LEUPROLIDE ACETATE - Generic Drug Details

What are the generic drug sources for leuprolide acetate and what is the scope of freedom to operate?

Leuprolide acetate is the generic ingredient in nine branded drugs marketed by Invagen Pharms, Ortho Mcneil Janssen, Abbvie Endocrine Inc, Tolmar, Amneal, Eugia Pharma, Genzyme, Meitheal, Rk Pharma, Sandoz, Sun Pharm, UBI, and Abbvie Endocrine, and is included in twenty-two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has sixty patent family members in thirty-six countries.

There are sixteen drug master file entries for leuprolide acetate. Fourteen suppliers are listed for this compound.

Summary for LEUPROLIDE ACETATE

International Patents:	60
US Patents:	4
Tradenames:	9
Applicants:	13
NDAs:	22
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	196
Patent Applications:	10,001
Drug Prices:	Drug price trends for LEUPROLIDE ACETATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEUPROLIDE ACETATE
What excipients (inactive ingredients) are in LEUPROLIDE ACETATE?	LEUPROLIDE ACETATE excipients list
DailyMed Link:	LEUPROLIDE ACETATE at DailyMed

See drug prices for LEUPROLIDE ACETATE

Recent Clinical Trials for LEUPROLIDE ACETATE

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

Sponsor	Phase
NRG Oncology	Phase 2
Johns Hopkins Bloomberg School of Public Health	Phase 2
Takeda	Phase 4

See all LEUPROLIDE ACETATE clinical trials

Pharmacology for LEUPROLIDE ACETATE

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for LEUPROLIDE ACETATE

Antineoplastic Agents, Hormonal

Fertility Agents, Female

US Patents and Regulatory Information for LEUPROLIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993		DISCN	Yes	No
Rk Pharma	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	213829-001	Aug 13, 2021	AP	RX	No	No
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020011-001	Oct 22, 1990		DISCN	Yes	No
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes	8,921,326		Y
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994		RX	Yes	Yes
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020		RX	Yes	Yes	11,771,841		Y	Y

Expired US Patents for LEUPROLIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995	4,849,228
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003	5,739,176
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-008	Aug 15, 2011	5,575,987
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994	5,716,640
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994	6,036,976
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-006	Jan 21, 1994	5,480,656

International Patents for LEUPROLIDE ACETATE

Country	Patent Number	Title	Estimated Expiration
South Korea	20090094272	SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME
Norway	20092662
South Korea	102742097
Israel	198845	תכשיר פפטיד לשחרור ממושך, תהליך להכנתו ושימוש בו להכנת תרופות (Sustained-release peptide composition, process for producing the same and use thereof in the preparation of medicaments)
Croatia	P20241446
Taiwan	I481424

Market Dynamics and Financial Trajectory for Leuprolide Acetate

Introduction to Leuprolide Acetate

Leuprolide acetate is a synthetic nonapeptide analog of the naturally occurring gonadotropin-releasing hormone (GnRH). It is widely used in the treatment of various conditions, including advanced prostate cancer, endometriosis, and precocious puberty. The market for leuprolide acetate is experiencing significant growth, driven by several key factors.

Market Size and Valuation

As of 2022, the leuprolide acetate market was valued at over USD 2 billion. This valuation is expected to grow substantially, with projections indicating a Compound Annual Growth Rate (CAGR) of around 6% between 2023 and 2032, reaching approximately USD 3.5 billion by 2032[1][4].

Growth Drivers

Increasing Incidence of Cancer

The rising global incidence of cancer, particularly prostate cancer, is a major driver of the leuprolide acetate market. Prostate cancer is the second-most common type of cancer among men, especially those over 50 years old. Leuprolide acetate is prescribed to lower testosterone levels, which helps slow down the growth of cancer cells. This hormonal therapy is often used in combination with radiation therapy, further boosting its demand[3][4].

Endometriosis and Other Conditions

In addition to cancer, the growing female population suffering from endometriosis is another significant factor. Endometriosis affects approximately 176 million women worldwide and 11% of American women between the ages of 15 to 44. Leuprolide acetate aids in complete preoperative pain relief for these patients, contributing to the market's growth[1].

Regulatory Approvals and R&D

Favorable regulatory landscapes, particularly in regions like North America, are supporting market growth. For instance, the U.S. FDA has approved several leuprolide acetate products, such as the leuprolide acetate injection kit by Eugia Pharma Specialty Limited in June 2022. Companies like Cipla Limited are also introducing new FDA-approved products, expanding their product portfolios and customer bases[1].

Distribution Channels

The leuprolide acetate market is segmented by distribution channels, including retail pharmacy, hospital pharmacy, and online pharmacy. The online pharmacy segment is expected to grow significantly, with a CAGR of more than 6% over the forecast period. This growth is attributed to the increasing patient inclination towards online shopping, especially post-COVID-19, and the wide reachability and inclusion of cutting-edge products on e-commerce platforms[1].

