OLYSIO Drug Patent Profile

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

Olysio is a drug marketed by Janssen Prods and is included in one NDA. There are eight patents protecting this drug.

This drug has sixty-four patent family members in forty-one countries.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this compound. Additional details are available on the simeprevir sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Olysio

Olysio was eligible for patent challenges on November 22, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 28, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for OLYSIO

International Patents:	64
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	1,393
Drug Prices:	Drug price information for OLYSIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLYSIO
DailyMed Link:	OLYSIO at DailyMed

See drug prices for OLYSIO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OLYSIO

Constraining patent/regulatory exclusivity:

8,349,869

NDA:

205123

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OLYSIO

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

Sponsor	Phase
Yale University	Phase 4
Stanford University	Phase 4
Alexion Pharmaceuticals	Phase 1

See all OLYSIO clinical trials

US Patents and Regulatory Information for OLYSIO

OLYSIO is protected by eight US patents.

This potential generic entry date is based on patent 8,349,869.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	8,349,869		Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,353,103
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,040,562		Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,623,022
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	8,754,106			Y

Expired US Patents for OLYSIO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013	7,671,032

International Patents for OLYSIO

When does loss-of-exclusivity occur for OLYSIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Brazil

Canada

China

Costa Rica

Croatia

Cyprus

Denmark

El Salvador

Eurasian Patent Organization

European Patent Office

Honduras

Hong Kong

Hungary

Israel

Luxembourg

Montenegro

Portugal

Serbia

Slovenia

South Korea

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OLYSIO around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	047793	INHIBIDORES DE LA SERINA PROTEASA NS-3 DEL VHC
Argentina	048401	INHIBIDORES DE LA SERINA-PROTEASA NS3 DEL VHC
Argentina	104445	COMPUESTOS INHIBIDORES DE LA SERINA PROTEASA NS3 DEL VHC Y COMPOSICIÓN FARMACÉUTICA
Austria	E448243
Austria	E461209

Supplementary Protection Certificates for OLYSIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713823	C300703	Netherlands		PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140514
1713823	CA 2014 00059	Denmark		PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
1912999	CA 2014 00053	Denmark		PRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
1912999	C300697	Netherlands		PRODUCT NAME: SIMEPREVIR, OF EEN ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924 20140514

OLYSIO (simeprevir) market dynamics and financial trajectory: pricing, uptake, competition, and revenue decay

Last updated: June 24, 2026

Executive summary
OLYSIO (simeprevir) reached peak sales in the mid-to-late 2010s on the back of interferon-free direct-acting antiviral (DAA) hepatitis C regimens, then experienced rapid demand erosion as newer, more pangenotypic DAAs displaced it. Financial trajectory is characterized by (1) an early post-launch growth phase, (2) sharp market-share loss as sofosbuvir-based and glecaprevir/pibrentasvir regimens expanded across genotypes and simplified treatment, and (3) sustained decline after restrictive clinical and labeling constraints reduced the addressable population. Global competition intensified when large branded portfolios and aggressive contracting reduced net prices for HCV cures and pushed payers toward lower-cost, simplified regimens.

---

How did OLYSIO (simeprevir) perform commercially after launch?

OLYSIO is a first-wave, NS3/4A protease inhibitor DAA designed for chronic hepatitis C (HCV) treatment, most commonly in combination regimens. Like most early DAAs, it benefited from a short window where effective interferon-free options were still emerging and payer formularies were building coverage pathways for cure regimens.

Featured answer (what defined early uptake):
OLYSIO’s uptake depended on genotype-specific positioning, regimen compatibility, and payer contracting that favored rapid access but often required switching as newer pan-genotypic regimens reduced clinical and logistical complexity.

Key adoption drivers in early years

• Interferon-free regimen pull: As interferon-free standards formed, protease inhibitors like simeprevir saw adoption where combinations and duration matched guidelines.
• Genotype targeting: Early use concentrated on genotypes where simeprevir performed well under guideline-based combinations.
• Treatment setting access: Specialty pharmacy and hospital contracting determined speed of uptake more than brand awareness.

Key adoption constraints

• Limited pan-genotypic positioning: OLYSIO’s clinical footprint narrowed relative to later pangenotypic DAAs.
• Evolving guidance: HCV guidance shifted quickly toward simplified, higher-efficacy regimens, which reduced the share of patients that remained on simeprevir-containing pathways.

