HYSINGLA ER Drug Patent Profile

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

Hysingla Er is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are nineteen patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and ninety-five patent family members in forty-eight countries.

The generic ingredient in HYSINGLA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hysingla Er

A generic version of HYSINGLA ER was approved as hydrocodone bitartrate by ALVOGEN on January 21^st, 2020.

Summary for HYSINGLA ER

International Patents:	295
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Drug Prices:	Drug price information for HYSINGLA ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYSINGLA ER
What excipients (inactive ingredients) are in HYSINGLA ER?	HYSINGLA ER excipients list
DailyMed Link:	HYSINGLA ER at DailyMed

See drug prices for HYSINGLA ER

See drug sales revenues for HYSINGLA ER

Pharmacology for HYSINGLA ER

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Paragraph IV (Patent) Challenges for HYSINGLA ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HYSINGLA ER	Extended-release Tablets	hydrocodone bitartrate	30 mg, 40 mg, 80 mg, and 100 mg	206627	1	2015-05-08
HYSINGLA ER	Extended-release Tablets	hydrocodone bitartrate	20 mg, 60 mg, and 120 mg	206627	1	2015-04-15

US Patents and Regulatory Information for HYSINGLA ER

HYSINGLA ER is protected by nineteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No			Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	AB	RX	Yes	No
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No			Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	AB	RX	Yes	No			Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	AB	RX	Yes	No			Y

Expired US Patents for HYSINGLA ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014

International Patents for HYSINGLA ER

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

Country	Patent Number	Title	Estimated Expiration
Argentina	045352	FORMA DE DOSIFICACION A PRUEBA DE ABUSO
Argentina	045353	FORMA DE DOSIFICACION A PRUEBA DE ABUSO
Argentina	046994	PROCESO PARA LA PRODUCCION DE UNA FORMA DE DOSIFICACION A PRUEBA DE ABUSO
Argentina	049083	PROCESO PARA LA PREPARACION DE UNA FORMA DE DOSIFICACION SOLIDA A PRUEBA DE ABUSO
Argentina	049839	PROCEDIMIENTO PARA LA PRODUCCION DEUNA FORMA FARMACEUTICA SOLIDA, PROTEGIDA FRENTE AL ABUSO
Argentina	054328	FORMAS FARMACEUTICAS RESISTENTES A LA ROTURA CON LIBERACION SOSTENIDA

Hysingla ER (Hydrocodone Bitartrate Extended-Release) Market Dynamics and Financial Trajectory: Sales, Competition, and Patent-Driven Generic Risk

Last updated: June 8, 2026

Hysingla ER (hydrocodone bitartrate extended-release; Acura Pharmaceuticals, Inc.) is an opioid analgesic with a concentrated commercial footprint tied to long-acting opioid prescribing, payer scrutiny, and ongoing opioid-supply chain restructuring. Its financial trajectory is shaped by (1) baseline demand for ER hydrocodone in chronic pain, (2) competitive pressure from other long-acting hydrocodone and ER opioids, (3) FDA controlled substance oversight and REMS-adjacent payer controls, and (4) patent and exclusivity runoffs that can enable generic entry in later years.

How is Hysingla ER performing commercially (sales trend, revenue drivers, and market size)?

Hysingla ER’s commercial performance is best understood through three demand drivers and one structural headwind:

• Demand drivers

  • Long-acting opioid (LAO) conversion: patients stabilized on LAO regimens maintain therapy unless safety signals, formulary changes, or switching incentives intervene.
  • Chronic pain prescribing patterns: ER hydrocodone competes within the broader LAO class that is sensitive to guidelines, state prescribing regimes, and CDC-linked payer restrictions.
  • Formulary placement and access: payer step therapy and prior authorization can shift net revenue more than unit volume.

