PEDIATRIC ADVIL Drug Patent Profile
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When do Pediatric Advil patents expire, and what generic alternatives are available?
Pediatric Advil is a drug marketed by Haleon Us Holdings and is included in one NDA.
The generic ingredient in PEDIATRIC ADVIL is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and thirty-eight suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pediatric Advil
A generic version of PEDIATRIC ADVIL was approved as ibuprofen by STRIDES PHARMA on September 24th, 1986.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for PEDIATRIC ADVIL?
- What are the global sales for PEDIATRIC ADVIL?
- What is Average Wholesale Price for PEDIATRIC ADVIL?
Summary for PEDIATRIC ADVIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 207 |
| Patent Applications: | 3,242 |
| DailyMed Link: | PEDIATRIC ADVIL at DailyMed |
Pharmacology for PEDIATRIC ADVIL
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Paragraph IV (Patent) Challenges for PEDIATRIC ADVIL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PEDIATRIC ADVIL | Oral Suspension | ibuprofen | 50 mg/1.25 mL | 020812 | 1 | 2007-06-29 |
US Patents and Regulatory Information for PEDIATRIC 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 | PEDIATRIC ADVIL | ibuprofen | SUSPENSION/DROPS;ORAL | 020812-001 | Jan 30, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 PEDIATRIC 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 |
