APTENSIO XR Drug Patent Profile
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Which patents cover Aptensio Xr, and when can generic versions of Aptensio Xr launch?
Aptensio Xr is a drug marketed by Rhodes Pharms and is included in one NDA.
The generic ingredient in APTENSIO XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aptensio Xr
A generic version of APTENSIO XR was approved as methylphenidate hydrochloride by SPECGX LLC on November 27th, 1998.
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Summary for APTENSIO XR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| Clinical Trials: | 4 |
| Patent Applications: | 3,514 |
| Drug Prices: | Drug price information for APTENSIO XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for APTENSIO XR |
| What excipients (inactive ingredients) are in APTENSIO XR? | APTENSIO XR excipients list |
| DailyMed Link: | APTENSIO XR at DailyMed |
Recent Clinical Trials for APTENSIO XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Matthew J O'Brien, PhD, BCBA-D | Phase 4 |
| Matthew O'Brien | Phase 4 |
| Rhodes Pharmaceuticals, L.P. | Phase 4 |
Pharmacology for APTENSIO XR
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Paragraph IV (Patent) Challenges for APTENSIO XR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 30 mg | 205831 | 1 | 2016-03-28 |
| APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 15 mg, 20 mg, 40 mg and 50 mg | 205831 | 1 | 2015-12-28 |
| APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 10 mg | 205831 | 1 | 2015-12-24 |
| APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 60 mg | 205831 | 1 | 2015-12-23 |
US Patents and Regulatory Information for APTENSIO XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-001 | Apr 17, 2015 | AB3 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-007 | Apr 17, 2015 | AB3 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-004 | Apr 17, 2015 | AB3 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-002 | Apr 17, 2015 | AB3 | RX | 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 |
Expired US Patents for APTENSIO XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-001 | Apr 17, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-004 | Apr 17, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-005 | Apr 17, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-007 | Apr 17, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for APTENSIO XR
See the table below for patents covering APTENSIO XR around the world.
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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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