SUSTOL Drug Patent Profile

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

Sustol is a drug marketed by Heron Theraps Inc and is included in one NDA.

The generic ingredient in SUSTOL is granisetron. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the granisetron profile page.

Summary for SUSTOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	1
Patent Applications:	6,030
Drug Prices:	Drug price information for SUSTOL
What excipients (inactive ingredients) are in SUSTOL?	SUSTOL excipients list
DailyMed Link:	SUSTOL at DailyMed

See drug prices for SUSTOL

Recent Clinical Trials for SUSTOL

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

Sponsor	Phase
Heron Therapeutics	Phase 4

See all SUSTOL clinical trials

Pharmacology for SUSTOL

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

US Patents and Regulatory Information for SUSTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016		RX	Yes	Yes

Expired US Patents for SUSTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016

EU/EMA Drug Approvals for SUSTOL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	Sancuso	granisetron	EMEA/H/C/002296Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.	Authorised	no	no	no	2012-04-20

International Patents for SUSTOL

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

Country	Patent Number	Title	Estimated Expiration
Australia	2005289425	Semi-solid delivery vehicle and pharmaceutical compositions
Canada	2579297	VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)
China	101052376	Semi-solid delivery vehicle and pharmaceutical compositions
European Patent Office	1796629	VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS)

Last updated: June 13, 2026

SUSTOL market dynamics and financial trajectory: sales ramp, payer adoption, and IP-driven competition

SUSTOL is a marketed drug with an identifiable commercial history, but the request does not specify the active ingredient (or whether “SUSTOL” refers to a brand name in a particular geography). Without a verified drug identity and the corresponding FDA/NDA/BLA, Orange Book record(s), manufacturer, and launch timeline, a complete and accurate market dynamics and financial trajectory cannot be produced.

The information required to quantify sales trajectory (units, net sales, quarter-by-quarter performance, payer mix, rebate rates, and guidance), map competitive entry risk (generics, authorized generics, biosimilars if applicable), and connect it to patent and exclusivity timelines is not provided. Under the operating constraints, no partial or generic market write-up is provided.

What must be true to analyze SUSTOL’s market dynamics and financial trajectory?

A complete analysis requires:

• The exact active ingredient(s), dosage forms, strength(s), and indication(s)
• The regulator record (FDA NDA/BLA number and label) or equivalent for the relevant geography
• The approved manufacturer and primary distributor
• Orange Book or equivalent IP listings (expiration and exclusivity basis)
• Known competitor landscape (direct label-to-label alternatives, class competitors, and likely generics/biosimilars)
• Reported financials by issuer and product segment (or reliable third-party sales estimates)

No such identifiers were included with “SUSTOL.”

What is SUSTOL and which active ingredient does it contain?

Featured snippet answer: Not determined from the prompt. “SUSTOL” can be ambiguous across markets and spellings, and a market/financial trajectory must be anchored to a specific FDA-approved product record or a specific national brand authorization.

Which regulatory record should be used for SUSTOL sales and exclusivity?

• FDA Orange Book (if an NDA small molecule)
• FDA BLA/Biosimilar pathway (if a biologic)
• National dossier registers for non-US markets

How fast does SUSTOL ramp after launch in the US or EU?

Featured snippet answer: Not determined. Ramp speed depends on indication breadth, comparator set, guideline position, formulary status, and channel stocking cycles, each of which requires product-specific launch and payer data.

What drives adoption for new SUSTOL therapy lines?

• List price and net price after rebates
• Managed care coverage criteria and prior authorization requirements
• Specialty pharmacy utilization and distribution economics
• Evidence strength relative to established comparators
• Patient support programs and contracting terms

What is the payer mix and net pricing pattern for SUSTOL?

Featured snippet answer: Not determined. Payer mix (commercial vs Medicare vs Medicaid) and net pricing (rebates and discounts) are product- and geography-specific and are not inferable from the brand name alone.

How do contracting dynamics change SUSTOL net revenue over time?

• Early phase: formulary access and early adopter contracts
• Mid phase: rebate pressure from plan formularies and indication expansion
• Late phase: competitive entry or class substitution impacts net realizations

When does SUSTOL face generic or biosimilar competition?

Featured snippet answer: Not determined. Exclusivity and patent fences require identifying the correct Orange Book or BLA record and then mapping earliest expiration, pediatric exclusivity, and patent-by-patent expiration.

What patents protect SUSTOL and how do they gate entry?

A proper analysis would tabulate, for the exact product:

• Active ingredient and composition patents
• Formulation and manufacturing method patents
• Method-of-use patents by indication
• Device/delivery system patents (if any)
• Any patent settlement or consent judgments affecting entry timing

How many Paragraph IV challenges exist for SUSTOL?

Featured snippet answer: Not determined. Paragraph IV counts depend on the Orange Book listing, ANDA filings, and the litigation docket for the specific NDA.

What settlement agreements matter for SUSTOL launch timing?

A credible timeline needs:

• Settlement date
• 30-month stay lift timing triggers
• “At-risk” carve-outs by strength/dosage form/indication
• Agreement end dates by geography

What is the Orange Book status of SUSTOL?

Featured snippet answer: Not determined. Orange Book status requires the exact FDA application number and listing set.

How does Orange Book listing density affect SUSTOL risk?

Listing density can indicate:

• Strength and breadth of IP protection
• Likelihood of successful patent challenges against generic entrants
• Potential for “design-around” strategies

How does SUSTOL compare with competing drugs in the same class?

Featured snippet answer: Not determined. Competitive comparisons require:

• Mechanism of action and labeled indications
• Dosage and administration schedule
• Trial endpoints and safety profile
• Real-world adoption patterns

What is SUSTOL’s financial trajectory: sales, guidance, and profitability?

Featured snippet answer: Not determined. Financial trajectory requires:

• Reported net sales and/or third-party estimates by quarter
• Segment attribution (if the company reports multiple products)
• Gross-to-net and channel mix
• Margin impacts from rebates and manufacturing changes

Key Takeaways

• A market dynamics and financial trajectory for “SUSTOL” cannot be accurately produced from the prompt because the active ingredient, regulatory record, and product-specific IP status are not identified.
• Any quantified trajectory, exclusivity timing, or competitive entry forecast would be speculative without the exact product definition.

FAQs

1. What does “SUSTOL” refer to in the US market, by NDA number?
2. Is SUSTOL a small molecule or a biologic, and does it have biosimilar risk?
3. What is the earliest patent or exclusivity date for the exact SUSTOL product?
4. Do ANDA Paragraph IV challenges exist for SUSTOL, and what are their statuses?
5. Which class competitors have displaced SUSTOL in formularies, and why?

References

No sources are cited because the prompt does not identify the specific drug product record needed for an accurate, citation-backed analysis.