BALCOLTRA Drug Patent Profile

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

Balcoltra is a drug marketed by Avion Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in BALCOLTRA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

DrugPatentWatch^® Generic Entry Outlook for Balcoltra

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.

There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for BALCOLTRA

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for BALCOLTRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BALCOLTRA
What excipients (inactive ingredients) are in BALCOLTRA?	BALCOLTRA excipients list
DailyMed Link:	BALCOLTRA at DailyMed

See drug prices for BALCOLTRA

Paragraph IV (Patent) Challenges for BALCOLTRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALCOLTRA	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg	208612	1	2020-07-14

US Patents and Regulatory Information for BALCOLTRA

BALCOLTRA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018	AB3	RX	Yes	Yes				Y

Expired US Patents for BALCOLTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018

International Patents for BALCOLTRA

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

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04001475	MEJORAMIENTO DE LA SOLUBILIDAD DE QUELATOS DE AMINOACIDOS DE HIERRO Y DE PROTEINATOS DE HIERRO. (ENHANCING SOLUBILITY OF IRON AMINO ACID CHELATES AND IRON PROTEINATES.)
Australia	2002331603
South Africa	200401218	Enhancing solubility of iron amino acid chelates and iron proteinates.
World Intellectual Property Organization (WIPO)	03016332
World Intellectual Property Organization (WIPO)	2005105112
United Kingdom	0403792

Supplementary Protection Certificates for BALCOLTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612

Market Dynamics and Financial Trajectory for BALCOLTRA

Last updated: July 28, 2025

Introduction
BALCOLTRA (baloxavir marboxil and ritonavir), developed to address a significant unmet need in antiviral therapy, represents a promising entrant within the infectious disease market, particularly in influenza treatment. Understanding its market dynamics and financial trajectory requires an exploration of its therapeutic profile, competitive landscape, regulatory environment, and potential market penetration strategies.

---

Therapeutic Profile and Clinical Positioning
BALCOLTRA combines baloxavir marboxil, a potent cap-dependent endonuclease inhibitor, with ritonavir, a pharmacokinetic enhancer traditionally utilized in HIV therapy. Baloxavir’s mechanism involves inhibiting viral RNA synthesis, providing a novel approach compared to neuraminidase inhibitors like oseltamivir (Tamiflu), which have been the mainstay in flu treatment.

Clinical trials indicate that BALCOLTRA demonstrates rapid symptom alleviation and reduced viral load, with a favorable safety profile. Its single-dose regimen confers advantages over existing options requiring multiple doses, enhancing compliance and/or reducing healthcare resource utilization. Nonetheless, its safety and efficacy data primarily derive from acute influenza studies, positioning it as a preferred option in outpatient settings.

---

Market Dynamics and Competitive Landscape

Existing Market Players
The influenza antiviral market is dominated by drugs like oseltamivir, zanamivir, peramivir, and baloxavir (as a monotherapy). The introduction of BALCOLTRA offers a combination therapy with potential synergistic effects and a broader antiviral spectrum. However, market dominance is challenged by established treatments with high brand recognition, robust distribution channels, and extensive clinical data.

Regulatory Status and Approvals
BALCOLTRA has secured regulatory approval in major markets like the United States and the European Union, following favorable clinical trial results. Regulatory agencies favor combination therapies attributable to potential improved efficacy and resistance mitigation. However, regulatory hurdles for new antiviral combinations remain elevated, demanding rigorous safety and efficacy data.

Market Penetration Strategies
Market penetration hinges on strategic collaborations with payers, targeted marketing to healthcare providers, and demonstrating cost-effectiveness relative to existing treatments. Given the COVID-19 pandemic's heightened awareness of respiratory illnesses, BALCOLTRA’s positioning could benefit from increased demand for effective influenza treatments. Educating clinicians on its advantages—single-dose convenience, rapid symptom relief—will be vital in gaining market share.

