Imagine building three successful products over years of research, patent filings, FDA approvals, and commercial launches – only to see the first official regulatory barrier protecting them fall away. That’s the reality facing Sumitomo Pharma as December 2025 marks the end of New Chemical Entity (NCE) exclusivity for Gemtesa®, Orgovyx®, and Myfembree®.
This moment does not mean the patents are gone. It does not mean generics will launch tomorrow. But it does signal the beginning of the competitive countdown – the point at which generic manufacturers can finally start serious planning, legal analysis, and ANDA preparations.
In the pharmaceutical world, this is where generics begin to sharpen their strategy. And for Sumitomo Pharma, it’s a period requiring precision, strategy, and foresight.
Sumitomo’s $900M Portfolio Under Pressure
With exclusivity protections nearing expiry, Sumitomo Pharma’s core portfolio is entering a vulnerable phase. The data reflects the scale of its market presence in 2024, showcasing three high-performing products that together generate nearly $900 million in annual sales.
| Product | Annual Sales (USD) | Projection Year |
| Gemtesa® | $431 Million | 2024 |
| Orgovyx® | $379 Million | 2024 |
| Myfembree® | $84 Million | 2024 |
Generic Landscape
- Are generics already approved? No
- Current status: No ANDA filings yet, as market entry is still restricted due to ongoing patent protections and exclusivity.
- Implication: Generic manufacturers will need to wait until the listed exclusivities and key patents expire before submitting ANDAs.
Similar exclusivity transitions have reshaped major pharma portfolios in the past. A recent analysis of Teva Pharma highlights how patent expiry timelines can redefine competitive dynamics – read the full article here.
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Drug Overview
Approved in December 2020, Sumitomo Pharma’s portfolio of Gemtesa®, Orgovyx®, and Myfembree® marked a pivotal moment in its innovation strategy. Together, these therapies expanded treatment options across urology, oncology, and women’s health-addressing overactive bladder, advanced prostate cancer, and heavy bleeding or pain from uterine fibroids and endometriosis.
Each product introduced a modern, oral alternative in areas long dominated by limited choices, positioning Sumitomo as a company delivering meaningful solutions across diverse patient needs.
| Drug Name | API | Dosage Form | Strengths | Brand Holder | Approval Year (NDA) |
| Gemtesa | Vibegron | Tablet, Oral | 75 mg | Sumitomo Pharma America Holdings, Inc. | Dec 23, 2020 |
| Orgovyx | Relugolix | Tablet, Oral | 120 mg | Sumitomo Pharma America Holdings, Inc. | Dec 18, 2020 |
| Myfembree | Eslicarbazepine Acetate | Tablet, Oral | 200 mg 400 mg 600 mg 800 mg | Sumitomo Pharma America Holdings, Inc. | May 26, 2021 |
Orange Book Patent Expiry Details
The Orange Book records the official expiry dates of drug patents, marking the moment when exclusivity protections fall away. For Sumitomo’s portfolio, these timelines are more than regulatory milestones-they are countdowns to competitive entry.
| Drug Name | Patent Number | Patent Expire |
| Gemtesa | US12102638B2 | Mar 22, 2040 |
| Gemtesa | US8247415B2 | Dec 23, 2034 |
| Gemtesa | US12357636B2 | May 4, 2042 |
| Gemtesa | US8653260B2 | Apr 2, 2029 |
| Gemtesa | US12180219B2 | Mar 12, 2034 |
| Orgovyx | US12144809B1 | Sep 29, 2037 |
| Orgovyx | US11583526B2 | Sep 29, 2037 |
| Orgovyx | US12336990B2 | Sep 29, 2037 |
| Orgovyx | US12097198B2 | Sep 29, 2037 |
| Orgovyx | US10449191B2 | Sep 29, 2037 |
| Orgovyx | US10786501B2 | Sep 29, 2037 |
| Orgovyx | US10350170B2 | Feb 25, 2036 |
| Myfembree | US7300935B2 | Jan 28, 2029 |
| Myfembree | US11795178B2 | Sep 27, 2033 |
| Myfembree | US12325714B2 | Sep 27, 2033 |
| Myfembree | US8058280B2 | Jan 28, 2026 |
| Myfembree | US11793812B2 | May 3, 2038 |
| Myfembree | US11033551B2 | Sep 29, 2037 |
| Myfembree | US11957684B2 | Sep 29, 2037 |
Exclusivity Details
Here are the exclusivity dates for three key drugs-expiring in December 2025. With patents ending, generic companies have a clear opportunity to step in and bring affordable options to the market.
| Drug Name | API | Exclusivity Type | Exclusivity Date |
| Gemtesa | Vibegron | NCE | Dec 23, 2025 |
| Orgovyx | Relugolix | NCE | Dec 18, 2025 |
| Myfembree | Eslicarbazepine Acetate | NCE | Dec 18, 2025 |
Exclusivity Ends, Strategy Begins
In December 2025, the exclusivity for Gemtesa®, Orgovyx®, and Myfembree® will end. This does not mean patents are gone or that generics will launch right away. But it does mark the first step toward competition, giving generic companies the chance to start planning and preparing.
For patients, this change could mean more affordable treatment options in urology, oncology, and women’s health. For Sumitomo Pharma, it is a test of strength-needing smart strategy, strong branding, and careful planning to protect nearly $900 million in sales before generics arrive.
The story of these drugs is not ending-it is moving to a new phase. December 2025 is the start of the countdown, and how Sumitomo responds will decide its place in the market in the years ahead.
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