EVOMELA Drug Patent Profile

Which patents cover Evomela, and what generic alternatives are available?

Evomela is a drug marketed by Acrotech Biopharma and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and five patent family members in twenty-two countries.

The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evomela

A generic version of EVOMELA was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9^th, 2009.

Summary for EVOMELA

International Patents:	105
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	21
Patent Applications:	1,605
Drug Prices:	Drug price information for EVOMELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOMELA
What excipients (inactive ingredients) are in EVOMELA?	EVOMELA excipients list
DailyMed Link:	EVOMELA at DailyMed

See drug prices for EVOMELA

Recent Clinical Trials for EVOMELA

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

Sponsor	Phase
Ehsan Malek	Early Phase 1
Washington University School of Medicine	Phase 1
CASI Pharmaceuticals (China) Co., Ltd.	PHASE4

See all EVOMELA clinical trials

Pharmacology for EVOMELA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for EVOMELA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVOMELA	Powder for Injection	melphalan hydrochloride	50 mg/vial	207155	1	2017-09-08

US Patents and Regulatory Information for EVOMELA

EVOMELA is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes			Y

International Patents for EVOMELA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2013334921
Brazil	112015008954
Canada	2888822
Chile	2015001016

Supplementary Protection Certificates for EVOMELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	CA 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	3/2023	Austria		PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
2701720	122023000007	Germany		PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
2701720	CR 2022 00054	Denmark		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818

Last updated: July 25, 2026

EVOMELA (tasonermin?) market dynamics and financial trajectory: sales, exclusivity timeline, and competitive pressure

EVOMELA revenue trajectory is not computable from the provided inputs because EVOMELA’s active ingredient, launch year, product strength, geography, and FDA/Orange Book status were not supplied. Without that baseline, EVOMELA’s sales history, payer/contracting dynamics, milestone-based revenue drivers, and the patent/exclusivity events that typically shape market share cannot be mapped to hard dates or quantified outcomes.

What is EVOMELA and what drives its market dynamics?

Answer: Not available from the provided inputs.

Which active ingredient, dosage form, and indication does EVOMELA correspond to?

Not available from the provided inputs.

How do hospital ordering patterns shape EVOMELA demand?

Not available from the provided inputs.

What payer and contracting factors most affect EVOMELA reimbursement?

Not available from the provided inputs.

How has EVOMELA sales changed over time and what is the revenue trajectory?

Answer: Not available from the provided inputs.

What do EVOMELA net sales look like by year (US and ex-US)?

Not available from the provided inputs.

Which customers and channels matter most for EVOMELA (group purchasing, wholesalers, IDNs)?

Not available from the provided inputs.

What event shocks (supply, label changes, shortages, FDA actions) moved EVOMELA revenue?

Not available from the provided inputs.

When does EVOMELA lose exclusivity and when can generics or biosimilars enter?

Answer: Not available from the provided inputs.

What is the Orange Book status of EVOMELA (US patent listings and exclusivities)?

Not available from the provided inputs.

What are the relevant exclusivity types (NCE, orphan, 505(b)(2), pediatric, market exclusivity)?

Not available from the provided inputs.

What is the Paragraph IV landscape for EVOMELA?

Not available from the provided inputs.

How strong is the EVOMELA patent estate for formulations, methods, and delivery/production?

Answer: Not available from the provided inputs.

Which EVOMELA patents protect drug substance, drug product, and manufacturing?

Not available from the provided inputs.

What method-of-use patents cover conditioning regimens and dosing protocols?

Not available from the provided inputs.

How many patents cover EVOMELA and what are the key expiration dates?

Not available from the provided inputs.

What patent litigation affects EVOMELA and how do settlements impact generic timing?

Answer: Not available from the provided inputs.

Which defendants challenged EVOMELA via Paragraph IV?

Not available from the provided inputs.

What court rulings or settlements set launch dates?

Not available from the provided inputs.

How do FDA labeling carve-outs affect substitution and revenue risk?

Not available from the provided inputs.

What is the FDA regulatory status of EVOMELA and how does it affect adoption?

Answer: Not available from the provided inputs.

What is EVOMELA’s approval pathway and current label scope?

Not available from the provided inputs.

What REMS, postmarketing requirements, or safety communications affect utilization?

Not available from the provided inputs.

What is EVOMELA’s manufacturing and supply risk profile?

Not available from the provided inputs.

How does EVOMELA compare with conditioning-regimen competitors in chemotherapy and transplant settings?

Answer: Not available from the provided inputs.

Which alternative products compete on efficacy, safety, administration, and cost?

Not available from the provided inputs.

How does EVOMELA’s acquisition cost compare with therapeutic alternatives?

Not available from the provided inputs.

What substitution barriers exist (protocol lock-in, formulary placement, nurse-admin workflows)?

Not available from the provided inputs.

Which companies are challenging EVOMELA and what generic entry risks exist?

Answer: Not available from the provided inputs.

What is the Paragraph IV filing and approval timeline risk?

Not available from the provided inputs.

What litigation or regulatory blockers delay or accelerate entry?

Not available from the provided inputs.

What are the likely launch jurisdictions and distribution constraints?

Not available from the provided inputs.

EVOMELA exclusivity and financial exposure model: revenue at risk under generic entry scenarios

Answer: Not available from the provided inputs.

Scenario assumptions for revenue-at-risk under fast generic entry vs. delayed entry

Not available from the provided inputs.

How patent expiry and FDA approval milestones map to sales drawdown

Not available from the provided inputs.

What mitigation levers (authorized generics, line extensions, contracting) are feasible

Not available from the provided inputs.

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Key Takeaways

• EVOMELA’s market dynamics and financial trajectory cannot be quantified or tied to actionable exclusivity and competitive events with the provided inputs.
• No Orange Book, litigation, regulatory pathway, or sales data points were supplied, preventing a defensible market and financial trajectory analysis.

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FAQs

1. What does EVOMELA treat and what hospital protocols determine patient uptake?
   Not available from the provided inputs.

2. Is EVOMELA listed in the FDA Orange Book, and what patents block generic entry?
   Not available from the provided inputs.

3. Have any companies filed Paragraph IV certifications for EVOMELA?
   Not available from the provided inputs.

4. Does EVOMELA face biosimilar-type competition or only generic small-molecule competition?
   Not available from the provided inputs.

5. What factors most influence EVOMELA price and payer coverage (WAC vs. ASP, MAC lists, IDN contracts)?
   Not available from the provided inputs.

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References

No sources cited because no factual inputs (active ingredient, FDA application number, Orange Book listings, litigation docket references, or sales datasets) were provided.