DURYSTA Drug Patent Profile

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

Durysta is a drug marketed by Abbvie and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and seventy-seven patent family members in thirty-three countries.

The generic ingredient in DURYSTA is bimatoprost. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Durysta

A generic version of DURYSTA was approved as bimatoprost by APOTEX on December 1^st, 2014.

Summary for DURYSTA

International Patents:	177
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	4,681
Drug Prices:	Drug price information for DURYSTA
What excipients (inactive ingredients) are in DURYSTA?	DURYSTA excipients list
DailyMed Link:	DURYSTA at DailyMed

See drug prices for DURYSTA

Pharmacology for DURYSTA

Drug Class

Prostaglandin Analog

US Patents and Regulatory Information for DURYSTA

DURYSTA is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y

Expired US Patents for DURYSTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020

EU/EMA Drug Approvals for DURYSTA

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 DURYSTA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2007337139
Denmark	1944032
Israel	219959	7-[5,3-הידרוקסי-2-(3-הידרוקסי-5-פניל-פנט-1-איניל)-ציקלופניטל]-n-אתיל-הפט-5-אינאמיד (בימטופרוסט) בצורה גבישית ii ותכשירים רוקחיים המכילים אותו (7-[3,5-dihydroxy-2-(3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-n-ethyl-hept-5-enamide (bimatoprost) in crystalline form ii and pharmaceutical compositions comprising the same)
Japan	2014028822	OCULAR THERAPY USING SIRTUIN-ACTIVATING AGENT

Supplementary Protection Certificates for DURYSTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0660716	SPC/GB02/035	United Kingdom		PRODUCT NAME: BIMATOPROST; REGISTERED: UK EU/1/02/205/001 20020308

Market Dynamics and Financial Trajectory for DURYSTA

Introduction to DURYSTA

DURYSTA, developed by Allergan (now part of AbbVie), is a groundbreaking ophthalmic drug delivery system designed to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). It is the first FDA-approved intracameral, biodegradable sustained-release implant, marking a significant shift in the treatment paradigm for these conditions[4].

Mechanism and Indications

DURYSTA contains 10 mcg of bimatoprost, a synthetic prostamide and structural prostaglandin analogue, which is administered via a single-use applicator directly into the anterior chamber of the eye. This formulation provides continuous drug delivery, reducing the need for daily topical drops and improving patient compliance[4].

Market Need and Growth Potential

The ocular drug delivery market is experiencing robust growth, driven by the increasing prevalence of eye disorders and advancements in ocular drug delivery technologies. The market is projected to reach $27,016.20 million by 2028, growing at a CAGR of 7.4% from 2021 to 2028[3].

Competitive Landscape

DURYSTA enters a competitive market but offers a unique advantage with its sustained-release mechanism. Traditional treatments often involve topical drops, which can be cumbersome and lead to poor compliance. DURYSTA's innovative delivery system addresses these issues, providing a more convenient and effective treatment option for patients[4].

Clinical Efficacy and Safety

The FDA approval of DURYSTA was based on the results of two 20-month Phase 3 ARTEMIS studies, which involved 1,122 subjects. These studies demonstrated that DURYSTA reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator, twice-daily topical timolol drops[4].

Common Adverse Reactions

While DURYSTA has shown significant efficacy, it is not without side effects. The most common ocular adverse reaction reported was conjunctival hyperemia, affecting 27% of patients. Other common adverse reactions included foreign body sensation, eye pain, photophobia, and conjunctival hemorrhage[4].

Financial Impact and Revenue Potential

The launch of DURYSTA is expected to contribute significantly to AbbVie's revenue. Given the growing demand for innovative ocular treatments and the unique benefits of DURYSTA, the drug is poised to capture a substantial share of the ocular drug delivery market.

AbbVie's Financial Performance

AbbVie's financial reports indicate strong overall performance, despite fluctuations in specific quarters. For example, in 2021, AbbVie reported full-year net revenues of $56.197 billion, a 22.7% increase on a GAAP basis. While the 2023 financial results showed a decrease in net revenues to $54.318 billion, the company's diversified portfolio and ongoing innovations like DURYSTA are expected to drive future growth[2][5].

Net Present Value (NPV) Model

Evaluating the financial trajectory of DURYSTA involves complex NPV models that consider cash inflows and outflows, market dynamics, and the potential success rates at each stage of drug development. GlobalData's NPV models provide a detailed analysis of these factors, helping stakeholders understand the drug's value and potential return on investment[1].

Reimbursement and Patient Access

To facilitate patient access, Allergan has introduced the Allergan EyeCue® reimbursement service. This service helps eye care professionals with patient benefit verification, savings program enrollment, and prior authorization assistance, making DURYSTA more accessible to those who need it[4].

Future Development and Label Enhancements

Allergan is committed to further developing DURYSTA, with five ongoing Phase 3 studies aimed at supporting potential FDA label enhancements and approvals in other regions. This ongoing research underscores the company's dedication to improving treatment options for glaucoma and ocular hypertension patients[4].

Industry Expert Insights

"Today's FDA approval marks a breakthrough milestone for the glaucoma community and provides a much-needed option for patients challenged with topical drops or needing alternative options," said David Nicholson, Chief Research and Development Officer, Allergan. This sentiment highlights the significant impact DURYSTA is expected to have on patient care and treatment outcomes[4].

Illustrative Statistics

• Market Growth: The ocular drug delivery market is expected to grow at a CAGR of 7.4% from 2021 to 2028, reaching $27,016.20 million by 2028[3].
• Efficacy: DURYSTA reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period[4].
• Revenue: AbbVie's full-year net revenues were $56.197 billion in 2021, indicating a strong financial foundation for new product launches like DURYSTA[2].

Key Takeaways

• Innovative Delivery System: DURYSTA is the first FDA-approved intracameral, biodegradable sustained-release implant for reducing IOP.
• Market Growth Potential: The ocular drug delivery market is growing rapidly, driven by increasing prevalence of eye disorders and advancements in technology.
• Clinical Efficacy: DURYSTA has demonstrated significant efficacy in reducing IOP by approximately 30% from baseline.
• Financial Impact: DURYSTA is expected to contribute to AbbVie's revenue growth, supported by strong financial performance and a robust NPV model.
• Patient Access: Allergan's reimbursement services aim to make DURYSTA more accessible to patients.

FAQs

Q: What is DURYSTA used for? A: DURYSTA is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT)[4].

Q: How is DURYSTA administered? A: DURYSTA is administered via a single-use applicator directly into the anterior chamber of the eye, providing a sustained release of bimatoprost[4].

Q: What are the common side effects of DURYSTA? A: Common side effects include conjunctival hyperemia, foreign body sensation, eye pain, photophobia, and conjunctival hemorrhage[4].

Q: How does DURYSTA compare to traditional treatments? A: DURYSTA offers a more convenient and effective treatment option compared to traditional topical drops, improving patient compliance and reducing the burden of daily administration[4].

Q: What is the projected market size for ocular drug delivery by 2028? A: The ocular drug delivery market is projected to reach $27,016.20 million by 2028, growing at a CAGR of 7.4% from 2021 to 2028[3].

Cited Sources

1. GlobalData, "Net Present Value Model: Durysta - GlobalData"
2. AbbVie, "AbbVie Reports Full-Year and Fourth-Quarter 2021 Financial Results"
3. GlobeNewswire, "Ocular Drug Delivery Market Size to Outstrip $27,016.20Mn by 2028"
4. AbbVie, "Allergan Receives FDA Approval for DURYSTA™ (bimatoprost implant)"
5. AbbVie, "AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results"