Progesterone - Generic Drug Details

What are the generic drug sources for progesterone and what is the scope of patent protection?

Progesterone is the generic ingredient in six branded drugs marketed by Amneal Pharms Ny, Bionpharma, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Virtus, Allergan, Accord Hlthcare, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, Alza, Ferring, and Ferring Pharms Inc, and is included in twenty NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are fifty-seven drug master file entries for progesterone. Twenty-five suppliers are listed for this compound.

Summary for progesterone

International Patents:	53
US Patents:	3
Tradenames:	6
Applicants:	18
NDAs:	20
Drug Master File Entries:	57
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	1,134
Drug Prices:	Drug price trends for progesterone
Drug Sales Revenues:	Drug sales revenues for progesterone
What excipients (inactive ingredients) are in progesterone?	progesterone excipients list
DailyMed Link:	progesterone at DailyMed

See drug prices for progesterone

See drug sales revenues for progesterone

Recent Clinical Trials for progesterone

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

Sponsor	Phase
Instituto Valenciano de Infertilidad, IVI VALENCIA	N/A
Ohio State University	Phase 3
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 3

See all progesterone clinical trials

Pharmacology for progesterone

Drug Class

Progesterone

Medical Subject Heading (MeSH) Categories for progesterone

Progestins

Anatomical Therapeutic Chemical (ATC) Classes for progesterone

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for progesterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Virtus	PROMETRIUM	progesterone	CAPSULE;ORAL	019781-001	May 14, 1998	AB	RX	Yes	No
Xiromed	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-002	Oct 20, 2017	AB	RX	No	No
Bionpharma	PROGESTERONE	progesterone	CAPSULE;ORAL	200900-002	Aug 16, 2013	AB	RX	No	No
Actavis Labs Ut Inc	PROGESTERONE	progesterone	INJECTABLE;INJECTION	017362-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Xiromed	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-001	Oct 20, 2017	AB	RX	No	No
Lilly	PROGESTERONE	progesterone	INJECTABLE;INJECTION	009238-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997		RX	Yes	Yes

Expired US Patents for progesterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007
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 progesterone

Country	Patent Number	Title	Estimated Expiration
Denmark	2249757
Brazil	PI0905946	"método para o tratamento de um defeito de fase luteal em uma paciente com necessidade do mesmo, anel intravaginal monolítico e processo para a produção de um anel intravaginal monolítico"
European Patent Office	2249757	ANNEAUX INTRAVAGINAUX MONOLITHIQUES COMPRENANT DE LA PROGESTÉRONE ; PROCÉDÉS DE FABRICATION ET UTILISATIONS (MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF)
China	104146948	Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof
Mexico	337634	ANILLOS INTRAVAGINALES MONOLITICOS QUE COMPRENDEN PROGESTERONA Y METODOS DE MANUFACTURA Y USO DE LOS MISMOS. (MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF.)
Spain	2645630
Taiwan	I655947

Supplementary Protection Certificates for progesterone

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
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--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 20210406
2782584	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
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

Progesterone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Progesterone

Market Size and Growth Projections

The progesterone market is poised for significant growth over the coming years. As of 2024, the market size is estimated to be around USD 1.74 billion, with projections indicating it will reach USD 2.67 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of 8.92% during this period[1][3][4].

Regional Market Performance

North America

North America is expected to dominate the progesterone market, driven by the increasing adaptability of advanced treatments among the population and the high disease burden in the region. The rise in cases of breast, uterine, and other cancers, along with the growing population of menopausal women, contributes to this dominance[1].

Asia Pacific

The Asia Pacific region is identified as the fastest-growing market for progesterone. This growth is fueled by increasing healthcare awareness, government initiatives to enhance maternal health, and the massive population in countries like China. The CAGR in this region is expected to be higher than in other regions, driven by urbanization and lifestyle changes that increase the prevalence of hormonal diseases[1][4].

United Kingdom and China

In the United Kingdom, the progesterone market is supported by strong healthcare facilities and a focus on women's health, leading to a CAGR of 13.70% from 2024 to 2034. Government schemes and favorable reimbursement programs further boost market growth[4].

In China, the market is expected to grow at a CAGR of 13.20% during the same period, driven by government-led initiatives for maternal health and the expanding healthcare infrastructure[4].

United States

The U.S. market is also experiencing significant growth, with a CAGR of 12.60% from 2024 to 2034. This is attributed to the increasing adoption of bioidentical hormone therapy and the expanding interest in organic alternatives. Strict regulatory rules ensure the safety of these therapies, sustaining consumer confidence[4].

