BETOPTIC PILO Drug Patent Profile

Which patents cover Betoptic Pilo, and when can generic versions of Betoptic Pilo launch?

Betoptic Pilo is a drug marketed by Alcon and is included in one NDA.

The generic ingredient in BETOPTIC PILO is betaxolol hydrochloride; pilocarpine hydrochloride. There are eleven drug master file entries for this compound. Additional details are available on the betaxolol hydrochloride; pilocarpine hydrochloride profile page.

Summary for BETOPTIC PILO

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	BETOPTIC PILO at DailyMed

Recent Clinical Trials for BETOPTIC PILO

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

Sponsor	Phase
Alcon Research	Phase 3

See all BETOPTIC PILO clinical trials

US Patents and Regulatory Information for BETOPTIC PILO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	BETOPTIC PILO	betaxolol hydrochloride; pilocarpine hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	020619-001	Apr 17, 1997		DISCN	No	No

Expired US Patents for BETOPTIC PILO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon	BETOPTIC PILO	betaxolol hydrochloride; pilocarpine hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	020619-001	Apr 17, 1997	5,635,172

International Patents for BETOPTIC PILO

See the table below for patents covering BETOPTIC PILO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	1607495
Australia	4575389
Australia	621692
Australia	688854
Canada	2004468	GOUTTES LUBRIFIANTES A LIBERATION SOUTENUE POUR LE TRAITEMENT DU GLAUCOME (SUSTAINED RELEASE, COMFORT FORMULATION FOR GLAUCOMA THERAPY)
Canada	2181929	COMPOSITIONS DE TRAITEMENT DU GLAUCOME COMPRENANT DE LA PILOCARPINE ET UN BETA-BLOQUANT (COMPOSITIONS FOR TREATMENT OF GLAUCOMA COMPRISING PILOCARPINE AND A BETA-BLOCKER)

BETOPTIC PILO (pilo—likely pilocarpine) market dynamics and financial trajectory: exclusivity, competitive pressure, and revenue outlook

Last updated: July 30, 2026

BETOPTIC PILO is a legacy ophthalmic product in the glaucoma/ocular-hypertension category. Commercial performance is driven by (1) post-generic erosion of branded pricing, (2) channel inventory cycles in ophthalmology, and (3) local formulary dynamics and substitution toward lower-cost pilocarpine and prostaglandin analog alternatives. Any remaining brand economics depend on whether BETOPTIC PILO still holds branded exclusivity in active markets and whether FDA/Orange Book listings still support a protected NDA/ANDA posture.

What is BETOPTIC PILO’s market positioning and where does revenue come from?

Quick answer: BETOPTIC PILO functions as a topical miotic option for glaucoma and ocular hypertension, typically used when other classes are contraindicated or insufficient. Revenue is largely a function of how often prescribers select pilocarpine-based therapy versus first-line agents (especially prostaglandin analogs) and how quickly generics displace branded pricing.

Category demand drivers for miotics vs first-line glaucoma therapies

• Prostaglandin analogs (first-line in many guidelines) generally capture the bulk of new prescriptions due to once-daily dosing and strong IOP-lowering efficacy.
• Miotics like pilocarpine face structural demand headwinds:
  • more frequent dosing in many regimens,
  • tolerability and adverse-event profiles that can limit adherence,
  • clinician preference for newer classes.
• Ophthalmology channel structure: demand concentrates in retina/glaucoma specialty practices, ambulatory surgical centers, and community ophthalmology. Pricing pressure is amplified by payer preference for generics.

Why branded BETOPTIC PILO economics are usually fragile

• Branded topical ophthalmics tied to older active ingredients often enter mature generic markets early.
• Once generic equivalents are entrenched, the brand typically relies on:
  • contract coverage,
  • prescriber habit,
  • limited NDC-specific supply constraints,
  • or niche protocol use.

What patents protect BETOPTIC PILO and how strong is the remaining patent estate?

Quick answer: This cannot be determined from the provided prompt alone. A complete, accurate patent-and-exclusivity map requires the exact active ingredient(s), NDA/ANDA identifier(s), and FDA Orange Book listing(s) tied to “BETOPTIC PILO” for the specific market(s).

When does BETOPTIC PILO lose exclusivity and when can generics enter?

Quick answer: Not computable from the provided prompt alone. Exclusivity and generic entry timing depends on the exact regulatory reference (NDA number), listed exclusivities, patent expiry dates, and whether any Paragraph IV challenges or authorized generics are already in play.

How does BETOPTIC PILO compare with competing glaucoma drug classes on pricing, uptake, and adoption?

Quick answer: Pilocarpine/miotic products generally underperform prostaglandin analogs in uptake due to dosing burden and tolerability, which shifts share toward older generics unless a clinician targets pilocarpine for specific patient scenarios.

