AEROLATE Drug Patent Profile

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

Aerolate is a drug marketed by Fleming Pharms and is included in two NDAs.

The generic ingredient in AEROLATE is theophylline. There are thirty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the theophylline profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aerolate

A generic version of AEROLATE was approved as theophylline by RHODES PHARMS on September 1^st, 1982.

Summary for AEROLATE

US Patents:	0
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for AEROLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fleming Pharms	AEROLATE	theophylline	SOLUTION;ORAL	089141-001	Dec 3, 1986		DISCN	No	No
Fleming Pharms	AEROLATE SR	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	085075-001	Nov 24, 1986		DISCN	No	No
Fleming Pharms	AEROLATE III	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	085075-003	Nov 24, 1986		DISCN	No	No
Fleming Pharms	AEROLATE JR	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	085075-002	Nov 24, 1986		DISCN	No	No

AEROLATE drug investment scenario and fundamentals analysis: exclusivity, patent estate, FDA status, and generic/biosimilar risk

Last updated: July 28, 2026

AEROLATE’s investment case hinges on (1) how long branded exclusivity and patent coverage persist for the exact approved dosage form and indications, (2) whether any Paragraph IV or biosimilar filings exist that could compress the commercial runway, and (3) whether the company’s manufacturing and regulatory footprint supports sustained supply at margin-preserving volumes. A complete, decision-grade fundamentals build requires verified drug identity (active ingredient and dosage form), FDA listing status, Orange Book entries, patent numbers with expiration dates, and current litigation. Without those inputs, no defensible exclusivity timeline, legal risk assessment, or revenue-at-risk scenario can be produced.

What is AEROLATE (active ingredient, dosage form, and FDA approval basis)?

Featured snippet answer: AEROLATE’s fundamentals depend on the underlying active ingredient and strength, because exclusivity and patent scope attach to specific FDA NDA/ANDA references and dosage forms.

Which active ingredient does “AEROLATE” refer to?

Investment analysis must be anchored to the exact label drug: active ingredient, route, strength, and dosage form, then matched to the corresponding FDA application (NDA or ANDA). Without that mapping, Orange Book patent lists cannot be correctly linked, and exclusivity calculations become non-actionable.

How does FDA approval basis affect exclusivity duration?

For exclusivity-heavy investment cases, the approval pathway matters:

• 505(b)(1) new chemical entity or new formulation
• 505(b)(2) with right-of-reference to earlier drug
• 505(j) generic route after marketing history

The approval type determines whether data exclusivity, 3-year new clinical investigation exclusivity, and 7-year/orphan-type frameworks apply, and how patent listings are interpreted against exclusivity windows.

What patents protect AEROLATE, and when do they expire?

Featured snippet answer: Patent protection is tied to the Orange Book patent list for the specific NDA/ANDA listed drug name. Expiration depends on each patent’s claim scope, regulatory trigger, and any extensions.

How many Orange Book patents cover AEROLATE?

A decision-grade estate count requires:

• Patent numbers listed in the Orange Book for the relevant NDA/ANDA
• Patent type: drug substance, drug product/formulation, method of use, and device/packaging if applicable
• Expiration dates and any regulatory patent term adjustments (PTA)

What is the likely patent stratification for an inhaled or specialty product?

Many “aero-” branded products cluster into:

• Composition/formulation patents (stability, particle engineering, excipient systems)
• Delivery device or pressurized container method patents
• Method-of-use patents (indications, dosing regimens)

The investment implication: formulation and device patents often constrain “design-around” more than simple generic substitution, especially when the approved product is sensitive to particle size, moisture uptake, or plume characteristics.

When does AEROLATE lose exclusivity (data and regulatory exclusivity timelines)?

Featured snippet answer: Exclusivity end dates come from FDA exclusivity codes and Orange Book listed drug history, not from patent expiration alone.

What are the key exclusivity buckets to model?

• New chemical entity (NCE): often 5 years (context dependent on statutory regime and application)
• New clinical investigation: often 3 years for eligible studies
• Orphan drug exclusivity (if applicable)
• Pediatric exclusivity awards (adds 6 months)
• 505(b)(2) exclusivity sharing effects

How should the exclusivity timeline be layered with patent term?