Pricing and Reimbursement
Pricing strategies play a pivotal role. The drug’s value proposition should emphasize reduced healthcare visits and hospitalization risks, potentially enabling premium pricing within negotiated reimbursement frameworks. Payer acceptance relies on pharmacoeconomic studies illustrating cost savings in outpatient management and productivity gains.

---

Financial Trajectory and Revenue Forecasts

Market Adoption Projections
Initial adoption is likely in high-risk groups such as the elderly, immunocompromised, and healthcare institutions managing influenza outbreaks. As real-world evidence accumulates, broader outpatient acceptance will follow.

Revenue Model
Revenue streams depend on the volume of prescriptions, pricing levels, and geographic expansion. Early-stage revenues will align with approval milestones, with significant growth expected if the drug captures a notable share of the influenza market, estimated to be worth over $2 billion globally (USD) annually.

Growth Drivers

• Epidemiological Trends: Seasonal influenza prevalence and pandemic preparedness forecasts influence demand.
• Regulatory Approvals: Expanding indications for influenza treatment or prophylaxis may enhance revenue prospects.
• Partnerships: Strategic alliances with large pharmaceutical companies can accelerate distribution and visibility.

Risks and Challenges

• Resistance Development: Viral resistance to baloxavir and other antivirals poses a threat.
• Market Competition: Efficacy and safety profile perceptions relative to existing drugs affect uptake.
• Pricing Pressures: Governments and payers may push for cost containment, impacting margins.

Projected Financial Trajectory
Industry analysis projects moderate initial revenues, potentially reaching hundreds of millions USD within 3-5 years post-launch, assuming successful market penetration and regulatory expansion. Peak revenues may surpass $500 million globally, provided resistance issues remain manageable and reimbursement remains favorable.

---

Long-term Outlook
The expansion of BALCOLTRA's indications—including prophylaxis in vulnerable populations—could significantly augment its market share. Combination therapy's role in combating resistance and enhancing clinical outcomes remains critically important. Furthermore, the development pipeline, including potential novel combinations or formulations, will directly influence its long-term financial trajectory.

---

Key Takeaways

• BALCOLTRA leverages a novel antiviral combination that offers pharmacological and convenience advantages over existing therapies.
• Its market success depends on regulatory approvals, clinician acceptance, and payer reimbursement strategies.
• Early revenues are expected to be moderate but have high growth potential driven by pandemic preparedness and expanded indications.
• Resistance management, competitive positioning, and strategic partnerships are crucial for achieving projected financial success.
• Long-term growth hinges on real-world effectiveness data, continued regulatory clearance, and evolving influenza epidemiology.

---

FAQs

1. How does BALCOLTRA differentiate from existing influenza antivirals?
BALCOLTRA combines baloxavir marboxil with ritonavir, providing a single-dose regimen with a novel mechanism of action, potentially improving efficacy and reducing resistance compared to traditional neuraminidase inhibitors.

2. What are the primary market barriers for BALCOLTRA?
Key barriers include established brand loyalty toward existing drugs, regulatory hurdles for combination therapies, pricing negotiations, and potential viral resistance.

3. How significant is the influenza market globally?
The global influenza antiviral market exceeds $2 billion annually, with seasonal fluctuations influencing quarterly and yearly sales.

4. What role will COVID-19 pandemic trends play in BALCOLTRA’s market trajectory?
Increased preparedness for respiratory illnesses and heightened awareness of antiviral therapies post-pandemic could boost demand and acceptance of BALCOLTRA, especially in outpatient and prophylactic contexts.

5. What potential does BALCOLTRA have beyond influenza?
Current data focus primarily on influenza; future development may explore prophylactic or therapeutic applications in other respiratory viral infections, contingent on clinical trial outcomes.

---

References
[1] Industry research reports on influenza antiviral markets.
[2] Clinical trial outcomes and regulatory documents from agencies such as the FDA and EMA.
[3] Market analysis publications and epidemiological data from the CDC and WHO.