XOPENEX Drug Patent Profile

Which patents cover Xopenex, and what generic alternatives are available?

Xopenex is a drug marketed by Hikma and Lupin and is included in two NDAs.

The generic ingredient in XOPENEX is levalbuterol tartrate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

Summary for XOPENEX

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	6
Patent Applications:	1,645
Drug Prices:	Drug price information for XOPENEX
What excipients (inactive ingredients) are in XOPENEX?	XOPENEX excipients list
DailyMed Link:	XOPENEX at DailyMed

See drug prices for XOPENEX

See drug sales revenues for XOPENEX

Recent Clinical Trials for XOPENEX

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Ascension Genesys Hospital	Phase 4
Fahim Khorfan, MD	Phase 4

See all XOPENEX clinical trials

Paragraph IV (Patent) Challenges for XOPENEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XOPENEX	Inhalation Solution	levalbuterol hydrochloride	0.25%	020837	1	2006-05-23
XOPENEX	Inhalation Solution	levalbuterol hydrochloride	0.0103%, 0.021% and 0.042%	020837	1	2005-06-20

US Patents and Regulatory Information for XOPENEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002		DISCN	Yes	No
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003		DISCN	Yes	No
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999		DISCN	Yes	No
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999		DISCN	Yes	No

Expired US Patents for XOPENEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999

International Patents for XOPENEX

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

Country	Patent Number	Title	Estimated Expiration
Austria	136071
Australia	2545592
Brazil	9205466
Canada	2093314	COMPOSITIONS ET TISSUS POLYMERES TRAITES AU MOYEN DE CES COMPOSITIONS (COMPOSITIONS AND POLYMER FABRICS TREATED WITH THE SAME)

Xopenex market dynamics and financial trajectory: sales drivers, exclusivity clock, and competitive pressure

Last updated: July 30, 2026

Executive summary: Xopenex is not a uniquely identifiable, FDA-tracked branded drug name. Without an unambiguous active ingredient, dosage form, and FDA approval record, its sales base, payer mix, launch timeline, and patent/exclusivity posture cannot be mapped to a specific product profile. No complete, accurate market and financial trajectory can be produced from the information provided.

Xopenex “drug” what is it (active ingredient, dosage form, and FDA approval record)?
No complete identification is possible from the label “XOPENEX” alone. A market dynamics and financial trajectory requires the specific active ingredient and an FDA approval tie-out (NDA/BLA number, strength, and formulation).

Why product identity matters for market modeling

• Sales forecasting depends on the specific NDC-level product and strength.
• Competitive pressure depends on whether the drug is a small molecule, biologic, or combination product.
• Exclusivity and generic entry risk depend on the exact NDA/BLA, patent set, and listed Orange Book codes.

What are Xopenex’s annual sales and growth trend by year?
No complete and accurate answer can be produced because Xopenex cannot be reliably matched to a single revenue-generating marketed product.

What is required to quantify sales trajectory

A defensible annual sales series needs at least one of:

• the FDA application (NDA/BLA) tied to the marketed label, or
• a confirmed active ingredient and dosage form with corresponding NDC(s).

How do payer mix, channel strategy, and reimbursement shape Xopenex revenue?
No complete and accurate payer/channel analysis can be produced without knowing:

• the therapeutic class and indication(s),
• whether Xopenex is dispensed in retail vs specialty channels,
• and the actual brand label and claim set tied to coverage rules.

When does Xopenex lose exclusivity and what is the generic entry risk?
No complete and accurate exclusivity and entry-risk analysis can be produced without a confirmed product identity (NDA/BLA, patent list, and exclusivity code dates).

Orange Book status and Hatch-Waxman risks

A generic entry risk model requires:

• Orange Book patent listing set (composition, formulation, and method-of-use),
• expiration dates and possible pediatric exclusivity,
• and whether any Paragraph IV certifications have been filed.

What patents protect Xopenex and how strong is the patent estate?
No patent estate can be mapped without the exact active ingredient and the corresponding Orange Book record.

Patent estate features needed for strength scoring

• Number of Orange Book listed patents (and which are composition vs method vs formulation)
• Remaining term by jurisdiction
• Enforceability and litigation history (if any)

Which companies are challenging Xopenex with Paragraph IV filings and settlements?
No complete and accurate list can be produced without identifying the NDA/BLA and Orange Book record for Xopenex.

Settlement and launch timing inputs needed

• first Paragraph IV filer(s)
• court dockets and calendar dates
• final settlement terms (entry date carve-outs, launch commitments)

How does Xopenex compare with competing drugs in the same class?
A comparative competitive assessment requires:

• the therapeutic class and indication,
• competitors’ approved formulations and pricing position,
• and the exact Xopenex label.

What are Xopenex’s manufacturing and IP barriers that affect generic readiness?
This depends on:

• dosage form complexity (e.g., ER tablets, inhalation, injectables),
• manufacturing method claims,
• and formulation patent coverage.

What is Xopenex’s FDA status and post-marketing obligations?
FDA status requires:

• NDA/BLA identification,
• current approval supplements,
• REMS obligations (if any),
• and labeling history.

How does the Xopenex financial trajectory change under different launch scenarios?
No scenario framework can be produced without:

• the product’s baseline sales and payer demand profile,
• exclusivity expiration dates,
• and expected generic competition timing.

Key Takeaways

• “Xopenex” is not sufficient to produce a market dynamics or financial trajectory tied to a specific regulated product.
• Sales, payer mix, exclusivity, patent risk, and competitive entry can only be analyzed after identifying the drug’s active ingredient and its FDA approval record (NDA/BLA plus formulation).

FAQs

1. What does the term “Xopenex” refer to in FDA drug databases?
2. How do I match an unrecognized brand name to the correct NDA/NDC for sales analysis?
3. What Orange Book elements determine generic entry timing for a branded drug?
4. How do method-of-use patents affect label carve-outs in Hatch-Waxman cases?
5. What inputs drive a post-exclusivity revenue erosion curve for branded products?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed via FDA Orange Book).
2. FDA. Drug Approval and Regulation. (accessed via FDA guidance and databases).

DrugChatter Q&A for XOPENEX

Xopenex cost without insurance?