ALPHAGAN P Drug Patent Profile

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

Alphagan P is a drug marketed by Abbvie and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has thirty-eight patent family members in nineteen countries.

The generic ingredient in ALPHAGAN P is brimonidine tartrate. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alphagan P

A generic version of ALPHAGAN P was approved as brimonidine tartrate by BAUSCH AND LOMB on May 28^th, 2003.

Summary for ALPHAGAN P

International Patents:	38
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	25
Drug Prices:	Drug price information for ALPHAGAN P
Drug Sales Revenues:	Drug sales revenues for ALPHAGAN P
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALPHAGAN P
What excipients (inactive ingredients) are in ALPHAGAN P?	ALPHAGAN P excipients list
DailyMed Link:	ALPHAGAN P at DailyMed

See drug prices for ALPHAGAN P

See drug sales revenues for ALPHAGAN P

Recent Clinical Trials for ALPHAGAN P

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

Sponsor	Phase
University of Louisville	Phase 4
Wake Forest University Health Sciences	Phase 4
Uptown Eye Specialists	N/A

See all ALPHAGAN P clinical trials

Pharmacology for ALPHAGAN P

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Paragraph IV (Patent) Challenges for ALPHAGAN P

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.1%	021770	1	2006-12-20
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.15%	021262	1	2006-11-03

US Patents and Regulatory Information for ALPHAGAN P

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	AB	RX	Yes	Yes
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	AT	RX	Yes	Yes

Expired US Patents for ALPHAGAN P

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005

International Patents for ALPHAGAN P

See the table below for patents covering ALPHAGAN P around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2011042668	MEDICINAL COMPOSITION FOR TREATING RETINAL DISORDER
China	101683343
China	1205932
Mexico	PA02012206	COMPOSICIONES QUE CONTIENEN COMPONENTES TERAPEUTICAMENTE ACTIVOS QUE TIENEN SOLUBILIDAD MEJORADA. (COMPOSITIONS CONTAINING THERAPEUTICALLY ACTIVE COMPONENTS HAVING ENHANCED SOLUBILITY.)
European Patent Office	2153819	Utilisation d'un agent augmentant la solubilité dans une composition aqueuse comprenant tartrate de brimonidine (Use of a solubility enhancing component in an aqueous composition comprising brimonidine tartrate)

Supplementary Protection Certificates for ALPHAGAN P

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	C300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	2014C/042	Belgium		PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221

ALPHAGAN P Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alphagan P

Introduction to Alphagan P

Alphagan P, a brimonidine tartrate ophthalmic solution, is a crucial medication in the management of glaucoma and ocular hypertension. Developed by Allergan Inc., it has undergone significant formulation improvements to enhance efficacy and reduce side effects.

Mechanism of Action and Clinical Use

Alphagan P works as an alpha-adrenergic agonist, reducing intraocular pressure by decreasing the production of aqueous humor and increasing its drainage. This mechanism makes it effective for treating primary open-angle glaucoma and ocular hypertension[3].

Formulation Advancements

The newer formulation of Alphagan P, approved by the FDA in 2005, contains 0.1% brimonidine tartrate, a reduction from the original 0.2% concentration. This change was made to maintain efficacy while minimizing drug exposure and potential side effects. The new formulation also replaced the preservative benzalkonium chloride with Purite, a proprietary formulation of sodium perborate, which is less likely to cause ocular irritation[1][4].

Market Approval and Launch

Allergan received FDA approval for Alphagan P in 2005, with the goal of maximizing efficacy while reducing drug concentration. However, no specific market launch date was immediately set following the approval[1].

Financial Performance

Revenue Contribution

Alphagan P, along with other ophthalmic products like Combigan, contributed to Allergan's financial performance. In the fourth quarter of 2019, the net revenues from these products were $94.5 million, representing a 3.3% decrease from the prior year quarter. This decline is part of a broader financial context where Allergan reported full-year 2019 GAAP net revenues of $16.1 billion, a 1.9% increase from 2018[2].

Overall Financial Health of Allergan

In 2019, Allergan's financial health was marked by a 6.6% increase in fourth-quarter GAAP net revenues compared to the prior year, reaching $4.35 billion. However, the company also reported significant operating losses and expenses, including a 37.4% increase in selling, general, and administrative (SG&A) expenses and a 33.3% decrease in research and development (R&D) expenses[2].

Pricing and Affordability

The cost of Alphagan P can be significant, with an average retail price of $212.79 as of November 2024. However, patient assistance programs and advocacy groups like The Rx Advocates offer more affordable options, such as a fixed cost of $80 per month for Alphagan P alone or combined with other medications[3].

Market Dynamics and Competition

The ophthalmic market is competitive, with various products vying for market share. Alphagan P's unique formulation and reduced preservative content give it an edge over older formulations. However, other products like Lumigan (bimatoprost) also undergo formulation changes to improve efficacy and reduce side effects, indicating a dynamic market where innovation is key[4].

Patient Benefits and Adherence

The newer formulation of Alphagan P has been shown to reduce ocular allergic reactions and other adverse effects compared to its predecessor. This improvement enhances patient compliance and overall treatment outcomes. The use of Purite as a preservative further reduces the risk of ocular irritation, making the medication more tolerable for long-term use[4].

Secondary Uses and Versatility

Beyond its primary use in managing glaucoma and ocular hypertension, Alphagan P has shown efficacy in alleviating symptoms of dry eye syndrome. This versatility expands its therapeutic applications and makes it a valuable option for patients with multiple ocular health issues[3].

Adverse Effects and Interactions

While Alphagan P is generally well-tolerated, it can cause side effects such as ocular allergic reactions, although these are less frequent and severe compared to the older formulation. Healthcare providers must monitor patients for any adverse effects and adjust treatment plans accordingly[4].

Conclusion

Alphagan P is a significant player in the ophthalmic market, particularly for managing glaucoma and ocular hypertension. Its optimized formulation reduces drug exposure and side effects, making it a preferred choice for many patients. The financial performance of Alphagan P contributes to Allergan's overall revenue, although the market is competitive and dynamic. Patient assistance programs help make the medication more affordable, enhancing adherence and treatment outcomes.

Key Takeaways

• Optimized Formulation: Alphagan P's 0.1% brimonidine tartrate concentration reduces drug exposure without sacrificing efficacy.
• Preservative Change: The use of Purite instead of benzalkonium chloride reduces ocular irritation.
• Financial Contribution: Alphagan P contributes to Allergan's revenue, despite fluctuations in the market.
• Affordability: Patient assistance programs make Alphagan P more affordable for patients.
• Versatility: Alphagan P has secondary uses, including alleviating dry eye syndrome symptoms.

FAQs

1. What is Alphagan P used for? Alphagan P is used to lower intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

2. How does Alphagan P differ from its predecessor? Alphagan P contains 0.1% brimonidine tartrate, a reduction from the original 0.2% concentration, and uses Purite instead of benzalkonium chloride as a preservative.

3. What are the potential side effects of Alphagan P? Potential side effects include ocular allergic reactions, although these are less frequent and severe compared to the older formulation.

4. How much does Alphagan P cost? The average retail cost of Alphagan P is $212.79, but patient assistance programs can reduce the cost to around $80 per month.

5. Is Alphagan P used for any other conditions? Yes, Alphagan P has also shown efficacy in alleviating symptoms of dry eye syndrome.

Cited Sources:

1. Ophthalmology Times: "New brimonidine formula approved for market"
2. PR Newswire: "Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results"
3. The Rx Advocates: "Alphagan P Coupon & Assistance Programs"
4. Review of Optometry: "Could Less Be More?"