FORFIVO XL Drug Patent Profile

When do Forfivo Xl patents expire, and what generic alternatives are available?

Forfivo Xl is a drug marketed by Twi Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in FORFIVO XL is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Forfivo Xl

A generic version of FORFIVO XL was approved as bupropion hydrochloride by APNAR PHARMA LP on February 7^th, 2000.

Summary for FORFIVO XL

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	138
Patent Applications:	1,256
Drug Prices:	Drug price information for FORFIVO XL
DailyMed Link:	FORFIVO XL at DailyMed

See drug prices for FORFIVO XL

Pharmacology for FORFIVO XL

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Paragraph IV (Patent) Challenges for FORFIVO XL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FORFIVO XL	Extended-release Tablets	bupropion hydrochloride	450 mg	022497	1	2013-02-28

US Patents and Regulatory Information for FORFIVO XL

FORFIVO XL is protected by 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
Twi Pharms	FORFIVO XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022497-001	Nov 10, 2011		RX	Yes	Yes	7,674,479		Y

International Patents for FORFIVO XL

See the table below for patents covering FORFIVO XL around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008038155

Supplementary Protection Certificates for FORFIVO XL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	2017/059	Ireland		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	SPC/GB17/078	United Kingdom		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607

FORFIVO XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Forfivo XL

Introduction

Forfivo XL, an extended-release bupropion HCl tablet, was introduced to the U.S. market in October 2012 by IntelGenx Corp. This drug is specifically designed for the treatment of Major Depressive Disorder (MDD) and offers a unique once-daily dosing regimen of 450mg. Here, we delve into the market dynamics and financial trajectory of Forfivo XL.

Market Need and Launch

Forfivo XL was developed to address a significant market need: providing a convenient, single-pill 450mg dose of bupropion for patients with MDD. Prior to its launch, patients requiring this dosage had to take multiple tablets, often 3 x 150mg tablets of other bupropion products like Wellbutrin XL[1].

Commercial Launch and Marketing

The commercial launch of Forfivo XL was facilitated through a license agreement between IntelGenx and Edgemont Pharmaceuticals. This partnership allowed for targeted marketing and distribution, with Edgemont obtaining exclusive rights to market and sell the product in the United States[1][3].

Financial Milestones and Royalties

The commercialization of Forfivo XL triggered several financial milestones for IntelGenx. These included an upfront payment of $1 million, launch-related milestone payments of up to $4 million, and additional milestones of up to $23.5 million based on sales and exclusivity targets. IntelGenx also received tiered double-digit royalties on the net sales of Forfivo XL[1][3].

Sales Performance

In the first year after its launch, Forfivo XL showed promising sales growth. By the end of 2014, gross sales had totaled $8.9 million, representing a 230% increase from the previous year[2]. This growth was partly driven by the convenience and simplicity of the once-daily dosing regimen.

Changes in Marketing and Distribution

In 2017, Edgemont assigned its product business, including Forfivo XL, to Alvogen Group. This transition did not significantly impact the financial obligations outlined in the original license agreement, and IntelGenx continued to receive milestone payments and royalties[3].

Generic Competition

The market dynamics for Forfivo XL were affected by the introduction of generic competition. In November 2014, IntelGenx settled a Paragraph IV litigation with Wockhardt Bio AG, allowing Wockhardt to market an authorized generic version of Forfivo XL starting January 15, 2018. This settlement marked a significant shift in the competitive landscape for Forfivo XL[3].

Royalty Sale

In August 2016, IntelGenx sold its U.S. royalty rights for future sales of Forfivo XL to SWK Holdings Corporation for $6 million. This transaction marked a strategic move to monetize future royalty streams upfront[5].

Patent Protection and Exclusivity

The patent protection for Forfivo XL in the United States has been a critical factor in its market dynamics. However, with the patent set to expire, the exclusivity period for Forfivo XL has come to an end, allowing for increased generic competition[5].

Financial Impact on IntelGenx

The launch and subsequent sales of Forfivo XL have had a positive financial impact on IntelGenx. The company received significant milestone payments and royalties, contributing to its revenue. For example, by December 2015, IntelGenx had received an upfront payment and several milestone payments totaling $5 million, in addition to ongoing royalties[3].

Market Challenges

Despite its initial success, Forfivo XL faced challenges in the market, particularly with the introduction of generic versions. The settlement with Wockhardt and the eventual launch of an authorized generic version reduced the market share and revenue potential for the branded product[3].

Conclusion

Forfivo XL has navigated a complex market landscape since its launch in 2012. From its initial success driven by convenience and targeted marketing to the challenges posed by generic competition, the financial trajectory of Forfivo XL reflects both the opportunities and challenges in the pharmaceutical market.

Key Takeaways

• Convenient Dosing: Forfivo XL introduced a once-daily 450mg dose of bupropion, simplifying treatment for MDD patients.
• Financial Milestones: IntelGenx received significant upfront payments, milestone payments, and royalties.
• Generic Competition: The introduction of authorized generics impacted the market share and revenue of Forfivo XL.
• Strategic Moves: IntelGenx sold its U.S. royalty rights to SWK Holdings Corporation to monetize future streams.
• Patent Expiry: The expiration of patent protection has increased competition from generic versions.

FAQs

Q: What is Forfivo XL used for? A: Forfivo XL is used for the treatment of Major Depressive Disorder (MDD).

Q: What is unique about the dosing regimen of Forfivo XL? A: Forfivo XL offers a once-daily dosing regimen of 450mg, which simplifies treatment for patients who previously had to take multiple tablets.

Q: Who markets and distributes Forfivo XL in the United States? A: Forfivo XL is marketed and distributed under an agreement between IntelGenx and Edgemont Pharmaceuticals, with the business later assigned to Alvogen Group.

Q: How has generic competition affected Forfivo XL? A: Generic competition, particularly the authorized generic version by Wockhardt, has reduced the market share and revenue potential for Forfivo XL.

Q: What was the financial impact of selling the U.S. royalty rights for Forfivo XL? A: IntelGenx received $6 million from SWK Holdings Corporation for the sale of its U.S. royalty rights, monetizing future royalty streams upfront.

Sources

1. IntelGenx Announces Commercial Launch of Forfivo XL® in USA - IntelGenx Corp.
2. IntelGenx Provides Update on Sales of Forfivo XL(R) - IntelGenx Corp.
3. IntelGenx Technologies Corp. - Annual Reports - Annual Reports
4. 022497Orig1s000 - accessdata.fda.gov - FDA
5. IntelGenx Announces Sale of Forfivo XL(R) Royalty for $6 Million - IntelGenx Corp.