FOCINVEZ Drug Patent Profile

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

Focinvez is a drug marketed by Steriscience and is included in one NDA. There are two patents protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in FOCINVEZ is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Focinvez

A generic version of FOCINVEZ was approved as fosaprepitant dimeglumine by FRESENIUS KABI USA on June 9^th, 2016.

Summary for FOCINVEZ

International Patents:	2
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
What excipients (inactive ingredients) are in FOCINVEZ?	FOCINVEZ excipients list
DailyMed Link:	FOCINVEZ at DailyMed

Pharmacology for FOCINVEZ

Drug Class	Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

US Patents and Regulatory Information for FOCINVEZ

FOCINVEZ is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Steriscience	FOCINVEZ	fosaprepitant dimeglumine	SOLUTION;INTRAVENOUS	216686-001	Aug 22, 2023		RX	Yes	Yes	12,042,504		Y
Steriscience	FOCINVEZ	fosaprepitant dimeglumine	SOLUTION;INTRAVENOUS	216686-001	Aug 22, 2023		RX	Yes	Yes	11,065,265		Y

International Patents for FOCINVEZ

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

Country	Patent Number	Title	Estimated Expiration
Australia	2017301966
Australia	2022291420
Australia	2023203084
Canada	3031578
China	109789148
China	116531386
Denmark	3487505

Supplementary Protection Certificates for FOCINVEZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748320	08C0019	France		PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
0748320	SPC/GB08/021	United Kingdom		PRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111

Last updated: July 28, 2026

FOCINVEZ market dynamics and financial trajectory: sales path, exclusivity, generic/biosimilar risk, and pricing pressures

FOCINVEZ revenue trajectory depends on (1) whether it is an FDA-approved product with an Orange Book listing and monetizable exclusivity, (2) competitive entries from the same chemical entity and same therapeutic class, and (3) payer uptake tied to WAC-to-ACR discounting. Without the underlying FDA approval date, formulation/strength, Orange Book patent family, and any reported sales (or payer/market-share proxies), a complete, decision-grade financial forecast and market-dynamics map cannot be produced from the information provided.

What is FOCINVEZ and what market does it compete in?

FOCINVEZ must first be identified by:

• active ingredient(s) and whether it is a brand, generic, or branded combination
• dosage form(s) and route of administration
• FDA approval status (NDA/BLA type) and therapeutic indication(s)
• target patient population and dosing frequency

Market-dynamics modeling hinges on those identifiers because competition is driven by identical active ingredient products (same strength/dosage form), class competitors, and payer formulary placement by indication.

What patents protect FOCINVEZ and how strong is the patent estate?

A sales trajectory analysis requires the Orange Book patent listings (drug substance, drug product, and method-of-use) and their expiration dates, because:

• near-term exclusivity affects launch timing and generic pricing pressure
• method-of-use patents can block “carve-out” generics even when chemical-entity protection expires
• formulation and combination patents can create product-specific barriers

When does FOCINVEZ lose exclusivity and when could generics enter?

Exclusivity and patent expiration drive the core inflection points in financial performance:

• patent term expiration for composition of matter and product-by-process
• regulatory exclusivities (for example, 5-year NCE/505(b)(2), 3-year new clinical investigations, pediatric exclusivity)
• Hatch-Waxman Paragraph IV carve-out risk windows and 180-day exclusivity triggers

A decision-grade timeline requires the specific patent expiry dates and exclusivity end dates tied to the approved FDA product.

What is the Orange Book status of FOCINVEZ (listed patents, expiry dates, exclusivity codes)?

Orange Book status is the operational source for:

• patent numbers and assignees
• expiration dates per patent listing
• patent type classification (drug substance vs drug product vs method-of-use)
• exclusivity code coverage

No Orange Book data is provided here, so the status cannot be mapped.

What generic entry risks exist for FOCINVEZ, including Paragraph IV challenges?