• Structural headwinds

  • Opioid contracting and mitigation strategies: health plans and pharmacy benefit managers have used tighter controls (PA, quantity limits, tiering) across long-acting products.
  • Net price compression: branded opioid pricing is volatile and often subject to rebates, wholesaler chargebacks, and dynamic payer contracting.
  • Substitution risk inside the LAO category: competitors with favorable payer positioning can displace Hysingla ER even before direct generic competition.

What revenue mix does Hysingla ER rely on (net sales composition and reimbursement mechanics)?

Net sales for branded opioid ER products typically correlate with:

• Contracting intensity with PBMs and integrated delivery networks.
• State Medicaid formularies and managed Medicaid plan behavior.
• Trend toward opioid alternatives and non-opioid adjuncts in higher-acuity chronic pain populations.

What competitive landscape pressures Hysingla ER (other ER hydrocodone products and LA opioid rivals)?

Hysingla ER competes in at least two layers:

1. Direct ER hydrocodone peers
   • Other ER hydrocodone formulations (including variants across manufacturers) compete on dosage strengths, abuse-deterrent profile, and payer preference.
2. Indirect LAO substitutes
   • ER oxycodone, ER morphine, ER oxymorphone, and other LAO classes compete via formulary equivalency and clinical-switch protocols.

How does abuse-deterrent and ER technology affect switching behavior?

Within LA opioids, formulary teams and prescribers weigh abuse-deterrent technologies and safety labeling constraints when selecting products for chronic patients. Even when a rival has similar pharmacokinetics, formulary adoption often follows payer risk scoring and utilization management outcomes.

Which competitors typically move faster during formulary changes?

Competition accelerates when:

• A rival has stronger payer placement in commercial and Medicaid formularies.
• A competitor has broader dosage coverage that aligns with patient titration.
• A competitor is positioned as lower total-cost-of-care under opioid contracting frameworks.

When do Hysingla ER patents and exclusivity end, and how does that affect generic entry timing?

Hysingla ER’s transition risk is governed by the intersection of:

• Orange Book-listed patents for active ingredient, formulation, and method-of-use.
• Regulatory exclusivity (drug product and approved application exclusivity, plus any pediatric exclusivity if triggered).
• Filing strategy by generics under ANDA Paragraph IV (if challengers target expiring listed patents).

What is the Orange Book status of Hysingla ER?

The Orange Book status must be assessed product-specific by NDA listing and listed patent families for hydrocodone bitartrate ER tablets. The practical outcome for financial trajectory is generic availability on specific strengths and dosage forms.

What patents protect Hysingla ER (formulation, method-of-use, and manufacturing)?

Patent estates for LA opioids typically include:

• Composition/formulation (including release-rate control and excipient systems).
• Methods of treatment (population-specific dosing and clinical use).
• Manufacturing and process claims tied to ER performance.

Financial impact follows claim strength and the probability that Paragraph IV challenges clear injunction risk or settlement terms.

What patent litigation and Paragraph IV challenges affect Hysingla ER exclusivity?

Generic risk materializes when either:

• A Paragraph IV ANDA is filed and the applicant litigates listed patents or settles,
• Or a patent expires and no injunction prevents launch.

How do settlements typically impact timing (180-day exclusivity, launch windows, and design-around)?

When a first filer obtains 180-day exclusivity, downstream generic launches usually accelerate once:

• Court injunctions lapse,
• Settlement carve-outs allow earlier supply for specific strengths,
• FDA approves manufacturing changes that design around formulation claims.

What generic entry risks exist for Hysingla ER?

For branded opioids, entry risk is often strength-specific:

• Some strengths may launch earlier based on patent landscape and facility readiness.
• Payer formularies may switch quickly after generic availability due to rebate dynamics and contract renegotiations.

What formulations and dosage strengths matter most for financial exposure?

LA opioid product portfolios usually monetize the strengths with the greatest prescribing prevalence and easiest switching characteristics.

Which dosage strengths typically drive volume and margin?

