QDOLO Drug Patent Profile

When do Qdolo patents expire, and when can generic versions of Qdolo launch?

Qdolo is a drug marketed by Rosemont and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in QDOLO 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 Qdolo

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

Summary for QDOLO

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Patent Applications:	2,915
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QDOLO
What excipients (inactive ingredients) are in QDOLO?	QDOLO excipients list
DailyMed Link:	QDOLO at DailyMed

Paragraph IV (Patent) Challenges for QDOLO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QDOLO	Oral Solution	tramadol hydrochloride	5 mg/mL	214044	1	2024-09-16

US Patents and Regulatory Information for QDOLO

QDOLO is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rosemont	QDOLO	tramadol hydrochloride	SOLUTION;ORAL	214044-001	Sep 1, 2020		DISCN	Yes	No	11,103,452		Y
Rosemont	QDOLO	tramadol hydrochloride	SOLUTION;ORAL	214044-001	Sep 1, 2020		DISCN	Yes	No	11,752,103		Y

International Patents for QDOLO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021092406

Supplementary Protection Certificates for QDOLO

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

Last updated: June 22, 2026

QDOLO drug market dynamics and financial trajectory (sales, pricing, volume, and exclusivity-driven risk)

Executive summary: QDOLO is a branded analgesic exposure with a commercialization path that is heavily shaped by (1) the route from launch to sustained volume, (2) price compression from generic competition typical for small-molecule pain products, and (3) patent and exclusivity windows that determine how long higher branded pricing can persist. Financial trajectory is therefore best modeled as a staged curve: launch ramp, mid-period stabilization, then margin pressure as lower-priced entrants take share, with the timing driven by Orange Book-listed IP and any patent settlements that move Paragraph IV timing.

No complete, reliable source set is provided here for QDOLO’s FDA listing, active ingredient(s), dosage strengths, market author, Orange Book patent numbers, approval date, exclusivity end dates, or reported U.S. revenues. Under the stated constraints, a complete and accurate financial trajectory cannot be produced.

What is QDOLO’s market definition (drug class, active ingredient, competitors)?

Featured snippet answer: QDOLO market positioning depends on its active ingredient and indication (acute pain, chronic pain, or specific post-procedure use). Without confirmed FDA label details for QDOLO, the relevant competitor set cannot be stated precisely.

Key market segmentation that drives pricing

• Analgesic category: NSAID, opioid, acetaminophen combination, neuropathic agent, or topical analgesic.
• Dosing frequency: once daily versus multiple daily dosing influences adherence and payer tiering.
• Setting: retail primary care versus specialty pain or hospital discharge.
• Formulation type: tablet/capsule versus extended-release impacts willingness-to-pay and generic substitutability.

Competitor sets vary by label

• If QDOLO is opioid-based, competition includes branded REMS-associated products and authorized generics.
• If QDOLO is NSAID-based, competition typically compresses faster through generic availability.
• If QDOLO is combination analgesic, formulary edits and reimbursement rules can shift share even before full IP expiry.

How do pricing and reimbursement dynamics affect QDOLO’s gross margin?

Featured snippet answer: For branded pain products, gross margin typically tracks net price after rebates and payer restrictions. Generic-driven substitution turns net price into the main determinant of revenue decline speed.

Net price erosion mechanics

• Formulary placement: preferred versus non-preferred tiers.
• PBM rebate pressure: tied to market share and therapeutic interchange.
• State substitution and pharmacist switching: accelerates volume transfer to generics.
• Wholesale acquisition cost (WAC) versus net: branded pricing headroom compresses during competitive entry.

Volume dynamics that matter more than WAC

• Script growth at launch: driven by conversion from existing analgesics and prescriber adoption.
• Refill rate: pain therapies with chronic use differ from short-course perioperative drugs.
• Channel mix: 340B, government, and commercial channel can produce different net realizations.

When does QDOLO face exclusivity or patent-expiration-driven revenue cliffs?

Featured snippet answer: The revenue cliff is tied to the earliest of (1) composition-of-matter patent expiry, (2) formulation or method-of-use patent expiry, and (3) regulatory exclusivity (if any) that blocks generic filing or approval.

What drives timing in practice

• Orange Book patent lifetimes: composition, formulation, and method-of-use often end at different dates.
• 30-month stay outcomes: Paragraph IV challenges can delay approval but may also trigger early settlement that changes effective generic entry timing.
• Authorized generic strategy: can begin immediately after first generic approval even when multiple patents remain.

Why pain products can devalue quickly

Small-molecule analgesics frequently have overlapping IP that is weaker against generic design-around, which can shorten the “premium pricing” period even if some patents remain.

What patent estate protects QDOLO, and how strong is it versus generic entry?

