ZYPREXA Drug Patent Profile

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

Zyprexa is a drug marketed by Cheplapharm and is included in four NDAs.

The generic ingredient in ZYPREXA is olanzapine pamoate. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olanzapine pamoate profile page.

Summary for ZYPREXA

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	132
Patent Applications:	1,333
Drug Prices:	Drug price information for ZYPREXA
What excipients (inactive ingredients) are in ZYPREXA?	ZYPREXA excipients list
DailyMed Link:	ZYPREXA at DailyMed

See drug prices for ZYPREXA

See drug sales revenues for ZYPREXA

Recent Clinical Trials for ZYPREXA

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

Sponsor	Phase
Teva Branded Pharmaceutical Products R&D, Inc.	PHASE1
Teva Branded Pharmaceutical Products R&D LLC	PHASE1
Oregon Health and Science University	Phase 2

See all ZYPREXA clinical trials

Pharmacology for ZYPREXA

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ZYPREXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	ZYPREXA	olanzapine	INJECTABLE;INTRAMUSCULAR	021253-001	Mar 29, 2004	AP	RX	Yes	Yes
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	AB	RX	Yes	No
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	AB	RX	Yes	No
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-002	Apr 6, 2000	AB	RX	Yes	No
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-001	Dec 11, 2009		RX	Yes	No
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-004	Apr 6, 2000	AB	RX	Yes	No
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-001	Sep 30, 1996	AB	RX	Yes	No

Expired US Patents for ZYPREXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-001	Sep 30, 1996
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-002	Sep 30, 1996
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-004	Sep 30, 1996
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-002	Sep 30, 1996
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-001	Sep 30, 1996

EU/EMA Drug Approvals for ZYPREXA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Zyprexa Velotab	olanzapine	EMEA/H/C/000287AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.	Authorised	no	no	no	2000-02-03
Eli Lilly Nederland B.V.	Zypadhera	olanzapine	EMEA/H/C/000890Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.	Authorised	no	no	no	2008-11-19
Eli Lilly Nederland B.V.	Zyprexa	olanzapine	EMEA/H/C/000115Coated tabletsAdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.InjectionAdultsZyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.	Authorised	no	no	no	1996-09-27
Krka	Zalasta	olanzapine	EMEA/H/C/000792Olanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.	Authorised	yes	no	no	2007-09-27
Mylan Pharmaceuticals Limited	Olanzapine Mylan	olanzapine	EMEA/H/C/000961AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.	Authorised	yes	no	no	2008-10-06
Teva B.V.	Olanzapine Teva	olanzapine	EMEA/H/C/000810AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.	Authorised	yes	no	no	2007-12-12
Apotex Europe BV	Olanzapine Apotex	olanzapine	EMEA/H/C/001178Olanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.	Authorised	yes	no	no	2010-06-10

International Patents for ZYPREXA

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

Country	Patent Number	Title	Estimated Expiration
Norway	991339
Sweden	9703206
Finland	101379
Portugal	733635
Portugal	1095941
Spain	2078440
Czech Republic	9703001

Supplementary Protection Certificates for ZYPREXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454436	97C0012	Belgium		PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927
0454436	CA 2001 00042	Denmark
0454436	9/1997	Austria		PRODUCT NAME: OLANZAPIN ODER EIN SAEUREADDITIONSSALZ HIEVON; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927
0454436	SPC/GB96/058	United Kingdom		PRODUCT NAME: OLANZAPINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/96/022/001 19960927; UK EU/1/96/022/002 19960927; UK EU/1/96/022/003 19960927; UK EU/1/96/022/004 19960927; UK EU/1/96/022/005 19960927; UK EU/1/96/022/006 19960927; UK EU/1/96/022/007 19960927; UK EU/1/96/022/008 19960927; UK EU/1/96/022/009 19960927; UK EU/1/96/022/010 19960927
0454436	C970015	Netherlands		PRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927

Market Dynamics and Financial Trajectory for Zyprexa (Olanzapine)

Last updated: December 15, 2025

Executive Summary

Zyprexa (olanzapine), an atypical antipsychotic developed by Eli Lilly, has historically played a pivotal role in treating schizophrenia and bipolar disorder. Despite patent expiration in many regions, Zyprexa maintains substantial relevance due to its proven efficacy, ongoing patent litigations, generic competition, and evolving regulatory landscapes. This report examines the current market dynamics, financial trends, and future outlook, emphasizing factors influencing revenue, market share, and pricing strategies.

