SOTYLIZE Drug Patent Profile

« Back to Dashboard

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

Sotylize is a drug marketed by Azurity and is included in one NDA. There are five patents protecting this drug.

The generic ingredient in SOTYLIZE is sotalol hydrochloride. There is one drug master file entry for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sotylize

A generic version of SOTYLIZE was approved as sotalol hydrochloride by TEVA on May 1^st, 2000.

Summary for SOTYLIZE

US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Patent Applications:	3,269
Drug Prices:	Drug price information for SOTYLIZE
What excipients (inactive ingredients) are in SOTYLIZE?	SOTYLIZE excipients list
DailyMed Link:	SOTYLIZE at DailyMed

See drug prices for SOTYLIZE

Pharmacology for SOTYLIZE

Drug Class	Antiarrhythmic
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Cardiac Rhythm Alteration

US Patents and Regulatory Information for SOTYLIZE

SOTYLIZE is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	SOTYLIZE	sotalol hydrochloride	SOLUTION;ORAL	205108-001	Oct 22, 2014		RX	Yes	Yes			Y
Azurity	SOTYLIZE	sotalol hydrochloride	SOLUTION;ORAL	205108-001	Oct 22, 2014		RX	Yes	Yes			Y
Azurity	SOTYLIZE	sotalol hydrochloride	SOLUTION;ORAL	205108-001	Oct 22, 2014		RX	Yes	Yes

International Patents for SOTYLIZE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015153762
World Intellectual Property Organization (WIPO)	2015153762

Sotylize Market Dynamics and Financial Trajectory (Revenue, Growth, Exclusivity, and IP Exposure)

Last updated: July 21, 2026

Sotylize has limited publicly traceable, monetizable market and financial disclosure in major, citable data sources, and there is no sufficiently complete dataset in the public domain to support a complete, accurate revenue trajectory, unit trend, or payer mix forecast at the product level. No quantified, litigation-linked, or Orange Book-linked exclusivity timeline can be compiled from the provided context with the citation standard required for an actionable patent/market investment view.

Therefore, a complete and accurate market-and-financial trajectory analysis for Sotylize cannot be produced under the operating constraints.

---

What is sotylize and who makes it?

No complete, citable identification of the drug product equivalent to “sotylize” (active ingredient, dosage form, NDA/BLA number, applicant/labeler, or marketed strength) is available in the provided context, preventing a product-level market model and exclusivity mapping.

Which active ingredient does sotylize contain?

Not determinable from the provided context.

What dosage forms are approved for sotylize?

Not determinable from the provided context.

---

What are the market drivers shaping sotylize demand?

No product-specific indications, patient volume base, uptake curves, or competitive displacement inputs are available from the provided context.

How do clinical outcomes and labeling affect adoption?

Not determinable from the provided context.

What payer and formulary dynamics apply to sotylize?

Not determinable from the provided context.

How does competitor positioning affect sotylize pricing power?

Not determinable from the provided context.

---

How much revenue has sotylize generated and what is its financial trajectory?

A quantified financial trajectory requires at minimum one of: FDA launch year with subsequent sales filings, company segment disclosure tied to the product, or third-party sales databases keyed to the exact product code. None is present in the provided context.

What is the revenue trend (YoY) for sotylize?

Not determinable from the provided context.

What is the unit and prescription trend for sotylize?

Not determinable from the provided context.

What is the trajectory by geography and wholesaler channel?

Not determinable from the provided context.

---

When does sotylize lose exclusivity and what is the generic/biosimilar risk?

No Orange Book or biologics exclusivity dataset can be compiled for Sotylize without the exact FDA application identifier, preventing a defensible exclusivity and generic entry risk assessment.

What is the Orange Book status of sotylize?

Not determinable from the provided context.

What patents protect sotylize and when do they expire?

Not determinable from the provided context.

Are there Paragraph IV challenges against sotylize?

Not determinable from the provided context.

What biosimilar risk exists for sotylize?

Not determinable from the provided context.

---

What patent estate strength does sotylize have, and how does it affect pricing and competition?

A patent estate strength assessment requires enumerated, jurisdiction-tagged patents tied to the exact marketed NDA/BLA, including expiration, exclusivity periods, and litigation/settlement history. None is available in the provided context.

How strong is the patent estate for each formulation and method-of-use?

Not determinable from the provided context.

What patent litigation affects sotylize competition?

Not determinable from the provided context.

What settlement agreements change generic launch timing?

Not determinable from the provided context.

---

How does sotylize compare with competing drugs in its therapeutic class?

A competitive comparison requires identification of the therapeutic class, mechanism of action, and the approved comparator list. None is available in the provided context.

Which competitors take share from sotylize (and why)?

Not determinable from the provided context.

What is the competitive landscape by mechanism and administration route?

Not determinable from the provided context.

---

What commercialization barriers could limit sotylize growth?

Barriers such as REMS, distribution constraints, manufacturing scale limits, and reimbursement hurdles cannot be mapped without product identity and label constraints.

Are there REMS, cold-chain, or manufacturing constraints for sotylize?

Not determinable from the provided context.

How do supply constraints affect revenue realization?

Not determinable from the provided context.

---

Key Takeaways

• Sotylize’s product identity (active ingredient, FDA application, label status) is not specified in the provided context, preventing a product-level market size, revenue trajectory, exclusivity, and IP-risk model.
• No sufficiently complete, citable dataset is available here to quantify revenue, unit growth, payer mix, or launch timing impacts tied to IP or litigation.

---

FAQs

1. What is sotylize’s FDA approval pathway and launch timeline?
   Not determinable from the provided context.

2. Is sotylize an NDA or BLA product, and does it face biosimilar risk?
   Not determinable from the provided context.

3. What patents are listed for sotylize in the Orange Book, and what are their expiration dates?
   Not determinable from the provided context.

4. Are there any Paragraph IV filings challenging sotylize?
   Not determinable from the provided context.

5. How does sotylize’s pricing compare with key competitors in its class?
   Not determinable from the provided context.

---

References

No sources are provided in the prompt to cite for Sotylize’s identity, FDA status, Orange Book listings, litigation, or sales.