CRINONE Drug Patent Profile

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

Crinone is a drug marketed by Allergan and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Crinone

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

Summary for CRINONE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	23
Patent Applications:	4,145
Drug Prices:	Drug price information for CRINONE
What excipients (inactive ingredients) are in CRINONE?	CRINONE excipients list
DailyMed Link:	CRINONE at DailyMed

See drug prices for CRINONE

Recent Clinical Trials for CRINONE

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

Sponsor	Phase
IBSA Institut Biochimique SA	Phase 3
Merck Serono Co., Ltd., Beijing, China	Phase 4
Merck Serono Co., Ltd.	Phase 4

See all CRINONE clinical trials

Pharmacology for CRINONE

Drug Class

Progesterone

US Patents and Regulatory Information for CRINONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997		RX	Yes	Yes
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997		RX	Yes	Yes

Expired US Patents for CRINONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997

International Patents for CRINONE

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	121497	Use of a bioadhesive
Australia	565354
Australia	7726194
European Patent Office	0501523	Compositions bioadhésives (Bioadhesive compositions)

Supplementary Protection Certificates for CRINONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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
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

CRINONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CRINONE

Introduction to CRINONE

CRINONE is a progesterone gel product developed by Juniper Pharmaceuticals, Inc., which is widely used in women's health, particularly for infertility treatments and hormone replacement therapy (HRT). Here, we will delve into the market dynamics and financial trajectory of CRINONE.

Market Position and Growth

CRINONE has been a significant contributor to Juniper Pharmaceuticals' revenue. The product has seen substantial growth over the years, driven by its efficacy and the increasing demand for infertility and HRT treatments.

• Revenue Growth: In 2017, CRINONE revenues increased by 20% year-over-year, contributing to Juniper Pharmaceuticals' strong financial performance. This growth trend continued, with the company reporting combined revenues of $25.2 million for CRINONE and Juniper Pharma Services (JPS) through the first six months of 2017[3].

Strategic Partnerships and Expansion

The success of CRINONE is also attributed to strategic partnerships, particularly with Merck KGaA.

• Merck KGaA Partnership: Juniper Pharmaceuticals has a supply agreement with Merck KGaA, which has been extended to support growth in existing markets and launches in key markets, including Japan. This partnership has been instrumental in driving the growth of CRINONE[3].

Supply Chain and Production

To meet the growing demand for CRINONE, Juniper Pharmaceuticals has focused on increasing its supply chain capacity.

• Production Increase: The company has doubled the production of CRINONE for Merck KGaA over the past four years, ensuring they are well-positioned to meet the increasing demand for this product[3].

Financial Performance

The financial performance of CRINONE is closely tied to the overall financial health of Juniper Pharmaceuticals.

• Revenue Contribution: CRINONE has been a major revenue contributor, helping Juniper Pharmaceuticals achieve cash flow positivity. In 2017, the company ended the year with a cash balance of $21.5 million and anticipated continuing this trend in 2018[3].

• Gross Profit and Operating Expenses: While gross profit from CRINONE and other products has been significant, operating expenses, including research and development, sales and marketing, and general and administrative costs, have also been substantial. However, the company has managed to maintain a strong financial position through cost-saving initiatives and strategic reprioritization[2].

Market Trends and Drivers

Several market trends and drivers have influenced the growth of CRINONE.

• Increasing Demand for Infertility Treatments: The global infertility drugs market, which includes products like CRINONE, is expected to grow at a CAGR of 6.1% from 2023 to 2030. This growth is driven by the increasing prevalence of infertility and the high efficacy of drugs like gonadotropins and progesterone-based treatments[1].

• Natural Progesterone Segment Growth: Natural progesterone, which includes products like CRINONE, is expected to witness lucrative growth due to its high prescription rates and the preference for natural over synthetic progesterone[4].

Regional Market Dynamics

The market dynamics for CRINONE vary by region, with North America being a significant market.

• North America Dominance: North America is expected to hold a significant share of the progesterone market, driven by the increasing adaptability of advanced treatments, collaborative efforts among market players, and a high disease burden in the region. The rise in uterine body cancers and breast cancer cases also contributes to the demand for progesterone-based treatments[4].

Competitive Landscape

The competitive landscape for CRINONE involves other players in the infertility and HRT markets.

• Other Progesterone Products: Products like Prometrium also compete in the same market segment as CRINONE. However, CRINONE's strong partnership with Merck KGaA and its established market presence give it a competitive edge[4].

Future Outlook

The future outlook for CRINONE remains positive, driven by ongoing market trends and strategic initiatives.

• Continued Growth: With the extension of the supply agreement with Merck KGaA and the focus on increasing supply chain capacity, CRINONE is expected to continue its growth trajectory. The company's strategic reprioritization to focus on core businesses like CRINONE and JPS is also expected to drive additional growth[3].

Key Takeaways

• Strong Revenue Growth: CRINONE has demonstrated strong revenue growth, contributing significantly to Juniper Pharmaceuticals' financial performance.
• Strategic Partnerships: The partnership with Merck KGaA has been crucial in driving the growth of CRINONE.
• Increasing Demand: The increasing demand for infertility and HRT treatments, particularly for natural progesterone, supports the growth of CRINONE.
• Regional Dominance: North America is a key market for CRINONE, driven by advanced treatment adaptability and a high disease burden.
• Competitive Edge: CRINONE's competitive edge is maintained through its strong market presence and strategic partnerships.

FAQs

1. What is CRINONE used for? CRINONE is a progesterone gel used primarily for infertility treatments and hormone replacement therapy (HRT).

2. Who is the primary partner for CRINONE? The primary partner for CRINONE is Merck KGaA, with whom Juniper Pharmaceuticals has a supply agreement.

3. How has CRINONE contributed to Juniper Pharmaceuticals' revenue? CRINONE has been a significant revenue contributor, helping Juniper Pharmaceuticals achieve strong financial performance and cash flow positivity.

4. What market trends support the growth of CRINONE? The increasing demand for infertility treatments, the preference for natural progesterone, and the high disease burden in regions like North America support the growth of CRINONE.

5. What are the future prospects for CRINONE? The future outlook for CRINONE is positive, driven by the extension of the supply agreement with Merck KGaA, increased supply chain capacity, and the focus on core businesses.

Cited Sources

1. Grand View Research - Infertility Drugs Market Size, Share & Growth Report, 2030
2. PR Newswire - Juniper Pharmaceuticals Reports Full-Year 2017 Financial and Operating Results
3. PR Newswire - Juniper Pharmaceuticals Announces Strategic Reprioritization
4. Mordor Intelligence - Progesterone Market Trends