OVIDREL Drug Profile

Summary for Tradename: OVIDREL

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for OVIDREL
Recent Clinical Trials:	See clinical trials for OVIDREL

See drug prices for OVIDREL

Recent Clinical Trials for OVIDREL

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Suzhou Centergene Pharmaceuticals Co.,Ltd.	PHASE1
EMD Serono	PHASE3
Ellen Greenblatt	PHASE3

See all OVIDREL clinical trials

Pharmacology for OVIDREL

Established Pharmacologic Class	Gonadotropin
Chemical Structure	Gonadotropins

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for OVIDREL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for OVIDREL Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for OVIDREL Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emd Serono, Inc.	OVIDREL	choriogonadotropin alfa	Injection	021149	10,016,338	2036-12-20	Patent claims search
Emd Serono, Inc.	OVIDREL	choriogonadotropin alfa	Injection	021149	10,154,856	2034-02-06	Patent claims search
Emd Serono, Inc.	OVIDREL	choriogonadotropin alfa	Injection	021149	10,577,154	2038-12-19	Patent claims search
Emd Serono, Inc.	OVIDREL	choriogonadotropin alfa	Injection	021149	10,656,152	2037-11-08	Patent claims search
Emd Serono, Inc.	OVIDREL	choriogonadotropin alfa	Injection	021149	10,912,714	2038-07-09	Patent claims search
Emd Serono, Inc.	OVIDREL	choriogonadotropin alfa	Injection	021149	10,953,073	2038-09-17	Patent claims search

Market Dynamics and Financial Trajectory for OVIDREL

Last updated: February 20, 2026

What is OVIDREL and how is it positioned in the market?

OVIDREL (choriogonadotropin alfa) is a recombinant human chorionic gonadotropin used primarily in fertility treatments. It stimulates ovulation and supports early pregnancy, positioning itself as a key drug in assisted reproductive technology (ART).

Manufactured by EMD Serono, OVIDREL gained FDA approval in 2000. It competes mainly with urinary-derived hCG products such as Pregnyl and Novarel.

What are the market drivers influencing OVIDREL?

Several factors influence OVIDREL’s market share and growth potential:

• Increased infertility rates: Driven by delayed childbearing, rising obesity, and other factors. The CDC reports a US infertility prevalence of approximately 12% among women aged 15-44 as of 2020. Globally, infertility affects 8-12% of couples. This growth drives demand for ART drugs.
• Advancements in infertility treatments: Innovations in IVF and ovulation induction favor the use of recombinant products like OVIDREL over urinary-derived sources, due to consistent potency, purity, and lower contamination risk.
• Regulatory landscape: Approvals in emerging markets, including China and India, expand access. Divergent regulations may impact market penetration.
• Pricing and reimbursement policies: Insurers’ coverage favors recombinant products, often making them more attractive despite higher manufacturing costs.
• Preferential shift towards recombinant gonadotropins: Both physicians and patients increasingly favor recombinant over urinary products for safety and efficacy reasons.

How does OVIDREL compare to competitors?

Feature	OVIDREL	Pregnyl/Novarel
Source	Recombinant (human)	Urinary-derived
Approval year	2000	1959/1971
Cost per dose (US)	$300-$400	$150-$300
Safety profile	Lower contamination risk	Higher variability
Consistency in potency	High	Variability possible

Recombinant formulations like OVIDREL offer advantages in safety and batch-to-batch consistency, which increasingly influence prescriber preference.

What is the revenue trajectory forecast for OVIDREL?

While exact sales figures remain proprietary, estimates based on market analysis suggest:

• Historical revenue: Estimated in the range of $140-$180 million annually in the US and Europe (2019-2022).
• Growth prospects: CAGR projected at approximately 4-6% over the next five years, driven by increased infertility treatments and regulatory expansion.
• Market share: OVIDREL currently accounts for roughly 20-25% of the recombinant gonadotropin gonadotropin market segment, which is valued at $600 million globally.

Market outlook by region:

Region	Estimated Market Size (2022)	Estimated OVIDREL Share	Growth Rate (2023-2028)
North America	$250 million	25%	4.5%
Europe	$200 million	22%	3.8%
Asia-Pacific	$100 million	15%	6.2%
Rest of world	$50 million	12%	5.0%

Emerging markets, particularly in Asia, could see accelerated adoption driven by expanding fertility clinics and local manufacturing approvals.

What are the risks impacting OVIDREL’s financial outlook?

Key risks include:

• Patent expiration: Original patents expired or are subject to challenges, increasing generic or biosimilar competition.
• Pricing pressures: Price sensitivity in cost-conscious markets may reduce margins.
• Regulatory hurdles: Changes may restrict access or delay approvals in key regions.
• Competitive innovations: Development of orally administered or novel gonadotropins could shift market preferences.

How does patent and regulatory status influence OVIDREL’s market stance?

As of 2023, OVIDREL’s core patents have largely expired. EMD Serono continues to hold exclusivity for certain formulations through data protections until 2026 in the US and later in other regions. Biosimilar entrants are on the rise; for instance, Sandoz announced biosimilar versions of recombinant gonadotropins, which could erode market share after patent expiry.

Regulatory approvals for biosimilars in the US and EU have increased, with several filings pending. Market entry of cheaper biosimilars will likely intensify price competition.

Closing analysis

OVIDREL remains a significant player in the fertility drug market, supported by the global increase in ART procedures and a shift toward recombinant formulations. The drug's revenue is projected to grow modestly, contingent on market expansion, biosimilar competition, and pricing strategies.

Key Takeaways

• OVIDREL is a recombinant hCG used in fertility treatments with steady demand driven by rising infertility rates.
• It faces competition from urinary-derived mimic drugs and biosimilars, which could impact pricing and sales.
• Market growth is expected between 4% and 6% annually over the next five years, with regional variations.
• Patent expiry and biosimilar entry pose near-term risks; however, ongoing regulatory and clinical differentiation sustain its market position.

FAQs

1. When did OVIDREL receive FDA approval?
In 2000.

2. What factors favor OVIDREL over urinary-derived alternatives?
Recombinant form offers higher safety, batch consistency, and lower contamination risks.

3. How might biosimilars impact OVIDREL’s sales?
Biosimilar competition could reduce prices and market share once patents expire, likely after 2026.

4. Which regions are experiencing the fastest growth for OVIDREL?
Asia-Pacific and other emerging markets show higher growth potential due to expanding fertility services.

5. What is the primary driver for increased demand of recombinant gonadotropins?
Physician and patient preference for safety, efficacy, and consistency over urinary-derived products.

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References

1. CDC. (2020). Data on infertility prevalence in the U.S.
2. IQVIA. (2022). Global fertility drugs market report.
3. EMD Serono. (2022). OVIDREL product information.
4. Grand View Research. (2022). Fertility Drugs Market Size & Trends.
5. EMA. (2022). Biosimilar approvals and regulations.