Competitive landscape: substitution patterns that compress brand revenue

• Substitution toward generics within the same active class: If there are multiple generic pilocarpine strengths or formulations, payers and pharmacy substitution reduce branded share.
• Substitution toward different mechanisms: Prostglandin analogs and fixed-combination products can displace miotics when formularies tighten.
• Clinic protocol drift: Newer patient pipelines and adherence-driven regimen choices reduce miotic “first selection.”

Revenue impact channels

• Wholesale acquisition cost (WAC) erosion: branded pricing moves downward or loses net pricing support when generics gain share.
• Contracting leverage: brand margins compress if payers require brand discounts to match generic benchmarks.
• Inventory dynamics: ophthalmic seasonality and prescriber restocking patterns can create short-term volatility, but mature products usually revert quickly to steady-state generic mix.

What is the Orange Book status of BETOPTIC PILO?

Quick answer: Not computable from the provided prompt alone. Orange Book status requires identifying the NDA and the associated “Reference Listed Drug” (RLD) and listing type (drug substance, drug product, patents, exclusivity).

What generic entry risks exist for BETOPTIC PILO?

Quick answer: Not determinable from the provided prompt alone. Generic entry risk hinges on whether BETOPTIC PILO’s active ingredient and formulation are already fully off-patent, whether any formulation/patient-use patents remain, and whether there are unexpired exclusivities (including patent term adjustment/extension).

What formulations are protected by BETOPTIC PILO and do delivery or strength matter?

Quick answer: Not determinable from the provided prompt alone. Ophthalmic brands often have separate patent coverage by strength, vehicle, preservative system, and particle or solution stability properties.

What patent litigation affects BETOPTIC PILO?

Quick answer: Not determinable from the provided prompt alone. Litigation risk depends on whether any ANDA filers challenged patents via Paragraph IV and whether any settlements delayed entry.

What FDA regulatory status does BETOPTIC PILO have and what does that mean for timelines?

Quick answer: Not computable from the provided prompt alone. FDA pathway status (505(b)(1) vs 505(j)) and current manufacturing authorization affect supply continuity, labeling changes, and the practical timeline for competition.

What licensing deals and settlements shape BETOPTIC PILO’s market trajectory?

Quick answer: Not determinable from the provided prompt alone. For mature ophthalmics, licensing and settlements typically affect net pricing and brand persistence only if there are remaining exclusivities or supply arrangements.

How does BETOPTIC PILO’s historical financial trajectory typically evolve in mature ophthalmic markets?

Quick answer: In mature, off-exclusivity ophthalmic categories, revenue trajectories often follow a pattern:

1. Pre-generic brand: relatively stable net sales supported by limited competition.
2. Generic entry: rapid share loss and steep net sales compression, driven by payer switching and channel substitution.
3. Stabilization: residual revenue remains from coverage at preferred formularies, patient-specific necessity, and supply/distribution advantages.
4. Further compression: as additional generics enter (including multiple strengths or abbreviated versions), price floors decline and brand share converges toward a small protected niche.

Practical financial metrics that usually move for legacy ophthalmic brands

• Net sales: declines post-generic entry; often stabilizes at a lower baseline.
• Gross-to-net: net price erosion and rebate/charge adjustments rise as contracts tighten.
• Market share: share remains sensitive to NDC-level availability and substitution policies.
• Operating leverage: marketing spend often must fall faster than fixed costs, squeezing profitability.

Geographic considerations: where BETOPTIC PILO faces the fastest compression

Quick answer: Global revenue usually compresses first in markets with:

• high generic penetration,
• strict reference pricing,
• and aggressive substitution at pharmacy or payer levels. Where substitution rules are weaker, branded revenue can remain higher for longer, but ophthalmology tends to normalize quickly due to interchangeable active ingredients.

Key Takeaways

• BETOPTIC PILO’s market dynamics are dominated by generic substitution and competition from first-line glaucoma therapies.
• Branded revenue persistence depends on whether any regulatory exclusivity or patent estate remains and on NDC-level channel positioning.
• A credible exclusivity, litigation, and Orange Book status assessment cannot be produced from the provided prompt alone.

FAQs

1. Is BETOPTIC PILO a pilocarpine product, and how does that affect generic substitution risk?
2. Does BETOPTIC PILO’s ophthalmic strength or preservative system change patent coverage and generic entry barriers?
3. How do payer formularies typically treat miotics versus prostaglandin analogs in glaucoma?
4. What signals indicate a branded ophthalmic product is nearing further net price erosion (NDC availability, contract changes, generic launches)?
5. How do ophthalmic distribution and inventory cycles influence quarterly net sales for mature products like BETOPTIC PILO?

References

1. APA-style references require cited source identifiers, including the Orange Book/NDA and patent listings for BETOPTIC PILO. No source identifiers were provided in the prompt.