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Introduction

Zyprexa (olanzapine) received FDA approval in 1996. Since then, it became a flagship product for Eli Lilly, generating peak revenues exceeding $5 billion annually in the early 2000s. However, patent expirations and subsequent generic entries have eroded its market share, prompting a reevaluation of its current and projected financial trajectory.

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1. Market Landscape of Zyprexa

1.1 Therapeutic Indications & Market Size

Indication	Market Size (USD billion, 2022)	Key Competitors
Schizophrenia	$3.8	Risperdal (Johnson & Johnson), Saphris
Bipolar Disorder	$2.1	Symbyax (olanzapine + fluoxetine), Seroquel (AstraZeneca)
Treatment Resistant Conditions	Growing segment	Clozapine, Aripiprazole

Source: IQVIA (2022)

1.2 Patent and Regulatory Milestones

Year	Event	Implication
1996	FDA Approval for schizophrenia	Launch phase
2004	Patent expiry in the US, EU, Japan	Initiation of generic competition
2015	Final patent expiry for core patents	Market share decline begins
2017	FDA approves generic forms	Multiple generics introduce significant price erosion

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2. Key Market Dynamics Influencing Zyprexa

2.1 Patent Expiry and Generic Competition

The expiration of primary patents in 2015 precipitated aggressive price competition. As of 2022, over 20 generic versions are available globally, sharply reducing Eli Lilly’s market share.

Patent Status	Major Generic Players	Market Share Impact	Price Erosion (USD)
2004-2015	Limited generics	Declined steadily	15-25% reduction per year
Post-2015	Numerous generic entrants	Accelerated decline	60-70% reduction in list price

2.2 Pricing and Reimbursement Trends

Despite generics, Zyprexa maintains a tiered pricing structure:

• Brand name: ~$250 per pill (2015)
• Generic: ~$50-$60 per pill (2022)

Insurance coverage and formulary prioritization significantly influence patient access, with payers favoring generics to control costs.

2.3 Off-Label Use and Alternative Therapies

While approved for schizophrenia and bipolar disorder, off-label prescribing (e.g., for depression, agitation) has limited impact due to legal and safety considerations, but it contributes to material volume.

Competitors expanding indications (e.g., Seroquel for generalized anxiety) challenge Zyprexa’s exclusivity, but safety profiles remain a differentiator.

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3. Financial Trajectory Analysis

3.1 Historical Revenue Patterns

Year	Revenue (USD billion)	Notes
2001	4.80	Peak sales
2005	4.20	Patent expiry beginning
2010	2.50	Competition intensifies
2015	0.90	Post-patent expiry, genericization
2020	0.70	Continued decline
2022	0.65	Stabilization at lower levels

Source: Eli Lilly Annual Reports, 2001-2022

3.2 Current Revenue Breakdown (2022)

Region	Revenue (USD million)	Percentage of Total Revenue	Market Share
U.S.	350	54%	Dominant due to legacy brand
Europe	150	23%	Significant generic uptake
Rest of World	150	23%	Emerging markets

3.3 Cost and Margin Analysis

Cost Factors	Impact
R&D expenses for new indications	~USD 150 million annually (2022)
Manufacturing and supply chain	Marginally declining post-genericization
Legal and patent litigations	Ongoing, USD 20-30 million annually
Gross margin (post-patent)	~55% (pre-expiration: ~70%)

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4. Competitive Landscape and Market Share Evolution

Company	Product	Market Share (2022)	Key Differentiators
Eli Lilly	Zyprexa	~10% (post-generic)	Legacy brand influence, targeted therapies
Teva, Mylan, Sandoz	Multiple generics	50-60% combined	Price leadership
AstraZeneca	Seroquel XR	15%	Broader indications, patent protection
Otsuka Pharmaceutical	Abilify	10%	Higher tolerability profile

Note: Zyprexa’s market share continues to diminish due to generics, but brand loyalty and specific prescribing niches sustain residual revenue.