A practical investor model layers:

1. Exclusivity end (first legal allowance for ANDA filers to rely on exclusivity timing)
2. Patent expiration (when an ANDA can launch without infringement)
3. Litigation/settlement-driven “stay” periods and negotiated launch dates

What generic entry risks exist for AEROLATE (Paragraph IV and FDA filings)?

Featured snippet answer: Generic risk is driven by whether ANDA or 505(j) filers have filed a Paragraph IV certification for the Orange Book patents listed for the exact AEROLATE NDA reference.

Is there any Paragraph IV litigation or FDA dispute for AEROLATE?

A decision-grade risk view needs:

• Presence of ANDA filers
• Paragraph IV certification against specific patent numbers
• 30-month stay triggers
• Court case filings and outcomes
• Settlement agreements and “carve-outs” (authorized generics, launch timing, royalty triggers)

How can “first-filer” status change the launch economics?

First-filer dynamics can:

• Delay additional challengers via exclusivity-like practical effects from the 30-month stay
• Concentrate market share into one generic supplier at launch
• Affect negotiated settlements, sometimes producing earlier branded-to-generic cannibalization

What is the Orange Book status of AEROLATE right now?

Featured snippet answer: The Orange Book status defines which patents are listed and therefore what infringement theories constrain generics.

What to extract from the Orange Book listing for AEROLATE

A complete extract includes:

• NDA/ANDA number(s) and listed drug name spelling variants
• Patent number list with “types” (composition, method, product)
• Each patent’s expiration date, with PTA where stated
• Legal status: active, expired, withdrawn, or superseded
• Exclusivity (if listed as drug-specific exclusivity)

How strong is the patent estate for AEROLATE (composition, formulation, and method-of-use coverage)?

Featured snippet answer: Patent strength is higher when multiple, staggered patents cover both the approved formulation/product and the use or dosing regimen.

Composition vs formulation vs method-of-use: what matters for design-around

• Drug substance patents are often easier to work around if a different salt/solid form is acceptable under label.
• Formulation patents can be harder if they cover stability, excipient ratios, particle size distribution, or moisture/temperature constraints.
• Method-of-use patents can block “off-label” substitution only if claims map cleanly to approved label and dosing.

What litigation posture usually signals enforceability?

Strong estates often show:

• Courts upholding key claim construction
• Broad independent claims with narrower dependent fallbacks
• Multiple patents surviving motions or being asserted in parallel

Which companies are challenging AEROLATE, and what do their filings imply?

Featured snippet answer: Challenger identity plus Paragraph IV target patents determines whether the next catalyst is a 30-month stay or an immediate generic launch.

Challenger mapping logic

For each challenger:

• ANDA filing date
• Paragraph IV patent list (which patents were challenged)
• Certification type (IV against one or multiple patents; I, II, III, IV)
• Intended market entry date language (often inferred from litigation timelines and settlements)

How settlements can change your risk model

Settlements can:

• Set brand retention with delayed generic launch
• Provide authorized generic timing to control price erosion
• Include “no-AG” or “limited-AG” structures that affect near-term revenue-at-risk

How does AEROLATE compare with competing products in its therapeutic area?

Featured snippet answer: Competitive risk depends on whether AEROLATE faces class competition with therapeutically substitutable products, not only on generic entry.

Key comparison axes for investment modeling

• Route of administration and dosing frequency
• Safety profile and label breadth
• Device or formulation constraints
• Clinical differentiation claims (durability, onset, symptom control)
• Reimbursement dynamics and formulary position

What to track in the payer landscape

• Net sales mix by channel (hospital vs retail vs specialty)
• Formulary tiers and prior authorization burden
• Tender and distribution contracts for institutional settings

What formulations are protected by AEROLATE patents (and what can be design-arounds)?

Featured snippet answer: Formulation patent scope determines whether a generic can meet label equivalence while changing composition.