Regional Market Dynamics

North America

North America holds the largest share of the leuprolide acetate market, accounting for over 39% of the industry share in 2022. The region's growth is driven by rising cancer incidences and a favorable regulatory environment. Increased healthcare spending in the U.S., which rose by over 2% in 2021, also contributes to higher demand for leuprolide acetate[1][4].

Europe

Europe is the second-largest market for leuprolide acetate, driven by advancements in medical care and the development of more effective treatments for conditions like prostate cancer and fertility issues. The region's healthcare infrastructure and increasing adoption of leuprolide acetate are key factors in its market growth[4].

Challenges and Pitfalls

Drug Price Control Policies

Strict drug price-control policies are a significant challenge for the leuprolide acetate market. These policies can lower prescription prices but also reduce Research and Development (R&D) funding, impacting business growth. For example, drug price control schemes in the U.S. can lower prescription prices by 40 to 50%, resulting in a 30 to 60% reduction in R&D funding[1].

COVID-19 Impact

The COVID-19 pandemic had a mixed impact on the leuprolide acetate market. While it disrupted supply chains and R&D processes, it also increased the adoption of online pharmacies and remote healthcare services, which benefited the market in some aspects[1].

Product Forms and Administration

Leuprolide acetate is available in various forms, including depot suspensions for 1-month, 3-month, 4-month, and 6-month administrations. These products, such as LUPRON DEPOT, must be administered in a doctor’s office and are not suitable for patients with allergic reactions to similar drugs. The initial therapy can cause a temporary increase in testosterone levels and worsening symptoms of prostate cancer[2].

Financial Support and Savings Programs

To make leuprolide acetate more accessible, various savings and support programs are available. For example, the LUPRON DEPOT Savings Card can help eligible patients pay as little as $10 per month or $600 per quarter, depending on the treatment frequency and insurance plan[5].

Key Players and Strategic Moves

Major pharmaceutical companies, such as Cipla Limited and Aurobindo Pharma Ltd., are actively involved in the leuprolide acetate market. These companies are engaging in rigorous R&D programs and strategic collaborations to expand their product portfolios and customer bases. Such initiatives are expected to enhance the business scenario and drive market growth[1].

Future Outlook

The leuprolide acetate market is poised for significant growth, driven by the increasing incidence of cancer, advancements in medical care, and favorable regulatory environments. Despite challenges such as drug price control policies, the market is expected to reach USD 5.41 billion by 2037, with a CAGR of around 6.8% during the forecast period[4].

Key Takeaways

• The leuprolide acetate market was valued at over USD 2 billion in 2022 and is expected to grow at a CAGR of around 6% until 2032.
• Rising cancer incidences, particularly prostate cancer, and the growing prevalence of endometriosis are key drivers of market growth.
• North America and Europe are the largest markets, driven by favorable regulatory environments and advancements in medical care.
• Online pharmacies are expected to grow significantly due to increased patient inclination towards online shopping.
• Drug price control policies and the COVID-19 pandemic present challenges but also offer opportunities for market adaptation.

FAQs

What is leuprolide acetate used for?

Leuprolide acetate is used in the treatment of advanced prostate cancer, endometriosis, and precocious puberty. It works by lowering testosterone levels, which helps slow down the growth of cancer cells and alleviates symptoms of other conditions.

How is leuprolide acetate administered?

Leuprolide acetate is administered via depot suspension injections, available for 1-month, 3-month, 4-month, and 6-month durations. These injections must be given in a doctor’s office.

What are the potential side effects of leuprolide acetate?

Initial therapy with leuprolide acetate can cause a temporary increase in testosterone levels, leading to worsening symptoms of prostate cancer, such as urinary symptoms and bone pain. Patients may also experience allergic reactions.

How does the COVID-19 pandemic impact the leuprolide acetate market?

The COVID-19 pandemic disrupted supply chains and R&D processes but also increased the adoption of online pharmacies and remote healthcare services, which benefited the market in some aspects.

What savings programs are available for leuprolide acetate?

Savings programs like the LUPRON DEPOT Savings Card can help eligible patients pay as little as $10 per month or $600 per quarter, depending on the treatment frequency and insurance plan.

Sources

1. GMI Insights: Leuprolide Acetate Market Share | Forecasts Report, 2023-2032.
2. Lupron Prostate Cancer: LUPRON DEPOT for advanced prostate cancer.
3. BioSpace: Global Leuprolide Acetate Market Opportunities and Growth Analysis Report.
4. Research Nester: Leuprolide Acetate Market Size & Share | Forecast Report 2037.
5. Lupron Gyn: LUPRON DEPOT® Copay Savings Card.

Last updated: 2024-12-16