ASHLYNA Drug Patent Profile

When do Ashlyna patents expire, and when can generic versions of Ashlyna launch?

Ashlyna is a drug marketed by Glenmark Pharms Ltd and is included in one NDA.

The generic ingredient in ASHLYNA is ethinyl estradiol; levonorgestrel. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for ASHLYNA

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ASHLYNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	ASHLYNA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203163-001	Feb 23, 2015	AB	RX	No	No

ASHLYNA (ethinyl estradiol / levonorgestrel?) investment scenario and patent-led fundamentals analysis

Last updated: July 7, 2026

Executive summary: Ashleyna’s investability hinges on (1) confirmable FDA status and labeling, (2) the Orange Book patent estate that maps to generic or biosimilar entry risk, and (3) proximity of exclusivity and patent expirations that set Paragraph IV and launch timelines. At present, the necessary primary facts to build a patent-expiration-backed investment model (drug identity, active ingredients, NDA/BLA number, FDA approval date, Orange Book listings, and any known Hatch-Waxman litigation) are not available in the provided prompt, so a complete, accurate fundamentals and litigation risk assessment cannot be produced.

What is Ashleyna and what FDA approval pathway governs exclusivity?

Featured answer: A defensible exclusivity model requires Ashleyna’s confirmed active ingredient(s), dosage form(s), and FDA application type (NDA vs ANDA reference product; label category; and whether it is an oral contraceptive, hormone therapy, or combination product).

What are Ashleyna’s active ingredients and dosage form?

• Active ingredient(s)
• Strength(s)
• Dosage form (tablet, extended-cycle pack, transdermal, injectable)
• Regimen type (21/7, 24/4, 28-day, continuous)

What is the reference product and regulatory timeline?

• NDA number or reference to a Listed Drug (if applicable)
• Original approval date
• Any supplemental approvals affecting exclusivity (new strength, regimen, label expansion)

What patents protect Ashleyna and how many are in the Orange Book estate?

Featured answer: The number, type, and remaining life of Orange Book patents determine whether generics can file Paragraph IV challenges and how quickly they can launch.

Which Orange Book patent types drive generic entry?

• Drug substance patents
• Drug product (formulation, composition) patents
• Method-of-use patents
• Combination/regimen patents tied to dosing schedule

Patent estate snapshot needed for an investment model

• Patent numbers
• Patent owners/assignees
• Expiration dates
• Exclusivity codes and terms tied to each patent
• Whether patents are “generic-blocking” (listed as required for approval) or less directly blocking

When does Ashleyna lose exclusivity, and what are the key dates for investors?

Featured answer: Exclusivity is typically calendar-driven (NCE, 3-year, 5-year, 7-year, pediatric, and patent expiry), but Ashleyna’s specific timeline must be computed from verified FDA and Orange Book facts.

How to structure the exclusivity and patent timeline

• Earliest patent expiration
• Hard exclusivity end date(s)
• 180-day exclusivity triggers (first-filer Paragraph IV)
• Potential pediatric exclusivity extension (if applicable)
• Automatic stays triggered by ANDA litigation

What is the likely generic launch window?

• ANDA filing date assumptions are model inputs only after verifying:
  • Existing Paragraph IV status
  • Settlement agreements
  • Listed patents that remain in force

What patent litigation affects Ashleyna’s generic competition?

Featured answer: Litigation determines whether generic entry is stayed, delayed via settlement, or accelerated by non-infringement/invalidity outcomes.

What to measure in the litigation record

• Case caption, court, docket number
• Parties (brand vs generic filers)
• Asserted patents and claims
• Filings, Markman schedule, and trial/settlement dates
• Injunction terms, covenants not to sue, and design-around requirements

Paragraph IV challenges: how many and by whom?

• First-filer vs subsequent challengers
• Whether any settlements were “no-early-entry” or included launch carve-outs
• Expected launch trigger tied to specific patent expiry

What formulations are protected for Ashleyna, and what barriers exist for copycats?

Featured answer: For combination oral products, formulation and method-of-use patents often block “same active ingredients” products even when a generic can match the reference formulation.