Typical formulation protection targets

Depending on the product type:

• Particle engineering and aerodynamic performance
• Surfactant and excipient system
• Stability under storage conditions
• Device compatibility and plume/dispersion characteristics

What “equivalence” standards mean for investors

Even if a generic is pharmaceutically equivalent, differences that affect delivered dose or performance can trigger:

• Additional regulatory hurdles
• Litigation leverage by the brand
• Delayed approvals or constrained indications

What manufacturing and IP barriers could block generic supply of AEROLATE?

Featured snippet answer: Barriers rise when process patents, critical raw material constraints, or device-integrated manufacturing is required.

Process and facility constraints that often matter

• Sterile processing or aseptic requirements (if applicable)
• Controlled humidity or moisture-protected handling
• Specialized fill-finish or device integration
• Analytical method IP (testing methods can be used tactically in disputes)

What patent litigation affects AEROLATE, and what is the likely outcome profile?

Featured snippet answer: The “likely outcome profile” is determined by asserted patents, claim constructions, injunction eligibility, and whether courts have already ruled on key issues.

What to extract from any AEROLATE litigation docket

• Parties and case captions (brand vs generic filer)
• Patents asserted and dates of service
• Markman claim construction status
• Summary judgment or trial milestones
• Settlement terms and dismissal status

How litigation timing changes revenue-at-risk

• Pending litigation can extend branded revenue via 30-month stay leverage
• Resolved cases can accelerate launch calendars
• Settlements can introduce negotiated royalty structures that change economics without changing sales timing

What is the FDA regulatory status of AEROLATE (NDA/ANDA, approval type, and label breadth)?

Featured snippet answer: FDA status defines regulatory pathways for generics, supplements, and possible reformulations.

Track the label and regulatory events that affect exclusivity

• Initial approval date
• Supplement approvals (new strengths, indications, dosing)
• Postmarketing safety actions and REMS (if any)
• Manufacturing site changes and inspection outcomes

Does AEROLATE have any exclusivity-consuming supplement risk?

If the brand invests in line extensions:

• Some supplements trigger new exclusivity periods
• Others only require patent linkage updates
• Generic challengers may still launch based on the broader original patent list

Investment scenario: what catalysts, risks, and decision triggers matter for AEROLATE?

Featured snippet answer: For AEROLATE, the primary catalysts are Orange Book status changes, litigation and settlement events, and any FDA exclusivity-relevant label updates. The primary risks are loss of patent/exclusivity barriers and the entry of a low-cost generic that wins formulary positioning.

Bull case drivers

• Patent estate contains multiple staggered expirations for product/formulation claims
• Litigation maintains stays and prevents early launch
• Brand retains payer access and maintains pricing or net retention during competitive pressure

Bear case drivers

• Key product/formulation or use patents expire early or are narrowed in construction
• Paragraph IV challenges target core patents and settlements set earlier launch dates
• Net sales erode due to formulary switches or authorized generic competition

Base case drivers

• Partial erosion expected at the first generic launch
• Brand maintains share via patient/provider preference, contracting, and line extensions
• Remaining patents extend profitability margin even if unit share declines

Key Takeaways

• AEROLATE’s investment fundamentals cannot be modeled without a verified mapping to its FDA application, Orange Book patent list, and any Paragraph IV challenges tied to those patents.
• The investment runway is driven by exclusivity and patent layering by formulation/product claims and method-of-use scope, not only by the earliest patent expiration.
• The generic launch risk is determined by Paragraph IV filings, settlement terms, and 30-month stay mechanics tied to specific patent numbers.
• Litigation outcomes and label-relevant regulatory events are the highest-impact catalysts for near-to-medium term revenue-at-risk.

FAQs

1. How do I determine the exact Orange Book listed drug name for a branded product like AEROLATE?
2. What is the difference between Orange Book patent expiration and FDA exclusivity end dates for launch timing?
3. How does a Paragraph IV certification strategy affect a brand’s settlement leverage?
4. What formulation-specific patents most often block generic inhalation or aerosol competitors?
5. What metrics should investors track quarterly to detect early erosion from generic competition in specialty drug categories?

References

No sources cited.