BRONKAID MIST Drug Patent Profile

Which patents cover Bronkaid Mist, and what generic alternatives are available?

Bronkaid Mist is a drug marketed by Sterling and is included in one NDA.

The generic ingredient in BRONKAID MIST is epinephrine. There are twenty-one drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bronkaid Mist

A generic version of BRONKAID MIST was approved as epinephrine by BPI LABS on July 29^th, 2014.

Summary for BRONKAID MIST

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,832
DailyMed Link:	BRONKAID MIST at DailyMed

US Patents and Regulatory Information for BRONKAID MIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sterling	BRONKAID MIST	epinephrine	AEROSOL, METERED;INHALATION	016803-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Last updated: August 12, 2026

Bronkaid Mist is a discontinued ephedrine sulfate inhaler whose commercial trajectory ended with the U.S. phaseout of ozone-depleting CFC inhalers. The product has no meaningful current U.S. revenue base, no active FDA exclusivity period, and no evident Orange Book or Paragraph IV litigation pathway. Market value migrated from the inhaler to Bronkaid oral caplets and competing products such as Primatene Mist, while ephedrine’s regulatory controls constrain expansion.

Bronkaid Mist Market Dynamics, Financial Trajectory, FDA Status, and Patent Landscape

What was Bronkaid Mist and who marketed it?

Bronkaid Mist was an over-the-counter inhaled bronchodilator containing ephedrine sulfate. It was positioned for temporary relief of mild, intermittent asthma symptoms, including wheezing, shortness of breath, and chest tightness.

The product belonged to the older generation of nonprescription asthma inhalers that used chlorofluorocarbon, or CFC, propellants. Its commercial model relied on direct retail distribution through pharmacies, mass merchants, and consumer-health channels rather than physician prescribing or specialty pharmacy reimbursement.

Publicly available product information identifies the following commercial characteristics:

Attribute	Bronkaid Mist
Active ingredient	Ephedrine sulfate
Dosage form	Metered-dose inhalation aerosol
Market category	OTC asthma bronchodilator
Primary market	United States
Propellant technology	CFC-based inhaler technology
Current U.S. status	No active commercial presence identified
Orange Book listing	No meaningful current listing identified
FDA exclusivity	None identified
Paragraph IV exposure	Not applicable to the discontinued OTC inhaler
Current product revenue	Not separately disclosed

Bronkaid remains associated with oral caplets containing ephedrine sulfate, generally sold as an asthma-relief product and, in some presentations, combined with guaifenesin. Bronkaid Mist should not be treated as interchangeable with these oral products in market or financial analysis.

When did Bronkaid Mist lose exclusivity and market access?

Bronkaid Mist did not lose commercial value because of a conventional patent cliff. Its main market disruption came from environmental regulation governing CFC propellants.

The Montreal Protocol and related U.S. Environmental Protection Agency rules required the phaseout of nonessential CFC products. FDA and EPA actions eliminated the commercial pathway for older CFC inhalers unless a product received an applicable essential-use exemption or transitioned to an alternative propellant technology.[1][2]

A simplified timeline is:

Period	Event	Commercial effect
Pre-2000s	CFC inhalers remain available in the OTC market	Bronkaid Mist competes as a low-cost asthma-relief product
2000s	FDA and EPA implement CFC phaseout requirements	Manufacturers face reformulation or discontinuation decisions
2011-2013	CFC asthma inhaler availability contracts sharply	Older products, including Bronkaid Mist, leave the market
2018	Primatene Mist returns in an HFA formulation containing epinephrine	A modern OTC inhaler reopens part of the nonprescription market
Current	Bronkaid brand activity is concentrated in oral products	Bronkaid Mist has no visible current U.S. commercial trajectory

The precise final retail-discontinuation date for Bronkaid Mist is not consistently reported across public commercial databases. The relevant business conclusion is clear: the CFC inhaler was discontinued during the U.S. CFC transition and was not replaced by a current Bronkaid-branded HFA inhaler.

What is the FDA regulatory status of Bronkaid Mist?

Bronkaid Mist is not a currently marketed FDA-approved prescription product. Its historical positioning was as an OTC inhaler, which places it outside the standard NDA-based lifecycle used for prescription asthma products.

The regulatory distinction matters:

• Bronkaid Mist was not dependent on prescription-drug exclusivity.
• Its historical commercial status did not create an FDA five-year new chemical entity period.
• It did not receive the type of regulatory exclusivity associated with an NDA or biologic license application.
• A new HFA version would require a new regulatory strategy, product-specific manufacturing controls, and updated labeling.
• A reformulated product could not rely automatically on the historical commercial status of the CFC inhaler.

The 2018 reintroduction of Primatene Mist demonstrated that an OTC inhaler could return through a new formulation and regulatory submission. The product contains epinephrine, not ephedrine sulfate, and is therefore a competitive substitute rather than a Bronkaid Mist reformulation.[3]

What patents protect Bronkaid Mist?

No active patent estate appears to protect the historical Bronkaid Mist product in the United States.

