BIMATOPROST - Generic Drug Details

What are the generic sources for bimatoprost and what is the scope of freedom to operate?

Bimatoprost is the generic ingredient in four branded drugs marketed by Abbvie, Alembic, Apotex, Eugia Pharma, Gland Pharma Ltd, Hikma, Lupin Ltd, Micro Labs, Sandoz, and Somerset Theraps Llc, and is included in seventeen NDAs. There are twenty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bimatoprost has two hundred and twenty-eight patent family members in thirty-five countries.

There are twelve drug master file entries for bimatoprost. Eleven suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for BIMATOPROST

International Patents:	228
US Patents:	22
Tradenames:	4
Applicants:	10
NDAs:	17
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	130
Patent Applications:	6,684
Drug Prices:	Drug price trends for BIMATOPROST
Drug Sales Revenues:	Drug sales revenues for BIMATOPROST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BIMATOPROST
What excipients (inactive ingredients) are in BIMATOPROST?	BIMATOPROST excipients list
DailyMed Link:	BIMATOPROST at DailyMed

See drug prices for BIMATOPROST

See drug sales revenues for BIMATOPROST

Recent Clinical Trials for BIMATOPROST

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

Sponsor	Phase
SpyGlass Pharma, Inc.	Phase 1/Phase 2
Latham Fund	Phase 2
Medstar Health Research Institute	Phase 2

See all BIMATOPROST clinical trials

Generic filers with tentative approvals for BIMATOPROST

Applicant	Application No.	Strength	Dosage Form
		0.03	SOLUTION; OPHTHALMIC
		0.01%	SOLUTION; OPHTHALMIC
		0.01%	SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BIMATOPROST

Drug Class

Prostaglandin Analog

Medical Subject Heading (MeSH) Categories for BIMATOPROST

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for BIMATOPROST

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for BIMATOPROST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUMIGAN	Ophthalmic Solution	bimatoprost	0.01%	022184	1	2011-04-05
LATISSE	Topical Solution	bimatoprost	0.03%	022369	1	2010-05-03
LUMIGAN	Ophthalmic Solution	bimatoprost	0.03%	021275	1	2008-12-22

US Patents and Regulatory Information for BIMATOPROST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	203991-001	Feb 20, 2015	AT	RX	No	No
Hikma	BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	203299-001	Nov 8, 2018		DISCN	No	No
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes	10,398,707

Expired US Patents for BIMATOPROST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	021275-001	Mar 16, 2001	6,403,649
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	8,986,715
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	8,906,962

EU/EMA Drug Approvals for BIMATOPROST

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Lumigan	bimatoprost	EMEA/H/C/000391 Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).,	Authorised	no	no	no	2002-03-08

International Patents for BIMATOPROST

Country	Patent Number	Title	Estimated Expiration
Australia	2010321831	7-[3,5-dihydroxy-2- (3-hydroxy-5-phenyl-pent-1-enyl)- cyclopentyl]-N-ethyl-hept-5-enamide (bimatoprost) in crystalline form II, methods for preparation, and methods for use thereof
Brazil	112012012387	7-[3,5-di-hidroxi-5-fenil-pent-1-enil)-ciclopentil]-n-etil-hept-5-enamida (bimatoprost) na forma cristalina ii, métodos para a preparação e métodos de utilização da mesma
Slovenia	3351239

Supplementary Protection Certificates for BIMATOPROST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0660716	SPC/GB02/035	United Kingdom		PRODUCT NAME: BIMATOPROST; REGISTERED: UK EU/1/02/205/001 20020308
0660716	02C0033	France		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:
0660716	C300099	Netherlands		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION: EU/1/02/205/001 20020308

BIMATOPROST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bimatoprost

Introduction to Bimatoprost

Bimatoprost is a prostaglandin analog used primarily in the treatment of glaucoma and ocular hypertension, as well as for promoting eyelash growth. Its market dynamics are influenced by a variety of factors, including increasing prevalence of eye conditions, technological advancements, and competitive market pressures.

Market Size and Forecast

The bimatoprost eye drop market was valued at USD 16,390.7 million in 2023 and is projected to reach USD 22,067.9 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.8% during the forecast period of 2024-2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Glaucoma

Glaucoma, a chronic eye condition characterized by increased intraocular pressure, is a major driver for the demand of bimatoprost. The rising incidence of glaucoma, particularly among aging populations, fuels the need for effective treatments like bimatoprost[1].

Rising Awareness and Diagnosis

Greater awareness of eye health and advancements in diagnostic techniques lead to earlier detection and treatment of conditions that bimatoprost addresses. This increased awareness and improved diagnostic capabilities contribute significantly to market growth[1].

Aging Population

The global population's aging trend increases the incidence of age-related eye conditions like glaucoma, thereby boosting the demand for bimatoprost[1].

Technological Advancements

Innovations in drug formulations and delivery methods enhance the efficacy and convenience of bimatoprost. For instance, the development of Bimatoprost SR, a sustained-release implant, offers a drop-free therapy option that can lower intraocular pressure for at least 4 months, freeing patients from daily eye drop regimens[5].