Featured snippet answer: Patent strength for QDOLO is assessed by the number of enforceable Orange Book-listed patents, their claims coverage breadth, remaining life, and whether generic entry requires bioequivalence only (or also must avoid method-of-use and formulation claim territory).

Patent types that determine enforceability

• Composition-of-matter: hardest to design around.
• Formulation patents: may cover specific excipients, particle size, crystal form, or release profile.
• Method-of-use patents: cover patient selection or dosing regimen; can be easier to circumvent label.
• Manufacturing process patents: sometimes weaker if generic sites use different processes but can still drive litigation.

Litigation leverage points

• Claim construction risk: narrower interpretations reduce settlement value.
• Filing date anchoring: earlier priority can extend enforceability.
• Validity challenges: obviousness and lack of enablement are common invalidity routes.

What is the Orange Book status of QDOLO?

Featured snippet answer: Orange Book status determines which patents are listed for each dosage form and strength, and whether any additional exclusivity is claimed that blocks generic approval.

What to extract for a commercial risk model

• Patent numbers and assignees
• Date of patent expiry for each listed patent
• Exclusivity codes (if applicable)
• Listed dosage forms and strengths

How many Paragraph IV challenges exist for QDOLO, and who filed them?

Featured snippet answer: Paragraph IV challenges determine the probability and timing of generic entry. The number and identity of filers also correlates with competitive intensity.

Key signals

• Number of filers on the first wave typically predicts faster share loss.
• Settlement terms can include:
  • “No-AG” provisions (limited)
  • launch date carve-outs
  • payment considerations tied to design-around constraints

What patent litigation affects QDOLO, and what settlement outcomes changed launch timing?

Featured snippet answer: Litigation affects when generics can launch and at what risk level. Settlements that include delayed entry or licensing can extend net-revenue runway.

Settlement outcomes that change the economics

• Staggered launch: partial bottle share early, full penetration later.
• Design-around approvals: entry even while some patents remain through non-infringing formulations.
• Authorized generic: can negate delayed exclusivity benefits.

What FDA pathway and label features drive QDOLO’s competitive substitutability?

Featured snippet answer: FDA pathway (505(b)(1) vs ANDA) and label scope drive whether generics are “drop-in” substitutes or whether clinical positioning limits interchange.

Label-driven substitution

• Indication breadth: narrower indications limit automatic switching.
• Dose and schedule: may affect bioequivalence interchangeability and payer edits.
• REMS or special controls: can constrain generic uptake if present.

Formulation and PK/BD modifiers

• Extended-release changes generic design constraints and time-to-entry.
• Some formulations preserve brand share longer by requiring more complex development and additional regulatory effort.

How does QDOLO compare with top analgesic brands and generics on market dynamics?

Featured snippet answer: Comparison requires QDOLO’s active ingredient and strengths. Without confirmed label and FDA status, an accurate competitor ranking cannot be provided.

Typical benchmarking variables

• Net price versus the reference category
• Generic penetration curve post-first approval
• Script share change in the first 12 to 24 months after generic entry
• Payer formulary changes and substitution rules

What generic launch scenarios exist for QDOLO (base, upside, downside)?

Featured snippet answer: Generic launch scenarios are a function of (1) earliest date of generic approval after patent and exclusivity barriers, (2) whether multiple ANDAs are launched simultaneously, and (3) whether an authorized generic appears.

Base case revenue trajectory mechanics

• Brand maintains premium pricing until first generic launch.
• After first generic approval, net price compresses as PBM and plan formularies allow interchange.
• Subsequent generic launches accelerate volume shift and further net price erosion.

Upside scenario mechanics

• Delay from additional patent obstacles or unfavorable claim validity outcomes.
• Settlements that extend effective launch timing.
• Higher-than-expected branded adherence, which limits substitution.

Downside scenario mechanics

• Early settlement that triggers fast generic launch.
• Multiple filers with co-launch.
• Authorized generic reduces branded exclusivity value.

Key Takeaways

• QDOLO’s financial trajectory is dominated by timing and strength of patent and exclusivity barriers, not by launch pricing alone.
• Pain-product dynamics typically produce faster net price compression once generic substitution becomes available through ANDA approval and formulary acceptance.
• A full, data-backed trajectory requires QDOLO’s FDA label identification, Orange Book patent listings, and any Paragraph IV and litigation timelines, none of which are provided here.

FAQs

1. What types of patents most commonly protect branded analgesics like QDOLO in the U.S.?
2. How do Paragraph IV settlements typically impact the effective generic launch date for small-molecule pain drugs?
3. What signals indicate whether a generic will launch into a payer-constrained market versus a fully reimbursed channel?
4. How does an extended-release formulation change generic entry risk compared with immediate-release?
5. What is the usual revenue pattern of branded analgesics after the first ANDA approval?

References

No sources were provided in the prompt for QDOLO’s FDA status, Orange Book listings, litigation, or financial reporting, so no citations can be generated.