Organization (WIPO)	2022006426

Last updated: June 16, 2026

MULTRYS (Drug Market Dynamics and Financial Trajectory): Revenue Drivers, Exclusivity Risk, and Competitive Threats

MULTRYS’ market trajectory depends on launch timing, payer adoption, and whether competitors can enter before regulatory and patent exclusivity lapse. Without verified product identity, FDA approvals, Orange Book listings, and financial reporting tied to the specific “MULTRYS” product name, a complete and accurate market-and-financial assessment cannot be produced.

What is MULTRYS and who markets it in the U.S.?

Answer: Insufficient verified information to identify the exact FDA-listed product, active ingredient, strength(s), dosage form(s), sponsor, and marketer for “MULTRYS.”

What active ingredient does MULTRYS contain and what therapeutic area is it in?

Answer: Not determined from available information.

Which FDA approval pathway does MULTRYS use (NDA, ANDA, 505(b)(2))?

Answer: Not determined.

What label and dosing schedule drive sales potential?

Answer: Not determined.

How do market dynamics shape MULTRYS revenue growth?

Answer: Not determinable without the drug’s indication, patient population size, pricing, uptake, and competitor set.

Payer coverage: formulary placement, prior authorization, step edits

Answer: Not determinable.

Pricing structure: WAC vs net price, rebates, patient assistance

Answer: Not determinable.

Channel mix: specialty pharmacy vs retail, distribution model

Answer: Not determinable.

What is MULTRYS’s financial trajectory from launch to the present?

Answer: Not determinable without verified financial statements or reliable disclosures mapping revenues to the exact MULTRYS product.

Historical revenue trend: quarterly and annual sales

Answer: Not determinable.

Guidance and analyst consensus for MULTRYS

Answer: Not determinable.

Key drivers: volume vs price, patient starts, persistence

Answer: Not determinable.

When does MULTRYS lose exclusivity and how does that affect revenue risk?

Answer: Not determinable without FDA exclusivity, Orange Book exclusivity codes, and patent expiration dates for the MULTRYS listing.

What patents protect MULTRYS under Orange Book listings?

Answer: Not determinable.

Drug product (formulation) patents

Answer: Not determinable.

Method-of-use patents

Answer: Not determinable.

Manufacturing and process patents

Answer: Not determinable.

When do the earliest patent expirations occur?

Answer: Not determinable.

Is there pediatric exclusivity or other listed extensions?

Answer: Not determinable.

What generic entry risks exist for MULTRYS (Paragraph IV, ANDA, 505(b)(2))?

Answer: Not determinable without Paragraph IV filings, ANDA status, and settlement documentation.

Have any ANDAs been filed with Paragraph IV certifications?

Answer: Not determinable.

What settlements or consent decrees affect launch timing?

Answer: Not determinable.

How strong is the patent estate for MULTRYS?

Answer: Not determinable without a consolidated list of patents, claims scope, remaining life, and jurisdiction.

How many patents cover MULTRYS and what is their remaining term?

Answer: Not determinable.

Which jurisdictions matter for enforcement (US, EU, etc.)

Answer: Not determinable.

What patent litigation affects MULTRYS and its competitive timeline?

Answer: Not determinable without case filings, dockets, and party names tied to the correct MULTRYS product.

Who are the challengers and what are the asserted patents?

Answer: Not determinable.

What are the settlement terms (entry date, royalty, stay duration)?

Answer: Not determinable.

What is the Orange Book status of MULTRYS and what does it imply for competition?

Answer: Not determinable without Orange Book product and patent listing details.

NDC and dosage form coverage

Answer: Not determinable.

Exclusivity codes and dates

Answer: Not determinable.

How does MULTRYS compare with competing drugs in its class?

Answer: Not determinable without the therapeutic indication, mechanism of action, and competitor set.

Efficacy, safety, and tolerability differentiators

Answer: Not determinable.

Dosing convenience and adherence impacts

Answer: Not determinable.

Real-world adoption vs clinical trial uptake

Answer: Not determinable.

Key Takeaways

• MULTRYS’ market dynamics and financial trajectory cannot be quantified without verified identification of the exact FDA-listed product, sponsor, exclusivity and patent posture, and linked financial reporting.
• A defensible revenue outlook requires confirmed Orange Book listings, exclusivity end dates, litigation posture, and confirmed competitor entry risks tied to the same product identity.

FAQs

1. What is the FDA approval status of MULTRYS?
2. Does MULTRYS have Orange Book-listed patents, and when do they expire?
3. Are there any Paragraph IV challenges targeting MULTRYS?
4. What is the expected generic or biosimilar entry timeline for MULTRYS?
5. Which drugs are most comparable to MULTRYS in prescribing and formulary placement?

References

1. (No citable sources available because the exact MULTRYS FDA product and its linked Orange Book and financial disclosures are not verified in the provided context.)