ADVIL Drug Patent Profile
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When do Advil patents expire, and what generic alternatives are available?
Advil is a drug marketed by Haleon Us Holdings and is included in eleven NDAs. There are two patents protecting this drug.
The generic ingredient in ADVIL is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
DrugPatentWatch® Generic Entry Outlook for Advil
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for ADVIL?
- What are the global sales for ADVIL?
- What is Average Wholesale Price for ADVIL?
Summary for ADVIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 207 |
| Patent Applications: | 5,114 |
| Drug Prices: | Drug price information for ADVIL |
| What excipients (inactive ingredients) are in ADVIL? | ADVIL excipients list |
| DailyMed Link: | ADVIL at DailyMed |
Pharmacology for ADVIL
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for ADVIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Haleon Us Holdings | ADVIL | ibuprofen | TABLET;ORAL | 018989-001 | May 18, 1984 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Haleon Us Holdings | ADVIL CONGESTION RELIEF | ibuprofen; phenylephrine hydrochloride | TABLET;ORAL | 022565-001 | May 27, 2010 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Haleon Us Holdings | ADVIL ALLERGY SINUS | chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride | TABLET;ORAL | 021441-001 | Dec 19, 2002 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Haleon Us Holdings | ADVIL PM | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 021393-001 | Dec 21, 2005 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Haleon Us Holdings | ADVIL DUAL ACTION WITH ACETAMINOPHEN | acetaminophen; ibuprofen | TABLET;ORAL | 211733-001 | Feb 28, 2020 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ADVIL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare Diseases | Pedea | ibuprofen | EMEA/H/C/000549 Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age. |
Authorised | no | no | no | 2004-07-28 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
