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 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:	2,915
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	021692-003	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	021692-002	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	021692-002	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
Austria	138566
Austria	172376
Austria	184786
Austria	196079
Austria	201989

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
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
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

ULTRAM ER (Tramadol Hydrochloride Extended-Release): Market Dynamics and Financial Trajectory

Last updated: July 26, 2026

Executive summary: ULTRAM ER (tramadol HCl extended-release) is a long-cycle, controlled-substance analgesic with a mature commercial profile and limited growth runway. Revenue is driven by the size of the chronic pain and orthopedic segments that favor once-daily ER opioids, offset by class-level constraints (opioid prescribing curbs, payer step edits, safety scrutiny) and ongoing competitive pressure from other ER tramadol and branded/non-branded opioid analgesics. Financial trajectory since launch has tracked typical “mature branded pain” patterns: gradual share erosion as generics and competing branded ER opioid products expanded, followed by plateauing and then decline as exclusivity ended and the market normalized.

How did ULTRAM ER perform commercially and what is its revenue trajectory?

ULTRAM ER targets chronic, moderate-to-severe pain requiring around-the-clock opioid therapy. Commercial performance is largely a function of:

• prescriber adoption of ER opioids for musculoskeletal and chronic pain
• payer coverage design (preferred drug lists, prior authorization, quantity limits)
• competitive substitution by other extended-release opioid analgesics and tramadol immediate-release or other ER tramadol brands
• enforcement and labeling-driven prescriber behavior following opioid safety initiatives

What typically happens to branded ER opioid revenues after exclusivity ends?

Branded ER opioid products generally experience:

• an initial revenue plateau post-launch as formularies lock in access
• step-down when generic entry expands or when competitors win preferred positioning
• eventual stabilization at a lower baseline for any remaining brand share that is protected by prescriber inertia, patient-specific tolerability, and contracting

What drives price erosion for ULTRAM ER?

Price compression comes from:

• generic tramadol ER availability dynamics (where permitted by the regulatory and patent landscape)
• net-to-gross compression tied to rebates, contracting, and payer re-pricing
• channel mix shifts (more government and managed care penetration vs commercial)

What market dynamics shape ULTRAM ER demand and prescribing?

Which therapeutic drivers matter most for ULTRAM ER?

Demand is concentrated in chronic pain treatment pathways, especially:

• osteoarthritis and chronic musculoskeletal pain
• neuropathic pain adjunct use in some practices (off-label patterns exist across the opioid class, but prescribing varies)
• post-surgical and ongoing pain management where ER opioids are favored for adherence

How do opioid prescribing policies affect ULTRAM ER sales?

Class headwinds include:

• tighter guideline adherence and opioid risk mitigation
• prescriber monitoring and restrictions on dose escalation
• payer step therapy requiring prior trials of non-opioid and lower-risk alternatives

What role do controlled-substance regulations play?

Tramadol ER is a DEA schedule medication. Operational and access factors that influence utilization include:

• stocking and dispensing compliance
• real-time prescribing controls that reduce impulsive initiation
• heightened scrutiny of opioid prescribing patterns and refill behaviors

Who competes with ULTRAM ER and how does competitive substitution impact revenue?

What product classes substitute for ULTRAM ER?

ULTRAM ER competes against:

• extended-release opioid analgesics (morphine ER, oxycodone ER, hydrocodone ER, oxymorphone ER formulations depending on market availability and payer contracting)
• other tramadol ER products and brand extensions in the same molecule space
• non-opioid alternatives (NSAIDs, acetaminophen combinations, duloxetine, gabapentinoids in practice patterns, topical therapies) that reduce opioid initiation

How does competition impact share in managed care?

Managed care typically shifts volume through:

• preferred status and formulary tiering
• prior authorization triggers (step therapy, opioid naive restrictions, dose thresholds)
• quantity limits and refill rules

A branded ER opioid can lose share without losing “absolute” competitors if it becomes non-preferred or requires additional documentation.

What is the FDA and regulatory positioning for ULTRAM ER?

ULTRAM ER is an FDA-approved extended-release tramadol product for:

• management of pain severe enough to require daily, around-the-clock, long-term opioid treatment that cannot be managed by alternative analgesics

What regulatory pathway and labeling themes constrain growth?

The ER opioid class labels emphasize:

• addiction, abuse, and misuse risk
• respiratory depression risks
• risks related to concomitant CNS depressant use
• seizure risk and serotonergic syndrome risk for tramadol These safety themes constrain promotional latitude and influence prescriber acceptance, especially for high-risk populations.

What patents protect ULTRAM ER and when does exclusivity end?

A complete, accurate patent-and-exclusivity inventory requires Orange Book and litigation records matched to ULTRAM ER’s specific NDA/strength and dosage forms. Without those records, only broad generalities can be stated, which is not actionable for a patent or generic-entry risk assessment.

What generic entry risks exist for ULTRAM ER and what timing matters?

A credible generic risk view depends on:

• Orange Book listings and any unexpired Orange Book patents
• whether any Paragraph IV ANDA challenges were filed and sustained
• court outcomes and settlement-triggered “at-risk” launch schedules
• exclusivity blocks such as 180-day exclusivity or additional regulatory exclusivity

Without the Orange Book patent list and ANDA filing/litigation docket for ULTRAM ER, a timing-based risk assessment cannot be completed.

How does ULTRAM ER compare with other extended-release opioid products financially?

Financial comparisons are usually dominated by:

• net pricing and payer netbacks
• formulary placement and switching costs
• adverse event and regulatory scrutiny exposure that affects prescribing behavior
• generic penetration rate

In mature opioid categories, branded products tend to converge into:

• modest residual share in non-preferred settings
• higher share where contracting retains the brand due to tolerability, patient history, or prescriber preference
• rapid share loss when preferred positioning shifts to generics or better-contracted competitors

What role do manufacturing and supply factors play in ULTRAM ER market dynamics?

ER opioids depend on:

• controlled release performance and bioequivalence reliability
• consistent manufacturing yields to avoid supply interruptions
• scale economics for generic manufacturers versus branded supply chain costs

Supply disruptions can temporarily lift brand share, but the structural driver remains formulary status and generic access.

What financial trajectory indicators should investors track for ULTRAM ER?

For any branded ER analgesic in a mature segment, monitor:

• prescription volume trends by channel (retail vs specialty, where applicable) and by payer segment
• net price trends and rebate pressure (net-to-gross changes)
• formulary placement changes, including prior authorization expansions and tier shifts
• generic penetration signals: NRx share shifts and pharmacy claims migration

Key Takeaways

• ULTRAM ER’s market dynamics are driven more by opioid-class policy, payer contracting, and safety-driven prescribing limits than by product-specific differentiation once the molecule is mature.
• The financial trajectory for branded ER opioid products typically shifts from launch growth to plateau, then declines as generic and competing ER opioids expand and payer preferences change.
• Competitive substitution in managed care is the dominant lever on revenue, with additional headwinds from opioid prescribing restrictions and controlled-substance scrutiny.

FAQs

1. How do prior authorization requirements typically affect ULTRAM ER prescription volume in managed care?
2. What payer contracting changes usually trigger rapid net sales declines for branded ER opioid products like ULTRAM ER?
3. How does tramadol ER utilization differ between commercial and government payer segments?
4. What formulary strategies do generic extended-release opioids use to take share from branded tramadol ER?
5. How do opioid safety label updates and risk mitigation policies impact long-term ER opioid prescribing patterns?

References

No sources were provided in the prompt, and no Orange Book, FDA labeling, litigation dockets, or financial disclosures were included.