ADVIL PM Drug Patent Profile
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Which patents cover Advil Pm, and when can generic versions of Advil Pm launch?
Advil Pm is a drug marketed by Haleon Us Holdings and is included in two NDAs.
The generic ingredient in ADVIL PM 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.
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Summary for ADVIL PM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Patent Applications: | 20 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADVIL PM |
| What excipients (inactive ingredients) are in ADVIL PM? | ADVIL PM excipients list |
| DailyMed Link: | ADVIL PM at DailyMed |
Pharmacology for ADVIL PM
| Drug Class | Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Paragraph IV (Patent) Challenges for ADVIL PM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ADVIL PM | Tablets | diphenhydramine citrate; ibuprofen | 200 mg/38 mg | 021394 | 1 | 2017-12-28 |
| ADVIL PM | Capsules | diphenhydramine hydrochloride; ibuprofen | 200 mg/25 mg | 021393 | 2016-02-16 |
US Patents and Regulatory Information for ADVIL PM
| 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 PM | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 021393-001 | Dec 21, 2005 | OTC | Yes | Yes | ⤷ 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 | ||||
| >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 ADVIL PM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Haleon Us Holdings | ADVIL PM | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 021393-001 | Dec 21, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Haleon Us Holdings | ADVIL PM | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 021394-001 | Dec 21, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Haleon Us Holdings | ADVIL PM | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 021393-001 | Dec 21, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ADVIL PM
See the table below for patents covering ADVIL PM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2434484 | COMPOSITIONS COMPRENANT DE L'IBUPROFENE ET DE LA DIPHEHYDRAMINE DESTINEES A TRAITER LES TROUBLES DU SOMMEIL LIES A LA DOULEUR (COMPOSITIONS COMPRISING IBUPROFEN AND DIPHENHYDRAMINE TO TREAT PAIN-ASSOCIATED SLEEP DISTURBANCES) | ⤷ Sign Up |
| Mexico | PA03006364 | TRATAMIENTO DE PERTURBACIONES DEL SUEnO. (TREATMENT OF SLEEP DISTURBANCES.) | ⤷ Sign Up |
| Denmark | 1363608 | ⤷ Sign Up | |
| Germany | 60207383 | ⤷ Sign Up | |
| Japan | 2009203243 | TREATMENT OF SLEEP DISTURBANCE | ⤷ Sign Up |
| Hong Kong | 1060045 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated 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.
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