Formulation patent themes that typically matter

• Film coating composition
• Tablet hardness, disintegration, dissolution profiles
• Stability and shelf-life improvements
• Extended-cycle regimen-specific composition changes

Manufacturing/IP barriers to FDA approval

• Process patents (if Orange Book lists method/process)
• Bioequivalence constraints tied to formulation changes
• Required clinical or bridge study risk if generic design differs materially

How does Ashleyna compare with other oral contraceptives or hormone products on patent strength?

Featured answer: Patent strength is scored by:

• Number of remaining blocking patents
• Diversity of patent types (substance, product, method-of-use)
• Litigation history and settlement aggressiveness
• Proximity to expiry relative to generic filing windows

Competitive landscape mapping investors use

• Therapeutic class competitors (same regimen or alternative dosing schedules)
• Generic penetration depth by market
• Pricing pressure and formulary positioning (if commercial data is available)

What is the Orange Book status of Ashleyna?

Featured answer: Orange Book status is a binary gate for investment diligence because it tells you what patents are tied to FDA approval.

What the Orange Book listing must show

• Listed drug name and active ingredient mapping
• Patent list by number and expiration
• Which patents have blocking effect based on listing type
• Orphan/other exclusivity flags (if any)

What generic entry risks exist for Ashleyna?

Featured answer: Generic entry risk is the combination of:

1. how many Orange Book patents remain,
2. whether any are likely invalid/non-infringed on typical litigation trajectories, and
3. whether settlement or court outcomes already lock in a launch schedule.

Generic entry scenarios investors underwrite

• “No Paragraph IV filed”: launch blocked until earliest patent expiry plus 180-day issues never triggered
• “Paragraph IV pending”: stay rules apply unless settlement or court decision removes injunction risk
• “Settlement reached”: launch can be earlier or delayed depending on terms

How strong is the patent estate for Ashleyna?

Featured answer: Patent strength can be scored using a compact metric:

• Blocking patent count with remaining life
• Proportion of method-of-use/formulation patents (often harder for “easy design-around”)
• Litigation outcomes or public admissions about scope
• Geographic coverage (US patents only vs foreign family breadth if relevant)

Patent family breadth check investors typically run

• US filings (priority date to maintenance status)
• International filings (EP, WO, CN) and whether they track US claims
• Whether foreign design-arounds can inform US claim interpretation

Commercial fundamentals needed to model returns on Ashleyna

Featured answer: Returns depend on market size, share trajectory, pricing, payer behavior, and the probability-weighted launch delay from patent and exclusivity facts.

Revenue model inputs (must be sourced from confirmed brand product identity)

• Net price and rebates (wholesale acquisition cost trends if available)
• Prescription volumes and churn
• Contracting position with PBMs and formularies
• Seasonality (oral contraceptives often show plan-driven patterns)

Cost and execution inputs

• Specialty sales vs broad primary care distribution
• Manufacturing capacity and cost-of-goods (COGS)
• Contract manufacturing dependencies
• Ongoing post-approval studies affecting label breadth

Key timelines investors should track for Ashleyna

Featured answer: The actionable set is a small list of hard dates once FDA and Orange Book facts are confirmed.

Timeline element	What to pin down	Why it matters
Original approval date	NDA approval date	Sets baseline exclusivity clocks
Orange Book blocking patents	Patent expiry dates	Controls ANDA filing and launch eligibility
Pediatric exclusivity (if applicable)	Any pediatric extension	Extends effective entry window
First Paragraph IV filing	If any exist	Sets 180-day exclusivity timing
Court or settlement date	Litigation disposition	Determines whether stay lifts
Expected generic launch	Based on remaining patents	Directly maps to revenue step-down

Key Takeaways

• Ashleyna’s investability is determined by verified FDA status and the Orange Book patent estate mapping, not by category assumptions.
• The core diligence deliverable is a full Orange Book table (patent numbers, owners, expiration dates, and patent types) paired with any Paragraph IV or settlement record.
• Without confirmed drug identity, NDA number, and Orange Book listing data, an accurate investment scenario and probability-weighted generic entry forecast cannot be built.

FAQs

1. How many blocking patents does Ashleyna list in the Orange Book?
2. What is Ashleyna’s earliest patent expiration date that could enable ANDA entry?
3. Are there any Paragraph IV filings challenging Ashleyna, and which companies filed?
4. Do any Ashleyna patents cover formulation or method-of-use rather than drug substance?
5. What exclusivity extensions (if any) could delay generic launch for Ashleyna?

References

(No sources were provided in the prompt to cite.)