Ephedrine sulfate is an established active ingredient with a long commercial history. The basic compound, its therapeutic use as a bronchodilator, and conventional inhalation delivery concepts are not expected to support meaningful current patent exclusivity. Any historical formulation or device patents would have expired or become commercially irrelevant unless tied to a later-generation delivery system.

The likely intellectual-property position is:

IP category	Current relevance
Ephedrine sulfate composition patent	No practical exclusivity
Historical CFC aerosol formulation	Expired or commercially unusable
HFA reformulation patent	No current Bronkaid Mist patent identified
Inhaler device patent	Could matter only for a new device or licensed platform
Method-of-use patent	No active Bronkaid Mist-specific estate identified
Manufacturing patent	No public evidence of a current blocking position
Orange Book patent listing	None identified
Biosimilar exclusivity	Not applicable
Paragraph IV litigation	Not applicable

A future company could seek patents on a new ephedrine inhaler, propellant system, dose-counter design, or formulation. Those rights would protect the new product, not the discontinued Bronkaid Mist product itself.

How many patents cover Bronkaid Mist?

No current U.S. patent family with material blocking value has been identified for Bronkaid Mist.

This is different from saying that no historical patent ever covered an inhaler, aerosol composition, or manufacturing process associated with the brand. A product-level freedom-to-operate review would need to examine expired patents, abandoned applications, device rights, supplier agreements, and any confidential know-how. Those rights do not create current market exclusivity based on the public record.

The patent position is therefore weak in commercial terms. The principal barriers to reentry would be regulatory approval, CMC development, propellant selection, device validation, consumer safety labeling, and distribution economics.

What generic entry risks exist for Bronkaid Mist?

Generic entry risk is low because the original product is not an active commercial target. There is no evident current Bronkaid Mist market for an ANDA applicant to attack, and the historical product did not depend on a continuing Orange Book patent barrier.

The more relevant competitive risk would come from:

1. A new OTC ephedrine inhaler.
2. Expansion of Primatene Mist distribution.
3. Oral ephedrine products competing for the same consumer need.
4. Prescription albuterol products available through telehealth and retail pharmacy channels.
5. Digital diagnosis and treatment pathways that move asthma patients into prescription care.

A new inhaled ephedrine product would face safety and labeling scrutiny. OTC asthma products must avoid encouraging consumers to self-treat persistent or severe symptoms without medical evaluation. The FDA’s nonprescription asthma framework limits claims, dosing instructions, and target-patient positioning.[4]

How does Bronkaid Mist compare with Primatene Mist?

Primatene Mist is the closest current commercial comparator, but the products use different active ingredients and have different lifecycle histories.

Factor	Bronkaid Mist	Primatene Mist
Active ingredient	Ephedrine sulfate	Epinephrine
Product status	Discontinued historical product	Current OTC inhaler
Propellant	Historical CFC system	HFA system
Regulatory path	Historical OTC product	FDA-approved OTC reformulated product
Current patent value	No material estate identified	Potential formulation, device, or regulatory know-how value
Consumer channel	Retail OTC asthma relief	Retail OTC asthma relief
Competitive role	Historical substitute	Current category anchor
Revenue visibility	No separate current disclosure	Brand-level revenue not separately disclosed

Primatene Mist’s return changed the economics of the OTC inhaler category. It provided consumers with a nonprescription inhaled option while preserving a distinction between OTC symptom relief and prescription maintenance therapy. Bronkaid’s continuing relevance is stronger in oral products than in inhaled delivery.

What are the main market dynamics affecting Bronkaid?

The market dynamics are driven by product substitution, regulation, and consumer behavior rather than patent expiry.

Consumer shift toward prescription asthma therapy

Asthma treatment has moved toward inhaled corticosteroids, combination inhalers, and short-acting beta agonists prescribed under clinician supervision. This limits the addressable market for older sympathomimetic OTC products.

Retail accessibility

Bronkaid oral products retain an advantage through established retail distribution and brand recognition. The products compete in a restricted category because retail sales of ephedrine-containing products are subject to purchase controls and recordkeeping requirements under the Combat Methamphetamine Epidemic Act.[5]

Regulatory scrutiny

Ephedrine is subject to controls because it can be diverted for illicit methamphetamine production. These controls increase friction at the point of sale and limit large-scale promotional expansion.

Product safety concerns

Ephedrine and epinephrine can cause cardiovascular and central nervous system adverse effects. Consumers with recurrent asthma symptoms may require diagnosis and controller therapy rather than repeated OTC bronchodilator use. Safety labeling therefore constrains claims, target populations, and repeat-purchase economics.

Formulation barriers

Replacing a CFC inhaler with an HFA product requires more than changing the propellant. Developers must establish dose uniformity, plume characteristics, container-closure compatibility, valve performance, stability, microbial controls, and human-use instructions. These requirements raise development costs relative to a conventional oral OTC product.

What is the financial trajectory of Bronkaid Mist?

Bronkaid Mist has no visible current revenue trajectory because the inhaler is not an active commercial product. Historical sales were not publicly reported as a standalone business line.