Key Drivers of Market Growth

Increasing Prevalence of Breast Cancer

One of the primary drivers of the progesterone market is the increasing prevalence of breast cancer. According to the International Agency for Research on Cancer (IARC), about 2.2 million new cases of breast cancer were reported worldwide in 2020, and this number is expected to reach 3 million by 2040. This rise in breast cancer cases significantly increases the demand for progesterone, which is used in treating associated symptoms like breast tenderness[1][3].

Technological Advancements

Technological advancements in drug delivery systems and the development of new formulations are also driving market growth. For instance, the launch of new products like Utrozhestan (progesterone) by Besins Healthcare in Russia has contributed to the market's expansion[1].

Patient Awareness and Monitoring

Increasing patient awareness and the routine monitoring of progesterone formulations are additional factors fueling market growth. Patients are becoming more informed about the benefits and uses of progesterone, leading to higher demand for these treatments[1].

Product Segments

Natural vs. Synthetic Progesterone

The progesterone market is segmented into natural and synthetic progesterone. Natural progesterone, derived from sources like soybeans or the Mexican yam Dioscorea Villosa, is expected to witness significant growth. Drugs such as Crinone and Prometrium are major contributors to the revenue in this segment[1].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the progesterone market. Clinical trials, such as the one conducted at Cedars-Sinai Medical Center, showed that progesterone could improve clinical outcomes for certain hospitalized male patients with COVID-19. This increased the demand for progesterone, contributing to market growth during the pandemic[1].

Market Trends

Focus on Women's Health

There is a growing focus on women's health globally, which is driving the demand for progesterone. Government initiatives and progressive policy frameworks, especially in regions like the United Kingdom and China, are supporting this trend[4].

Bioidentical Hormone Therapy

The increasing adoption of bioidentical hormone therapy in regions like the United States is another significant trend. This shift towards organic and natural alternatives is boosting the demand for progesterone[4].

Challenges and Regulatory Environment

Stringent Regulations

Despite the growth drivers, the progesterone market faces challenges such as stringent regulations. These regulatory hurdles can impede market growth by ensuring strict safety standards and potentially slowing down the approval process for new products[3][4].

Carcinogenicity Concerns

There are also concerns regarding the carcinogenic potential of progesterone, particularly in relation to breast cancer. While the clinical relevance of these findings is still under investigation, they could impact consumer confidence and regulatory approvals[2].

Financial Outlook

The financial trajectory of the progesterone market is robust, with significant growth projected over the next decade. Here are some key financial highlights:

• Market Size in 2024: USD 1.74 billion[1]
• Projected Market Size in 2029: USD 2.67 billion[1]
• CAGR from 2024 to 2029: 8.92%[1]
• Projected Market Size in 2034: USD 4.80 billion[4]
• CAGR from 2024 to 2034: 12.30%[4]

Key Players

The progesterone market is competitive, with several key players driving innovation and growth. Some of the major companies operating in this market include Cadila Pharmaceuticals, Alkem Labs, Cipla Limited, Lupin Limited, and Glenmark Pharmaceuticals[1].

Conclusion

The progesterone market is poised for substantial growth, driven by increasing demand due to the rising prevalence of breast cancer, technological advancements, and growing patient awareness. While regulatory challenges and carcinogenicity concerns exist, the overall financial outlook is positive, with significant growth projected over the next decade.

Key Takeaways

• The progesterone market is expected to grow from USD 1.74 billion in 2024 to USD 2.67 billion by 2029.
• The Asia Pacific region is the fastest-growing market for progesterone.
• North America holds the largest market share due to high disease burden and advanced treatment adaptability.
• The increasing prevalence of breast cancer is a key driver of market growth.
• Natural progesterone is expected to witness lucrative growth due to its widespread use in drug therapies.
• Regulatory challenges and carcinogenicity concerns are potential impediments to market growth.

FAQs

What is the current size of the progesterone market?

The progesterone market size is estimated to be USD 1.74 billion in 2024[1].

Which region is expected to dominate the progesterone market?

North America is expected to hold the largest share of the progesterone market[1].

What is the fastest-growing region for the progesterone market?

The Asia Pacific region is estimated to grow at the highest CAGR over the forecast period[1].

What are the key drivers of the progesterone market growth?

The increasing prevalence of breast cancer, technological advancements in drug delivery systems, and growing patient awareness are key drivers of market growth[1][3].

Which segment of progesterone is expected to witness healthy growth?

The natural progesterone segment is expected to witness lucrative growth due to its widespread use in drug therapies[1].

Sources

1. Mordor Intelligence: Progesterone Market - Growth, Report, Applications & Manufacturers
2. DrugBank: Progesterone: Uses, Interactions, Mechanism of Action
3. Technavio: Progesterone Market Growth Analysis - Size and Forecast 2024-2028
4. Future Market Insights: Progesterone Market Size, Share, Trends & Forecast by 2034