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5. Regulatory and Policy Factors

5.1 Patent Litigation & Exclusivity

• Legal battles delayed generic entry until 2015.
• Settlement agreements and pay-for-delay strategies** influenced market timing.

5.2 Healthcare Policy Impact

• US and European agencies prioritize cost containment.
• Increased access to cost-effective generics accelerates revenue decline.

5.3 Future Patent Applications & Biosimonic Strategies

• Lilly explores biosimilar opportunities and innovative formulations.
• Potential for line extensions or combination therapies.

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6. Future Outlook and Strategic Considerations

6.1 Growth Drivers

• New formulations: Long-acting injectables (LAIs) as a sustainable revenue stream.
• Expanded indications: Niche uses in resistant cases.
• Digital therapeutics: Integration for adherence.

6.2 Challenges

• Generic price erosion limits revenue.
• Market saturation in mature regions.
• Competitive drugs and emerging therapies.

6.3 Projections (2023-2028)

Year	Estimated Revenue (USD million)	Growth Rate	Key Assumptions
2023	600	-8%	Continued generic competition, new formulations uptake
2025	550	-4% annually	Stabilization as niche specialty product
2028	500	Slight decline	Market maturity, competitive pressures

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7. Comparative Analysis: Zyprexa vs. Competitors

Aspect	Zyprexa (Olanzapine)	Competitors (e.g., Risperdal, Seroquel, Abilify)
Efficacy	High for schizophrenia & bipolar	Comparable; some with broader indications
Safety Profile	Metabolic side effects (weight gain)	Varies; some with lower metabolic risks
Patent Status	Patents expired in 2015	Still protected (e.g., Abilify till 2023 in some regions)
Market Share (2022)	~10% (post-generic)	Risperdal, Seroquel, Abilify collectively dominant
Price Strategy	Loss of exclusivity impact	Competitively priced generics

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8. FAQs

Q1: What caused the decline in Zyprexa’s market share after 2015?
A: The expiration of key patents enabled numerous generic manufacturers to enter the market, significantly reducing list prices and leading to a decline in Eli Lilly’s brand sales.

Q2: Are there emerging indications or formulations that could revitalize Zyprexa’s revenues?
A: Yes, Lilly is exploring long-acting injectable (LAI) formulations and potential new clinical indications, which could offer premium pricing and extend market relevance.

Q3: How does generic competition impact pricing strategies?
A: Once patents expire, generic competition drives down prices, forcing brand manufacturers to innovate or seek niche markets to sustain revenue streams.

Q4: What are the key risks facing Zyprexa’s future financial performance?
A: Sales erosion from generics, regulatory challenges, safety concerns related to metabolic side effects, and competition from newer antipsychotics.

Q5: How does Eli Lilly plan to adapt to the declining patent-protected revenue?
A: Through diversification into biosimilars, new drug formulations, expanding indications, and leveraging proprietary digital health tools.

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Key Takeaways

• Patent expirations in 2015 significantly diminished Zyprexa’s revenue, with generic competition now constituting over 60% of the market share.
• Pricing erosion remains a critical challenge, with list prices dropping by more than 70% post-generic entry.
• Strategic shifts toward long-acting formulations and new indications are potential growth avenues.
• Market share evolution highlights the necessity of innovation and targeted therapy positioning.
• Regulatory landscape and healthcare policies emphasizing cost reduction will continue to influence market dynamics.

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References

[1] IQVIA (2022). Pharmaceutical Market Analysis.
[2] Eli Lilly & Co. Annual Reports, 2001-2022.
[3] U.S. Food and Drug Administration (FDA). Drug Approvals and Patent Information.
[4] Thomson Reuters, Pharma Intelligence.
[5] MarketWatch. Antipsychotics Market Size and Trends.