---

When did simeprevir lose market exclusivity and how did that affect revenue?

Featured answer (exclusivity impact pattern):
Revenue erosion in HCV DAAs typically starts before patent expiration because guideline movement and payer preferences shift toward newer regimens. Patent and data exclusivity matters, but competitive displacement often drives the majority of the decline.

Exclusivity-to-competition transmission

For OLYSIO, the revenue “cliff” dynamics in the category were driven by:

• Label and guideline replacement: Later pangenotypic regimens changed prescriber behavior.
• Contracting and price pressure: Payers moved to regimens with better net pricing and broader patient coverage.
• Formulary tiering: Once competing regimens were added, simeprevir-containing use was often pushed to narrow scenarios.

Economic effect timeline (category-consistent)

• 2014-2016: Establishment of DAAs and early adoption curve
• 2016-2018: Margin compression and share loss as multiple DAAs competed in the same lines of therapy
• 2018-2020: Acceleration in displacement as newer simplified regimens captured most eligible patients
• 2021 onward: Residual demand largely tied to niche eligibility, access constraints, or historical prescribing patterns

---

What market dynamics accelerated decline for OLYSIO compared with newer HCV DAAs?

Featured answer:
The HCV market moved from genotype- and regimen-specific complexity to pan-genotypic simplicity. OLYSIO’s protease-inhibitor positioning lost share as newer regimens reduced the need for genotype stratification and improved operational efficiency for payers.

Competitive factors that mattered most

1. Pangenotypic coverage
   • Newer regimens covered more patients without genotype testing burdens.
2. Simplified dosing and shorter pathways
   • Lower operational friction increased payer comfort and expanded clinic utilization.
3. Net price compression
   • Aggressive contracting reduced branded DAA net prices across the board.
4. Higher cure rates across broader populations
   • Expanded efficacy reduced the use of older generation regimens.

---

How did payer contracting and net pricing shape OLYSIO’s financial trajectory?

Featured answer:
Net pricing, not list price, drove the profit and revenue trajectory. In DAAs, payer negotiations and managed care formularies determine effective pricing and volume. When payers secured better terms for competing regimens, OLYSIO’s relative economics worsened.

Mechanisms of net price pressure

• Formulary placement shifts: As competitors entered preferred tiers, OLYSIO utilization declined.
• Prior authorization tightening: Coverage criteria often migrated to newer regimens requiring less verification.
• State and national purchasing dynamics: Public-sector and large PBM contracts shifted procurement toward lower-cost alternatives.

---

What is the revenue profile of OLYSIO versus competing hepatitis C drugs?

Featured answer (directional):
Simeprevir was materially outpaced in share by later pan-genotypic DAAs and by large branded portfolios that dominated mainstream payer contracting. OLYSIO’s revenue curve peaked earlier than later leaders, then declined faster as new standards took over.

Competitive set that re-allocated patients away from simeprevir

• Sofosbuvir-based regimens (multiple combinations across genotype landscapes)
• Glecaprevir/pibrentasvir (Mavyret) with strong pan-genotypic adoption
• Ledipasvir/sofosbuvir (Harvoni) early dominance for genotype-specific populations
• Pan-genotypic evolutions that reduced the need for NS3/4A protease inhibitors

(Exact annual revenue comparisons require company-specific financial disclosures and product net sales schedules.)

---

What did OLYSIO’s sales look like by geography and patient segments?

Featured answer:
Adoption was uneven. Early growth benefited regions where genotype workflows supported protease inhibitor combinations. As pangenotypic regimens broadened, geography-specific differences narrowed, with payers increasingly harmonizing formularies.

Segment dynamics

• Commercial insured and PBM-covered: More sensitive to net pricing, formularies, and payer pathways.
• Public programs: Procurement often moved quickly once state contracts favored lower-cost pan-genotypic regimens.
• Treatment-naïve vs treatment-experienced: Clinical guideline preferences determined which regimens were used in more complex populations, affecting residual share.

---

How did patent estate and litigation risk impact OLYSIO’s competitive exposure?

Featured answer:
For DAAs, generic and biosimilar-like dynamics do not map 1:1 to biologics, but the patent estate still shapes timing of generic entry and payer adoption of lower-cost versions. For OLYSIO, competitive pressure largely stemmed from new branded DAAs rather than generic displacement early in the product lifecycle.

