MILPROSA Drug Patent Profile

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

Milprosa is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-three patent family members in twenty-five countries.

The generic ingredient in MILPROSA is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the progesterone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Milprosa

A generic version of MILPROSA was approved as progesterone by FRESENIUS KABI USA on April 25^th, 2001.

Summary for MILPROSA

International Patents:	53
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,632
DailyMed Link:	MILPROSA at DailyMed

US Patents and Regulatory Information for MILPROSA

MILPROSA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		DISCN	Yes	No	10,548,904
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		DISCN	Yes	No	8,580,293
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		DISCN	Yes	No	10,537,584		Y

International Patents for MILPROSA

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

Country	Patent Number	Title	Estimated Expiration
China	102098991	Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof
New Zealand	596844	Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof
Eurasian Patent Organization	031017	СПОСОБ ПОДДЕРЖАНИЯ ИЛИ ЗАМЕЩЕНИЯ ФАЗЫ ЖЁЛТОГО ТЕЛА (METHOD FOR SUPPORT OR SUBSTITUTION OF YELLOW BODY PHASE)
Canada	2713943	ANNEAUX INTRAVAGINAUX MONOLITHIQUES COMPRENANT DE LA PROGESTERONE ; PROCEDES DE FABRICATION ET UTILISATIONS (MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF)
Spain	2648640

Supplementary Protection Certificates for MILPROSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
2782584	LUC00245	Luxembourg		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406

MILPROSA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for MILPROSA

Introduction to MILPROSA

MILPROSA, a once-weekly progesterone vaginal ring, has been approved by the FDA for the luteal phase support of female infertility in women undergoing assisted reproductive technology (ART) treatment cycles. This innovative product addresses a significant unmet need in the female infertility sector by offering a more convenient and patient-friendly method of progesterone administration.

Market Need and Unmet Demand

The female infertility sector, particularly those undergoing ART cycles, has long faced challenges with traditional progesterone administration methods. Intramuscular (IM) progesterone injections, though widely used, are associated with significant pain and discomfort, while vaginal gels and inserts have their own set of drawbacks. MILPROSA fills this gap by providing a once-weekly dosing regimen, which is more convenient and potentially less intrusive for patients[1][3].

Clinical Efficacy and Safety

Clinical trials, including a Phase III study published in Fertility and Sterility, have demonstrated that MILPROSA is as effective as daily 8% progesterone vaginal gel in supporting embryo implantation and early pregnancy. The study involved 1,297 patients and showed comparable clinical pregnancy rates between the MILPROSA group and the vaginal gel group. The adverse event profiles were also similar, aligning with known side effects associated with progesterone[3].

Regulatory Approval and Recommendations

MILPROSA received FDA approval in 2020 for women up to and including 34 years of age. The labeling includes a limitation of use, noting that efficacy in women 35 years of age and older has not been established. The FDA approval highlights the drug's benefit-risk profile, which is anticipated to be favorable for the intended population[2].

Market Potential and Sales Projections

The market for progesterone options used in ART cycles is significant and growing. In 2019, US sales of these products were estimated at $78 million. By 2028, sales are projected to exceed $100 million, with MILPROSA expected to capture approximately one-third of these sales. This indicates a strong financial trajectory for the drug, driven by its convenience, efficacy, and the increasing demand for more patient-friendly progesterone administration methods[1].

Competitive Landscape

MILPROSA enters a market where traditional methods such as IM injections and vaginal gels are dominant. However, its once-weekly dosing regimen and ease of use are expected to make it a preferred option for many patients and healthcare providers. Key opinion leaders (KOLs) have expressed confidence that increased physician familiarity and confidence in MILPROSA will drive its adoption and market share[1].

Financial Implications for Ferring Pharmaceuticals

The acquisition of global rights to MILPROSA by Ferring Pharmaceuticals in 2015 marked a strategic move into the fertility sector. With the FDA approval and positive clinical data, Ferring is well-positioned to capitalize on the growing demand for innovative fertility treatments. The projected sales figures indicate a substantial revenue stream for Ferring, contributing to the company's financial growth and stability[5].

Patient and Physician Adoption

The convenience and efficacy of MILPROSA are expected to drive patient and physician adoption. Patients will benefit from reduced discomfort and easier administration, while physicians will appreciate the comparable pregnancy rates and safety profile. As more data becomes available and physician confidence grows, MILPROSA is likely to become a standard option in ART treatment protocols[1][3].

Potential Challenges and Limitations

While MILPROSA offers several advantages, there are some limitations and potential challenges. The drug is not recommended for women over 34 years of age due to lack of efficacy data in this age group. Additionally, there are common side effects associated with progesterone, such as bloating, abdominal pain, and vaginal discharge, which need to be managed. Long-term safety data are also limited, which may influence long-term prescribing patterns[2].

Future Outlook and Expansion

The success of MILPROSA could pave the way for further innovation in fertility treatments. Ferring Pharmaceuticals and other companies may invest in additional research and development to address other unmet needs in the fertility sector. The growing demand for biologics and innovative therapeutics, especially in emerging markets, could also present opportunities for expansion and collaboration[4].

Key Takeaways

• Market Need: MILPROSA addresses the need for a more convenient and patient-friendly progesterone administration method in ART cycles.
• Clinical Efficacy: Comparable pregnancy rates to daily vaginal gels and a favorable safety profile.
• Regulatory Approval: FDA-approved for women up to 34 years of age.
• Market Potential: Projected to capture a significant share of the growing $100 million market by 2028.
• Financial Trajectory: Expected to contribute substantially to Ferring Pharmaceuticals' revenue.
• Patient and Physician Adoption: Convenience and efficacy are likely to drive adoption.

FAQs

1. What is MILPROSA used for?

   • MILPROSA is used for the luteal phase support of female infertility in women undergoing assisted reproductive technology (ART) treatment cycles.

2. How is MILPROSA administered?

   • MILPROSA is administered as a once-weekly progesterone vaginal ring.

3. What are the common side effects of MILPROSA?

   • Common side effects include bloating, abdominal pain, headache, dizziness, nausea, and vaginal discharge.

4. Is MILPROSA approved for all age groups?

   • No, MILPROSA is approved for women up to and including 34 years of age. Efficacy in women 35 years of age and older has not been established.

5. What is the projected market share of MILPROSA by 2028?

   • MILPROSA is expected to capture approximately one-third of the projected $100 million market for progesterone options used in ART cycles by 2028.

Sources

1. Pharmaceutical Technology: "Ferring's Milprosa approval to address support female infertility sector"
2. FDA: "201110Orig1s000 - accessdata.fda.gov"
3. Teva Pharmaceutical Industries Ltd.: "Phase III Study of Teva's Milprosa™ (Progesterone) Vaginal Ring Published in Fertility and Sterility"
4. CPhI: "Biologics CDMO Trends and Opportunities in China"
5. BioSpace: "Ferring Pharmaceuticals Acquires Global Rights To MILPROSA Progesterone Vaginal Ring"