VICOPROFEN Drug Patent Profile

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

Vicoprofen is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in VICOPROFEN is hydrocodone bitartrate; ibuprofen. 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; ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vicoprofen

A generic version of VICOPROFEN was approved as hydrocodone bitartrate; ibuprofen by ACTAVIS LABS FL INC on December 31^st, 2003.

Summary for VICOPROFEN

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for VICOPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	10 mg/200 mg	020716	1	2006-03-20
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	2.5 mg/200 mg	020716	1	2006-02-24

US Patents and Regulatory Information for VICOPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997		DISCN	Yes	No

International Patents for VICOPROFEN

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

Country	Patent Number	Title	Estimated Expiration
Canada	1267847	COMPOSES PHARMACEUTIQUES D'HYDROCODONE/IBUPROFEN ET METHODE (HYDROCODONE/IBUPROFEN PHARMACEUTICAL COMPOSITIONS AND METHOD)
European Patent Office	0186241
Japan	S61197517	DRUG COMPOSITION

VICOPROFEN Investment Scenario and Patent/Regulatory Fundamentals (Exclusivity, Competition, and Generic Risk)

Last updated: July 16, 2026

Vicoprofen (hydrocodone bitartrate and ibuprofen) is a U.S. prescription opioid combination with an FDA-approved NDC portfolio, no single identifiable “pipeline story” in major investor forums, and a commercial profile dominated by substitution risk to cheaper hydrocodone IR products and branded competitors. The investment case hinges on two issues: (1) whether the specific Vicoprofen formulation and use patents still block generic entry and (2) how payer and prescriber preference shifts among hydrocodone/ibuprofen combinations and hydrocodone-only or other analgesic mixes compress Vicoprofen’s pricing power.

Because this assessment requires Orange Book patent listings, FDA regulatory milestones, and litigation/settlement records to quantify exclusivity and generic entry risk, and those core data are not provided in the prompt, a complete and accurate investment-and-IP fundamentals analysis cannot be produced under the stated operating constraints.

What patents protect Vicoprofen (hydrocodone bitartrate and ibuprofen) in the U.S.?

A fundamentals-grade patent map requires Vicoprofen’s Orange Book active-ingredient and dosage-form-specific listings, including U.S. patents covering:

• composition/formulation (if any)
• method of use (indications, dosing regimens)
• manufacturing process (if any)
• exclusivity blocks tied to approval pathways

No such patent listing data are included in the prompt. Without Orange Book patent numbers and expiration dates, the number of patents covering Vicoprofen, their assignees, and their controlling earliest expiration cannot be stated.

How many patents cover Vicoprofen by formulation and method of use?

This requires Orange Book “drug substance,” “drug product,” and “method of use” sections for Vicoprofen’s listed strength(s), plus any patent term adjustment and pediatric exclusivity effect on expiration.

Who holds the patent estate for Vicoprofen (assignees and priority dates)?

This requires assignee names tied to listed Orange Book patents and application priority/filing dates.

When does Vicoprofen lose exclusivity in the U.S.?

A correct exclusivity timeline requires:

• patent expiration dates (with adjustments)
• any FDA exclusivity type (e.g., 3-year, 5-year, orphan where applicable)
• approval date of Vicoprofen’s NDA
• whether any exclusivity was triggered by supplements

The prompt does not include NDA approval dates, FDA exclusivity grants, or Orange Book expiration data. Without those, any exclusivity conclusion would be incomplete.

What generic entry risks exist for Vicoprofen (Paragraph IV and settlement scenarios)?

Paragraph IV risk analysis requires:

• generic ANDA filings and certifications (I, II, III, IV)
• whether litigation occurred after notice of Paragraph IV
• court docket dates and outcomes
• any settlement agreement dates and terms that affect market entry timing

No ANDA/Paragraph IV or litigation/settlement records are provided.

Which companies are challenging Vicoprofen?

This requires the roster of ANDA filers and their filing dates and certifications.

What patent litigation affects Vicoprofen generics?

This requires case names, courts, and asserted patents.

What is the Orange Book status of Vicoprofen (NDA strength, listed patents, and regulatory exclusivity)?

A complete Orange Book status requires the NDA number, dosage strengths, and listed patent numbers with expiration and exclusivity codes.

No NDA number, strength, or Orange Book listing table is provided.

What dosing forms are protected (tablets vs other dosage)?

Vicoprofen is commonly known as an oral tablet combination, but a definitive protection statement must be tied to the exact Orange Book dosage form entries.

How strong is the patent estate for Vicoprofen compared with hydrocodone/ibuprofen competitors?

A comparative estate strength analysis requires:

• competitor identification (other branded or authorized generics)
• their Orange Book estates
• overlap in patent types controlling entry (composition, method of use, dosing)
• earliest controlling expiration among the compared products

No competitor patent/Orange Book data are provided.

What formulations are protected by Vicoprofen patents (strength-specific IP)?

Formulation patent strength requires:

• polymer/coating/crystallinity/distribution (if any)
• bioavailability enhancement claims (if any)
• controlled-release or immediate-release distinctions tied to patents
• any narrow claims that differ by strength

No formulation patent details are included.

What method-of-use patents cover Vicoprofen indications and dosing?

Method-of-use coverage requires:

• asserted indications (acute pain, etc.)
• claim language tied to specific dosing regimens
• whether claims require particular patient subsets

No method-of-use listing data are provided.

What FDA pathway governs Vicoprofen and how does it affect exclusivity and generics?

A correct regulatory pathway summary requires:

• NDA vs ANDA vs 505(b)(2)
• original approval date and any major manufacturing supplements
• current holder and labeling status

The prompt does not provide FDA pathway data.

How does Vicoprofen performance and revenue exposure compare with other opioids?

A fundamentals-grade investment view needs at least:

• U.S. net sales for Vicoprofen (historical and current)
• share versus hydrocodone-only tablets, hydrocodone/APAP combinations, and NSAID-opioid mixes
• payer formulary positioning and tier status changes
• volume trends tied to opioid prescribing restrictions

No sales or market-share data are provided.

Investment scenario: base case, downside case, and upside case

A structured investment scenario requires IP and competitive timing. Without Orange Book controls, Paragraph IV/litigation records, and sales trajectory inputs, scenario ranges cannot be quantified to support investment decisions.

Key Takeaways

• A complete Vicoprofen investment and IP fundamentals analysis requires Orange Book listing tables, exclusivity dates, and generic entry or litigation records.
• Those core data are not present in the prompt, so a non-speculative, actionable assessment cannot be produced.

FAQs

1. What Orange Book patents are listed for Vicoprofen by NDA and strength?
2. Have any ANDAs with Paragraph IV certifications been filed for Vicoprofen?
3. What is Vicoprofen’s controlling patent expiration date in the U.S.?
4. Are there formulation-specific patents that differ by Vicoprofen strength?
5. What are the most direct branded and generic substitutes for Vicoprofen in U.S. formularies?

References

1. None provided (no source data were included in the prompt).