Patent and entry channels that matter economically

• Composition-of-matter and formulation patents: Affect generic launch timing and formulation workarounds.
• Method-of-use and combination patents: Affect labeling and allowed indications, shifting utilization even after generic availability.
• Orange Book listing coverage: Determines whether Paragraph IV filings can enter “at-risk” and whether settlements delay launch.

(A complete, accurate patent-by-patent economic impact mapping requires Orange Book data and litigation dockets tied to each listing; that level of granularity is not provided in the prompt.)

---

What is the Orange Book status of OLYSIO and generic entry risk?

Featured answer:
Orange Book status dictates whether generics can enter for specific strengths and whether they can obtain label-level equivalence for key indications. For HCV DAAs, even when generics appear, clinical switching depends on payer coverage policy and guideline preference, which often favor newer branded regimens and later-generation generics.

Typical post-DAA entry behavior

• Generic availability does not equal immediate volume shift
  • Clinicians may default to the newest simpler regimen.
• Payer policies may restrict older regimens
  • Prior authorization focuses on preferred regimens.

---

How did clinical positioning influence OLYSIO’s utilization curve?

Featured answer:
OLYSIO’s utilization declined as clinical practice shifted from genotype-stratified protease inhibitor regimens toward pan-genotypic regimens with simpler treatment pathways.

Labeling and practice shift effect

• Earlier DAAs: Protease inhibitor-based regimens were used where supported.
• Later DAAs: Pangenotypic options captured the majority of new starts.
• Remaining population: Residual use depended on specific patient history, treatment access barriers, and clinician familiarity.

---

What did OLYSIO’s competitive landscape look like year by year?

Featured answer:
The year-by-year landscape transitioned from a limited set of effective DAAs to a crowded pan-genotypic field where simeprevir lost differentiation.

Market phases

• Early market formation (2013-2015)
  Protease-inhibitor regimens were among the best available options.
• Consolidation (2016-2018)
  Sofosbuvir-based and pangenotypic options expand coverage and reduce protease inhibitor share.
• Dominance and displacement (2019-2022)
  Payers prioritize simpler pan-genotypic regimens with stronger contracting terms.
• Residual period (2023 onward)
  Use persists in narrow clinical or access scenarios rather than broad uptake.

---

Did OLYSIO face manufacturing or supply constraints that affected sales?

Featured answer:
Demand dynamics in HCV were more sensitive to payer and guideline shifts than to supply constraints in the mainstream period. Unless supply was restricted, market share typically tracked clinical adoption and reimbursement policy rather than availability.

(No supply-event dataset is provided in the prompt.)

---

Key Takeaways

• OLYSIO’s commercial trajectory followed the early DAA wave: strong initial adoption, then rapid share loss as pangenotypic, simpler, and higher-contracting-advantaged regimens displaced protease-inhibitor-based options.
• Revenue decline in HCV DAAs is often driven more by payer contracting and guideline replacement than by patent expiration timing.
• The economic competitive environment tightened quickly: net price pressure and formulary tiering moved volume to later entrants, leaving simeprevir to niche or historical use patterns.

---

FAQs

1. Why did payers move away from NS3/4A protease inhibitors like simeprevir?
   Because later regimens reduced genotype stratification and simplified prior authorization while offering better net economics.

2. How does a “generic launch” timeline differ from “market displacement” in hepatitis C DAAs?
   Generic availability can lag behind treatment guideline shifts; payers and prescribers often redirect volume to newer regimens before patents expire.

3. What drives residual OLYSIO use after pangenotypic adoption?
   Narrow clinical circumstances, patient history, and access friction where newer regimens are constrained.

4. Do Orange Book protections materially affect uptake after newer branded DAAs enter?
   They affect labeling and entry timing, but uptake is still governed by payer coverage and guideline preference, which often dominate.

5. What is the main financial risk for holders of older HCV DAAs as newer pan-genotypic regimens expand?
   Persistent margin compression from net price renegotiations and accelerating share erosion as formularies shift preferred status.

---

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. FDA. Drug Approval Package for OLYSIO (simeprevir). (Accessed 2026).
3. American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA). HCV Guidance. (Guideline updates accessed 2020-2026).

DrugChatter Q&A for OLYSIO

Can Olysio be used with Interferon?