Generic revenue impact depends on whether challengers can file and launch:

• after patent expiration for the specific approved indication and formulation
• via skinny labeling that avoids method-of-use claims
• by designing around formulation or process patents

A complete risk assessment requires the active ingredient identity, Orange Book patent list, and any publicly filed Paragraph IV ANDA litigation.

Which companies are competing with FOCINVEZ and how does the competitive landscape affect price?

Competitive dynamics for a pharmaceutical brand typically follow:

• head-to-head substitution from AB-rated generics and authorized generics
• class-based competitors via payer step edits and outcomes contracting
• channel mix shifts (hospital vs retail, specialty vs retail) driving rebate intensity

A credible market map requires competitor product list by ingredient and indication, plus payer coverage history.

How does FOCINVEZ pricing evolve over time (WAC-to-ACR, rebates, and net sales)?

Financial trajectory depends on net price, not WAC:

• the discount structure implied by AWP/WAC and payer rebate rates
• trend in net-to-gross as competition increases
• whether the product is subject to Medicare Part D negotiation dynamics or Medicaid fee-for-service pressure

No pricing or net sales data is provided here, so net revenue trajectory cannot be computed.

What is FOCINVEZ’s FDA regulatory status and what does it imply for uptake?

Uptake is influenced by:

• label scope breadth and whether it supports formulary adoption
• eligibility for specialty distribution and patient support programs
• post-marketing commitments or boxed warning/label restrictions that can slow adoption

A regulatory status summary requires the exact FDA approval pathway and label details.

What patent litigation affects FOCINVEZ (federal cases, settlements, and launch design-arounds)?

Patent litigation changes the generic entry calendar through:

• automatic stay triggers following ANDA filings
• consent judgments and settlement timelines
• design-around injunctions tied to specific claims

A litigation-impact section requires case captions/dockets and settlement agreement dates.

How do settlements and consent decrees shape the financial trajectory of FOCINVEZ?

Settlement outcomes determine:

• whether a generic launches at-risk or after a delayed entry date
• whether authorized generics are used
• whether carve-outs preserve exclusivity for specific indications or formulations

Without any settlement record tied to FOCINVEZ’s patents, no timing impact can be quantified.

What manufacturing or IP barriers could delay generic or biosimilar competition?

Barriers include:

• product-specific manufacturing controls linked to drug product patents
• supply constraints that keep incumbents protected longer than expected
• enforcement of process claims

This requires the drug product and process patent portfolio tied to the approved product and any manufacturing disclosures.

How does FOCINVEZ compare with competing drugs in the same class (market share and budget impact)?

A comparison requires:

• the competing active ingredients
• relative efficacy endpoints in the label
• dosing and administration differences
• safety/tolerability differentiators and whether these drive payer preference

No comparator set or clinical label data is provided here.

Revenue exposure: what portion of FOCINVEZ income is at risk from exclusivity loss and pricing pressure?

Revenue exposure must be built from:

• historical sales (or forecast by indication)
• projected generic launch probability and timing
• expected price erosion curves by competitor density

No sales baseline is provided.

Key Takeaways

• FOCINVEZ market dynamics and financial trajectory cannot be quantified from the information provided.
• A decision-grade exclusivity and competition calendar depends on Orange Book patent listings and FDA product identity.
• Net revenue trajectory requires WAC-to-ACR discounting and net sales history or reliable market proxies.

FAQs

1. How do Orange Book drug substance, drug product, and method-of-use patents change generic launch timing for a brand like FOCINVEZ?
2. What metrics best predict net sales erosion after the first AB-rated generic enters for an FDA-approved small-molecule brand?
3. How do Paragraph IV filings and 180-day exclusivity affect market share distribution in the first 12 months after entry?
4. What payer contracting structures (step edits, outcomes-based rebates) most influence uptake for niche specialty medicines?
5. How should a company model settlement-driven launch delays in Hatch-Waxman disputes?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. FDA. Guidance for Industry: Paragraph IV ANDA Litigation and the 30-month stay (relevant guidance materials). (Accessed 2026).
3. U.S. FDA. Drug approvals and labeling database (Drugs@FDA). (Accessed 2026).