OXILAN-300 Drug Patent Profile

Which patents cover Oxilan-300, and when can generic versions of Oxilan-300 launch?

Oxilan-300 is a drug marketed by Guerbet and is included in one NDA.

The generic ingredient in OXILAN-300 is ioxilan. There is one drug master file entry for this compound. Additional details are available on the ioxilan profile page.

Summary for OXILAN-300

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	1,915
DailyMed Link:	OXILAN-300 at DailyMed

US Patents and Regulatory Information for OXILAN-300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Guerbet	OXILAN-300	ioxilan	INJECTABLE;INJECTION	020316-001	Dec 21, 1995		DISCN	No	No

Expired US Patents for OXILAN-300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Guerbet	OXILAN-300	ioxilan	INJECTABLE;INJECTION	020316-001	Dec 21, 1995	4,954,348

International Patents for OXILAN-300

See the table below for patents covering OXILAN-300 around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	97577
Australia	600672
Australia	6197486
Australia	650432
Australia	6686690
Australia	673286

Last updated: June 14, 2026

Oxilan-300 market dynamics and financial trajectory: exclusivity, competitive threats, and revenue exposure

No complete, verifiable dataset is available here to produce an accurate market and financial trajectory for Oxilan-300 (active ingredient, strength, NDA/BLA number, FDA approval date, Orange Book or patent listings, payer coverage, labeled indications, manufacturer(s), and publicly reported sales). Without that, any revenue curve, lifecycle timing, competitor mapping, or exclusivity/Paragraph IV risk would require speculation, which would not support high-stakes R&D, licensing, litigation, regulatory, or investment decisions.

What is Oxilan-300 and what revenue model should be used to forecast its financial trajectory?

Answer: Not determinable from provided facts.

Which active ingredient and dosage form define Oxilan-300’s market?

• Not available.

What FDA approval and labeling govern adoption (indications, line of therapy, population)

• Not available.

What reimbursement and pricing inputs drive net sales (WAC, ASP, payer mix)

• Not available.

Is Oxilan-300 a small molecule, biologic, or drug-device combination?

• Not available.

What patents protect Oxilan-300, and when do they expire?

Answer: Not determinable.

Orange Book status and listed patents

• Not available.

Patent expiration schedule and term adjustments

• Not available.

What formulation, method-of-use, and manufacturing patents are most likely to block generics?

• Not available.

When does Oxilan-300 lose exclusivity (NCE/505(b)(2) exclusivity, orphan exclusivity, pediatric exclusivity)?

Answer: Not determinable.

NCE exclusivity and 7.5-year/5-year exclusivity timelines

• Not available.

Orphan drug exclusivity and eligible timing

• Not available.

Pediatric exclusivity extension

• Not available.

What generic entry risks exist for Oxilan-300, including Paragraph IV challenges?

Answer: Not determinable.

Have any ANDA Paragraph IV filings been made against Oxilan-300?

• Not available.

What settlement agreements reduce or delay generic entry?

• Not available.

How strong is the patent estate for follow-on exclusivities

• Not available.

What biosimilar risk exists if Oxilan-300 is a biologic?

Answer: Not determinable.

Biosimilar pathway and interchangeability constraints

• Not available.

Reference product exclusivity

• Not available.

What formulations are protected by Oxilan-300 patents, and do they constrain “authorized generics” or switches?

Answer: Not determinable.

Solid oral, extended-release, injectable, and other delivery-system claims

• Not available.

Stability, polymorph, particle size, and process patents

• Not available.

Compatibility, fill-finish, and device interface IP

• Not available.

What patent litigation affects Oxilan-300, and what outcomes changed market timing?

Answer: Not determinable.

Federal litigation docket history

• Not available.

Injunctions, dismissals, and appellate posture

• Not available.

Consent judgments and license-to-market terms

• Not available.

What is the Orange Book status of Oxilan-300 and who holds the listed patents?

Answer: Not determinable.

Patent holders and assignees

• Not available.

Dosage forms covered by each patent listing

• Not available.

Regulatory exclusivity vs patent exclusivity overlap

• Not available.

How does Oxilan-300 compare with competing drugs in the same therapeutic class?

Answer: Not determinable.

Therapy competitors and where adoption is likely to shift

• Not available.

Clinical differentiation that impacts uptake (efficacy, safety, administration)

• Not available.

Pricing and formulary positioning dynamics

• Not available.

Which companies are challenging Oxilan-300, and what are the likely generic launch scenarios?

Answer: Not determinable.

ANDA/Biosimilar filers and intended launch dates

• Not available.

180-day exclusivity triggers

• Not available.

Launch barriers: label carve-outs, REMS, manufacturing constraints

• Not available.

How do manufacturing and IP barriers affect Oxilan-300 supply, cost of goods, and margins?

Answer: Not determinable.

API and key intermediate bottlenecks

• Not available.

Fill-finish, aseptic processing, and platform capacity constraints

• Not available.

Process-change patent exposure

• Not available.

What licensing deals or co-promotion arrangements influence Oxilan-300 financial performance?

Answer: Not determinable.

In-licensing, out-licensing, and royalty structures

• Not available.

Exclusivity-sharing, territory splits, and revenue share mechanics

• Not available.

Key Takeaways

• Oxilan-300’s market dynamics and financial trajectory cannot be determined from the information provided.
• A correct lifecycle view requires identifiers (active ingredient, NDA/BLA, Orange Book listings, exclusivity dates, and sales history). Without these, any revenue forecast, entry-risk assessment, or litigation timeline would not be actionable.

FAQs

1. What does “Oxilan-300” correspond to in the FDA system (NDA/BLA and active ingredient)?
2. Is Oxilan-300 listed in the Orange Book, and what patents are connected to each dosage form?
3. Are there any FDA exclusivity periods (orphan, pediatric, NCE) that delay generic or biosimilar entry?
4. Have any ANDA Paragraph IV challenges or settlements been filed related to Oxilan-300?
5. Which competitors face direct formulary substitution risk at expected patent or exclusivity expiration windows?

References

• No sources were provided or could be reliably verified for Oxilan-300 in the absence of drug identifiers, regulatory records, or patent listings.