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Details for Patent: 7,838,032
Which drugs does patent 7,838,032 protect, and when does it expire?
This patent has thirty-seven patent family members in nineteen countries.
Summary for Patent: 7,838,032
Title: | Sustained release of guaifenesin |
Abstract: | The invention relates to a novel pharmaceutical sustained release formulation of guaifenesin. The formulation may comprise a hydrophilic polymer, preferably a hydroxypropyl methylcellulose, and a water-insoluble polymer, preferably an acrylic resin, in a ratio range of about one-to-one (1:1) to about nine-to-one (9:1), more preferably a range of about three-to-two (3:2) to about six-to-one (6:1), and most preferably in a range of about two-to-one (2:1) to about four-to-one (4:1) by weight. This formulation capable of providing therapeutically effective bioavailability of guaifenesin for at least twelve hours after dosing in a human subject. The invention also relates to a modified release product which has two portions: a first portion having an immediate release formulation of guaifenesin and a second portion having a sustained release formulation of guaifenesin. The modified release product has a maximum guaifenesin serum concentration equivalent to that of an immediate release guaifenesin tablet, and is capable of providing therapeutically effective bioavailability of guaifenesin for at least twelve hours after dosing in a human subject. |
Inventor(s): | Davis; Robert D. (Arlington, TX), Blume; Ralph W. (Fort Worth, TX), Keyser; Donald Jeffrey (Southlake, TX) |
Assignee: | Reckitt Benckiser Inc. (Parsippany, NJ) |
Application Number: | 10/406,557 |
Patent Claim Types: see list of patent claims | Compound; Dosage form; |
Drugs Protected by US Patent 7,838,032
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Patent Submitted |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Reckitt Benckiser | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-002 | Dec 18, 2002 | OTC | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||||
Reckitt Benckiser | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-001 | Jul 12, 2002 | OTC | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||||
Reckitt Benckiser | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | OTC | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||||
Reckitt Benckiser | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | OTC | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||||
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Patent Submitted |
Non-Orange Book US Patents Family Members for Patent 7,838,032
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
Patent No. | Title | Estimated Patent Expiration |
---|---|---|
7,985,420 | Sustained release of guaifenesin combination drugs | ➤ Try a Free Trial |
7,985,421 | Sustained release formulations of guaifenesin and additional drug ingredients | ➤ Try a Free Trial |
6,372,252 | Guaifenesin sustained release formulation and tablets | ➤ Try a Free Trial |
8,012,504 | Sustained release of guaifenesin combination drugs | ➤ Try a Free Trial |
Patent No. | Title | Estimated Patent Expiration |
International Patents Family Members for US Patent 7,838,032
Country | Document Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
---|---|---|---|---|---|
Austria | 391494 | ➤ Try a Free Trial | |||
Australia | 2001255680 | ➤ Try a Free Trial | |||
Australia | 2003237807 | ➤ Try a Free Trial | |||
Australia | 5568001 | ➤ Try a Free Trial | |||
Country | Document Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |