Diphenhydramine citrate; ibuprofen - Generic Drug Details
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What are the generic sources for diphenhydramine citrate; ibuprofen and what is the scope of freedom to operate?
Diphenhydramine citrate; ibuprofen
is the generic ingredient in two branded drugs marketed by Haleon Us Holdings, Aurobindo Pharma, Dr Reddys Labs Ltd, Perrigo R And D, and Pld Acquisitions Llc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.Thirty-one suppliers are listed for this compound.
Summary for diphenhydramine citrate; ibuprofen
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 31 |
| Clinical Trials: | 2 |
| DailyMed Link: | diphenhydramine citrate; ibuprofen at DailyMed |
Recent Clinical Trials for diphenhydramine citrate; ibuprofen
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr. Reddy's Laboratories Limited | Phase 1 |
Pharmacology for diphenhydramine citrate; ibuprofen
| Drug Class | Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for diphenhydramine citrate; ibuprofen
Paragraph IV (Patent) Challenges for DIPHENHYDRAMINE CITRATE; IBUPROFEN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ADVIL PM | Tablets | diphenhydramine citrate; ibuprofen | 200 mg/38 mg | 021394 | 1 | 2017-12-28 |
US Patents and Regulatory Information for diphenhydramine citrate; ibuprofen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 216204-001 | May 31, 2022 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Ltd | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 090619-001 | Jul 8, 2009 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo R And D | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 079113-001 | Dec 22, 2008 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Haleon Us Holdings | ADVIL PM | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 021394-001 | Dec 21, 2005 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pld Acquisitions Llc | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 211404-001 | Apr 11, 2024 | OTC | No | 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 |
Expired US Patents for diphenhydramine citrate; ibuprofen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Haleon Us Holdings | ADVIL PM | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 021394-001 | Dec 21, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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