Higher volume often clusters around mid-range ER strengths, where:

• Patients can be stabilized without complex titration.
• Prescribers follow common chronic pain dosing pathways.
• Payer policies standardize coverage tiers.

Financial trajectory changes most when generics arrive in the most-prescribed strengths first.

How strong is the patent estate for Hysingla ER (claim categories and enforcement leverage)?

Patent strength affects:

• Likelihood of successful injunctions against generic manufacture/marketing,
• Size of settlement value,
• Duration of brand protection on the most commercially important strengths.

What is the typical hierarchy of patent leverage for opioid ER products?

Commercially relevant enforcement usually follows:

• Product-specific formulation and release-control claims (harder to design around),
• Method-of-use claims (weaker if generic labels carve out),
• Process claims (depends on manufacturing comparability).

How does Hysingla ER compare with other branded LA opioids in market economics?

Relative performance versus peers is driven by:

• Total LAO market contraction or growth in the specific payer segments,
• Brand-to-generic spread at the moment of generic entry,
• Contracting behavior that can reduce net price independent of FDA competition.

What differs between hydrocodone ER and oxycodone ER market dynamics?

Hydrocodone ER can be sensitive to:

• Shifts in opioid prescribing preferences and guideline emphasis,
• Payer-driven restrictions that may target certain opioid classes,
• State-level enforcement trends.

What does FDA regulatory status imply for ongoing commercialization risk?

Key commercialization risks include:

• Safety labeling changes,
• Risk management obligations that affect prescriber behavior,
• Facility or manufacturing compliance issues that reduce supply reliability.

Even without generic entry, regulatory events can cause volume volatility.

What FDA milestones typically shift commercial outcomes?

• Label changes that restrict use can depress sustained demand.
• Manufacturing approval changes can affect supply continuity.
• Controlled substance enforcement and audit outcomes can shift wholesalers and dispensing patterns.

What are the likely financial trajectory scenarios for Hysingla ER over the next exclusivity window?

Three scenarios dominate branded opioid economics:

1. Continuation scenario (no meaningful launch disruption)

   • Brand maintains stable net sales due to formulary retention and slower switching.

2. Gradual erosion scenario (select generic access or competitive substitution)

   • Net price declines as payers renegotiate and patients transition within LAO classes.

3. Accelerated erosion scenario (broad generic availability)

   • Branded revenue compresses quickly as PBS and PBM contracts reprice to generic benchmarks.

The distinguishing factor is whether generic launch is broad across strengths and whether settlements delay rollout.

How much revenue exposure does Hysingla ER face from generic competition?

Revenue exposure depends on:

• Remaining listed patent life for commercial strengths,
• Presence of multiple challengers (often increases launch probability and accelerates switching),
• Strength-specific generic approval timing and ability to supply.

Key Takeaways

• Hysingla ER’s market dynamics are driven by chronic pain ER opioid demand, payer contracting controls, and substitution within the LAO class.
• Its financial trajectory is primarily sensitive to Orange Book patent runoffs and the timing of Paragraph IV ANDA filings, litigation outcomes, and settlement terms.
• Commercial risk is strength-specific: generic entry on the most prescribed ER hydrocodone strengths typically causes the largest net sales compression.
• Ongoing FDA and controlled-substance risk management can create supply and utilization volatility even before direct generic competition.

FAQs

1. What PBM formulary patterns usually determine Hysingla ER net sales durability?
2. How do Paragraph IV ANDA filings typically shift the branded opioid contract negotiation cycle?
3. Which Hysingla ER dosage strengths are most exposed to early generic launch risk?
4. How does substitution between ER hydrocodone and ER oxycodone change market share during patent expiration?
5. What regulatory label changes most often impact long-acting hydrocodone prescribing and revenue?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drugs@FDA. Hysingla ER (hydrocodone bitartrate extended-release).
3. U.S. Food and Drug Administration. ANDA and patent certification guidance for Paragraph IV disputes (Hatch-Waxman framework materials).