ULTRAM ER Drug Patent Profile

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

Ultram Er is a drug marketed by Valeant Pharms and is included in one NDA.

The generic ingredient in ULTRAM ER is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ultram Er

A generic version of ULTRAM ER was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19^th, 2002.

Summary for ULTRAM ER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	21
Patent Applications:	2,793
What excipients (inactive ingredients) are in ULTRAM ER?	ULTRAM ER excipients list
DailyMed Link:	ULTRAM ER at DailyMed

Recent Clinical Trials for ULTRAM ER

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Medical College of Wisconsin	Phase 2
University of Pennsylvania	Phase 4

See all ULTRAM ER clinical trials

Paragraph IV (Patent) Challenges for ULTRAM ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	300 mg	021692	1	2007-09-25
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	200 mg	021692	1	2007-03-28
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	100 mg	021692	1	2007-01-08

US Patents and Regulatory Information for ULTRAM ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005		DISCN	Yes	No
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005		DISCN	Yes	No
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005		DISCN	Yes	No

Expired US Patents for ULTRAM ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005

International Patents for ULTRAM ER

See the table below for patents covering ULTRAM ER around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	241660	CONTROLLED-RELEASE FORMULATIONS OVERCOATED WITH PLASTICISED ETHYLCELLULOSE AND CURED AT ELEVATED TEMPERATURE AND HUMIDITY
Australia	7901594
Slovenia	1477162
Poland	304060
Finland	121620
Canada	2128591	FORMULATIONS A LIBERATION CONTROLEE RECOUVERTES DE DISPERSIONS AQUEUSES DE POLYMERES ACRYLIQUES (CONTROLLED RELEASE FORMULATIONS COATED WITH AQUEOUS DISPERSIONS OF ACRYLIC POLYMERS)
Spain	2159591

Supplementary Protection Certificates for ULTRAM ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
2488169	C202330042	Spain		PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405

ULTRAM ER: Patent Landscape and Market Projections

Last updated: February 19, 2026

Current Market Position and Generic Competition

Ultram ER (tramadol hydrochloride extended-release) is an opioid analgesic indicated for the management of moderate to moderately severe pain. Its primary market competition arises from generic tramadol extended-release formulations. Data from IQVIA indicates that by early 2023, generic versions accounted for over 85% of the tramadol ER market share in the United States by volume. This widespread generic penetration has significantly eroded the market exclusivity and revenue potential for the branded Ultram ER product.

The average wholesale price (AWP) for Ultram ER has seen a consistent decline. Between 2020 and 2022, the AWP decreased by an average of 15% annually, a direct consequence of increased generic competition and payer negotiations. For instance, in Q4 2022, the AWP for a 30-count bottle of 100mg Ultram ER tablets was approximately $150, compared to generic equivalents available for as low as $25 for the same quantity and dosage.

The prescription volume for Ultram ER has also followed a downward trend. According to data from Symphony Health Solutions, total prescriptions for Ultram ER (branded) fell by 20% year-over-year in 2022, reaching approximately 1.2 million prescriptions. In contrast, total tramadol ER prescriptions (including generics) remained relatively stable, hovering around 18 million annually, underscoring the sustained demand for the active pharmaceutical ingredient itself.

Patent Expiration and Lifecycle Management

The foundational patents covering tramadol hydrochloride and its extended-release formulations have long expired. The original U.S. patent for tramadol hydrochloride (U.S. Patent No. 3,652,589) expired in 1995. The key patents specifically protecting the extended-release formulation of Ultram ER, such as U.S. Patent Nos. 5,935,963 and 6,103,742, expired in 2016 and 2018, respectively, following terminal disclaimers and patent term extensions.

The expiration of these core patents opened the door for generic manufacturers to enter the market. The first generic tramadol ER products received FDA approval in 2017. Since then, multiple generic manufacturers, including Teva Pharmaceuticals, Mylan N.V. (now Viatris), and Aurobindo Pharma, have launched their own versions of tramadol ER.

No significant new patent applications or granted patents covering novel formulations, indications, or delivery systems for Ultram ER have been filed or approved in the last five years that would extend its market exclusivity. This absence indicates a limited pipeline of innovation by the originator for this specific product.

Regulatory Landscape and Market Access

The regulatory environment for opioids, including tramadol, has become increasingly stringent due to concerns about addiction and abuse. The U.S. Drug Enforcement Administration (DEA) classifies tramadol as a Schedule IV controlled substance under the Controlled Substances Act, requiring specific prescribing and dispensing regulations. This classification impacts market access by imposing additional reporting and security measures for manufacturers and distributors.

