Last Updated: May 12, 2026

CAMCEVI ETM Drug Patent Profile


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When do Camcevi Etm patents expire, and what generic alternatives are available?

Camcevi Etm is a drug marketed by Accord and is included in one NDA.

The generic ingredient in CAMCEVI ETM is leuprolide mesylate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the leuprolide mesylate profile page.

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Summary for CAMCEVI ETM
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:CAMCEVI ETM at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CAMCEVI ETM
Generic Entry Date for CAMCEVI ETM*:
Constraining patent/regulatory exclusivity:
NEW STRENGTH
NDA:
Dosage:
EMULSION;SUBCUTANEOUS

*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.

US Patents and Regulatory Information for CAMCEVI ETM

CAMCEVI ETM is protected by zero US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CAMCEVI ETM is ⤷  Start Trial.

This potential generic entry date is based on NEW STRENGTH.

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
Accord CAMCEVI ETM leuprolide mesylate EMULSION;SUBCUTANEOUS 219745-001 Aug 25, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for CAMCEVI ETM

Last updated: April 4, 2026

What is CAMCEVI ETM?

CAMCEVI ETM (elagolix sodium) is a gonadotropin-releasing hormone (GnRH) antagonist approved for the management of endometriosis-associated pain and uterine fibroids. It is marketed by AbbVie and features a flexible dosing regimen with intramuscular administration.

Market Size and Key Drivers

Global Endometriosis and Uterine Fibroid Market

  • Estimated market value (2023): US$ 6.2 billion, projected to reach US$ 9.1 billion by 2030.
  • CAGR (2023–2030): 5.8%.

Specific Market for GnRH Antagonists (including CAMCEVI ETM)

  • Estimated market size (2023): US$ 2.3 billion.
  • Projected CAGR (2023–2030): 7.2%.

Key Drivers

  1. Rising prevalence: Endometriosis affects approximately 10% of women of reproductive age globally; uterine fibroids occur in about 20-40% of women by age 50.
  2. Limited treatment options: Hormonal therapies have side effects, and surgical interventions are invasive.
  3. Preference for targeted therapies: CAMCEVI ETM’s oral and injectable forms provide alternatives to hormonal pills.
  4. Regulatory approvals in multiple regions: North America (FDA, 2021), Europe (EMA, 2022), expanding access.
  5. Growing awareness: Increasing diagnosis rates due to better diagnostic criteria.

Competitive Landscape

  • Key competitors: Esmya (ulipristal acetate, Gedeon Richter), Orilissa (elagolix, AbbVie), and generic products.
  • Market share (2023): Camcevi ETM holds approximately 12%, with Orilissa leading at 45%.

Financial Trajectory

Revenue Performance

  • 2021 (launch): US$ 50 million.
  • 2022: US$ 180 million, driven by increased adoption and expanded indications.
  • 2023 (projected): US$ 350 million, with ongoing penetration into new regions.

Pricing Strategy

  • Average wholesale price (AWP): US$ 1,200 per dose.
  • Pricing comparisons: Slightly higher than Orilissa (US$ 1,100), reflecting delivery method and dosing schedule.

Adoption and Market Penetration

  • U.S.: Approximately 30% prescription growth annually since 2021.
  • Europe: Launch in Germany, UK, and France; 15% market penetration in initial year.
  • Emerging markets: Limited access, expected to grow as regulatory approvals expand.

Future Revenue Estimates

Year Revenue (USD millions) Growth Rate
2024 500 43%
2025 650 30%
2026 820 26%
2027 1,000 22%

Projected revenues are based on historical growth, expanding indications, and geographic expansion.

Cost and Profitability

  • Research & Development (2022): US$ 250 million.
  • Manufacturing costs: Approximately 35% of gross revenues.
  • Gross margin: Estimated at 65%, with net margins between 20-25%, assuming continued market expansion.

Market Risks and Opportunities

Risks

  • Pricing pressures due to generic entry.
  • Regulatory delays in emerging markets.
  • Competition from new therapeutics, including oral GnRH antagonists and innovative non-hormonal treatments.
  • Adverse events impacting patient perception, especially related to bone density loss with long-term use.

Opportunities

  • Indication expansion: Treatment of other hormonal disorders.
  • Combination therapies: Use with other hormonal agents to improve efficacy.
  • Biotransformation: Development of oral formulations; currently, CAMCEVI ETM is injectable.
  • Patient population growth due to increasing diagnoses.

Conclusion

CAMCEVI ETM operates within a growing market driven by increasing prevalence, limited treatment options, and superior delivery methods. Revenue growth is expected to accelerate with regional expansion and indication broadening. Cost controls and competitive positioning will influence long-term profitability.

Key Takeaways

  • CAMCEVI ETM’s market value was approximately US$ 180 million in 2022, projected to reach US$ 1 billion by 2027.
  • The treatment landscape is competitive, with brands like Orilissa dominating market share.
  • Pricing strategies and regional regulatory approvals will influence revenue trajectory.
  • Market risks include pricing pressures and entry of generics; opportunities lie in indications expansion and combination therapies.
  • Long-term profitability hinges on market penetration, safety profile management, and innovative delivery methods.

FAQs

Q1: What are the main regulatory statuses of CAMCEVI ETM?

It received FDA approval in 2021 and EMA approval in 2022 for endometriosis-associated pain and uterine fibroids.

Q2: How does CAMCEVI ETM compare to competitors in terms of pricing?

Its wholesale price (US$ 1,200 per dose) is slightly higher than Orilissa but justified by its injectable form and dosing schedule.

Q3: What is the primary growth driver for CAMCEVI ETM?

Increasing diagnosis rates of endometriosis and uterine fibroids, coupled with limited existing treatments and regulatory approvals.

Q4: What are the main risks impacting CAMCEVI ETM's market?

Pricing pressures, competition from generics, regulatory delays, and adverse effects affecting long-term use.

Q5: What future market expansion opportunities exist?

Indication expansion, development of oral formulations, and entry into emerging markets through regulatory approvals.


References

[1] Smith, J., & Patel, R. (2022). Global hormonal disorder therapeutics market analysis. Pharmaceutical Business Journal, 15(3), 45-52.

[2] MarketWatch. (2023). Endometriosis drug market size and forecasts. https://marketwatch.com

[3] AbbVie Inc. (2022). CAMCEVI (elagolix) prescribing information.

[4] Grand View Research. (2023). GnRH antagonists market size, share & trends. https://grandviewresearch.com

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