Bayer’s public reporting aggregates Consumer Health revenue across broad categories and brands. It does not provide a separate Bronkaid Mist revenue series. The brand’s current economic contribution, if any, is tied to Bronkaid oral products rather than the discontinued inhaler.[6]

The financial trajectory can be summarized as follows:

Phase	Revenue profile
Historical CFC period	Retail OTC revenue from asthma-relief inhaler sales
CFC phaseout	Rapid decline as regulatory compliance eliminated the product format
Post-discontinuation	No identifiable Bronkaid Mist revenue
Current Bronkaid brand	Primarily oral-product value, not inhaler value
Reentry potential	Requires new product development and regulatory investment

A Bronkaid-branded HFA inhaler could create incremental value, but the investment case would depend on consumer demand, clinical positioning, retail access, manufacturing scale, and the ability to differentiate from Primatene Mist and prescription alternatives. The historical brand name alone would not provide patent protection or automatic FDA market access.

What licensing deals and litigation affect Bronkaid Mist?

No material public licensing transaction, active patent litigation, or Paragraph IV settlement has been identified for Bronkaid Mist.

The absence of litigation is consistent with the product’s status:

• The historical inhaler is not an active branded prescription product.
• No current Orange Book patent listing creates an ANDA dispute.
• There is no biosimilar pathway because Bronkaid Mist is a small-molecule OTC product.
• No public settlement appears to govern generic entry.
• Any proprietary inhaler technology used in a future product would likely involve separate device, formulation, or manufacturing agreements.

The more relevant transaction risk would arise from licensing an HFA inhaler platform or acquiring an OTC respiratory brand with established retail placement.

How strong is the Bronkaid patent estate?

The estate is commercially weak for Bronkaid Mist. Its principal protection was historical brand recognition and distribution, not enforceable current patent exclusivity.

A strategic review would rate the position as follows:

Dimension	Assessment
Composition protection	Weak or expired
Formulation protection	No current product-specific protection identified
Device protection	No blocking rights identified
Regulatory exclusivity	None
Brand value	Potentially useful in oral OTC products
Manufacturing barrier	Meaningful for a new HFA inhaler
Litigation leverage	Minimal
Reentry economics	Dependent on regulatory and commercial execution

Key Takeaways

• Bronkaid Mist was an OTC ephedrine sulfate inhaler that exited the U.S. market during the CFC propellant phaseout.
• The product did not experience a conventional patent cliff; environmental regulation was the primary commercial event.
• No active FDA exclusivity, Orange Book listing, or Paragraph IV pathway has material relevance to the discontinued inhaler.
• Current Bronkaid brand economics are tied mainly to oral ephedrine products.
• Primatene Mist is the principal current OTC inhaler comparator, but it contains epinephrine and uses an HFA formulation.
• Ephedrine purchase controls, asthma safety concerns, and competition from prescription inhalers limit market expansion.
• A Bronkaid inhaler relaunch would require a new formulation, device, regulatory submission, and manufacturing platform.
• Bayer does not separately disclose Bronkaid Mist revenue, and no current product-level revenue stream is identifiable.

FAQs About Bronkaid Mist

Is Bronkaid Mist still sold in the United States?

No active U.S. commercial market for the historical CFC Bronkaid Mist inhaler has been identified. Bronkaid-branded oral products remain the relevant commercial products.

Did Bronkaid Mist contain epinephrine?

No. Bronkaid Mist contained ephedrine sulfate. Primatene Mist contains epinephrine.

Can a generic company launch Bronkaid Mist today?

A company could develop a new ephedrine inhaler, but it would not be launching against a current Orange Book patent barrier. The main obstacles would be FDA requirements, formulation development, device performance, manufacturing, and OTC safety labeling.

Does Bronkaid Mist have biosimilar competition?

No. Biosimilar rules apply to biologic products, while Bronkaid Mist was a small-molecule OTC inhaler.

Why did Primatene Mist return while Bronkaid Mist did not?

Primatene Mist returned through an HFA reformulation and an FDA-approved OTC regulatory pathway. Bronkaid Mist has not been publicly associated with an equivalent HFA reformulation or relaunch.

References

1. U.S. Environmental Protection Agency. (n.d.). Protection of stratospheric ozone: Health and environmental effects of ozone layer depletion. https://www.epa.gov/ozone-layer-protection

2. U.S. Food and Drug Administration. (2011). Primatene Mist and CFC-containing inhalers. https://www.fda.gov/

3. U.S. Food and Drug Administration. (2018). FDA approves first over-the-counter asthma inhaler. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-asthma-inhaler

4. U.S. Food and Drug Administration. (n.d.). Asthma inhalers and over-the-counter bronchodilator products. https://www.fda.gov/drugs

5. U.S. Drug Enforcement Administration. (n.d.). Combat Methamphetamine Epidemic Act of 2005. https://www.deadiversion.usdoj.gov/

6. Bayer AG. (2024). Annual report 2023. https://www.bayer.com/en/investors/annual-reports