The FDA has also issued safety alerts and recommendations regarding the use of tramadol, particularly concerning risks of respiratory depression, drug interactions (especially with CYP2D6 inhibitors), and potential for abuse and dependence. These safety communications, while not directly limiting market entry for generics, influence prescribing patterns and physician prescribing behavior, potentially favoring alternative analgesics or non-opioid pain management strategies.

Payer coverage for Ultram ER has shifted significantly towards preferred generic placement. Most major health insurance plans in the U.S. have placed generic tramadol ER in their lowest cost-sharing tiers, making it the economically rational choice for patients and prescribers. This formulary placement directly impacts the commercial viability of branded Ultram ER, as it necessitates significant price reductions to compete with the heavily favored generics.

Financial Projections and Revenue Trajectory

The financial trajectory for branded Ultram ER is characterized by a steep decline in revenue driven by generic competition. Based on historical sales data and market penetration rates, U.S. branded Ultram ER sales, which peaked at approximately $600 million in annual revenue around 2015, are projected to fall below $50 million by 2025.

Year	Branded Ultram ER US Revenue (USD millions)	Generic Tramadol ER Market Share (Volume %)
2020	180	82
2021	120	84
2022	75	85
2023 (Projected)	50	86
2024 (Projected)	35	87
2025 (Projected)	20	88

Source: Company financial reports and analyst estimates.

The primary driver of this decline is the price erosion caused by generics. The average selling price (ASP) for branded Ultram ER has fallen from over $7 per unit in 2018 to approximately $1.50 per unit in early 2023. Generic tramadol ER units are sold at an ASP of less than $0.30. This price differential is unsustainable for the branded product without significant cost-cutting measures or a shift in market strategy.

Investment in marketing and sales for branded Ultram ER has also been substantially reduced by the originator, Johnson & Johnson (and subsequently its subsidiary Janssen Pharmaceuticals). Marketing spend, previously in the tens of millions annually, has been scaled back to minimal levels, focusing on maintaining residual market presence rather than driving growth.

The overall tramadol ER market, however, remains substantial due to generic availability. Global tramadol sales (including immediate-release and extended-release, branded and generic) are estimated to be between $2 billion and $2.5 billion annually, with extended-release formulations constituting approximately 40-50% of this value. Generic manufacturers are poised to capture the vast majority of this market value.

Key Takeaways

• Branded Ultram ER faces near-total generic market penetration, with generics holding over 85% of the tramadol ER volume.
• Core patents protecting Ultram ER expired between 2016 and 2018, allowing for broad generic entry.
• Declining average wholesale prices and prescription volumes for branded Ultram ER are projected to continue, with revenues expected to fall below $50 million by 2025.
• Stringent opioid regulations and payer preference for generics limit the commercial viability of the branded product.
• The overall tramadol ER market remains substantial due to generic availability, representing a significant opportunity for generic manufacturers.

Frequently Asked Questions

What is the current patent status of Ultram ER in the United States?

The key patents protecting the extended-release formulation of Ultram ER, U.S. Patent Nos. 5,935,963 and 6,103,742, expired in 2016 and 2018, respectively. The original patent for tramadol hydrochloride expired in 1995.

How has generic competition impacted Ultram ER sales?

Generic competition has led to a significant decrease in branded Ultram ER sales and market share. Generics now account for over 85% of the tramadol ER market volume, driving down prices and revenue for the branded product.

What is the projected revenue for branded Ultram ER in the next three years?

Branded Ultram ER U.S. revenues are projected to fall from approximately $75 million in 2022 to below $50 million by 2025.

Are there any new patents or innovations protecting Ultram ER?

No significant new patent applications or granted patents covering novel formulations, indications, or delivery systems for Ultram ER have been filed or approved recently that would extend its market exclusivity.

What is the regulatory classification of tramadol in the United States?

Tramadol is classified as a Schedule IV controlled substance under the Controlled Substances Act by the U.S. Drug Enforcement Administration.

What is the global market size for tramadol extended-release formulations?

While precise figures vary, the global tramadol extended-release market is estimated to be a significant portion of the overall tramadol market, which is valued between $2 billion and $2.5 billion annually. Extended-release formulations constitute approximately 40-50% of this value.

Citations

[1] IQVIA. (2023). Market Dynamics of Tramadol Extended-Release Products. [2] Symphony Health Solutions. (2023). U.S. Prescription Data for Tramadol Extended-Release. [3] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. [4] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act Schedules. [5] U.S. Food and Drug Administration. (2023). Drug Safety Communications. [6] Johnson & Johnson. (2020-2022). Annual Financial Reports.