REVATIO Drug Patent Profile

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

Revatio is a drug marketed by Viatris and is included in three NDAs.

The generic ingredient in REVATIO is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Revatio

A generic version of REVATIO was approved as sildenafil citrate by CHARTWELL RX on November 6^th, 2012.

Summary for REVATIO

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	66
Patent Applications:	7,242
Drug Prices:	Drug price information for REVATIO
What excipients (inactive ingredients) are in REVATIO?	REVATIO excipients list
DailyMed Link:	REVATIO at DailyMed

See drug prices for REVATIO

Recent Clinical Trials for REVATIO

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

Sponsor	Phase
Cairo University	PHASE1
The University of Texas Medical Branch, Galveston	Phase 2
Christoph P Hornik, MD MPH	Phase 2

See all REVATIO clinical trials

Pharmacology for REVATIO

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

US Patents and Regulatory Information for REVATIO

REVATIO is protected by zero US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	REVATIO	sildenafil citrate	FOR SUSPENSION;ORAL	203109-001	Aug 30, 2012		DISCN	Yes	No
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005	AB	RX	Yes	Yes
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473-001	Nov 18, 2009	AP	RX	Yes	Yes

International Patents for REVATIO

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	238586	PYRAZOLOPYRIMIDINONE DERIVATIVES; INTERMEDIATES, PREPARATORY PROCESSES, PHARMACEUTICAL COMPOSITIONS, AND USE THEREOF
Cyprus	1971	Pyrazolopyrimidinone antianginal agents
Norway	1999004

Supplementary Protection Certificates for REVATIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0463756	SPC/GB99/004	United Kingdom		PRODUCT NAME: SILDENAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE CITRATE SALT; REGISTERED: CH 54642 19980622; UK EU/1/98/077/001 19980914; UK EU/1/98/077/002 19980914; UK EU/1/98/077/003 19980914; UK EU/1/98/077/004 19980914; UK EU/1/98/077/005 19980914; UK EU/1/98/077/006 19980914; UK EU/1/98/077/007 19980914; UK EU/1/98/077/008 19980914; UK EU/1/98/077/009 19980914; UK EU/1/98/077/010 19980914; UK EU/1/98/077/011 19980914; UK EU/1/98/077/012 19980914
0463756	5/1999	Austria		PRODUCT NAME: ''SILDENAFIL'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, EINSCHLIESSLICH DES CITRATS; NAT. REGISTRATION NO/DATE: EU/1/98/077/001 - EU/1/98/077/012 19980914; FIRST REGISTRATION: LI 54642 01-54642 03 19980622
0463756	99C0007	Belgium		PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622

REVATIO (sildenafil) Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is REVATIO and where does it sit in sildenafil’s commercial landscape?

REVATIO is branded sildenafil for specific pulmonary arterial hypertension (PAH) indications. Commercial performance depends on (1) how widely patients remain on chronic PAH therapy, (2) competitive intensity from other PAH classes, and (3) payer and formulary access for branded versus generic sildenafil.

Positioning

• Active ingredient: sildenafil
• Core use case: PAH therapy (REVATIO brand is used for pulmonary hypertension; sildenafil also exists as generic and as other branded sildenafil products in other indications depending on jurisdiction and labeling).
• Business implication: REVATIO’s revenue is structurally tied to long-duration PAH treatment adherence and stability in PAH guideline-directed therapy penetration.

Key market dynamic

• The sildenafil molecule faces generic erosion where patent exclusivity on the brand has lapsed. In practice, revenue trajectory of REVATIO is typically shaped less by molecular differentiation and more by brand retention, payer policy, and patient access relative to lower-cost sildenafil.

How do demand drivers and payer mechanics shape REVATIO’s market trajectory?

Demand and utilization drivers

REVATIO demand is driven by:

• PAH prevalence and incident pool (diagnosis and treatment initiation volumes).
• Treatment persistence (continuation on stable PAH regimens).
• Shift in line of therapy (sildenafil use in combination regimens affects dose distribution across competitors).
• Route and convenience (REVATIO’s dosage forms and dosing schedule influence persistence and switching).

Payer and channel dynamics

For chronic PAH, payer behavior tends to follow:

• Formulary tiering that pressures branded products once generics are available.
• Step therapy or prior authorization aligned to PAH diagnosis confirmation and class sequencing.
• Reimbursement velocity that can change with plan design cycles and pharmacy benefit manager (PBM) bidding dynamics.
• Wholesale buying patterns reflecting patient demand and channel inventory cycles rather than molecule-level demand alone.

Competitive intensity by therapeutic class

PAH therapy competes across:

• PDE-5 inhibitors (sildenafil class comparator set)
• Endothelin receptor antagonists (ERAs)
• Soluble guanylate cyclase stimulators
• Prostacyclin pathway agents
• Combination therapy norms

Even when sildenafil remains in guideline frameworks, competitive share can shift as clinicians intensify regimens with newer mechanisms or as payers steer to lower net-cost options.

What external forces usually move REVATIO financial results?

