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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Questions you can ask:
- What is the 5 year forecast for APTENSIO XR?
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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 | |||
Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-003 | 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 | 205831-004 | Apr 17, 2015 | ⤷ Sign Up | ⤷ Sign Up |
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 | 205831-003 | Apr 17, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-006 | Apr 17, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-002 | 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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2371200 | ⤷ Sign Up | |
Japan | 2012184235 | CONTROL/PREPARATION RELEASE TYPE METHYLPHENIDATE ORAL PREPARATION | ⤷ Sign Up |
Portugal | 1140088 | ⤷ Sign Up | |
Cyprus | 1108253 | ⤷ Sign Up | |
Slovenia | 1143937 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |