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Generated: May 22, 2017
Which drugs does patent 7,838,032 protect, and when does it expire?
| 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; |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Reckitt Benckiser | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-002 | Apr 29, 2004 | OTC | Yes | No | 7,838,032 | ► Subscribe | Y | ||||||||||||||||||
Reckitt Benckiser | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-001 | Apr 29, 2004 | OTC | Yes | Yes | 7,838,032 | ► Subscribe | Y | ||||||||||||||||||
Reckitt Benckiser | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-002 | Dec 18, 2002 | OTC | Yes | Yes | 7,838,032 | ► Subscribe | Y | ||||||||||||||||||
Reckitt Benckiser | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-001 | Jul 12, 2002 | OTC | Yes | No | 7,838,032 | ► Subscribe | Y | ||||||||||||||||||
Reckitt Benckiser | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | OTC | Yes | Yes | 7,838,032 | ► Subscribe | Y | ||||||||||||||||||
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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 | ► Subscribe | |||||||||||||||||||||||||||
| 6,372,252 | Guaifenesin sustained release formulation and tablets | ► Subscribe | |||||||||||||||||||||||||||
| 8,012,504 | Sustained release of guaifenesin combination drugs | ► Subscribe | |||||||||||||||||||||||||||
| 7,985,421 | Sustained release formulations of guaifenesin and additional drug ingredients | ► Subscribe | |||||||||||||||||||||||||||
| 6,955,821 | Sustained release formulations of guaifenesin and additional drug ingredients | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2003237807 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2405031 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2481739 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1655766 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 60133538 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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