Growing Medical Tourism

Patients traveling abroad for advanced medical treatments can contribute to increased demand for specialized medications like bimatoprost, particularly in regions with well-developed healthcare infrastructure[1].

Expanding Pharmaceutical Market

The growing pharmaceutical sector and increased availability of bimatoprost in various markets contribute to its broader adoption. Major players such as Cayman Pharma, Tecoland Corporation, and others play a significant role in this expansion[4].

Market Segmentation

By Application

The bimatoprost eye drop market is primarily segmented into two main applications: glaucoma and hypotrichosis. Glaucoma treatment is the dominant segment due to the high prevalence of the condition and the effectiveness of bimatoprost in lowering intraocular pressure. The hypotrichosis segment, which involves the cosmetic use of bimatoprost for promoting eyelash growth, also contributes to market growth[1].

By Geography

The market is segmented geographically into North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. North America, particularly the United States, is a significant market driven by a high incidence of glaucoma and advanced healthcare systems. Europe follows closely, while the Asia-Pacific region is rapidly emerging due to rising healthcare expenditure and increasing prevalence of eye disorders[1].

Financial Trajectory

Cost-Effectiveness

Studies have shown that bimatoprost is a cost-effective treatment option compared to other prostaglandin analogs like latanoprost. For instance, a cost-effectiveness analysis found that bimatoprost resulted in a lower cost per treatment success, averaging USD 568 less than latanoprost per success[3].

Revenue Forecast

The global Latisse (bimatoprost) market is anticipated to grow significantly, with North America being the largest market, holding about 90% of the share. The market is expected to witness substantial growth driven by increasing demand and the introduction of new formulations like Bimatoprost SR[4].

Challenges and Limitations

Side Effects and Safety Concerns

Bimatoprost eye drops can cause side effects such as eye redness, itching, and darkening of the iris. These safety concerns may limit market growth as patients and healthcare providers weigh the benefits against potential adverse effects[1].

High Cost

The cost of bimatoprost eye drops can be relatively high compared to other treatments, which might restrict their accessibility and adoption, especially in price-sensitive markets[1].

Regulatory Challenges

Stringent regulatory requirements and lengthy approval processes can hinder the introduction of new formulations or brands into the market, affecting market dynamics and growth[1].

Availability of Alternatives

The presence of alternative treatments for conditions like glaucoma and eyelash growth can impact the demand for bimatoprost. Other prostaglandin analogs and surgical options are among the alternatives that patients and healthcare providers consider[1].

Market Competition

Intense competition from generic versions of bimatoprost and other pharmaceutical companies can affect market share and pricing strategies. The global top three players in the Latisse (bimatoprost) market hold about 40% of the market share, indicating a competitive landscape[4].

Clinical Research and Development

Ongoing research and development activities are crucial for the market's future. The introduction of new formulations, such as Bimatoprost SR, and potential expanded indications for bimatoprost can significantly influence market dynamics. Positive results from clinical trials, such as the Phase 3 study on Bimatoprost SR, highlight the sustained and predictable benefits of this new approach in treating glaucoma[5].

Insurance Coverage and Accessibility

Improved insurance coverage and reimbursement policies for eye care treatments can enhance the accessibility and affordability of bimatoprost, thereby driving market growth. However, variations in insurance coverage across different regions can impact market dynamics[1].

Key Takeaways

• The bimatoprost eye drop market is expected to grow significantly, driven by increasing prevalence of glaucoma and other ocular conditions.
• Technological advancements, such as the development of Bimatoprost SR, are enhancing the efficacy and convenience of the treatment.
• Cost-effectiveness studies indicate that bimatoprost is a more economical option compared to other prostaglandin analogs.
• Market growth is also influenced by factors such as aging population, growing medical tourism, and expanding pharmaceutical market.
• However, the market faces challenges including side effects, high cost, regulatory hurdles, and competition from alternative treatments.

FAQs

Q: What is the projected market size of bimatoprost eye drops by 2031?

A: The bimatoprost eye drop market is projected to reach USD 22,067.9 million by 2031[1].

Q: What are the primary applications of bimatoprost?

A: The primary applications of bimatoprost are in the treatment of glaucoma and hypotrichosis (promoting eyelash growth)[1].

Q: How does Bimatoprost SR differ from traditional bimatoprost eye drops?

A: Bimatoprost SR is a sustained-release implant designed to lower intraocular pressure for at least 4 months, freeing patients from daily eye drop regimens[5].

Q: Which region holds the largest market share for bimatoprost?

A: North America, particularly the United States, holds the largest market share for bimatoprost[4].

Q: What are some of the challenges facing the bimatoprost market?

A: Challenges include side effects, high cost, regulatory hurdles, availability of alternatives, and market competition[1].

Sources

1. Verified Market Research: Bimatoprost Eye Drop Market Size, Share, Trends & Forecast[1].
2. PubMed: The cost-effectiveness of bimatoprost 0.03% in the treatment of glaucoma[2].
3. PubMed: Estimated comparative costs of achieving a 20% reduction in intraocular pressure[3].
4. Valuates Reports: Global Latisse (Bimatoprost) Market Research Report 2024[4].
5. Abbvie News: Allergan Announces Positive 3-Month Topline Results from Second Phase 3 Study of Bimatoprost SR[5].