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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Citi
US Army
AstraZeneca
McKinsey
Cantor Fitzgerald
Teva
Daiichi Sankyo

Generated: May 26, 2018

DrugPatentWatch Database Preview

APTENSIO XR Drug 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. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has thirty-seven patent family members in fourteen countries.

The generic ingredient in APTENSIO XR is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Drug patent expirations by year for APTENSIO XR
Pharmacology for APTENSIO XR
Synonyms for APTENSIO XR
113-45-1 (Parent)
2-Piperidineacetic acid, .alpha.-phenyl-, methyl ester, hydrochloride
2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride
2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (R*,R*)-(+-)-
298-59-9
298M599
AC1L1SQ4
AC1Q5YRN
AK116471
AKOS016010356
alpha-phenyl-2-piperidineacetic acid methyl ester hydrochloride
AN-23356
API0003340
CAS-298-59-9
CC-30903
CCG-213572
CCRIS 6258
Centedrin
Centedrine
CHEBI:31836
CHEMBL1722
ciba 4311b
Concerta (TN)
CS-4658
D-erythro-Methylphenidate Hydrochloride
D01296
DSSTox_CID_886
DSSTox_GSID_20886
DSSTox_RID_75843
DTXSID8020886
EINECS 206-065-3
FT-0603372
FT-0672046
FT-0672047
H-Tic-OtBu.HCl
HE332528
HY-B1091A
JUMYIBMBTDDLNG-UHFFFAOYSA-N
LS-42
Medikinet
Meridil hydrochloride
Metadate
Metadate (TN)
Metadate CD
Metadate ER
Methyl .alpha.-phenyl-2-piperidineacetate hydrochloride
methyl 2-phenyl-2-(2-piperidyl)acetate hydrochloride
METHYL 2-PHENYL-2-(PIPERIDIN-2-YL)ACETATE HCL
Methyl 2-phenyl-2-(piperidin-2-yl)acetate hydrochloride
methyl 2-phenyl-2-piperidin-2-ylacetate hydrochloride
methyl alpha-phenyl-2-piperidine-acetate hydrochloride
Methyl alpha-phenyl-2-piperidineacetate hydrochloride
Methyl Phenidylacetate Hydrochloride
methyl phenyl(piperidin-2-yl)acetate hydrochloride
Methylin ER
Methylphenidan Hydrochloride
Methylphenidate (hydrochloride)
Methylphenidate HCl
METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate hydrochloride (JAN/USP)
Methylphenidate hydrochloride [USAN:JAN]
Methylphenidate hydrochloride [USP:JAN]
Methylphenidate Hydrochloride ER
Methylphenidate hydrochloride solution, (Racemic mixture), ampule of 1 mL, 1.0 mg/mL in methanol (as free base), certified reference material
Methylphenidate hydrochloride, European Pharmacopoeia (EP) Reference Standard
METHYLPHENIDATE HYDROCHLORIDE(SEE ALSO: METHYLPHENIDATE, CAS 113-45-1, NTPNO M20344)
Methylphenidate.HCl
Methylphenidate(Ritalin)
Methylphenidylacetate hydrochloride
Metilfenidat hydrochloride
MFCD00058191
MLS003922100
NCGC00091942-01
NCGC00257863-01
NSC 169868
NSC-169868
NSC-759278
NSC169868
NSC759278
Pharmakon1600-01505907
QuilliChew ER
Quillivant XR
Quillivant xr (TN)
Rilaline
Rilatine
Ritalin
Ritalin (TN)
Ritalin hy drochloride
Ritalin hydrochloride
Ritalin LA
Ritalin SR
Ritalin-SR
SC-83308
SCHEMBL41067
SMR000058998
threo-Methyl |A-phenyl-|A-(2-piperidyl)acetate hydrochloride
Tox21_111186
Tox21_200309
TRANSGENIC MODEL EVALUATION (METHYLPHENIDATE HYDROCHLORIDE) (SEE ALSO: METHYLPHENIDATE HYDROCHLORIDE)
WLN: T6MTJ BYR & VO1 & GH

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 205831-006 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-004 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-006 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for APTENSIO XR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Capsules 15 mg, 20 mg, 40 mg and 50 mg ➤ Subscribe 2015-12-28
➤ Subscribe Extended-release Capsules 10 mg ➤ Subscribe 2015-12-24
➤ Subscribe Extended-release Capsules 30 mg ➤ Subscribe 2016-03-28
➤ Subscribe Extended-release Capsules 60 mg ➤ Subscribe 2015-12-23

Non-Orange Book US Patents for APTENSIO XR

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
6,673,367 Controlled/modified release oral methylphenidate formulations ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
McKinsey
Johnson and Johnson
Merck
Colorcon
Dow
US Department of Justice
UBS

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