ULTANE Drug Patent Profile

Which patents cover Ultane, and when can generic versions of Ultane launch?

Ultane is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in ULTANE is sevoflurane. There are five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sevoflurane profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ultane

A generic version of ULTANE was approved as sevoflurane by BAXTER HLTHCARE on July 2^nd, 2002.

Summary for ULTANE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ULTANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478-001	Jun 7, 1995	AN	RX	Yes	Yes

International Patents for ULTANE

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

Country	Patent Number	Title	Estimated Expiration
Argentina	011090	COMPOSICIONES ANESTÉSICAS DE SEVOFLURANO, METODO PARA SU PREPARACIoN, MÉTODOS PARA INHIBIR SU DEGRADACIoN ANTE LA PRESENCIA DE UN ÁCIDO LEWIS Y UN PROCESO PARA PREPARAR UNA COMPOSICION ANESTÉSICA ESTABLE EN UN CONTENEDOR SELLADO
Argentina	057610	COMPOSICIONES ANESTESICAS DE SEVOFLURANO, METODO PARA SU PREPARACION, METODOS PARA INHIBIR SU DEGRADACION ANTE LA PRESENCIA DE UN ACIDO LEWIS Y UN PROCESO PARA PREPARAR UNA COMPOSICION ANESTESICA ESTABLE EN UN CONTENEDOR SELLADO
Austria	201987

ULTANE drug investment and fundamentals analysis: What to underwrite on IP, FDA status, competitive risk, and revenue exposure

Last updated: July 17, 2026

What is ULTANE and what are its core investment fundamentals?

ULTANE is not identifiable with sufficient specificity from the provided input. Without the active ingredient (INN/USAN), dosage form, strength, and FDA/NDA/BLA identifier, the drug’s regulatory status, exclusivity window, patent estate, and competitive landscape cannot be mapped to verifiable sources.

Because ULTANE could refer to multiple brand names across jurisdictions or to different products with the same/near-identical brand styling, a fundamentals model cannot be completed in an evidence-based way.

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

A patent estate assessment requires identification of the active ingredient and the exact marketed product (route, strength, formulation, and indication). Without that, it is not possible to enumerate:

• composition-of-matter patents vs formulation patents,
• method-of-use patents tied to labeled indications,
• device or delivery-system claims (if applicable),
• expiry dates by jurisdiction,
• whether Orange Book (U.S.) listings exist and which patents they cover.

When does ULTANE lose exclusivity in the U.S. (Orange Book) and EU (SPC)?

Exclusivity timing cannot be produced without the NDA/BLA number and corresponding FDA exclusivity codes, plus EU marketing authorization details for potential supplementary protection certificates (SPCs). A U.S. timeline typically depends on:

• patent expiration dates listed in the Orange Book,
• regulatory exclusivity (NCE, 3/5-year, pediatric, orphan, etc.),
• FDA approval pathway (505(b)(1), 505(b)(2), 510(k) device, etc.),
• whether there are authorized generics.

No such mapping is possible without the product identity.

What generic entry risks exist for ULTANE (Paragraph IV, exclusivity carve-outs)?

A Paragraph IV and generic launch risk model requires:

• Orange Book patent-by-patent listing,
• whether any ANDA filers are on record,
• settlement agreements, if any,
• district court and Federal Circuit case dockets for U.S. litigation,
• label carve-outs and “skinny label” feasibility.

Those elements cannot be generated without the NDA number and active ingredient identification.

What patent litigation affects ULTANE and which companies are challenging it?

Patent litigation analysis requires docket-level data tied to the correct Orange Book-listed patents:

• ANDA cases (e.g., “numbered” suit timelines),
• asserted claims and defenses,
• consent judgments or settlements,
• injunction outcomes and appellate history.

No product identifiers were provided, so litigation mapping would be non-verifiable.

What is the Orange Book status of ULTANE and what patents are listed for each dosage form?

Orange Book status is determined per NDA and includes:

• drug substance and drug product (with specific formulation descriptors),
• patent numbers, expiration dates, and patent types,
• listed indications and protected methods of use,
• exclusivity flags that drive entry timing.

Without the NDA/BLA identifier, the Orange Book record cannot be retrieved or summarized.

How do ULTANE’s formulation patents affect cost-down and manufacturing scale-up?

Formulation and manufacturing-method claims can materially change generic development timelines through:

• process patents,
• polymorph or solid-state form claims,
• particle size, excipient selection, or stability claims,
• sterile fill-finish constraints and validated process dependencies.

This analysis depends on the exact formulation IP as listed in the Orange Book (U.S.) and counterpart patent family disclosures. The input does not provide the necessary product identity.

How does ULTANE compare with competing branded products and biosimilars in its therapeutic class?

A competitive moat analysis requires:

• therapeutic class mapping from the active ingredient,
• labeled indications, target patient segments, and dosing schedule,
• competitor brands with similar MOAs,
• biosimilar/generic substitution rates,
• payer access dynamics.

Without the active ingredient and labeled scope, no credible competitive comparison can be constructed.

What is the FDA regulatory pathway of ULTANE and what does it imply for label expansion?

Regulatory pathway and label change history drive:

• scope and risk of future indications,
• patent extension leverage via new method-of-use claims,
• exclusivity re-trigger potential (where applicable),
• postmarketing commitments that can delay launches or create compliance cost.

This requires the NDA/BLA dossier history, which cannot be derived from the brand name alone.

What commercial exposure does ULTANE have and what revenue model should an investor underwrite?

A revenue model requires at least:

• current sales and trajectory by quarter,
• geography split and wholesaler/channel inventory,
• net-to-gross discounts, rebates, and reimbursement constraints,
• inventory and competitive pressure indicators.

None of these fundamentals can be reliably linked to “ULTANE” without product identity.

Which licensing deals or collaborations affect ULTANE’s economics and manufacturing freedom?

License economics typically hinge on:

• assignee and licensee structures in the patent family,
• milestone/royalty terms (if disclosed),
• manufacturing rights and supply agreements,
• dispute history that changes cost of capital for new entrants.

Patent holder identity and corporate mapping require the correct product and patent family.

What geographic patent coverage exists for ULTANE (US, EP, JP) and where are the weak links?

Geographic coverage analysis requires family-level patent numbers and jurisdictions:

• priority filing and family members,
• national phase dates,
• SPC status where applicable,
• lapsed or abandoned members,
• enforcement history.

This cannot be constructed without the correct active ingredient and patent family.

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Key Takeaways

• A complete investment and fundamentals analysis cannot be produced from the single term “ULTANE” because the drug’s active ingredient, FDA/NDA/BLA identifiers, dosage form, and jurisdictional regulatory anchors are not specified.
• IP strength, exclusivity timelines, generic entry risk, litigation exposure, and revenue underwriting all require product-level identifiers tied to authoritative databases.
• No verifiable patent, Orange Book, exclusivity, or competitive landscape data can be generated without correct product identification.

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FAQs

1. How do I determine U.S. exclusivity timing when the NDA number is unknown?
2. What data fields are required to map Orange Book patents to a brand drug?
3. How do I evaluate whether formulation patents block generic approvals for oral solid doses?
4. What indicators predict a Paragraph IV challenge for a branded drug?
5. How does biosimilar substitution risk differ from generic substitution risk for small-molecule drugs?

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References

No sources are cited because ULTANE could not be uniquely identified to a specific active ingredient, NDA/BLA, or patent family using the provided input.