PENNSAID Drug Patent Profile

Which patents cover Pennsaid, and what generic alternatives are available?

Pennsaid is a drug marketed by Horizon and Nuvo Pharms Inc and is included in two NDAs. There are nineteen patents protecting this drug and two Paragraph IV challenges.

This drug has eighteen patent family members in fourteen countries.

The generic ingredient in PENNSAID is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-seven suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pennsaid

A generic version of PENNSAID was approved as diclofenac sodium by ACTAVIS ELIZABETH on March 26^th, 1996.

Summary for PENNSAID

International Patents:	18
US Patents:	19
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	6
Patent Applications:	4,203
Drug Prices:	Drug price information for PENNSAID
Drug Sales Revenues:	Drug sales revenues for PENNSAID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PENNSAID
What excipients (inactive ingredients) are in PENNSAID?	PENNSAID excipients list
DailyMed Link:	PENNSAID at DailyMed

See drug prices for PENNSAID

See drug sales revenues for PENNSAID

Recent Clinical Trials for PENNSAID

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

Sponsor	Phase
Nathan Wei, MD, FACP, FACR:	Phase 3
Medtronic - MITG	Phase 3
Arthritis Treatment Center, Maryland	Phase 3

See all PENNSAID clinical trials

Pharmacology for PENNSAID

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Paragraph IV (Patent) Challenges for PENNSAID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PENNSAID	Topical Solution	diclofenac sodium	2.0%	204623	1	2014-06-03
PENNSAID	Topical Solution	diclofenac sodium	1.5%	020947	1	2012-07-11

US Patents and Regulatory Information for PENNSAID

PENNSAID is protected by twenty-one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	8,741,956
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	8,871,809
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,339,551
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,132,110
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,375,412
Horizon	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	204623-001	Jan 16, 2014		DISCN	Yes	No	9,168,304		Y

International Patents for PENNSAID

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

Country	Patent Number	Title	Estimated Expiration
Australia	2007311019	Diclofenac gel
Canada	2666398	GEL DE DICLOFENAC (DICLOFENAC GEL)
China	104606126	DICLOFENAC GEL
Denmark	2086504
Hong Kong	1134024	DICLOFENAC GEL
Mexico	2009004038	GEL DE DICLOFENACO. (DICLOFENAC GEL.)

Market Dynamics and Financial Trajectory for PENNSAID

Introduction to PENNSAID

PENNSAID, a topical solution containing diclofenac sodium, is a non-steroidal anti-inflammatory drug (NSAID) used to treat the pain of osteoarthritis (OA) of the knee. It is available in two concentrations: 1.5% and 2%.

Market Context

The market for OA treatments is significant, driven by the prevalence of osteoarthritis among the aging population. Topical NSAIDs like PENNSAID offer an alternative to oral NSAIDs, which can have gastrointestinal side effects.

Acquisition and Ownership

In 2014, Horizon Pharma plc acquired the U.S. rights to PENNSAID 2% from Nuvo Research Inc. for $45 million in cash. This acquisition was part of Horizon's strategy to expand its primary care product portfolio and leverage its existing commercial infrastructure[1].

Product Differentiation

PENNSAID 2% is a second-generation version of the original 1.5% formulation, offering improved efficacy and patient tolerance. It is specifically designed for patients who cannot tolerate oral NSAIDs, providing a topical alternative that reduces systemic side effects[1].

Market Performance

• Sales and Revenue: Prior to the generic launch, PENNSAID 2% had estimated annual sales of $509 million in the U.S. as of October 2022, according to IQVIA data[4].
• Generic Competition: In December 2022, Lupin launched a generic version of PENNSAID in the U.S. market, which could impact the branded product's sales. However, the branded version may still maintain market share due to its established reputation and patient loyalty[4].

Financial Impact on Horizon Pharma

• Acquisition Costs: The $45 million cash payment for the U.S. rights to PENNSAID 2% was funded from Horizon's existing cash balances[1].
• Revenue Contribution: The addition of PENNSAID 2% was expected to be accretive to Horizon's net income in 2015. It diversified the company's revenue streams, adding a third NSAID product to its portfolio[1].
• Operational Expansion: Horizon planned to expand its primary care sales force by approximately 75 representatives to support the launch of PENNSAID 2% and included it in the Prescriptions Made Easy™ (PME) specialty pharmacy program to ensure reasonable out-of-pocket costs for patients[1].

Competitive Landscape

The OA treatment market is competitive, with various oral and topical NSAIDs available. However, PENNSAID 2% holds a unique position due to its topical application and lower risk of systemic side effects compared to oral NSAIDs.

Patient and Physician Adoption

PENNSAID 2% has been well-received by patients and physicians as an alternative to oral NSAIDs. Its inclusion in the PME program helped in ensuring patient access and affordability, which contributed to its market acceptance[1].

Regulatory Approvals

PENNSAID 2% was approved by the FDA on January 16, 2014, marking a significant milestone in its commercialization. This approval underscored the product's safety and efficacy profile[1].

Supply and Distribution

Horizon entered into an eight-year exclusive supply agreement with Nuvo Research Inc. to ensure a stable supply of PENNSAID 2% in the U.S. market. This agreement was crucial for maintaining consistent product availability[1].

Future Outlook

The launch of generic versions may impact the branded product's sales, but the established brand and patient loyalty could help maintain a significant market share. Continuous marketing and educational efforts by Horizon Pharma (now part of Amgen) will be essential in sustaining the product's market position.

Key Takeaways

• Market Position: PENNSAID 2% is a differentiated topical NSAID with a strong market presence.
• Financial Impact: The acquisition was accretive to Horizon's net income and diversified its revenue streams.
• Competitive Landscape: The product faces competition from generic versions but retains a unique position due to its topical application.
• Regulatory Approvals: FDA approval in 2014 validated its safety and efficacy.
• Patient and Physician Adoption: Well-received by patients and physicians as an alternative to oral NSAIDs.

FAQs

Q: What is PENNSAID used for?

PENNSAID is used to treat the pain of osteoarthritis (OA) of the knee.

Q: Who acquired the U.S. rights to PENNSAID 2%?

Horizon Pharma plc acquired the U.S. rights to PENNSAID 2% from Nuvo Research Inc. in 2014.

Q: How much did Horizon Pharma pay for the U.S. rights to PENNSAID 2%?

Horizon Pharma paid $45 million in cash for the U.S. rights to PENNSAID 2%.

Q: What is the significance of the 2% concentration of PENNSAID?

The 2% concentration is a second-generation version of the original 1.5% formulation, offering improved efficacy and patient tolerance.

Q: Has a generic version of PENNSAID been launched?

Yes, Lupin launched a generic version of PENNSAID in the U.S. market in December 2022.

Cited Sources

1. Horizon Pharma plc Announces Acquisition of U.S. Rights to PENNSAID(R) 2% From Nuvo Research Inc. - Biospace.
2. AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS - Amgen.
3. SHAREHOLDERS 2023 - Amgen Investors.
4. Lupin launches generic joint pain drug in US market - The Economic Times.