Question 1

Is there a generic for Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate?

Accepted Answer

XYWAV (NDA 212690, JAZZ) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate?

Accepted Answer

The Orange Book lists 22 patents against Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate products, with the earliest listed expiry in 2033. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate are approved?

Accepted Answer

Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate is approved in the following dosage form: solution.

Patent	Expires	In	Type
10675258	Jan 11, 2033	in 6 yr 8 mo	U-2938
9132107	Jan 11, 2033	in 6 yr 8 mo	Product
8901173	Jan 11, 2033	in 6 yr 8 mo	Product
10195168	Jan 11, 2033	in 6 yr 8 mo	Product
8591922	Jan 11, 2033	in 6 yr 8 mo	Product
11554102	Jan 11, 2033	in 6 yr 8 mo	Product
8772306	Mar 15, 2033	in 6 yr 10 mo	U-3198
11986446	Mar 15, 2033	in 6 yr 10 mo	U-3017
9050302	Mar 15, 2033	in 6 yr 10 mo	U-1532
10213400	Mar 15, 2033	in 6 yr 10 mo	U-2499
9486426	Mar 15, 2033	in 6 yr 10 mo	U-1532
10864181	Mar 15, 2033	in 6 yr 10 mo	U-3017
11253494	Mar 15, 2033	in 6 yr 10 mo	U-3323
11253494*PED	Sep 15, 2033	in 7 yr 4 mo
9050302*PED	Sep 15, 2033	in 7 yr 4 mo
10213400*PED	Sep 15, 2033	in 7 yr 4 mo
9486426*PED	Sep 15, 2033	in 7 yr 4 mo
8772306*PED	Sep 15, 2033	in 7 yr 4 mo
10864181*PED	Sep 15, 2033	in 7 yr 4 mo
11426373	Sep 19, 2037	in 11 yr 5 mo	U-3432
12138233	Feb 22, 2041	in 14 yr 11 mo	U-4044
12582622	Feb 22, 2041	in 14 yr 11 mo	U-4044

Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate

Brand (NDA) products · solution

Marketing exclusivity (3)

Listed patents (22)

Calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate — frequently asked questions

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