REVATIO’s financial trajectory generally follows a set of predictable market forces:

1) Generic penetration and net-price compression

Once generic sildenafil becomes widely available, branded pricing power narrows. The effect often shows up first in:

• Net revenue decline (mix shift from brand to generic at the pharmacy level)
• Higher rebates and discounts to protect formulary position
• Reduced persistence if payers limit branded claims to higher-cost sharing tiers

2) PAH market growth versus brand share loss

Even if the overall PAH treated population expands, REVATIO may still lose revenue share if:

• Other branded PAH products capture add-on initiation share
• Generic sildenafil captures chronic maintenance demand
• Payers move to “preferred generic” or restrict branded dispensing

3) Product and supply chain constraints

Wholesale and pharmacy claims can swing with:

• Manufacturing capacity changes
• Distribution interruptions
• Normalization after channel inventory adjustments

These factors impact short-term revenue recognition even when underlying patient counts remain stable.

4) Guideline and payer policy shifts

Policy changes can alter:

• Preferred sequencing (PDE-5 inhibitor earlier vs later)
• Evidence requirements for PAH confirmation
• Coverage criteria for continuation approvals

Those changes can move use rates across all PDE-5 inhibitors, but branded products are more exposed when coverage criteria tighten.

How should investors read REVATIO’s revenue pattern over time?

For branded sildenafil in PAH, the revenue pattern typically shows a post-exclusivity inflection:

1. Peak period prior to generic erosion
2. Gradual net-price pressure as contracts reprice
3. Accelerated share loss if branded access deteriorates
4. Stabilization if the brand maintains a residual formulary foothold (for example, via patient support programs, specific plan preferences, or historical inertia)

Where the sildenafil class remains a clinical anchor in PAH regimens, REVATIO’s revenue can stabilize later even with declining share, because:

• Patient retention in chronic therapy reduces annual turnover
• Clinicians continue PDE-5 inhibitor use in combination regimens

But branded financial upside is usually capped once generic competition becomes dominant.

What metrics best track REVATIO’s financial trajectory?

A practical tracking set for market and financial direction:

• Net revenue trends (gross-to-net compression indicators)
• Prescription share versus generic sildenafil at plan and segment level
• TRx and persistence proxy (claims-based continuing use)
• Average selling price trajectory (ASP under net-to-gross pressure)
• Formulary placement (preferred vs non-preferred status)
• PA policy requirements changes (authorization rate and approval rules)
• Channel inventory (days on hand and sell-through)

How do you benchmark REVATIO against PAH peers under competitive pressure?

Benchmarking requires class-aware comparisons rather than general oncology-style growth comparisons. The most decision-useful peer set is:

• Other PAH drugs in PDE-5 and adjacent mechanisms that compete for combination therapy share
• Branded versus generic versions within the sildenafil molecule category

The investment insight is usually directional:

• If the overall PAH market grows faster than REVATIO’s TRx share, the brand is losing incremental share.
• If revenue stabilizes while TRx declines, the brand may be benefiting from contracting mix, higher remaining branded penetration, or category pricing.
• If both revenue and TRx decline, payer access and/or channel de-stocking are likely drivers.

What is the likely financial trajectory under plausible market structures?

Given the molecule’s generic exposure in most major markets, REVATIO’s trajectory typically points to:

• Moderate long-run revenue decline from volume erosion and pricing pressure
• Lower volatility after PAH treated population stabilizes
• Limited upside unless there is a localized branded access advantage (managed-care contracting, specialty pharmacy channel, or specific patient subsets that retain branded use)

Key Takeaways

• REVATIO’s commercial path is dominated by chronic PAH demand stability versus generic sildenafil net-price and share erosion.
• Financial trajectory usually follows a classic branded pattern post-exclusivity: net-price compression first, then share loss, with later stabilization at a residual branded base.
• The most actionable signals for direction are prescription share vs generic sildenafil, gross-to-net compression, formulary placement, and PA policy changes.
• Peer benchmarking should be class-based: judge REVATIO against other PAH mechanisms competing for combination regimen share, not against unrelated therapeutic categories.

FAQs

1. Does REVATIO growth depend more on PAH prevalence or on brand retention?
   It depends on both, but long-run branded performance is typically more sensitive to brand retention outcomes (formulary access and net pricing) once generic erosion starts.

2. What is the earliest commercial signal of generic displacement for REVATIO?
   Declining prescription share and increased branded net-to-gross pressure often precede major headline revenue declines.

3. Why can REVATIO revenue stabilize even when TRx falls?
   Stabilization can occur if remaining branded volume is concentrated in higher-contract tiers or if net pricing and rebate structures adjust while overall volume trends down.

4. How do PA policies affect REVATIO’s monthly performance?
   Prior authorization rules affect initiation and continuation claims. Tightening tends to reduce throughput faster than it reduces diagnosed prevalence.

5. What benchmarking approach best reflects REVATIO’s competitive reality?
   Compare against PAH class peers and track sildenafil-specific branded share against generic sildenafil within the same payer segments.

---

References

[1] U.S. National Library of Medicine. “Sildenafil (systemic).” DailyMed.
[2] FDA label information for REVATIO (sildenafil) and prescribing information. FDA.
[3] National Organization for Rare Disorders (NORD) and other clinical overviews of PAH epidemiology and treatment classes.
[4] IQVIA / EvaluatePharma-style industry reporting conventions for branded-to-generic performance metrics (general methodology).