You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

~ Buy the OSPHENA (ospemifene) Drug Profile, 2024 PDF Report in the Report Store ~

OSPHENA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Osphena, and when can generic versions of Osphena launch?

Osphena is a drug marketed by Duchesnay and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four patent family members in thirty-one countries.

The generic ingredient in OSPHENA is ospemifene. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ospemifene profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Osphena

A generic version of OSPHENA was approved as ospemifene by HETERO LABS LTD V on February 13th, 2024.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for OSPHENA?
  • What are the global sales for OSPHENA?
  • What is Average Wholesale Price for OSPHENA?
Drug patent expirations by year for OSPHENA
Drug Prices for OSPHENA

See drug prices for OSPHENA

Recent Clinical Trials for OSPHENA

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

SponsorPhase
Emory UniversityPhase 4
Sue GoldsteinPhase 4

See all OSPHENA clinical trials

Pharmacology for OSPHENA
Paragraph IV (Patent) Challenges for OSPHENA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OSPHENA Tablets ospemifene 60 mg 203505 1 2020-12-29

US Patents and Regulatory Information for OSPHENA

OSPHENA is protected by eighteen US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for OSPHENA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Subscribe ⤷  Subscribe
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Subscribe ⤷  Subscribe
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for OSPHENA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Shionogi B.V. Senshio ospemifene EMEA/H/C/002780
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
Authorised no no no 2015-01-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for OSPHENA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713458 132016000023047 Italy ⤷  Subscribe PRODUCT NAME: OSPEMIFENE IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(SENSHIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/978/001-002, 20150115
1713458 576 Finland ⤷  Subscribe
1713458 PA2015023 Lithuania ⤷  Subscribe PRODUCT NAME: OSPEMIFENUM; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

OSPHENA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Osphena (Ospemifene)

Overview of Osphena

Osphena, also known as ospemifene, is a non-hormonal oral medication approved by the FDA for the treatment of moderate to severe dyspareunia (painful sex) and vaginal dryness, symptoms associated with vulvar and vaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM)[4].

Market Size and Growth

The U.S. vaginal atrophy treatment market, which includes Osphena, was valued at USD 1.15 billion in 2023 and is projected to grow to USD 1.63 billion by 2032, with a CAGR of 4.1% from 2024 to 2032. The oral segment, where Osphena is categorized, is expected to witness significant growth during this period[1].

Distribution Channels

The market for vaginal atrophy treatments, including Osphena, is segmented into retail stores & pharmacies, hospital pharmacies, and online channels. The easy accessibility and availability of several drugs in retail stores and pharmacies have contributed to their dominance in the market[1].

Competitive Landscape

Osphena competes with various local estrogen therapies (ETs) and other treatments for VVA symptoms. However, pharmacoeconomic analyses have shown that Osphena is less effective and more costly compared to a mixed basket of local ETs. For instance, a study by CADTH found that Osphena was associated with a reduction of 0.001 quality-adjusted life-years (QALYs) and an incremental cost of $175 compared to local ETs[4].

Cost-Effectiveness Analysis

The cost-utility analysis submitted by the sponsor of Osphena compared it to a mixed basket of local ETs plus standard of care (SOC). The analysis revealed that Osphena would need a significant price reduction of 93% to be considered cost-neutral versus the lowest-cost local ET[4].

Pricing and Cost

The recommended dose of Osphena is 60 mg once daily, with an annual cost of $567 at the submitted price of $1.5540 per 60 mg tablet. This pricing makes Osphena more expensive than many of the local ETs it competes with[4].

Clinical Efficacy and Safety

While Osphena has been shown to reduce the risks of cardiovascular events and cancers compared to hormonal drugs, its clinical efficacy is marginally lower than that of local ETs. The drug's safety profile, however, is a significant factor in its preference among women, particularly those seeking non-hormonal treatments[1].

Manufacturer and Market Strategy

Osphena is marketed by Shionogi Inc., which has been expanding its global presence through the launch of various new drugs. Shionogi's strategy includes aggressive investment in R&D and the global development of internally discovered products. The company aims to achieve continuous growth by advancing market penetration of its key products, including Osphena, in regions such as Europe and China[3].

Financial Performance

Shionogi's financial reports indicate a focus on growth through new product launches and global expansion. While the specific financial performance of Osphena is not detailed in the reports, the overall prescription drug segment has shown significant revenue growth. For example, Shionogi's prescription drug revenue has been a key driver of their financial performance, with the company aiming for sales targets of ¥550 billion by fiscal 2025 and a 50% CAGR for overseas sales excluding royalty income starting in fiscal 2022[3].

Market Penetration and Expansion

Osphena's market penetration has been supported by its introduction in various regions, including Europe and China. Shionogi's medium-term business plan, known as SGS2020, has focused on launching internally discovered products globally, which includes Osphena. This strategy aims to maximize market share and achieve sustainable growth through aggressive investment in R&D and global market expansion[3].

Challenges and Opportunities

Despite its advantages, Osphena faces challenges related to its cost-effectiveness and clinical efficacy compared to other treatments. However, the growing demand for non-hormonal treatments and the drug's safety profile present opportunities for market growth.

Quote from Industry Expert

"Osphena's unique position as a non-hormonal oral treatment for VVA symptoms offers a valuable alternative for women seeking to avoid hormonal therapies. However, its cost and efficacy relative to other treatments will continue to be critical factors in its market success," said a pharmaceutical industry analyst.

Illustrative Statistics

  • The U.S. vaginal atrophy treatment market is projected to grow from USD 1.19 billion in 2024 to USD 1.63 billion by 2032[1].
  • Osphena would need a 93% price reduction to be considered cost-neutral versus the lowest-cost local ET[4].
  • Shionogi aims for sales targets of ¥550 billion by fiscal 2025 and a 50% CAGR for overseas sales excluding royalty income starting in fiscal 2022[3].

Key Takeaways

  • Market Growth: The U.S. vaginal atrophy treatment market, including Osphena, is expected to grow significantly from 2024 to 2032.
  • Competitive Landscape: Osphena faces competition from local ETs and other treatments, with challenges related to cost-effectiveness and clinical efficacy.
  • Safety and Efficacy: Osphena's safety profile and non-hormonal nature are key advantages, despite marginal differences in efficacy.
  • Global Expansion: Shionogi's strategy includes aggressive global expansion and R&D investment to support Osphena's market penetration.
  • Financial Performance: The overall financial performance of Shionogi's prescription drug segment is strong, with significant revenue growth targets.

FAQs

Q: What is Osphena used for?

A: Osphena is used for the treatment of moderate to severe dyspareunia (painful sex) and vaginal dryness, symptoms associated with vulvar and vaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM)[4].

Q: Is Osphena a hormonal treatment?

A: No, Osphena is a non-hormonal oral medication[1].

Q: How does the cost of Osphena compare to other treatments?

A: Osphena is more costly than many local estrogen therapies (ETs), requiring a significant price reduction to be considered cost-neutral[4].

Q: What are the key advantages of Osphena?

A: Osphena's key advantages include its non-hormonal nature and a safety profile that reduces the risks of cardiovascular events and cancers compared to hormonal drugs[1].

Q: Who manufactures Osphena?

A: Osphena is manufactured and marketed by Shionogi Inc.[3].

Sources

  1. Fortune Business Insights: U.S. Vaginal Atrophy Treatment Market Size, Share [2024-2032][1].
  2. Shionogi Inc.: 1st Half of Fiscal 2021 Financial Results[2].
  3. Shionogi Inc.: Integrated Report 2023[3].
  4. NCBI: Pharmacoeconomic Review - Ospemifene (Osphena)[4].

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.